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M A R C H 1 9 6 9

P A P E R S

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i T a i k i i i i i M r iIncident lii Gloucester

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L O S A N G E L E S D I S T R I C TDoes Something About It

PRODUCT SAFETY ACTIONThe Third Dimension

P O I S O N C O N T R O L D I V I S I O N

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"We ore carefully to preserve that life which the Author ofnature has given us, for it was no idle gift."

Harvey W. WileyF r o m h i s c o m m e n c e m e n t a d d r e s s

"Life and the Coming Time"Hanover Coliege, 1867

In the name of the great Jehovah and the Continental Congress," Revolutionary soldier-patriot EthanAllen is said to have replied when the British defendersasked him by whose authority he demanded the surrender of Fort Ticonderoga in 1775. Providence alsohad a hand in the crowded ser ies of events that fo l lowedan explosion in a New England cold storage warehouselast January 2 which left 11 million pounds of fishexposed to the elements (see page 21).

Given 6 precious days of 5° to 10° temperatures following the tragic and destructive explosion, local,State, Federal, and industry officials were able to planand win a formidable race with time, moving 9 millionpounds of salvageable fish to cold storage plants inother areas and safely disposing of 2 million poundsfound unsalvageable.

This considerable feat of logistics and health protection would not have been possible without the excellent and ready cooperation that took place among industry, the Commonwealth of Massachusetts, the cityof Gloucester, the military, the Department of Interior,the Environmental Control Administration, and EDA.It is a case where the several concerned parties carriedout tbeiT respective responsibilities in a coordinatedeffort that served all interests and protected the publich e a l t h .

R o b e r t H . F i n c hSecretary, U.S. Department ofHealth, Education, and WelfareW i l l i a m H . S t e w a r t , M . D .Surgeon General, Public Health ServiceActing Asst. Secretary for Health andS c i e n t i fi c A f f a i r s

C h a r l e s C . J o h n s o n , J r .A d m i n i s t r a t o r , C o n s u m e rP r o t e c t i o n a n d E n v i r o n m e n t a lH e a l t h S e r v i c e

Herbert L Ley, Jr., M.D.C o m m i s s i o n e r o f F o o d a n d D r u g s

Harold 0. Hopkins/Editorial Director

John G. Stringer/Editor

Sheldon Cohen/Art Director

TIcIa Edwards/Asst. Art Director

Dan O'Toole/Photographer

Joan M. Galloway/Managing Editor

Frederick L. Townshend/Production Mgr.

PHOTOGRAPHY: FDA, inside front cover, 22, 23. 25.

FDA PAPERS, the official magazine of the Foodand Drug Administration, is publTshed monthly,except for combined July-August and December-January issues. Subscriptions may be orderedfrom the Superintendent of Documents,Government Printing Office, Washington, D.C. 20402,at $5.50 a year ($1.25 additional forforeign mailing).

Address fo r ed i to r ia l ma t te rs : FDA PAPERS,Food and Drug Administration, 200 C St., S.W.,Wash ing ton , D . C . 20204.

Articles published in FDA PAPERS are in thepublic domain and text may be republishedwithout permission. Use of funds for printing thispublication approved by Director of the Bureauo f t he Budge t Augus t 15 , 1966 .

Section 705 [375] of the Food, Drug, andC o s m e t i c A c t .

(a) The Secretary shall cause to be publishedfrom time to time reports summarizing alljudgments, decrees, and court orders which havebeen rendered under this Act, including the natureof the charge and the disposition thereof.

(b) The Secretary may also cause to be disseminatedinformation regarding food, drugs, devices, orcosmetics in situations involving, in the opinionof the Secretary, imminent danger to health, orgross deception of the consumer. Nothing in thissection shall be construed to prohibit the Secretaryfrom collecting, reporting, and illustrating theresults of the investigations of the Department.

A d v i s e r s t o t h e E d i t o r *

H. Nelson Fitton, Department of Agriculture;Wayne Phillips, Department of Housing and UrbanDevelopment; Henry B. Montague, Post OfficeD e p a r t m e n t ; H e n r y S c h a r e r, D e p a r t m e n t o fCommerce; Dr. Milner B. Schaefer, Department oft h e I n t e r i o r ; D r. S a m K a i m , Ve t e r a n s A d m i n i s t r a t i o n ;Dr. Peter V. S iege! , Federa l Av ia t ion Agency;Dr. Spofford G. English, United States AtomicEnergy Commission; Dr. Harve J. Carlson, NationalScience Foundation; Howard J. Lewis, NationalAcademy of Sciences- Edward J. McVeigh, PublicHea l th Serv i ce ; A r thu r Se t te l , Bu reau o f Cus toms .

* The Food and Drug Admin is t ra t ion i s so le ly

responsible for the contents of FDA PAPERS. TheAdv isers to the Ed i to r a re consu l tan ts on mat te rsrelating to the functions of the Federal Departmentsand Agenc ies l i s ted .

F D A P A P E R SV O L . 3 . N O . 2 / M A R C H 1 9 6 9

Doing Something About It at Los Angeles District In the land of 4superlatives, the consumer gets superlative protection.

The Poison Control Division Deaths, injuries, and illnesses are being 11reduced by a massive and coordinated attack on accidental poisonings.

The Third Dimension of Product Safety Action A Presidential 14commission believes consumer safety and satisfaction are legitimate business goals.

Detecting and Confirming Mycotoxin What FDA is doing about these 17naturally occurring poisons produced in some foods by molds.

Partnership for Health: An Incident in Gloucester 21Industry and Government move quickly to remove a menace to health and save 9 million pounds of fish.

Field Reports 25

S t a t e A c t i o n s 2 9

Se izu res and Pos t O ffice Cases so

Notices of Judgment 32

FDA Papers / March 1969 / 3

Doing Something About ItAt Los Angeles District

by Gordon R. Wood

An inspector at Los Angeles District (top photo) is taking a random sample oflettuce from a field near Glendale, Ariz., for pesticide analysis. The photos belowshow the harbor where a tuna fleet docks at Terminal Island, Los Angeles, and '«an FDA Inspector (right in photo) making an organoleptic (smell, sight) exam- / Wfmation of tuna in a Terminal Island tuna processing plant. In the photo at the /far right, an inspector observes the unloading of raw kelp, processed for seasonings and animal food at San Pedro, Calif.

The American Southwest isan empire of dramatic growth and development. Superimpose these changes upon a regional topography thatpermits skiing in the morning, lunch at a desert resort,and surfing on the Pacific in the afternoon, and theresulting diversification and variety translate into achallenge to the Food-and-Drugger. Los Angeles District, often called the Southland, includes Arizona, thenine southernmost counties of California, Clark Countyin Nevada, and American Samoa. We have some ofalmost every food and drug industry; much of mostspecialties, and practically all of certain ones; and morequackery than we like to admit.

The food industry that commands more of our attention than any other is agriculture, with its attendant pesticide problems. The volume and variety of agriculturalproduction are staggering. Agricultural development inthe Southwest is a chronicle of change and progress.Through ingenuity and irrigation, deserts have become orchards and fields. They produce aroundthe calendar, with no winter respite. Unfortunately, in aclimate where man and crops thrive, so do insects.

As long as there has been a Los Angeles District, thePesticide Project has been of prime importance. We haveapproached it from all angles. Federal-State cooperationon pesticides between the California State Departmentof Agriculture's Field Crops and Agricultural ChemicalsOffice and Los Angeles District has existed as long as theDistrict. We have conducted educational programs forpesticide manufacturers, applicators, growers, and shippers through meetings and seminars. We counsel withprivate laboratories on analytical methods. We participate in programs for the health education departmentsof schools and colleges. We also maintain active enforcement programs, when necessary, by conventional legalprocedures. The first three FDA prosecutions for pesticide violations under the Food, Drug, and Cosmetic Actwere filed at Los Angeles District in 1961.

However, we believe the man on the scene is our mosteffective tool to promote consumer protection throughvoluntary compliance on pesticide requirements. Wekeep inspectors in the field the year around. They meetgrowers, packers, and shippers at the working levelwhere the action is. They discuss problems, regulations,and responsibilities. They collect samples and we reportback to the grower, if known, and to the shipper thepesticide residue content of his products. There aremore than 12,000 growers for us to try to reach. Wedon't know how many high residue shipments we prevent, but we do know from analyses of 1,500 domesticsamples a year that the overall level of compliance inthe proiduce industry is higher than in any other of ouri n d u s t r i e s .

Then why so much continued attention?

We have sensed for years a growing concern amongconsumers about pesticides. Some is stimulated byirresponsible alarmists; some arises from a legitimateconcern over the role of pesticides in the considerationsof overall environmental health. The consumer cannotprotect himself against illegal and harmful residues,but must rely on State and Federal agencies. We believewe serve our consumers and our industry best whenwe acquire sufficient reliable scientific data to assurethat our food supply is safe, and on those occasionswhen we find it may not be, we do something about it.

w have other responsibilities in the field of agriculture. Southern California'sSan Bernardino and Riverside Counties rank one-twoin egg production in the United States. Los AngelesCounty boasts the largest egg-producing unit in theNation, a single ranch with 1,600,000 laying hens. Thisindustry requires assiduous attention for Salmonella,decomposition, and standards compliance in liquid orfrozen eggs. Imperial County is a major cattle-feedingarea that presents us with occasional problems ofpesticide residues in hay. Los Angeles County, not commonly thought of as an agricultural area, produces moremilk and butterfat than any other county in the UnitedStates. Los Angeles District produces 100 percent ofthe commercial dates grown in this country. In the dategroves of Coachella Valley ancient hand-packing practices persist alongside modern mechanical methods.Sanitation and insect infestation are presently our majorinterests in this industry.

There is no way to stop progress. The freeways, housing projects, factories, and shopping centers are takingtheir toll of the agricultural areas. Since production mustgo somewhere, it is moving south of the border—increasing our import load. There are 20,000 entries offresh vegetables from Mexico each year. Most comethrough Nogales, Arizona, by truck and rail. We coverthese importations for pesticide residues as completelyas we do our own producers. To avoid the cost and delays of shipping samples from the border to Los Angeles, we station our trailer laboratory at Nogales forseveral weeks each winter, spread out intermittently overthe peak season. We have never found a violative pesticide sample from Mexican produce, with one exception.Last August the California State Office of AgriculturalChemicals advised us of high residues on two importations of purslane, a leafy vegetable sold in local markets. These lots bore as much as 85 parts per million ofDDT and 158 parts per million of toxaphene, the highest results we have ever encountered. Fortunately production was confined to a few small plots near Tijuana.The material was disposed of under State quarantineand we notified health officials in Tijuana of theirproblem.

6 / March 1969 j FDA Papers

The Southland has a large Mexican-American population that is supplied with traditional Mexican foodstuffs from across the border. We sometimes find thatcornhusks for tamales are moldy or infested with insects. Peppers used for spicing Mexican food wereonce widely grown in southern California. The fields forthis crop have largely given way to population encroachment, and spice grinders now rely heavily onimportations from Mexico. During a recent Mexicantragedy resulting from contamination by parathion in aTijuana bakery supply warehouse, we made extensiveinvestigations to be certain that none of the contaminated bakery products reached our side of the border.In cooperation with Mexican officials, arrangedthrough the San Diego County Health Department andthe Office of the Mayor of Los Angeles City, weanalyzed approximately 25 samples of foods and packaging for parathion residues.

In Baja California, Mexico, there are now port facilities for large freighters. More and more, cargoes oncedestined for California ports are now discharging atEnsenada and are carried northward by truck, requiringincreased FDA vigilance at the border. We receive some3,700 entries of frozen shellfish from Mexico annually.Detentions for decomposition detected by inspector-analyst teams at the border at one time reached as highas 40 percent of the entries. Significant improvements inproduction have been made and now we seldom needto detain these products.

In addition to border traffic,imports arrive from all over the world at Southlandseaports. We receive 58,000 formal entries of foodproducts a year, representing 12 percent of the UnitedStates total. These include basic food commodities produced in Europe and South America, food seeds fromthe Middle East, copra and spices from the SouthPacific, and both basic and exotic foods from the Orient.A total of 190,000 tons of tuna, comprising half of thetonnage handled by the United States and all its possessions, was landed in 1967 to supply the southern California tuna canning industry. Much of this tuna originates in Japan, South America, and other foreign fisheries. This import workload is handled through a working agreement with the Cannery Inspection Section ofthe California State Bureau of Food and Drug. Thisagency maintains continuous inspection in tuna canneries, examining every fish that enters the cannery, andrejecting those that fail to meet standards of quality andwholesomeness. This agreement of many years standingis an excellent example of Federal-State cooperation thatprotects consumers without duplication of effort.

An increasing volume of imports is arriving by air,adding a third dimension to land and sea for importcoverage .

The proximity of an easily accessible foreign bordercan pose problems on matters other than imports. Communities in Mexico can be a haven for dispensers ofworthless and sometimes dangerous remedies for cancer,arthritis, and other serious diseases. These include theHoxsey treatment and Laetrile for cancer and Liefcortfor arthritis, all of which are illegal in the United States.Victims of cancer and arthritis, the hopeless, the despairing, the frightened travel from all over the UnitedStates to these so-called clinics where at best they maylose their money and, at worst, their lives.

Not all quackery is south of the border. It exists inmany forms in the Southland. A mild climate that makesliving easier attracts the aged and the ill. They forma group subject to exploitation whose gull ibi l i tyspreads to other segments of the population. Los Angelesis a center for health food advocates. Several of the nationwide promoters of vitamin and mineral pills offeredfor treatment and prevention of practically every disease known had their beginnings here. Seizures, injunctions, and prosecutions have checked but haven'tstopped these door-to-door peddlers. Their labelsmerely become a little more sophisticated. We arenow relying more on health education to help consumersprotect themselves against the nutritional nonsense conjured up about alfalfa, royal jelly, chlorophyll, sea salt,and other worthless concoctions offered for diseases theyd o n o t h a v e .

Our devices program is always active. Some devicefrauds come and go; old ones return to haunt ns; newones are developed. Evidence of destruction of lungtissue of mice exposed to ozone helped us eliminateozone generators. Affidavits from cancer specialiststhat vacuum-type "bust developers" could stimulategrowth of dormant breast cancers helped to sustain injunctions and seizures on these worthless devices. Colortherapy, an ancient delusion, is revived from time totime. The wavelength therapists with their radionics and"little black boxes" are a persistent lot who need constant surve i l lance. Rad ium was used in a we i rd dev ice toirradiate blood that was then reinjected to treat childrenf o r m e n t a l r e t a r d a t i o n . S i n c e t h e s e k i n d s o f d e v i c e s a r e

virtually worthless for any purpose, "voluntary compliance" means abandonment of the operation, a fate towhich the ambitious promoters are reluctant to submit.Therefore, at Los Angeles District we rely heavily onlegal action, and devices constitute a substantial part ofo u r s e i z u r e r e c o r d .

We would not be honest, however, if we did not recognize the many contributions of our cooperating agencies in controlling quackery in southern California. Under that State's laws, direct action can be taken oncharges of grand theft against licensed practitioners orother promoters who use worthless drugs for certainspecifically named, serious diseases. These cases are

FDA Papers / March 1969 / 7

Top photos: In the Los Angeles District lab, amicrobiologist (left) is using rubber gloves builtinto a sterile enclosure to operate a lyopbilizationapparatus, which dries live bacterial cultures forpreservation after they have been frozen in anearlier process. Center, a chemist prepares asample of carrots for pesticide residue analysis.Right, a microbiologist works with white ratsu s e d i n t e s t s f o r d e t e c t i o n a n d a s s a y o fClostridium botulimim micro-organisms and toxi n s .

Middle: A chemist in the District lab (left) usescolumn chromatography during a pesticide residue analysis. In a mobile FDA lab at Phoenix(right), a chemist is conducting a pesticide residueanalysis on a sample of carrots.Bottom: An Import Inspector (upper left) checksincoming parcels at Los Angeles InternationalAirport for products that may be in violation ofthe Food, Drug, and Cosmetic Act. Another Import Inspector (right) at Terminal Island, LosAngeles, collects a sample of shredded coconutfrom the Philippines to be analyzed for Escherichia coli bacteria. Cinnamon bark from Ceylon(lower left) is being examined by an Import Inspector at Terminal Island for the presence ofi n s e c t s a n d m o l d .

developed by the capable and energetic Fraud Sectionof the California State Bureau of Food and Drug. TheSection has successfully prosecuted many importantcases that could not have been handled under Federall a w .

Los Angeles District has moderate but growing drugand cosmetic industries. Along with other Districts, weare presently involved in the Intensified Drug InspectionProgram. Manufacture of drugs is another area wherewe have developed a high level of cooperation and workplanning with the California State Bureau of Food andDrug. An example will illustrate.

A consumer complaint that niacin had been substi

tuted for quinidine sulfate led to a joint FDA-State factory inspection. The investigation disclosed a case ofwidespread conspiracy involving a factory employee,who substituted niacin capsules for the more expensivequinidine sulfate capsules and who disposed of the latterthrough "backdoor" sales to distributors. After study ofthe case, we agreed that action could best be taken underState laws. A successful prosecution resulted.

The population growth inCalifornia and Arizona in the past 10 years is greaterthan the entire population of 41 other States. This increase affects our food manufacturers in two ways.

First, there is the expansion of production needed toprovide for the millions who arrive each decade. Thismeans new and enlarged factories, and new products requiring coverage.

Second, there is the race to keep pace in older facilities: the overcrowding, the overtime operations, thepressure for production. There is no time to clean house,no room for better storage of materials, no time to cleanequipment. When contamination results, we do something about it: education where it is needed; appropriatelegal action where there is neglect. We do not believe thepublic should have to consume contaminated food whilea negligent manufacturer is learning about sanitation

and potential health hazards.Los Angeles District follows a policy of balanced en

forcement through education, cooperation, and legalaction. Education includes both industry and consumers.The goal of industry education is compliance. We havealready referred to the field aetivities of pesticide inspectors and their contributions to compliance efforts. Theinspector in the food, drug, or cosmetic factory servesthe same purpose. Inspectors are trained to make eachinspection an educational experience, directed towardvoluntary compliance, for the firm under inspection.These direct communications with responsible personnelon the factory premises supplement our programs of

Top photos: At Indio, Calif, (left), the inspector looking at dates is checking in-plant sanitation in the operation of a date processing and pitting plant. Center, an inspector in a LosAngeles plant that reconditions some violative food products collects a sample of cumin seedfor analysis after reconditioning to remove camel dung and straw found in the product earlier.Right, worker and plant sanitation practices in the packing of lipsticks in a Los Angeles cosmetic factory are being observed by the inspector.Middle: At a citrus fruit packing house at Indio, Calif, (left), an inspector takes samples oftangerines from the packing line for pesticide residue analysis. Center, in an abaloneprocessing plant at San Diego, an inspector watches a worker remove the abalone from itsshell as a first step in processing. The abalones are later cut into steaks. Right, at Wilmington,Calif., an inspector checks sanitary conditions at a cold-roll-process machine in a margarineproduction plant. Hanging from the roller are strips of margarine.Bottom: A meeting of the Los Angeles District staff includes (from left) Gordon R. Wood,Distr ic t Director ; Ar thur A. Dickerman, FDA Legal Counsel ; Dominic Ziccardi , ChiefInspector; John R. Weatherwax, Chief Chemist; Elaine G. Roentgen, Consumer Specialist;Gene M. Slota, Administrative Officer; and David J. Holliday, Food and Drug Officer. Mr.Wood, shown talking to a visitor in the photo below, joined FDA as an inspector in 1931and has held a number of executive positions over the years, taking over as head of theLos Angeles District in 1952.

meetings and voluntary compliance seminars and mightwell be the most effective channel of industry education.We do not neglect other opportunities. Industry andtrade organizations have standing invitations to discusstheir problems with the District at any time. Several havetaken advantage of the offer.

Consumer education is an equally important project.We have long since abandoned the shotgun approach oflarge numbers of speeches to all kinds of audiences. Instead, we take dead aim at organizations of persons whoin turn communicate to others. Teachers' institutes forcredits were sponsored in city and county school systems.Programs include "Read the Label," "How Safe AreOur Foods and Drugs," "Drug Abuse," and "Safety inthe Home." Attendance has reached more than 1,000.

With the appointment by FDA of Consumer Specialists, three primary target groups were designated, theelderly, the low-income, and youth. Los Angeles Districtinitiated and planned with the Los Angeles County Department of Senior Citizens Affairs and the Universityof Southern California the first FDA seminar for specialists in the field of aging. We organized and developedthe first FDA seminar sponsored by a major labor organization, the Teamsters Union. Our Drug Abuse seminar for youth held in Las Vegas, under the sponsorshipof the Las Vegas Sun, the Clark County CooperativeExtension Service, and Los Angeles District, drew anattendance of more than 12,000. It was the largest liveaudience ever addressed by a Food and Drug representative and the largest audience ever assembled in LasVegas.

Los Angeles District public information efforts arenot confined to spectaculars. Our policy is to assist everyperson who seeks information, whether or not it pertainsto food and drug matters. If we can't provide the desiredinformation, we make an extra effort either to locate itor to tell the caller where he can obtain it. Apparentlyour efforts are getting some recognition: callers frequently tell us they were referred to FDA by someother government agency.

Other information seekers are the motion picture,radio, and television studios. They call in for informationon the effects of drugs, food poisoning, toxicity of various products, and legal requirements to assist them inplots and sequences for shows.

Federal-State cooperation in the interest of consumer protection is a way of life at Los AngelesDistrict. We have been favored with energetic Stateorganizations under dynamic leadership and supportedby strong laws. Current examples of cooperation withthe California State Bureau of Food and Drug and theOffice of Field Crops and Agricultural Chemicals havebeen mentioned previously. Prior to punch cards anddata processing, communication was on a personallevel, by visits and almost daily telephone interchange.

Computers and printouts now make cooperative planning a different operation. But there is more to intergovernmental cooperation than computers and statistics.There must be understanding and mutual confidence.Without these intangibles, no computer system, howeverelaborate, wiU succeed.

Intergovernmental cooperation at Los Angeles District reaches beyond the States. Our good neighbors tothe north some months ago advised us of a shipment ofbrazil nuts found to contain aflatoxin. Denied entry atVancouver, British Columbia, the shipment was divertedto Los Angeles. We intercepted the shipment and confirmed the aflatoxin contamination. This vigilance andcooperation led directly to the FDA's present system ofcompulsory aflatoxin examination for all importationsof brazil nuts. On our part at Los Angeles District weadvise the Food and Drug Directorate of Canada whenwe learn of illegal articles destined for delivery there.Last December, we alerted them about 12 shipmentsof carrots suspected of contamination with endrin. Tothe south we have cooperated with Mexican officials bymaking analyses of products produced and distributedin Mexico and suspected of pesticide contamination.

We are proud of our progressive Southland industriesand the many whose own standards impose a higherlevel of compliance than the laws require. As an example, one major industry has a program on pesticideresidues that is the virtual equivalent of self-certification.

There are others whose ideas of voluntary complianceconsist of destroying adulterated materials when an inspector points them out, but who make no effort to correct the cause until the inspector comes back again.Inspectors have encountered delays in a plant's frontoffice while the mess in the firm's production lines ishurriedly cleaned up. Defective raw materials have beengranulated or otherwise comminuted so their conditionis masked in the finished product. Articles known by thefirm to be violative may be distributed in the hope thatthey will not be discovered. We are not so naive as tobelieve that such offenders either lack education—orare amenable to it—until they learn the hard waythrough the sanctions of the law. Consumers and legitimate industry are entitled to this protection.

We do not run a tight ship at Los Angeles District.Everyone is expected to understand his job and want todo it. The Food-and-Drugger is trained to hate sin, inthis case, violation of the laws FDA administers. He isthen on his own. Confidence begets the extra effort thatproduces leaders.

Superlatives are the order of the day in the Southland:the biggest and the best, the most and the greatest. Perhaps this is a legacy from the stupendous and colossalvocabulary of Hollywood and Las Vegas. Perhaps California and all the Southwest are great because those whohave made it so think in superlatives.

10 I March 1969 j FDA Papers

P O I S O NCONTROL DIVISIONJ L / T o m m y e a t i n g s o m e l l v V v J L i

o f the laundry soap. Wi l l , t x r i ihe be poisoned from it?" Henry L. Verhulst a

The bewildering increase in the number and varietyof products that began to enter the American household after World War II and the corresponding proliferation of such incidents as this, involving accidentalpoisoning or suspected poisoning of children, createdmounting concern among pediatric and other medicalgroups, public health authorities, and other responsiblepersons about accidental poisonings. This concern setin motion a series of events which has resulted today inthe daily 24-hour operations of some 560 autonomousPoison Control Centers in the major population areasacross the country, among whom information abouthousehold products and medicines that are toxic (andnontoxic) is coordinated by a National Clearinghouse.This Clearinghouse has operated as part of the PublicHealth Service since it was formed and since July 1,1968, has been the responsibility of the Poison ControlD i v i s i o n o f t h e F D A B u r e a u o f M e d i c i n e ' s n e w O f fi c eof Product Safety.

By 1952, incidents involving possible poisoning of ■children from various products used in the home, including medicines, were being encountered by physicians in 51 percent of reported childhood accidents.Obviously, the practicing physician cannot be familiarwith the composition of all household products; yet,knowledge of the ingredients is necessary for the propertreatment of an ingestion case. Can the doctor be expected to be proficient in knowing the effects of sodiumtripolyphosphate, ammonium thioglycolate, dimethyldistearyl, ammonium chloride, and the many other unfamiliar chemical ingredients found in common household products?

Because of this knowledge gap and because therewere hundreds of thousands of such ingestions annually, the Illinois Chapter of the American Academyof Pediatrics initiated a pilot project called the "PoisonControl Center," in Chicago. From the first, the projectenjoyed cooperation from the pediatric services in thelocal major hospitals, the State Health Department, theState Toxicological Laboratory, and other State andlocal authorities, and a working unit was formed representing some 20 hospitals, four full-time health departments, five medical colleges, the local medical society,the Illinois Chapter of the Academy of Pediatrics, andthe American Public Health Association.

The Chicago Poison Control Center opened in November 1953. It provided information on and treatment for poisonings, and had the further objective ofestablishing a prevention program. The number of otherpoison control groups that subsequently were organizedwith the same goals as the Chicago Center can be considered a tribute to the latter's success. The centerssoon found, however, that they were duplicating eachother's work in compiling information and that the in-

TTQT/^X T formation gathered by one-L-'l V \ was not finding distributionnd John J. Crotty, M.D. aU Moreover, informa-tion about poisonmg experiences was fragmented. It became apparent that somecoordination of Poison Control Center activities wasnecessa ry.

In November 1956, at a meeting of the American Public Health Association, a committee on which several groups were represented recommended that a National Clearinghouse be established to provide sourcesof reliable data and a meaningful case reporting systemfor Poison Control Centers. APHA presented this

... daily 24-hour operations ofs o m e 5 6 0 a u t o n o m o u s P o i s o n

Control Centers in the majorpopulation areas

recommenda t i on t o t he Pub l i c Hea l t h Se rv i ce o f t he De

partment of Health, Education, and Welfare. Repres e n t e d o n t h e c o m m i t t e e w e r e t h e P o i s o n C o n t r o l C e nters, the American Academy of Pediatrics, the American Pharmaceutical Association, the National ResearchCouncil, and DHEW's Food and Drug Administrationa n d C h i l d r e n ' s B u r e a u . T h e c o m m i t t e e a l s o i n c l u d e dPHS representatives.

As a result, the Surgeon General designated the National Clearinghouse for Poison Control Centers as anofficial activity of PHS and it was assigned to PHS's Accident Prevention Program. Although the NationalClearinghouse for Poison Control Centers is the nameby which it became best known, it is now officially designated as the Poison Control Division of the FDA Bureau of Medicine's Office of Product Safety.

Since 1957, approximately 560 Poison Control Centers have been established in the United States. Exceptfor the few in Government hospitals, these centers arenot under Federal control. They are largely autonomousorganizations developed by local hospital or paramedical groups in cooperation with the State health departments. Most are located within hospitals, and a few inhealth departments. Although every hospital should beprepared to treat the emergency aspects of poisoningcases, only a comparatively small number of PoisonControl Centers are needed to accumulate the specialized experience and reference material to provide information services. With few exceptions, financial support of the Poison Control Center comes from the hospital in which it resides.

The structure of a Poison Control Center varies considerably from one area to another. The majority, however, are usually located in emergency rooms of large

FDA Papers / March 1969 / 11

community hospitals. Their documentary resources consist of a file of 5- by 8-inch cards provided by the National Clearinghouse that lists information on commercial household products and other substances, alongwith references that usually include textbooks on poisoning, plant toxicity, pharmacology, and occupationalmed ic i ne . Mos t cen te rs ma in ta in a l i s t o f consu l t an t ex

perts who are called when unusual poisonings occur.Although the Poison Control Centers were originally

established as a service to physicians, they have evolvedto a point where today almost 75 percent of the callsthey receive are from the lay public. Centers in somecommunities maintain the original concept, that is, theyprovide information to physicians only. Most of the centers are located in hospitals and, therefore, providetreatment facilities along with their information services. Those centers located in health departments provide information and consultation to hospitals as wellas to physicians and the nonmedical community. A recent survey shows that the centers were able to providespecific information in 92 percent of the cases of ingestion over the period of a year. The occupation of theprofessional person taking calls at the center also mayvary: Often, it is a nurse or a pharmacist with severalyears of experience with a physician on call.

The National Clearinghouse supports Poison Control Centers by providing data to them on the ingredients, toxicity, symptoms and findings, and recommended treatment involving the more common household products and medicines children are likely to ingest. This material is periodically supplemented to coverchanges in formulations and new products that enterthe market. The information is gathered from a numberof sources. Many manufacturers voluntarily submit formulations and toxicity data on new products. Others re-

... providing data to themon the ingredients, toxicity,symptoms and findings, andrecommended treatment

spond to Clearinghouse questionnaires concerning newproducts discovered from the case reporting system andfrom reviews of commercial and scientific journals. Theinformation is researched thoroughly and evaluated bythe staff. Then it is submitted to four consultants forreview before distribution.

The Poison Control Centers submit case reports voluntarily to the Clearinghouse. Over 100,000 were submitted in 1967. The reports are reviewed and codedand the data placed on magnetic tape, where it can bernore easily tabulated and manipulated. This information provides a variety of program materials useful in

the Division's operation. The age and sex of the victimand the circumstances of the incident form a basis forprevention and education programs. The amount of asubstance ingested, compared with the symptoms of thepatient and days of hospitalization required, provide important clinical data on toxicity of a particular product.

. . . t h e c i r c u m s t a n c e s o f t h e

inc iden t f o rm a bas i s f o r

prevention and educationp r o g r a m s .

In addition to the technical and clinical data and information for program planning, these case reports haveproved useful to other Government agencies and organizations that are required by law to maintain surveillance of particular problems. The Hazardous Substances Division of the FDA's Office of Product Safetyreviews the reports to obtain data on human toxicitythat will aid in administering the Federal HazardousSubstances Act. The Public Health Service's PesticideOffice uses case reports involving pesticides to advisethe U.S. Department of Agriculture on labeling of pesticides. Private industry also examines the reports relating to the product a company manufactures. Sincethe material is kept confidential to Government agencies and to the products' manufacturer, the manufacturing company in its tabulations omits data that identifiespersons involved in the cases under examination.

For several years the National Clearinghouse hasbeen processing the reports according to the categoryof the substance involved. The 1968 data, for the mostpart, can be analyzed in several ways, including thetrade name of the product. Systems work has been developed to the point where there is no longer a lag of 6months after the close of the reporting year before tabulations are made available. Data can now be processedwithin the reporting year for those reports that havebeen coded and punched.

A data bank is now being compiled that will includeall the information on the 5- by 8-inch index cards inthe Poison Control Centers. In the future all the information in the Clearinghouse files will be added, alongwith pertinent information from textbooks and othersources. Eventually, information from the reporting system will be added to the toxicology data bank. As thesystem now exists, it alerts the Clearinghouse to newproducts that are ingested and provides data on thoseitems that cause serious illness as well as the equallyimportant data on those products that do not seem tocause problems.

The Clearinghouse publishes a bulletin every 60 daysthat is distributed to the Poison Control Centers, State

12 / March 1969 / FDA Papers

Health Departments, many schools of medicine andpharmacy, and to certain designated individuals whohave a need for it. The bulletin contains statistical information, interesting case reports, short reviews of newproblems, and treatments. It makes no attempt to index the literature but supplements it with subjects thatare of interest to the National Clearinghouse and togroups involved in poison control and management.

Prevention of poisonings and ingestion accidents is amajor facet of the Clearinghouse operation. The motivation that causes a child to ingest household productsand medicines has not, in the opinion of many, beenappropriately defined. Although such ingestions havelong been attributed to the oral curiosity of the youngchild, some authorities have stated the belief that theyare expressions of defiant behavior vis-a-vis the adultparent. Whatever the motivation for childhood ingestions, they are preventable. If they are caused by simplecuriosity, household products and medicines can bestored and locked in places where they will not excitethe child's interest. If they are due to defiant behavior,then the parent should be educated to the fact that suchingestions do occur—and not only to someone else'schild. Again, the same positive steps can be taken tomake these i tems less avai lable.

Prevention of poisonings andingestion accidents is a majorf a c e t . . . .

The National Clearinghouse conducts an energeticand ongoing prevention program. This work is climaxedeach year by National Poison Prevention Week. In 1961the Congress enacted Public Law 87-319, which authorizes designation by Presidential proclamation ofthe third week in March each year as National PoisonPrevention Week. Many governmental, medical, industrial, and trade organizations have joined in the effort to

This work is climaxed each

year by National PoisonPrevent ion Week.

promote this week by emphasizing through national andlocal communications media and through communityprograms the hazards of medicine and household products as they relate to accidental poisonings. The periodis also used to initiate year-round community programsfor prevention of poisonings. The Clearinghouse servesas secretariat for the Planning Council for Poison Pre

vention Week, which sponsors the Week. The Council,on which more than 20 interested organizations arerepresented, arranges for the design, production, anddissemination of such Council materials as newspaperadmats and factsheets, television material, window banners, prepared public addresses, proclamations for public officials, and other promotional aids.

Besides this well-known program, the Poison Control Division, through controlled community demonstration studies, investigates various methods andtechniques through which poisonings can be reduced.These findings can then be applied to other communities with their differing cultural, socioeconomic, andclimatic conditions. Through the media of seminars andsymposiums, journals and periodicals, and professionalmeetings, these educational and training methodologiesare discussed and analyzed.

An important program among the Division's preventive activities is a device actually developed duringone of the community demonstration projects: Youngsters are taught poison prevention habits concurrentlywith programs that are aimed at their parents. Througha series of learning experiences, youngsters learn fromkindergarten through third grade about the hazards ofthe world around them and how to cope with thesesituations. Their experiences include class interviews ondifferent days with a mother, the school nurse, theschool physician, a pediatrician, a pharmacist, a grocer,the health officer, or the sanitarian. The class makes excursions to the grocery store and the pharmacy. Children participate in games, songs, and plays, all on thecautionary theme of "asking first."

Thus, the Poison Control Division is involved in thetotal management of this serious childhood problem. Itsaim is to prevent such occurrences, and when these efforts fail, to provide appropriate diagnostic and therapeutic information to alleviate the seriousness of poisoning accidents, reduce hospital stays, and promoter e c o v e r y.

Henry L . Verfiu ls t ,D i r e c t o r o f t fi e P o l - / Is o n C o n t r o l D i v i -

s i o n , j o i n e d t fi eP u b l i c H e a l t t i S e r v -

in 1948, becameD e p u t y o ft fi e C o n t r o l

a n d :

John J. Crotty, M.D.,D e p u t y D i r e c t o r o f g sthe Poison Control ^D i v i s i o n , h a s b e e n ' - y .w i t h t h e D i v i s i o n

j o i n i n g t h eS e r v -

FDA Papers / March 1969 j 13

The Third Dimensionof Product Safety Action

ris important not to take too insu la r a v i ew o f t he e f f o r t s o fthose concerned with improvingproduct safety. This caveat has special application to the work of theN a t i o n a l C o m m i s s i o n o n P r o d u c t

Safety.It is not enough to flatly concep

tualize the Commission's problemsin terms of ways and means of reducing 18,000 deaths per year, mosto f w h i c h a r e s a i d t o b e a t t r i b u t a b l eto i tems used in and around thehome, or of cutting down on theover 20 million injuries said to result primarily from the same source.There is another dimension to thesaving of lives and the reduction ofaccidents by group action directedto product safety.

There is in fact no certainty thateveryone would agree on the nobility of the objective of saving livesand cutting down on accidents! Atthe December hearings of the Commission a representative of the National Safety Council expressed thev i e w t h a t l i m i t e d t r a u m a t o a n i nfant from his toys is, in fact, desirable as a part of the child's educational process! A representative ofthe Toy Manufacturers Associationapocryphally observed that one wayof enhancing safety is to "stay inbed all day"!

Realistically, living has alwaysentailed elements of risk of physicalh a r m o r s u d d e n d e a t h . D e a t h i s a ninevitable consequence of living,and it is impossible to visualize thetype of proliferation of legislation,regulations, and agencies that wouldbe necessary to substantially eliminate all hazards of injury from theuse of products. But I consider thew o r k o f t h e N a t i o n a l C o m m i s s i o non Product Safety to be infinitely

by Arnold B. Elkind

important because it pertains to, andis very much involved with, ouremerging national character and ournotions of justice. An ethic embracing the need to treat the consumerfairly and not to invade his right tosafety is a sine qua non for survivalof our system.

I t has been observed tha t theUnited States is too recent and inexperienced an institution for itscitizenry to have developed a settledn a t i o n a l c h a r a c t e r . T h e C o m m i s s i o ncan make an important contributiontoward increasing the consciousnessof the relative values to which wem u s t b e c o m m i t t e d a s A m e r i c a n s .

The concept of what represents"good American character" is stillvery malleable and is being hamm e r e d o u t i n o u r t i m e s . T h e h e a tc o m e s f r o m t h e c o n fl i c t i n t h e c e ntral cities, but the form and outlineof our national character emergesthrough our legal and legislative institutions and through voluntaryadaptation. This Commission has ani n t i m a t e c o m m i t m e n t w i t h t h e e v o

lutionary process. The languageestablishing the Commission andsetting forth our responsibilities isclear. Pursuant to statute [PublicLaw 90-146], the Commission isconducting

"a comprehensive study and investigation of the scope and adequacy of measures currently employed to protect consumers againstunreasonable risk of injuries whichmay be caused by hazardous household products. Such study and investigation includes consideration ofthe following:

"7. The identity of categories ofhousehold products which may pres e n t a n u n r e a s o n a b l e h a z a r d t o t h e

health and safety of the consumingpublic;

" 2 . T h e e x t e n t t o w h i c h s e l f -regulation by industry affords suchprotection;

"5. The protection against suchhazardous products afforded atcommon law in the States, includingthe relationship of product warrantyto such protection; and

"4. A review of Federal, State,and local laws relating to the protection of consumers against categories of such hazardous products,including scope of coverage, effectiveness of sanctions, adequacy ofinvestigatory powers, uniformity ofapplication, and quality of enforcem e n t o f t h o s e l a w s . "

These four charges, however, inthe aggregate seek an expression ofpriorities in a specialized area.Which is more important as far ashousehold products are concerned—profits or freedom from hazard?

There is no question but thatthere was a time when profits andindustrial and economic growthwere a prime concern of our society.Historically, this was manifested byan absence of governmental controlor regulation of industry and by alack of remedy in the courts for thev i c t i m s o f i n d u s t r i a l f a l l o u t . T h e

proliferation of governmental agencies which have assumed a role inconsumer protection evidences apolitical search for expressing someadjustment in that order of priori t ies.

Industry itself, through the adoption of safety standards, certification programs, testing laboratorylistings, has made a limited responseto the need for adjusting priorities.Where is the balance now, andwhere should it be? Have we now

14 ! March 1969 / FDA Papers

reached that stage of high regardfor individual dignity where we canagree (except for the dissent of extremists) that we can continue tohave profitable industry and aprofitable economy even thoughsubstantial sums are expended toeliminate possibilities of serious accidents which are, in truth, only aremote likelihood? Ten years agothe answer would have Ijeen easyand clear. Such an expenditurew o u l d b e c o n s i d e r e d w a s t e f u l . T h e

"unnecessary" cost would be"cruelly" passed on to the consumerin any event. We would be depriving people with marginal purchasingpower of objects which they mightpurchase if the cost were somewhatl o w e r .

By 1969 standards, however, thiskind of answer seems overlysimplistic. We observe masses ofpeople acquiring the manufacturedgoods that they want on an installment basis, often selecting articlesthat do not seem appropriate totheir income level. We see increasesin the sale of consumer goods andincreases in the profits of the manufacturers year in and year out inspite of increases in the usual product ion cost cr i ter ia (man-hour oflabor, ton-mile of shipping cost,etc.). We see tremendous budgetaryallotments for advertising and for

A r n o l d B . E l k i n d ,C h a i r m a n o f t h eN a t i o n a l C o mm i s s i o n o n P r o duct Safety, is atr ial lawyer inNew York City.

the styling even of household appliances. It is economically possible togive the safety of a product a muchhigher priority than it receives today; the gains are obvious on theeconomic front and on the publich e a l t h f r o n t .

More impor tant , though notnearly as obvious, is the fact of ourc o m m i t m e n t t o e l e v a t e i n d i v i d u a lrights over property rights wherethe two are in unequal conflict. Ina perfect society we would hopethat industries would regulate themselves to achieve this objective. Dissatisfaction in the marketplace imperils the very system in which ourindustry has flourished. Long-rangestatesmanship unmistakably mandates advocating and working forthe optimum in consumer safety.The consumer must be kept satisfied if he is to continue to lay thosegolden eggs.

Unfortunately, our hearings andinvestigations have uncovered evidence of serious-gaps in the effortsof business to cater to the safetyneeds of our country.

The great challenge to the Nat i o n a l C o m m i s s i o n o n P r o d u c t

Safety is to find the formulae tobuttress, validate, and legitimatizethe aspirations of statesmanlike industrial leaders who recognize thelong-range goal of enshrining consumer safety and satisfaction asparamount business objectives.S o m e r e f e r t o t h i s a s " M i s s i o n I mpossible," but it is the third dimension of Product Safety Action anda sou rce o f much exc i t emen t t o t heC o m m i s s i o n e r s a n d s t a f f .e d i t o r ' s n o t e ; T h e P r e s i d e n t i a l l y - a ppointed National Commission on ProductSafety represents a broad spectrum ofinterests including law, science, research,merchandising, and consumer informat i o n .

In addition to the author of this article,the legal profession is also representedby Emory J. Crofoot, Settlor Deputy Attorney for the city of Portland, Oreg.,and Michael Pertschuk, General Counselt o t h e U . S . S e n a t e C o m m e r c e C o m m i t t e e .

T h e o t h e r f o u r c o m m i s s i o n e r s a r eHugh L. Ray, Director of Sears, Roebuck & Company's Merchandise Development ai td Test ing Laboratory in Chic a g o ; D a i t a Yo u n g , a n e n g i n e e r a n dformer Dean of the Yale EngineeriitgSchool, currently Senior Vice Presidentof Southwest Research Institute in SanAntonio; Henry Aaron Hil l, chemist andPresident of the Riverside Research Laboratory in Haverhil l, Mass.; and SidneyMargolius, New York author, columnist,and authority on consumer issues.

The Execut ive Director of the Commission is IVilliam V. White, whose long-term experience as a U.S. Public HealthService career official has incltided workon injury control and family safety.

T h e G e n e r a l C o u n s e l i s M i c h a e lLemov, formerly with the Department ofJus t i ce .

Three staff task forces are carrying outcomprehensive studies and investigationsfor the Commission. Task Force I is putt ing together in format ion on the re lationship between household products andaccidental injuries or deaths. The Chiefof this unit is Dr. Samuel C. Southard,former chairman of the Accident Prevent ion Commit tee of the American Academy of Pediatrics.

Task Force H, headed by BiophysicistDr. Car l C. Clark, is reviewing meansemployed by industry to regulate itself toattain product safety. This unit is lookingin to ways s tandards are deve loped invarious industries, how long It takes todevelop them, the quality of the standards, and how they are applied in themarketplace.

Task Force HI is looking into legalmeans of protecting the consumer fromaccidents involving household products.Under the direction of New York Attorney Theodore J. Jacobs, this unit is compiling, studying, and analyzing Federal,State, and local laws, regulations, codes,attd the common law to find out howconflicting legal reqidrements affect bothmanufacturers and consumers.

16 ! March 1969 / FDA Papers

The problem of mycotoxins inFDA's mission of assuring

the healthfulness of food consumed by Americans was, until

a few years ago, of little or noconcern. Mycotoxins are naturally

occurring poisonous substancesproduced by some types of molds.

Like antibiotics, mycotoxins aremetabolites produced by the living

processes of some molds, but theformer are toxic primarily to certain

types of bacteria and are nontoxic or less toxic tohumans and other warmblooded animals. Mycotoxins

have been shown to be toxic to laboratory test animalsand some farm animals. Some mycotoxins, fed at low,

nonlethal doses, have caused liver cancer in test animals.Not all molds produce mycotoxins. Many molds are

harmless so far as health is concerned, and some moldsare even cultivated as a part of the processing of certain

foods, such as Roquefort cheese.The Agency's concern about mycotoxins dates from 1961

when about 100,000 young turkeys died in Great Britainfrom an unknown cause. The deaths were found to be

caused by a toxic substance produced by Aspergillusflavus, a common mold that contaminated peanut mealused to feed the turkeys and which had been imported

from Brazil. This mycotoxin was named aflatoxin, and ithas since been found in other crops, particularly

peanuts, brazil nuts, cottonseed, copra, and to a lesserextent in cereal grains. A number of other mycotoxins

have been found andisolated from foods and

feeds. Although somemycotoxins are MiaJlTKIN

known, there are undoubtedlyothers yet undiscovered that arepotentially harmful to the health ofman and animals. FDA in recent

years has been pursuing a programaimed at finding and isolating thesemycotoxins so it can devise effectiveways for their detection and control.FDA has developed analyticalmethods that detect aflatoxin in

specific foods within 3 hours whereonce this took several days, and has

devised chemical and biological confirmation methodsto fully support and enforce regulatory action againstcontamination of foods by aflatoxin.

FDA has been carrying out a training program inmycotoxins to benefit its own scientists and others.Continued research or other work is needed in the effecton mycotoxins of various processes in production offoods; in isolation and growth of molds; in isolation ofthese toxins and establishment of their chemistry tomake possible the development of detection andconfirmation methods; in the toxicity of a givenmycotoxin to biological systems and to small and largeanimals, including those where toxic substances may bedeposited in edible tissues; and in surveys of foods fordetection of known mycotoxins and for assessment oftheir extent and distribution.

The photographs show molds of various kindsgrown on corn in the laboratory (left and right),and three adjacent mold colonies grown in the

process of isolating various molds in the searchfor mycotoxins(center).

In FDA's procedure fordetecting and confirmingaflatoxin, the product sample is putinto a machine that thoroughlygrinds and mixes it to give a uniformmass (small photo, top left). In thechemical analysis to detectmycotoxins, a portion of the mixedsample is subjected to an extractionand cleanup process in achromatographic column thatseparates the mycotoxin fromthe rest of the sample by theuse of solvents (small photo,bottom left) . This extract isthen spotted in small amountsat the edge of a thin-layerchromatographic plate, a glassplate covered with anadsorbent layer of silica gel(small photo, bottom right).This edge of the plate isplaced in a pool of solventwhich travels up the plate ina m a n n e r s i m i l a r t o o i l

traveling up a wick. If one ofthe three mycotoxinsdetectable by the procedureis present, it will be depositedon the plate in a characteristicpattern of spots as thesolvent creeps upward. The TLCplate, here under ultraviolet light(top left), shows three groups ofmycotoxins: the three spots at theright are characteristic of ochratoxins,the one in the center of the

estrogenic factor of gibberella zeae,a n d t h e f o u r a t t h e l e f t o faflatoxins. FDA has developedthis multidetection method thatdetects these three groups ofmycotoxins simultaneously.

The preparatory TLC plate (topright) shows how the aflatoxin froma sample is obtained from the platefor chemical and biologicalconfirmation tests. The extract fromthe sample is spotted in a number

of places at the bottom edge of theplate and the edge dipped in thesolvent. The aflatoxin thus is

deposited as a strip across the plate.To obtain the aflatoxin (bottom left),this strip is marked while under UVil luminat ion and then retr ieved

along with the dried silica gelcoating by the use of a vacuumingdevice. The vacuum cleaner

c o n t a i n s a fi l t e r

that prevents thematerial from escaping upward.This filter receptacle is theninverted and another solvent is

passed through the filter to dissolvethe aflatoxin, which is caught ina small flask (bottom center).Three chemical derivatives are madewith portions of this aflatoxin. Theseaflatoxin derivatives are shown onthe TLC plate (bottom right) andprovide chemical proof becausethey are characteristic of aflatoxin.

Another portion of the sampleextract is subjected to one of twotests which confirm the biologicaltoxicity of the aflatoxin.

In the chicken embryotest, a hole is drilled

in one end of a fert i lechicken egg and a portion

of the extract depositedtherein (bottom). Specific

a m o u n t s o f a fl a t o x i n

deposited in an egg at thebeginning of the 21-day

incubation period willdestroy life in the embryo.

These photos of candled eggsshow regression of the blood vessels of the

dead embryo in an egg in which aflatoxin hasbeen deposited (center left), as compared to

the network of healthy blood vessels in alive embryo of the same age (center right).

In the bacteriological test to confirm toxicity,quantities of the same extract are placed on a

culture plate seeded with Bacillus megatarium,micro-organisms whose growth are inhibited

by aflatoxin. Not only do theaflatoxin deposits createzones of inh ib i t ion to thebacteria growth as shown inthe photo (top left), butaround the edge of this zone,as seen under a microscope,appear abnormal forms of theinjured bacteria. Themicroscopic photos show then o r m a l a n d t h e a b n o r m a l

B. megatarium (top right,above and below). Antibiotics and othermycotoxins tried so far by FDA have notproduced similar aberrant effects in theseb a c t e r i a .

FDA insists on a positive presumptivechemical test, a positive chemical derivativetest, and a positive toxicity test before takingregulatory action in an aflatoxin contaminationc a s e .

Partnershipfor Health: An Incident in Gloucester

A tragic and destructive explosionat a New England cold storagewarehouse earlier this year provedto be the catalyst in a prime example of FDA-industry cooperation inbehalf of the consumer. It also provided an opportunity for Government agencies to demonstrate theimportance of their supportive rolesin safeguarding the health of Americans.

In the early morning of January2, at 12:02 a.m., an explosionripped through the plant of theQuincy Market Cold Storage andWarehouse Co. at Gloucester, Massachusetts. Two engineers werekilled and a third injured as thepressurized ammonia gas in the refrigeration complex exploded bec a u s e o f a m a l f u n c t i o n i n t h e c o m

plex and completely devastated a300 - foo t sec t i on o f t he ex te r i o r wa l lof the freezer. The explosion leftapproximately 11 million pounds ofpalletized frozen fish and fish foodsexposed to the elements. The refrigeration system at the warehousewas completely destroyed and theindustry was confronted with theenormous task of salvaging 11 million pounds of fish. The problemwas compounded because of thedanger of ammonia fumes furthercontaminating the exposed foodproducts.

Later in the day, inspectors fromFDA's Boston District Office, theU.S. Department of Interior, theCommonweal th o f Massachuset ts ,and the city of Gloucester met withrepresentatives from Gorton's ofGloucester, a fish processing firmwhich owned about 80 percent ofthe products in the warehouse, andthe Quincy Market Cold Storage andWarehouse Co. All parties agreedthat close State-Federal cooperationwith industry was of paramount importance in dealing with the problem at hand. Russell Boshell, Director of Quality Control of Gorton's of

by Edward J. McDonnell

Gloucester, scheduled daily meetingsbetween industry and Governmentrepresentatives to avoid problemsthat might arise from inadequatecommunications and to expedite salvage operations.

The enormity of the crisis is difficult to comprehend. Eleven millionpounds of frozen fish products wereexposed to the elements without anyrefrigeration. Obviously the frozenf o o d h a d t o b e m o v e d w i t h o u t d e

lay to other freezers to preventthawing. The job of moving sucha huge quantity of fish on short notice is extremely difficult and comp l i ca ted . Dangerous ammon iafumes impeded salvage operationsa n d t h r e a t e n e d t o c o n t a m i n a t e t h a t

part of the food still salvageable. Anadded impediment was that inventory records at the warehouse werecompletely destroyed in the blasta n d t h e l o c a t i o n a n d i d e n t i fi c a t i o nof product lots was impossible.

The problems of the various healthagencies involved were also immense. The FDA, charged with protecting the consumer from adulterated food products, faced the taskof inspecting the 11 million poundso f f r o z e n fi s h f o r a m m o n i a c o n t a mination and mechanical damage. TheC o m m o n w e a l t h o f M a s s a c h u s e t t s 'Division of Food and Drugs was interested in inspecting all of suchf o o d t h a t m o v e d i n t h e S t a t e o fMassachusetts. Finally, the Bureauof Solid Waste Management of theEnv i ronmenta l Cont ro l Admin is t ration, Consumer Protection and Environmental Health Service, wasconcerned with finding a way forthe damaged merchandise to besafely disposed of without furtherpollution of the environment.

M r . B o s h e l l o f G o r t o n ' s o fGloucester directed salvage operations for the 35 fish processing firmsi n v o l v e d . F r o m t h e o u t s e t i t w a sessential to remove the apparentlyundamaged goods to other freezers

with the greatest haste to reduce thetotal loss and to prevent secondarycontamination of the products. Thisconsideration made inspection ofthe goods at the warehouse locationpractically impossible.

During a progress meeting onJanuary 3, Gorton's of Gloucester estimated that 275 refrigeratedtrailer trucks, each carrying 40,000pounds of the frozen products,would be necessary to move thesalvageable fish. Mr. Boshell reported afterward that he had secured 200 t ra i le r t rucks to t ransport that part of the merchandisewhich was apparently undamagedto cold storage warehouses in Massachusetts, Maine, and Ohio. ViceP r e s i d e n t M i c h a e l J . B u r k e o f t h e

Quincy Market Cold Storage andWarehouse Co. arranged for storagein these warehouses for the productsof the other 34 processing firms inv o l v e d . G o r t o n ' s o f G l o u c e s t e r a n dthe governmental health agenciesagreed that the frozen goods shouldbe inspected at destination rathert h a n a t t h e b l a s t a r e a t o h a s t e n r em o v a l t o f r e e z e r s .

FDA Inspectors estimated that ifthe loading crews worked 24 hoursa day, it still would take 10 days tor e m o v e a l l o f t h e f r o z e n f o o d . O b v i

ously some cooperation from theweather was necessary to preventthawing. The unpredictable NewEngland weather responded by driving temperatures down around 5°to 10° F. for the next 6 days.

At the blast site, city. State, andFederal inspectors assisted Gorton'squality control inspectors in thesegregation of damaged goods andsalvageable products. For the next6 days, field examinations were conducted to examine samples of thevarious products for mechanicaldamage, chemical contamination,and evidence of thawing. A fieldkitchen, equipped with ovens and

FDA Papers / March 1969 / 21

Gloucester cold storagewarehouse explosion,which blew out a 300-footsection of one 400-footwall of the structure, areshown on the oppositepage. Stored fish productsh a d n o t b e e n r e m o v e d a t

the time the picture wastaken. The car, wreckedin the blast, was about 50feet away from thebuilding. At top left,inspecting the damage are(left to right) InspectorsF r a n k F r o s t a n d J a c k

G i a c a l o n e , C o m m o nwealth of Massachusetts 'Division of Food andDrugs, and InspectorCharles E. Phillips ofF D A ' s B o s t o n D i s t r i c t . A t

top right is a mobilerefrigeration unit broughtin to keep .salvageable fishrefrigerated until theyc o u l d b e m o v e d . I n c e n t e r

i s a c r a n e u s e d t o r e m o v e

r u b b l e a n d l a t e r t o r e m o v e

unsalvageable fi.sh. At thebottom, right photo showscartons of unsalvageablefish at dockside waiting tobe loaded into barges likethat shown in the photoat left and then carriedout to sea and dumped. Atupper left are shownsome of the trailer trucksused to transfer

.salvageable fish to cold

.storage plants in othera r e a s .

E d w a r d J . M cDonnell joinedF D A ' s B o s t o nD i s t r i c t i n J u n e1 9 6 6 a s a F o o d

I n s p e c t o r .

deep-fat cookers, was placed intoservice for organoleptic examinationof suspect merchandise. The inspectors' organoleptic examinationconsisted of thawing the products atroom temperature, smelling themf o r e v i d e n c e o f a m m o n i a f u m e s o r

decomposition, and cooking theproducts according to package directions and then smelling and tasting them. A variety of cardboard,plastic-wrap, cello-wrap, and unwrapped packages of breaded fishsticks, fried fish portions, scallops,and crabmeat were examined in thisw a y .

Boston District Supervisory Inspector Bill R. Wobbleton coordinated FDA inspectional activitiesinvolved in the salvage operation.FDA Inspectors visited truckingfirms delivering salvaged fish anddetermined the dest inat ion of theproducts. The Commonwealth ofMassachusetts Inspectors agreed toinspect all frozen foods that wereshipped to cold storage warehouseswithin the State of Massachusetts.Mr. Wobbleton coordinated theFDA resident inspectors located inAugusta, Maine, Concord, NewHampshire, and Cleveland, Ohio, toinspect frozen fish shipments at destination. Gorton's of Gloucesterquality control specialists assistedFDA Inspectors in segregating suspect lots pending positive evaluationof ammonia damage.

As a result of combined industry-Government inspectional activities,11 large lots of frozen productswere detained upcm receipt at various cold storage depots. Subsequentexamination following several daysof storage, however, did not revealany evidence of ammonia contamination. The lots were eventually released by industry quality controlexperts.

After 8 days of intensified inspectional effort. Government and

industry inspectors had succeededin segregating approximately 2 million pounds of damaged, contaminated, and decomposed frozen foodproducts. The next problem was todetermine a method by which thissolid waste could be disposed ofwithout further contaminating theenvironment. Because of the potential air pollution hazard and thesemifrozen nature of the product,burning did not appear practicable.Gorton's of Gloucester finally decided to dump the solid waste atsea on an outgoing tide.

T h e fi r m c h o s e a s u i t a b l e s i t e a ts e a a n d c o n t a c t e d t h e U . S . C o a s t

Guard, Army Corps of Engineers,a n d t h e M a s s a c h u s e t t s D i v i s i o n o f

Waterways to obtain permission todump the product. The Environmental Control Administration, theCPEHS Agency which has the authority to permit dumping of solidwastes at sea, reviewed the dumpingoperation and the safety precautionsutilized by the firm. A total of 26bargeloads was eventually depositedin the Atlantic Ocean on outgoingt ides .

T h i s i n c i d e n t e s t a b l i s h e d h e wl i n e s o f c o m m u n i c a t i o n b e t w e e nGovernment agencies and the military which may be used in solvingfuture waste disposal problems. Asa result of this improvement in cooperation and communication, everyindividual can expect better environmental health protection.

The story of the Gloucester fishdisaster is of particular interest because it represented one of the firstopportunities for Government healthagencies within the Consumer Protect ion and Env i ronmenta l Heal thService to share responsibility forsafeguarding the environment.

Charles C. Johnson, Administrator of CPEHS, in a statement lastN o v e m b e r s a i d :

"The new service is concerned

with the whole spectrum of environmental and consumer hazards andbrings together, in a relationship inwhich they can be mutually supportive, the principal activities of theDepartment of Health, Education,a n d W e l f a r e w h i c h d e a l w i t h t h e s e

problems."

'T^he organization of CPEHS gaveJ- recognition to the impractica

bility of considering as separate andu n r e l a t e d t h e h u m a n e n v i r o n m e n t a l

problems of food contamination andair pollution. Both health problemscombine to produce a total effect ont h e h e a l t h o f t h e i n d i v i d u a l . T h eG louces te r fish d i sas te r i s an exam

ple of how CPEHS can work effectively in providing the Americanconsumer with better health protect i o n .

Douglas C. Hansen, now CPEHSRegional Assistant Administrator,in a speech last December on theapproach FDA would make in discharging the responsibilities ofCPEHS, said:

"To accomplish this, we hope toenter into a dynamic partnershipwith the States and local governments. In solving the problems ofinadequacy in our health care system and improving the quality ofour environment, we are pledged toa program of 'partnership for health'with all segments of our society,which obviously includes industry."

We b e l i e v e t h a t t h e s o - c a l l e dpartnership for health was the essential ingredient in dealing withthe special health problems presented by the Gloucester explosion.The cooperation between FDA andState-local health agencies, andFDA and industry, protected thewelfare of the American consumerand assisted industry in minimizingthe possibilities of further contamin a t i o n f r o m a m m o n i a f u m e s a n dthawing.

24 / March 1969 / FDA Papers

field reportsAT L A N TA D I S T R I C T F D A ' s A t l a n t a D i s t r i c t O f fi c eand the Florida Department of Agriculture are establishing a collection of beans and other seeds which maybe poisonous to man. This collection will aid rapididentification of the various attractively colored beansand seeds used in the manufacture of necklaces andother novelty items. The decorative beans are frequently "imported from Central and South America orfrom the islands of the Caribbean. The possibility ofjequirity beans and other toxic beans or seeds beingused in these necklaces and novelty items creates anever present hazard.

The head of the Bacteriology Lab of International Surveyors in Peru spent 10 days at the District laboratorystudying methods and techniques involving analysis forSalmonella in fishmeal. Senor Juan Revolo Ampuero,an employee of Certificaciones Technicas S.A., International Surveyors, La Feria-Callo, Peru, is responsiblefor examination of fishmeal before it is exported to theUnited States. As part of his studies, he also has visitedHolland and Germany, but says the aseptic samplingtechniques used in the Atlanta District laboratories aresuperior to those used in other countries.

V

Peruvian visitor, Senor Revolo Ampuero, at work inAtlanta District's microbiology laboratory.

BALTIMORE DISTRICT The State of Virginia hasagreed to extend an existing Memorandum of Understanding with Baltimore District to include State inspection of food warehouses and candy firms. The agreement became effective January 1. Cooperative inspection programs between Virginia and the Baltimore District already include bottling plants, corn and flourmills, canneries, and feed mills. These programs aredesigned for more effective consumer protection byefficiently utilizing both State and Federal manpower.

A consignment of approximately 480 pounds of carrotsshipped by John Jacobs Farms, Phoenix, Ariz., to adistributor in Baltimore, Md., was found to containexcessive residues of endrin, a pesticide. The lot wasvoluntarily destroyed under Baltimore District's superv i s i o n .

BOSTON DISTRICT An inspection of a New Englandfish processor showed that breading of frozen oceanperch was taking place in the plant under insanitaryc o n d i t i o n s c o n d u c i v e t o m i c r o b i a l c o n t a m i n a t i o n . L a b

oratory examination showed that the product containedE. coli, excessive coliforms, and a high bacterial count.Two shipments of the firm's frozen breaded oceanperch were seized, one 16,980-pound shipment, valuedat $6,620, at Nashville, Tenn., and one 5,940-poundshipment, valued at $2,391, at New Orleans, La. Thefirm, Channel Fish Co., Boston, requested and receiveda portion of the sample collected at Nashville from theBoston District office for its own laboratory analysis.A seminar on Labeling of Household Hazardous Substances, held in Boston last December 5, was attendedby 95 representatives of various industries. The seminar was cosponsored by Boston District, the ChemicalSpecialties Manufacturers' Association, the NationalPaint, Varnish and Lacquer Association, and the NewEngland Paint, Varnish and Lacquer Association.

During the morning session, FDA representativesspoke on the mutual benefits to FDA and industry ofvoluntary compliance, and on the requirements and exemptions of the Federal Hazardous Substances Act.In the afternoon, industry spokesmen discussed problems of labeling hazardous products, proper label control, and civil liability under the FHSA.

At the conclusion of the seminar, representatives ofthe National Paint, Varnish and Lacquer Associationsaid that their organization would explore the possibilities of producing with the FDA a television documentary film on the hazards of household products.

BUFFALO DISTRICT FDA seized two shipments ofcarrots consigned to distributors in Buffalo, and Pittsburgh, Pa., by John Jacobs Farms, Phoenix, Ariz. Thecarrots had been found to contain excessive residues ofe n d r i n .

CHICAGO DISTRICT The I l l inois Department ofPublic Health's Division of Milk Control is expandingits activities to deal with manufactured dairy productsas well as Grade A market milk. It is being aided in thenew activities by the Chicago District.

Thirteen members of the Division attended a work-

FDA Papers / March 1969 / 25

shop at District offices December 3 and 4. The DivisionChief, Enos Huffer, outlined statutory requirements forinspection under the Illinois Food, Drug, and CosmeticAct. Chicago District Inspectors discussed inspectionsof cheese and butter plants, concentrating and dryingoperations, imitation dairy products, and general in-spectional techniques and writing of reports.A colloquium entitled "Man's Health and his Environment" was cosponsored by the Chicago District and theDepartment of Health and Safety Education of theUniversity of Illinois on December 5 and 6. It was oneof the first in a series of meetings being conductedunder governmental and academic auspices on man'senvironment, both physical and social. A series of in-depth scientific papers was presented, followed by paneldiscussions among the health educators and scientistsfrom academic, private, and governmental agencieswho attended the meeting.

The main speakers and their topics: Dr. John J.Hanlon, Deputy Administrator, Consumer Protectionand Environmental Health Service, Department ofHealth, Education, and Welfare, "EnvironmentalHealth Concerns and Issues"; C. Jelleff Carr, Director,Life Science Research Office, Federation of AmericanSocieties for Experimental Biology, "Man and Drugs";Hilda S. White, Associate Professor of Home Economics, Northwestern University, "Man and his Diet"; Daniel Horn, Director, National Clearinghouse for Smokingand Health, "Man, Cigarettes, and the Abuse of Gratifi c a t i o n . "

CINCINNATI DISTRICT "Non-medicated" dairyfeed, contaminated at the manufacturer's plant in La-Ver e, Tenn., by the addition of returned feeds containing penicillin, was seized by the Tennessee Divisionof Feeds, Fertilizer, and Seeds. The seizures, based onCincinnati District's inspectional findings and laboratory confirmation of the presence of penicillin, tookplace within the State at various branch facilities of themanufacturer, Tennessee Farmers Cooperative.Frozen breaded ocean perch, valued at $6,620, wasseized at Nashville, Tenn., last December 15 becausethe 16,980-pound lot contained E. coli, excessive coli-forms, coa lase positive staphylococci, and a hightotal bacterial count. The lot, shipped by Channel FishCo., Boston, Mass., had been prepared in an insanitaryplant (see Boston District).

DALLAS DISTRICT Publicity about the recall ofjewelry items containing poisonous jequirity beans, soldthrough Sears, Roebuck & Co., attracted the attentionof a husband and wife, who then turned in a jequiritybean necklace to the Dallas District office last December 17. The necklace had been purchased at a Dallasmuseum. The District investigated and found the museum had sold 26 of the necklaces, imported fromSouth Africa. On December 18, the story was carried

by the news media and as a result over 100 telephonecalls were received by the District office. Within a shorttime, 16 necklaces were recovered—six sold by them u s e u m a n d 1 0 f r o m o t h e r s o u r c e s .

The State of Texas has successfully terminated its courtcase against Carl Emil Sweeny, trading as the DurlisFish Camp, Oyster Creek, Tex., in which he wascharged with selling oysters from an uncertified source.Dallas District worked with the Texas Department ofHealth's Food and Drug Division in prosecuting thecase, which was concluded last December 16. Mr.Sweeny was fined $200, plus costs, and was placed onprobation for a year.An explosion at Comet Rice Mill, Houston, Tex., lastDecember 13, injured several employees and causedwater damage to 300 to 400 barrels of rice. FDA'sDallas District worked in conjunction with the city ofHouston sanitarians in seeing that the water-damagedrice was destroyed by the firm.

DENVER DISTRICT Frozen french-fried potatoescontaminated by excessive ammonia residues fromfaulty cooling mechanisms in a storage warehouse wereseized by deputy U.S. marshals in Greeley, Colo. Approximately 13,500 cases, valued at $40,000, wereseized from the warehouse because of FDA charges ofc o n t a m i n a t i o n .

Failure to print proper label warnings and an affirmative statement of hazards resulted in the seizure of 371"Bellini Oil Painting Kits" in Denver. Required warnings such as "Keep out of the reach of children,""Danger," and "Harmful or Fatal if Swallowed" wereomitted from the labels. Each kit contained three tubesof permanent oil colors, a half-ounce bottle of turpentine, and other, nontoxic materials.

DETROIT DISTRICT Representatives of the disadvantaged living in the Model Cities attended a series of10 2-hour seminars on the scope of contemporaryhealth products. The seminars were sponsored by FDAand Wayne State University and were held November26 and December 3, 5, 10, and 12 in Detroit on theuniversity campus. Topics included the safety, efficacy,purchase, storage, use, misuse, and quackery involvedin drugs, therapeutic devices, and cosmetics.

The audience was selected by the Consumer Research Advisory Council for its members' ability tocommunicate the information within the inner city.They represented 60 inner city organizations.

KANSAS CITY DISTRICT A quantity of a veterinary drug, valued at $600, was seized by a U.S. marshallast December 20 after various charges had been madeby the Government against it. The drug, "Ru-'Vi-OticPowder," is manufactured by the I. D. Russell Co.Labs, Kansas City, Mo. The Government charged thatthe drug differed in strength from that it purported to

26 I March 1969 I FDA Papers

possess; that its manufacturing, processing, and packingdid not conform to current good manufacturing practices; that the drug was from a batch that lacked certification; and that it was misbranded because labelstatements concerning the amounts of potassium penicillin and streptomycin sulfate were false and misleading.A bottle of medicinal bitters—part of a cargo that sankaboard a Missouri river trading boat over a centuryago—could become a source of preatomic-age data forF D A .

Cases of the medicinal bitters were among the firstitems salvaged from the wreckage of a steamboat whichmay be the Bertrand. It is speculated that FDA couldbe interested in the products to determine the normalbackground radiation of products manufactured in thepreatomic era. Dr. Wilfred Logan, archeologist withthe National Park Service, has offered FDA samples ofthe bitters for museum purposes.

Salvaging operations are taking place near Omaha,Nebr., where the Bertrand sank on a sandbar about1865. The boat was covered with 30-40 feet of silt,then the Missouri changed course, so salvaging istaking place in the DeSoto Bend Recreation Area. TheNational Park Service has contracted with the salvagersto retain certain items classified as antiques. OmahaSenior Resident Inspector Carl A. Larrick is FDA'sl i a i son w i th t he Na t i ona l Pa rk Se rv i ce .

LOS ANGELES DISTRICT Samples of shipments ofcarrots grown in the fields of John Jacobs Farms,Phoenix, Ariz., were found by Los Angeles District tocontain the pesticide chemical, endrin. Five seizureswere made at destination—totaling 948 bags and cartons. Other dealers destroyed their stocks voluntarily.

Although the firm claimed it had not used endrin onany crop grown on the plots of land since 1963, endrinstill persisted in the soil from prior applications, andwas picked up by the carrots in later years.The absence of warning statements on hazardous substances was the basis for seizure of 92,000 tear gasgun shells in possession of the distributor, G-G 31,Inc., North Hollywood, Calif. The shells had beenshipped from a Pennsylvania firm and were being distributed in States whose laws are not restrictive for thistype of product.

MINNEAPOLIS DISTRICT A product its promotersclaimed would restore natural color to gray hair anddestroy dandruff was seized in possession of NationalProducts Co., Eau Claire, Wis. FDA charged that theproduct, "K. O. Gray," was misbranded by false andmisleading statements in the accompanying labelingwhich represent and suggest that the article is adequateand effective for restoring natural color to gray hair.FDA further charged that the article, manufactured andshipped by Laser Laboratories, Inc., Minneapolis, is anew drug that may not be introduced or delivered into

interstate commerce since it lacks an approved NewDrug Application.

NEW ORLEANS DISTRICT An industry workshopfor the rice growing industry, held last December 3 atthe Rice Festival Building, Crowley, La., drew an attendance of approximately 200. The meeting was co-sponsored by the Rice Millers Association, the Louisiana Rice Dryers and Warehousing Association, Louisiana Rice Growers Association, Louisiana Farm Bureau Federation, and FDA.

Principal speakers at the workshop included: Dr.John Bagent of Louisiana State University ExtensionService; Dr. John B. Halleck of Uncle Ben's Rice Mill;George Abraham, Division of Wildlife Service, U.S.Department of Interior, Baton Rouge; Bob Russell,National Pest Control Association; J. P. Gaines, Executive Vice President, Rice Millers Association; DavidH. Brpnt, FDA Inspector, and Helen C. Barry, ChiefChemist, New Orleans District.

Foods contaminated by Salmonella organisms accounted for a significant number of import detentionsin December by the New Orleans District. Salmonellad e t e n t i o n s i n v o l v e d o n e l o t o f 4 1 0 c a s e s o f c h o c o l a t e

candy eggs manufactured in Holland by Konink LijkeFabrieken Boon, N. V., and a shipload of 25,021 bagsof fishmeal worth $125,511. In the latter case, Salmonella was found in each of the 11 lots in the shipment,which had originated with Pasquero Indo S.A., Arica,C h i l e .

N E W Y O R K D I S T R I C T M i s b r a n d e d m o z z a r e l l acheese valued at $2,560 was seized in Brooklyn onDecember 9 by the U.S. marshal for the Eastern District of New York. The seizure involved 128 cases eachcontaining 8 5-pound loaves of cheese. When introduced into interstate commerce, the cheese was misbranded in that it was represented as low moisture andcontained less than 45 percent of milk fat. The cheesewas manufactured and shipped by Richmond Co-opAssociation, Inc., Richmond, Vt.The District seized approximately 798 pounds ofsmoked salmon in Brooklyn on December 11 becauseexcessive nitrates were found in the product. Thesalmon, manufactured by Roodman's, Inc., St. Louis,Mo., was valued at $1,750.FDA's concern with setting standards and providingpractical assistance to industry in meeting those standards was pointed out recently at a Good ManufacturingPractice seminar. The day's seminar, sponsored by theNew Jersey Pharmaceutical Control Association, hearda progress report by Kenneth Silver, New York District's Executive Officer, on the District's operationsunder the Intensified Drug Inspection Program, one ofthe key elements in the FDA's new approach. Mr.Silver reported that of the 10 drug firms undergoingintensified drug inspections, five have been rated satis-

FDA Papers / March 1969 j 27

factory, four inspections are still underway, and aconsent decree of permanent injunction was obtainedagainst the 10th firm.

PHILADELPHIA DISTRICT Feed grade bulk riboflavin, contaminated with 2,4-D, a pesticide chemical, wasdestroyed December 6 at Nutley, N.J. FDA InspectorSamuel Jones of the Newark office, was present at thedestruction of the lot of 815 kilograms.

Con tamina t ion occu r red when the r i boflav in wasspray-dried by Custom Processing Corp., Trenton,N.J., which used the same equipment for drying as hadbeen used for 2,4-D a week previously. A report on theoperations of the dryer has been filed with the NewJersey Bureau of Foods and Drugs.An extensive series of court proceedings, started in1964, culminated December 20 in the signing of aconsent decree of permanent injunction against YorkBarbell Corp., Hoffman Laboratories, Inc., and RobertC. Hoffman. The injunction enjoined the firm fromshipping dietary foods which utilize as part of theirlabeling certain specific literature which may misbrandthe product or any presentation for a long list ofmaladies and deficiencies due to improper diet.

SAN FRANCISCO DISTRICT On December 17, 43100-pound bags of converted long grain rice were seizedin the possession of the California Sun Dry Bulgur Co.,Fresno, Calif. The lot was valued at $694. FDA's complaint charged that the rice had been held under conditions whereby it may have become contaminated withinsects and that it was in fact so infested.

S E A T T L E D I S T R I C T D i s t r i c t D i r e c t o r F r a n k l i n

BUFFALO- • N B V . Y O R K -

L . - , -

Y IphilaoelphiaYJ , ' . V Y

• OBliiCl Headoiurlers

■ PUERTO RiCO

Clark and Supervisory Inspector Richard Dawson metw i t h t h e A l a s k a C o m m i s s i o n e r o f H e a l t h a n d W e l f a r eand some members of his staff at Juneau, Alaska, todiscuss findings for salmon cannery inspections duringthe past season and areas of priority attention for thenext season. Walt Yonker, Manager, Northwest Branchof the National Canners Association, also attended.

The Seattle District's annual conference, held December 4-6, was attended by three men who have becomenew FDA members through the Consumer Protectionand Environmental Health Service reorganization. Theyare: William Beck, Director of the Pacific NorthwestMarine Health Science Laboratory, Purdy, Wash.;Homer Wolfe, Acting Director, Pesticide Research Laboratory, Wenatchee, Wash.; and Dr. William Stevenson,Public Health Service Project Coordinator, State Pesticide Control, Portland, Oreg.

The three new FDA'ers presented talks on theirorganizations, staffs, and programs.

FDA DISTRICT OFFICES

AT L A N TA 6 0 E i g h t h S t r e e t , N . E .A t l an ta , Georg ia 30309

B A LT I M O R E 9 0 0 M a d i s o n A v e n u eBaltimore, Maryland 21201

B O S T O N 5 8 5 C o m m e r c i a l S t r e e tB o s t o n , M a s s a c h u s e t t s 0 2 1 0 9

B U F FA L O 5 9 9 D e l a w a r e A v e n u eBuf fa lo , New York 14202

CHICAGO Main Post Office BIdg.Rm. 1222 /433 W. Van Buren S t ree tCh i cago , I l l i no i s 60607

CINCINNATI 1141 Central ParkwayC i n c i n n a t i , O h i o 4 5 2 0 2

DALLAS 3032 Bryan StreetDa l las , Texas 75204

DENVER New Customhouse BIdg.R m . 5 6 0 4 / 2 0 t h & C a l i f o r n i a S t r e e t sDenver, Co lorado 80202

D E T R O I T 1 5 6 0 E . J e f f e r s o n A v e n u eD e t r o i t , M i c h i g a n 4 8 2 0 7

KANSAS CITY 1009 Cherry StreetKansas City, Missouri 64106

L O S A N G E L E S 1 5 2 1 W. P i c o B o u l e v a r dLos Ange les , Ca l i fo rn ia 90015

MINNEAPOLIS 240 Hennepin AvenueMinneapolis, Minnesota 55401

N E W O R L E A N S U . S . C u s t o m h o u s eRm. 222/423 Canal StreetNew Or leans, Lou is iana 70130

NEW YORK 850 3rd Avenue (at 30th Street)R m . 7 0 0 / B r o o k l y n , N e w Yo r k 11 2 3 2

P H I L A D E L P H I A U . S . C u s t o m h o u s eRm. 1204/2nd & Chestnut StreetsPhiladelphia, Pennsylvania 19106

SAN FRANCISCO Federal Office BIdg.Rm. 518/50 Fulton StreetSan Franc isco, Ca l i fo rn ia 94102

SEATTLE Federal Office BIdg.R m . 5 0 1 / 9 0 9 F i r s t Av e n u eSea t t l e , Wash ing ton 98104

CPEHS REGIONAL ASSISTANTA D M I N I S T R AT O R S ' O F F I C E S

R E G I O N S M X

BOSTON J. p. Kennedy Federal BIdg.G o v e r n m e n t C e n t e rB o s t o n , M a s s a c h u s e t t s 0 2 2 0 3

N E W Y O R K 2 6 F e d e r a l P l a z aNew York, New York 10007

CHARLOTTESVILLE 220 7th Street, N.E.Charlottesville, Virginia 22901ATLANTA 50 7th Street, N.E.Rm. 404/Atlanta, Georgia 30323

CHICAGO New Post Office BIdg.433 W. Van Buren S t ree tCh i cago , I l l i no i s 60607K A N S A S C I T Y 6 0 1 E a s t 1 2 t h S t r e e tKansas C i t y, M issour i 64106

D A L L A S 111 4 C o m m e r c e S t r e e tRm. 911/Dallas, Texas 75202DENVER Federal Office BIdg.19 th & S tou t S t ree tsDenve r, Co lo rado 80202

SAN FRANCISCO Federal Office BIdg.R m . 4 1 6 / 5 0 F u l t o n S t r e e tSan F ranc i sco , Ca l i f o rn ia 94102

28 j March 1969 / FDA Papers

Poison Honey Bees gatheringnectar from mountain laurel (Kal-mia Latifolia) instead of the usualfireweed produced a toxic honey believed to have caused the illness offive persons reported by a localWashington health district. Washington State Inspectors tested thehoney and found it contained an-dromedotoxin, a substance toxic toman and f ound i n moun ta i n andsheep laurel. The honey was disposed of under the inspector's supervision.

The afflicted persons exhibitedthe typical symptoms of breathingdifficulty, blurred vision, slight paralysis of extremities, and nausea.All recovered, though one personrequired hospitalization.

Similar events occurred in 1942,1953, and 1959. During seasonswhen fireweed does not blossom, thebees gather nectar from the laurel,which abounds in the area, extracting the poisonous andromedotoxinfrom these plants along with thenectar. The substance is apparentlyh a r m l e s s t o b e e s .

False Alarm Local publicity in thePortland, Oreg., area concerningthe recall of products containingjequirity beans was too effective.Portland officials relayed information to FDA's Seatt le Distr ict thatdecorative table centerpieces containing these beans were producedin the Portland area. Considerableinvestigative efforts by city officialsand the District's Portland residentinspectors turned up nothing. Itnow appears that overzealous citizens were responsible for a falsea l a r m .

Toxic Dfshware Baltimore, Md.,residents were warned by the cityhealth department last December 27that a glazed dishware with a hollygreen and red pattern, sold duringthe holiday season, was potentially

toxic. In view of possible nationaldistribution, the department notifiedthe Baltimore District office of FDAso that action could be taken at theFederal level, if necessary.

Baltimore City Health Department laboratory tests revealed ahigh percentage of lead in the dish-ware glaze which could be leachedinto liquids or other foods withwhich it came into contact, andcould cause lead poisoning.

M e r c h a n t s k n o w n t o h a v e s o l dt h e s e i t e m s w e r e a s k e d t o d i s c o nt i n u e t h e i r s a l e .

M a i n e - F D A C o o p e r a t i o n T h eM a i n e S t a t e D i v i s i o n o f C o n s u m e rP r o t e c t i o n m e t w i t h F D A ' s B o s t o nD i s t r i c t i n D e c e m b e r t o d i s c u s s amutual agreement whereby theState of Maine inspects sardinemanufacturers, warehouses, andbakeries. Since this agreement wasinitiated, the State of Maine reportsdiscovery of warehouses which hadnever previously been inspected byany agency. State inspection ofthese warehouses has brought aboutvoluntary corrective measures inconstruction of additional storagespace and placement of pallets under warehoused merchandise.

As part of the agreement, Mainesends written reports of its inspections to the Boston District to improve the exchange of inspectioninformation between the agencies.Initial findings indicate that this cooperation is improving consumerprotection.

Can-opener Problem A consumer's complaint brought an investigation of a bakery's operations by theLincoln-Lancaster County HealthDepartment, Lincoln, Nebr. It wasfound that metal filings were beingproduced by the cutting blade of amachine used to open cans of fillingfor rolls and pastries. R. E. Devol,Chief Food Sanitarian, reported that

c o r r e c t i v e m e a s u r e s t o e l i m i n a t ethis problem have been taken bythe bakery.

Drug Safety Talks Representatives of professional, youth, educational and service organizations metunder the auspices of the Twin City(St. Paul/Minneapolis) Federal Executive Board and FDA's Minneapolis District, to discuss safe use ofdrugs in Minnesota. After severalmeetings, the group recommendedthat coordination of drug educationa n d i n f o r m a t i o n b e e s t a b l i s h e du n d e r t h e d i r e c t i o n o f t h e G o v e rn o r ' s o f fi c e . G o v e r n o r H a r o l d L e -V a n d e r h a s n o w r e c o m m e n d e d e stablishment of a drug educationc e n t e r i n h i s s t a t e - o f - t h e - S t a t e m e s

sage to the legislature.

Single System Plans Facets ofthe State-Federal Single SystemConcept are being worked out incooperative efforts between NewYork S ta te and FDA D i s t r i c t o f ficials. George Gerstenberg, Chief,Brooklyn Section, and SupervisoryInspector Joseph Faline conferredwith State officials at Albany lastOctober 16-17 to work out preliminary details for implementation ofthe system. The New York StateDepartment of Agriculture andMarkets is reviewing a suggestednew fo rma t wh i ch w i l l enab le i t sinspection reports to mesh with theF D A ' s .

In addition, the State Board ofPharmacy will implement the SingleSystem Concept for drugs. Theboard has agreed to its line personnel to be trained by the FDA and tomake joint inspections with a viewtoward being commissioned. Theboard has also agreed to take responsibility for over-the-counterdrug work (non-DACA drugs) notbeing covered by the FDA due toshortage of manpower.

FDA Papers / March 1969 / 29

seizures and post office casesSEIZURE ACT IONS charging violation of the Federal Food, Drug, and Cosmetic Act and the Federal Hazardous Sub

stances Act are published when they are reported by the FDA District Office.

A total of 24 seizure actions to remove adulterated, mis- 8 because of contamination, and 2 because of economicbranded, and unsafe products from the consumer market, violations. Other seizures included 2 of vitamins, and 11 ofwere reported in December. These included 11 seizures of drugs (including 1 for veterinary use),foods: 1 because of poisonous and deleterious substances.

P R O D U C T , P L A C E & D A T E S E I Z E DMANUFACTURER (M), PACKER (P),

S H I P P E R ( S ) , D E A L E R ( D )

Lettuce/Landover, Md. 11/27/

FOOD I Poisonous and Deleterious Substances

/lei Finerman Co., Inc./Toltec, Ariz. Contains excessive parathion and toxaphene residues.

Contamination, Spoilage, Insanitary Handling

Cocoa powder/Collinsville, III. 12/12/68 L. Bruno & Sons, Inc./Collinsville, III. (D) Held under insanitary conditions; insect contaminated.Flour/Selma, Ala. 11/12/68

Ginger ale/Hampton, Va. 12/10/68

Perch, breaded/Nashville, Tenn. 12/15/68

Rice/Fresno, Calif. 12/17/68

Salmon, canned, unlabeled/La Conner,Wash. 12/3/68

Tomatoes, canned/New Albany, Miss.10/3/68

Starkville, Miss. 10/21/68

Selma Wholesale Grocery Co., Inc./Selma, Held in a rodent-contaminated warehouseAla. (D)

Suburban Club Carbonated Beverage Co., Moldy.Inc./Baltimore, Md. (M,S)

Channel Fish Co./Boston, Mass. (P,S) Inspection of the packer showed that the productwas prepared and packed under insanitary conditions; E. coli and coagulase positive staphylococci.

California Sun Dry Bulgur Co./Fresno, Calif. Held under insanitary conditions; insect contaminated.

New England Fish Co./La Conner, Wash. (P), Prepared and packed under insanitary conditions./Noyse Island, Alaska (S)

Emerson Canning Co./Reeds Spring, Mo.(M,S)

; fly eggs and maggots.

Mixed fruit/Columbus, Ohio 12/4/68

Economic Violations

Tri-Valley Growers/Modesto, Calif. (P,S) False and misleading vignette depicting grapes andapproximately equal portions of diced peaches and

Mozzarella cheese, whole milk, lowmoisture/Brooklyn, N.Y. 12/9/68

hchmond Co-op Association, Inc.,/Richmond, Vt. (M,S)

Contains less than 45 percent of milk fat.

Vitamins—Dietary Foods

',7?J"'''®'' Formulations, Inc./Milwaukee, Wis. (M,S) Prepared, packed, and held under insanitary condi-1 2 / 11 / 6 8

RMP Vitamin B-12, 30-cc. and 10-cc. vials/ Rocky Mountain Pharmacal Co./Phoenix, Below USP standard of strength.P h o e n i x , A r i z . 1 0 / 1 8 / 6 8 A r i z . ( D )

30 / March 1969 / FDA Papers

M A N U F A C T U R E R ( M ) , P A C K E R ( P ) ,

P R O D U C T , P L A C E & D A T E S E I Z E D S H I P P E R ( S ) , D E A L E R ( D ) C H A R G E S

DRUGS / Human Use

Apacol tablets/Philadelphia, Pa. 12/4/68 S. F. Durst & Co./Philadelphia, Pa. (D), Below labeled strength; inadequate directions for use.C. M. Bundy Co./Cincinnati, Ohio (bulk but no adequate directions can be written for chil8) dren under 6 years of age, since preparation con

tains atropine sulfate.

Bismuth subgallate tablets/Largo, Fla. United Surgical Corp./Largo, Fla. (D) New drug not approved for safety and efficacy.

11/13/68

Consin-Diu tablets, Consin cold capsules/ Formulations, Inc./Milwaukee, Wis. (M,S) Prepared, packed, and held under insanitary condiMilwaukee, Wis. 12/10/68 tions; methods used, facilities, and controls not

in conformity with good manufacturing practice.

Digoxin tablets, Conjutrone tablets.Methenamine Mandelate tablets.

Phenobarbital USP tablets, The-Ephetal

tablets/Milwaukee, Wis. 12/10/68

Fingernail conditioner cream/Indianapolis, Amazing Corp./Groves, Tex. (M,S) New drug not approved for safety and efficacy.

Ind. 11/20/68

Jensenex tablets/Auburn, N.Y. 11/25/68 C. M. Bundy Co./Cincinnati, Ohio (M,S) Contaminated by zinc and copper; not produced under

good manufacturing practice.

Oracon capsules/Plymouth, Mich. 12/13/68 Plymouth Labs./Plymouth, Mich. (M,P) Below labeled strength.

Pituitary gland tablets, 1 gr./Milwaukee, C. M. Bundy Co./Cincinnati, Ohio (M,S) Inadequate directions for use; no full disclosureWis. 12/13/68 labeling.

Propoxyphene HCI w/APC tablets/Plainview, Milan Pharmaceuticals, Inc./Morgantown, New drug not approved for safety and efficacy.

L.I., N.Y. 11/22/68 W.Va. (M,S)

Salipap tablets, Fedacap capsules/Freeport, Formulations, Inc./Milwaukee, Wis. (M,S) Prepared, packed, and held under insanitary condiIII. 11/26/68 tions; methods used, facilities, and controls not in

conformity with good manufacturing practice.

Veterinary / Medicated Feed

Ru-Vi-Otic Powder/Kansas City, Mo. 1. D. Russell Co. Labs./Kansas City, Mo. Below labeled strength in potassium penicillin and

12/20/68 (D) streptomycin sulfate; methods used and facilitiesnot in conformity with good manufacturing practice.

ar.tinns taken in medical cases under provisions of the Postal Fraud Statutes asPOST OFFICE DEPARTIvlENT reported by the Chief Postal Inspect o r .

Fraud Orders Issued by Judicial Officer Under 39 U.S.C. 4005 (Fraud)

January 14,1969: Fraud Order issued against Hydromassagic Research through the mails of "Jaqualator," for $24.95, a device claimedCenter, Los Angeles, Calif. Solicitations of orders and sales to develop and increase size of male erectile tissue.

FDA Papers / March 1969 / 31

notices of judgmentNOTICES OF JUOGMENT on Seizure Actions

FOOD / Poisonous and Deleterious SubstancesEggs, frozen, at Buffalo, W. Dist. N.Y.

Charged 12-31-67: when sh ipped by Brasher Bros. , Inc. , Burbank, Cal i f . ,t h e a r t i c l e c o n t a i n e d t h e a d d e d p o i s o n o u s a n d d e l e t e r i o u s s u b s t a n c eSalmonel la micro-organisms; 402(a)(1) . Consent decree author ized re leaset o E d w a r d C . F a l l o n , I n c . , B u f f a l o , N . Y. , f o r r e c o n d i t i o n i n g . ( 1 )

Squash, zucchini, fresh, Purr, at El Paso, W. Dist. Tex.Charged 3-29-68: when shipped by Van Buren County Fruit Exchange, Inc.,Pompano Beach, Fla., the article contained the pesticide chemical endrinfor which there was no tolerance or exemption; 402(a)(2)(B). Consent decree o rdered des t ruc t ion . (2 )

FOOD / Contamination, Spoilage, Insanitary HandlingBeans, Great Northern, at Cairo, E. Dist . I I I .

Charged 1-4-68: while held by Greaney Brokerage Co., Cairo, III., thearticle contained rodent filth and was held under insanitary conditions;402(a)(3), 402(a)(4). Default decree ordered destruction. (3)

Beans, turtle-soup, black, at Miami, S. Dist. Fla.Charged 12-4-67: while held by Green Bros., Inc., Miami, Fla., the articlecontained insect filth and was held under insanitary conditions; 402(a)(3),402(a)(4). Default decree ordered destruction. (4)

Candy, at Laredo, S. Dist. Tex.Charged 12-15-67: while held by Mexican Import Co., Laredo, Tex., thearticle contained insect filth and was held under insanitary conditions;402(a)(3), 402(a)(4). Default decree ordered destruction. (5)

Caraway seed, sesame seed, poppyseed, and shelled peanuts, at Detroit, E.D i s t . M i c h .Charged 12-11-67: while held by Philip Olander & Co., Detroit, Mich., thearticles contained rodent filth and were held under insanitary conditions;recond?t\'ontng^ (6^ Consent decree authorized release to dealer for

Cashew nuts, shelled, at Denver, Dist. Colo.Charged 1-25-68: when shipped by Hollander Trading Corp., New York.

tK,.article, labeled in part "She'led Cashew Nuts Packed byLekshmi Vihar Cashew Industries Quilon—I.S. India," contained insectfilth; 402(a)(3). Default decree ordered destruction. (7)

Chili pods, dried, at Los Angeles, C. Dist. Calif.Charged 2-26-68: while held by Weber Truck & Warehouse, Los Angeles,Calif, the article contained rodent and insect filth and was held underinsanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorizedrelease to Thomas P. Gonzalez Corp., Los Angeles, Calif., for salvaging.

Chocolate drink, bottled, at Cincinnati, S. Dist. Ohio.Charged 90 or about 1-29-68: when shipped by Chocolat Royale, Ltd.(The Glacier Co.), Cincinnati, Ohio, to Louisville, Ky., and returned tothe shipper, the article contained insect filth and mold; 402(a)(3). Consentdecree authorized release to the shipper for destruction of the chocolatedrink and salvaging of the bottles. (9) i^nuLuidie

Cocoa beans, at Brooklyn, E. Dist. N.Y.conta ined insect and

Coffee beans, green, at Port Allen, E. Dist. La."""6® '■"'■t Commission,Port Allen, La., the article contained bird filth and was held under in-

conditions; 402(a)(3), 402(a)(4). Consent decree authorized re-lease to Lafaye & Arnaud, New Orleans, La., for salvaging. (11)Cookies, Dutch Village, at Paramount, C. Dist. Calif.

shipped by Bakkers Royal Dutch Cookies, Inc.,Dryer, Uty, the article contained insect filth and had been preparedd«re?'Slfdered"dlstr:ction''Tl2r"'''''""''

Cornhusks, at New Orleans, E. Dist. La.Charpd 1-3-68: when shipped by M-G Farm Service, Weimar, Tex., the

'H P®''' • • • M-G inc. Feed Division Weimar,Texas, contained insect filth and moldy cornhusks; 402(a)(3) Defaultd e c r e e o r d e r e d d e s t r u c t i o n . ( 1 3 ) '

Danish mix, donut flour, and donut sugar, at Franklin Park, N. Dist IIICharged 12-7-67: while held by Chesapeake & Ohio Railway Co., FranklinPark, Ml., the articles contained rodent filth and were held under insani-tary conditions; 402(a)(3), 402(a)(4). Consent decree authorized releaseto the railway company for salvaging. (14)

Filberts, shelled, at Denver, Dist. Colo.Nut Growers, Dundee, Oreg.,the article, labeled "Nut Sweet Brand Filbert Meats . . . Packed By

Norpac Growers, Inc. Newberg-Dundee, Oregon," contained E. coli andpacked under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (15)

Flour, at New Orleans, E. Dist. La.Chargy 11-28-67: while held by George W. Groetsch, New Orleans, La..®"'' "3® '^®''' insanitary conditions;402(a)(3), 402(a)(4). Default decree ordered destruction. (16)

Flour, at West Point, N. Dist. Ga.Charpd 12-8-67: while held by West Point Wholesale Grocery, West

u o f 3 n d w a s h e l d u n d e r i n s a n i t a r yraler?or'saWaging''(17) '''' *• release to

Garlic, at San Juan, Dist. P.R.^2-18-67: while held for sale, the article contained insect filth;y2(a)(3). Consent decree authorized release to Quintana Hermanos, IncS a n J u a n , P . R . , f o r s a l v a g i n g . ( 1 8 ) '

Ham, chopped, canned, at Los Angeles, C. Dist. Calif.

Charged 5-8-68: while held for sale, the article contained decomposedham and was unfit for food by reason of presence of swol len cans; 402(a)(3). Default decree ordered destruction. (19)

Instant breakfast (Chocolate-mint flavor), Carnation, at Denver, Dist. Colo.Charged 2-13-68: when shipped by Carnation Co., St. Joseph, Mo., thear t i c le con ta ined insec t fi l t h ; 402(a ) (3 ) . De fau l t dec ree o rde red des t ruct i o n . ( 2 0 )

Meat, beef, frozen, at Canton, N. Dist. Ohio.Charged 1-18-68: when shipped by Beacon Foods, Highland Park, III., thear t ic le , labe led in par t "The A l len Pack ing Co. , E l i zabeth , N.J . . . . Tr -Beef-Cheek-Meat," contained decomposed meat; 402(a)(3). Consent decreeauthorized release to Food Fair Stores, Inc., t/a The Allen Packing Co.,El izabeth, N.J., for salvaging. (21)

Meat, potted, Baxter, at Los Angeles, C. Dist. Calif.Charged 9-26-67: when shipped by United Packers, Inc., Opelousas, La.,the article contained decomposed meat; 402(a)(3). Default decree orderedd e s t r u c t i o n . ( 2 2 )

Milk, nonfat, dried, at Mendota, N. Dist. III.Charged 12-8-67: while held by Mendota Creamery Co., Mendota, III., thearticle contained rodent filth and was held under insanitary conditions;402(a)(3), 402(a)(4). Consent decree authorized release to National CheeseCo., for salvaging. (23)

Onions, pickled, and olives, unpitted, pitted, and pimento stuffed, at Denver,D i s t . C o l o .Charged on or -about 11-27-67: while held by Superior Honey & OliveCo. , o f Co lo rado , Inc . , the a r t i c les con ta ined insec t fi l th and were he ldunder insanitary conditions; 402(a)(3), 402(a)(4). Consent decree condemned the articles. The onions were subsequently destroyed and theolives were released to the dealer for reconditioning. (24)

^Paprika, powdered, at New Orleans, E. Dist. La.Charged 1-23-68: while held by Lykes Brothers Steamship Co., Inc.. NewOrleans, La., the article was held under insanitary conditions; 402(a)(4).Consent decree authorized release to dealer for reconditioning. (25)

Pecan pieces, Kentucky Kernel, at Indianapolis, S. Dist. Ind.Charged 2-1-68: when shipped by Roper Pecan Co., Hickman, Ky., thearticle contained E. coli and had been prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruct i o n . ( 2 8 )

Pecans, shelled, at Birmingham, N. Dist. Ala.Charged 1-8-68: when shipped by H. G. Bergan Pecan Shelling Plant, NewRoads, La., the article contained E. coli and had been prepared andpacked under insanitary conditions; 402(a)(3), 402(a)(4). Default decreeauthorized donation to public institution for use as animal feed. (27)

Pecans, shelled, at Odessa, W. Dist. Tex.Charged 1-8-68: when shipped by The Thompson Co., Inc., Searcy, Ark.,the article contained E. coli and had been prepared and packed underinsanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorizedrelease to shipper for reconditioning. (28)

Pepper, black, at Brooklyn, E. Dist. N.Y.Charged 5-29-68: while held for sale, the article contained insect filthand was moldy; 402(a)(3). Consent decree authorized release to FrenchAmerican Banking Corp., New York, N.Y., for salvaging. (29)

Perch fillets, frozen, at Detroit, E. Dist. Mich.sale, the article contained decomposedfish; 402(a)(3). Default decree ordered destruction. (30)

Popcorn, at Dallas, N. Dist. Tex.Charpd 11-28-67: while held by Matthews Candy Co., Dallas, Tex., thearticle was held under insanitary conditions; 402(a)(4). Consent decreeauthorized release to dealer for reconditioning. (31)

Popcorn and cornmeal, at Vicksburg, S. Dist. Miss.Charpd 1-10-.68: whMe held by P. P. Williams Co., Vicksburg, Miss., the

insanitary conditions;402(a)(3), 402(a)(4). Default decree ordered destruction. (32)Potatoes, french fried, frozen. New Sweden, at Laramie, Dist. Wyo

shipped by Idaho Potato Growers, Inc., Aberdeenbeen prepared and packed under insanitaryconditmns; 4q2(a)(4). Consent decree authorized release to public/charitable institutions for use as animal feed. (33)

Pretzels, citric acid, and sodium bisulfite, at Kaysville, Dist. Utah'29-68: while held by Clover Club Foods Co., Inc., kaysville,Utah the articles contained rodent filth and were held under insanitary

conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction

Rice, at Atlanta, N. Dist. Ga.Charged 12-6-67: while held by Raley Bros., Inc., Atlanta, Ga., the ar-ticle was held under insanitary conditions; 402(a)(4). Consent decreeordered destruction. (35)

Rice, at Emeryville, N. Dist. Calif.Charged 12-7-67: while held by Saroni Sugar & Rice, Inc., Emeryville,Calif the article contained rodent filth and was held under insanitaryconditions; 402(a)(3), 402(a)(4). Consent decree authorized release todealer for salvaging. (36)

Rice, at Miami, S. Dist. Fla.Charged 2-6-68: while held by Great Southern Wholesale Grocery CorpMiami, Fla., the article .contained rodent and bird filth and was held

destruction"' (37) °" ' '°" ' 02(a)(4). Default decree orderedRice, at Philadelphia, E. Dist. Pa.

Charged 1-29-68: when shipped by Comet Rice Mills, Inc., StuttgartArk., the article contained insect and rodent filth and had been prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (38)

Salmon, canned, at Seattle, W. Dist. Wash.Charged 11-16-67: when shipped by Marine Foods Packing Co., Yakutat,

32 / March 1969 / FDA Papers

Alaska, as frozen salmon and canned at Seattle, Wash., the articlecontained decomposed fish; 402(a)(3). Consent decree authorized releaseto shipper for salvaging. (39)

Shrimp, breaded, frozen. Treasure, 3 seizure actions at Chicago, N. Dist. ML,and Urbana, E. Dist. III.Charged 11-17-67, 11-2-67, and 11-9-67; when shipped by Morgan CityFreezer & Cold Storage Co., Morgan City, La., the article containedbacterial filth and was prepared and packed under insanitary condi-

(40)S' 402(a)(4). Default decrees ordered destruction.Shrimp, frozen, at Brownsville, S. Dist. Tex.

Charged 12-29-67: when shipped by Florida Seafood Canning Co., Inc.,Apalachicola, Fla., the article contained decomposed shrimp; 402(a)(3).Default decree ordered destruction. (41)

Tomatoes, canned, at East St. Louis, E. Dist. III.Charged 1-16-68: while held for sale, the article contained decomposedtomatoes—402(a)(3); and when shipped by Naas Foods, Inc., Portland,Ind., the article, labeled in part "Switzer Brand Crushed Whole Tomatoes . . . Packed For Switzer's Inc., East St. Louis, Illinois," lackedconformity to the standard of identity, since the article was improperlysealed, having leaks at the can seams—403(g)(1). Consent decree authorized release to shipper for salvaging. (42)

Walnuts, shelled, at Omaha, Dist. Nebr.Charged 1-3-68: when shipped by Barnes & Son, Inc., Bolivar, Mo., thearticle contained E. coli; 402(a)(3). Default decree ordered destruction.(43)

Walnuts, shelled, at Vancouver, W. Dist. Wash.Charged 1-26-68: when shipped by Compton Nut Co., Dundee, Greg., thea r t i c l e c o n t a i n e d E . c o l i a n d h a d b e e n p r e p a r e d a n d p a c k e d u n d e ri n s a n i t a r y c o n d i t i o n s ; 4 0 2 ( a ) ( 3 ) , 4 0 2 ( a ) ( 4 ) . D e f a u l t d e c r e e o r d e r e d d es t r u c t i o n . ( 4 4 )

Wheat, at Kansas City, Dist. Kans.Charged "1-2-68: when shipped by Farmers Cooperative Association, Dallas,S. Dak., the article contained insect and rodent filth; 402(a)(3). Consentdecree author ized re lease to Wolcot t & L inco ln , Inc . , KansasCi ty, Kans. ,f o r sa l vag ing . (45 )

Wheat, at Spokane, E. Dist. Wash.Charged 12-7-67: when shipped by Edinburg Farmers Elevator Co., Edin-burg, N. Dak., the article contained rodent filth; 402(a)(3). Consent decreeauthor ized re lease to shipper for salvaging. (46)

Wheat, at Spokane, E. Dist. Wash.Charged 3-18-68: when shipped by Farmers Union Elevator Co., BigSandy, Mont., the article contained rodent filth; 402(a)(3). Consentd e c r e e a u t h o r i z e d r e l e a s e t o s h i p p e r f o r s a l v a g i n g . ( 4 7 )

Wheat germ and rice, at Los Angeles, C. Dist. Calif.Charged 1-16-68: while held by Kahan & Lessin Co., Inc., Los Angeles,Calif., the articles contained rodent filth and were held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction.(48)

FOOD / Economic and Labeling Violations

Catsup, banana. Papa, and assorted Japanese rice crackers, at Los Angeles,C . D i s t . C a l i f . . .Charged 11-9-67: when shipped by Godofredo Lorenzana, Manila, Philippines, the Papa banana catsup was imitation catsup and its label lackedthe word "Imitation" and an accurate statement of quantity of contentsin terms of avoirdupois pounds and ounces as required by law, and thearticle lacked conformity to the standard of identity for catsup, sinceit contained unauthorized ingredients—403(c), 403(e)(2), 403(g)(1): andwhen shipped by various unknown shippers from Japan, the labeling ofthe rice crackers failed to declare the presence of artificial coloring—403(k). Default decree ordered destruction. (49)

Chili pepper, ground, at Phoenix, Dist. Ariz. x r^u • « • «Charged 2-13-68: while held by Bernard Peralta, Phoenix, Ariz., afterrepacking, the article labeled "Hot Crush Birds Beak 31/2 Oz. B. Peralta,Phoenix, Arizona," was short weight (approx. 7 percent), and the labellacked the common or usual name of the food; 403(e)(2), 403(i)(l). Default decree authorized donation to charitable institution. (50)

Cookies, diet. Prince, at Boston, Dist. Mass.Charged 12-8-67: when shipped by Prince Butter Cookie Co., Inc., Brooklyn, N.Y., the name "Diet Cookies" and label statements "artificiallysweetened" and "made without sugar" were false and misleading,since the article had no special value in weight reduction and weightcontrol; 403(a). Default decree authorized donation to charitable instit u t i o n . ( 5 1 )

Lemon-lime concentrate, at Lynn, Dist. Mass.Charged 1-19-68: when shipped by Beverage Developers, Anaheim, Calif.,the label statement "Lemon-Lime Concentrate" was false and misleading,since the article contained no lime juice; 403(a). Consent decree authorized release to shipper for reconditioning. (52)

Margarine, at Woodville, S. Dist. Miss.Charged 12-27-67: when shipped by Fort Worth Poultry & Egg Co., FortWorth, Tex., the article, labeled in part "IGA Table Rite Corn OilMargarine . . . Distributed by Independent Grocers' Alliance Distributing Co., Chicago," had a valuable constituent, vitamin D, in part omittedor abstracted from the article, and the label was false and misleading,since the article contained less than the declared amount of vitaminD; 402(b)(1), 403(a). Default decree authorized donation to public/chari tab le ins t i t u t i ons . (53 )

Meat stabilizers, Murray's M-500 and Macco M-505, at Buffalo, W. Dist. N.Y.Charged 4-10-68: when shipped by McClancy Spice Co., Beaumont, Tex.,the label statements of being suitable for use in meat and of beingUSDA certified food colors were false and misleading, since New YorkState law prohibited use of such articles in meats, and since the articlescontained coloring not certified by United States Department of Agriculture; 403(a). Default decree ordered destruction. (54)

Taco sauce, Old El Paso, at Little Rock, E. Dist. Ark.Charged 1-12-68: when shipped by Valley Canning CO., Div. of MountainPass Canning Co., Anthony, Tex., the article was short weight (approx.5 percent); 403(e)(2). Default decree authorized donation to Statei n s t i t u t i o n . ( 5 5 )

Tomatoes, canned, at Kansas City, W. Dist. Mo.Charged 3-13-68:; when shipped by U.S.P. Corp., San Jose, Calif., the

article, labeled in part "Lee Tomatoes . . . Isis Foods, Inc., Distributors, Kansas City, Missouri," fell below standard of quality becauseof excess peel; 403(h)(1). Default decree authorized donation to charitable institution. (58)

Tomato juice, at Williamsburg, E. Dist. Ky.Charged 1-10-68: when shipped by Kenneth N. Rider Co., Inc., Trafalgar,Ind., the article was short volume (approx. 2 percent); 403(e)(2). Default decree authorized donation to charitable institution. (57)

Water ices of various fruit flavors, Hawaiian, at Jacksonville, M. Dist. Fla.Charged 1-4-68: when shipped by Circus Ices, Inc., Anaheim, Calif.,t h e l a b e l s t a t e m e n t s " L o w I n C a l o r i e s " a n d " N o B u t t e r f a t " w e r e m i sleading, since they suggested and implied that the article was unlikeo t h e r w a t e r i c e s b y r e a s o n o f i t s c a l o r i e c o n t e n t a n d a b s e n c e o fbutterfat, and that the article in comparison with other water ices,w a s o f u n u s u a l v a l u e f o r w e i g h t c o n t r o l ; t h e l a b e l s t a t e m e n t " R e a lFruit in Every Bite" was misleading, since the article did not containa significant amount of fruit; and the article failed to conform to theidentity standard, since it was deficient in fruit ingredient, and sincethe presence of artificial flavoring and coloring was not stated immediately and conspicuously preceding or following the name of the article'sfruit flavor; 403(a), 403(g)(1). Default decree ordered destruction. (58)

VITAMINS / DIETARY FOODSDuras t ress v i t am in capsu les , a t Sou th Bend , N . D i s t . I nd .

Cha rged 1 -19 -65 : when sh i pped by S t r i p -Pack Co . , Ch i cago , ML , wh i chhad packed and labeled the article on order of North East Pharmacals,L t d . , S o u t h B e n d , I n d . , t h e l a b e l s t a t e m e n t t h a t t h e n e e d i n h uman nutr i t ion for calc ium pantothenate was not establ ished was fa lse andm i s l e a d i n g ; a n d t h e n a m e " D u r a s t r e s s " a n d t h e l a b e l i n g o f t h e a r t i c l ew e r e f a l s e a n d m i s l e a d i n g i n r e p r e s e n t i n g t h e a r t i c l e t o b e e f f e c t i v ein prov id ing more endurance under s t ress, prevent ing and t reat ing s t ressc o n d i t i o n s , f a t i g u e , i n f e c t i o n s , p r o m o t i n g r e c o v e r y f r o m i n j u r y, b r u i si ng and l ace ra t i ons and i nc reas ing a th l e t i c capab i l i t i e s ; 403 (a ) , 502 (a ) .North East Pharmacals, Ltd. , c la imed the ar t ic le and denied the charges.A f t e r t h e G o v e r n m e n t s e r v e d w r i t t e n i n t e r r o g a t o r i e s , J a m e s P. L e d d ymoved fo r a p ro tec t i ve o rde r aga ins t answer ing the in te r roga to r ies s ta ting thai; he personally was doing business as North East Pharmacals, Ltd.,that the business was not incorporated, and that the information soughtwould, if divulged, subject Leddy to criminal prosecution. The courtgranted Leddy's mot ion saying:

" A f t e r c a r e f u l c o n s i d e r a t i o n o f t h e i s s u e i n v o l v e d a n d a p p l y i n g t h etes t s ta ted in l ibe l lan t 's b r ie f in suppor t o f i t s pos i t ion , tha t i s , whetherthe answers 'would expose the witness to the danger of prosecutiono r r e s u l t i n d i s c l o s u r e o f f a c t s w h i c h f o r m a n e c e s s a r y a n d e s s e n t i a ll i n k i n a c h a i n o f e v i d e n c e t h a t w o u l d b e s u f fi c i e n t t o c o n v i c t h i m o fany crime,' the Court does now find that the motion should be grantedand c la iman t re l i eved f rom hav ing to answer any o f the in te r roga to r ies .Boyd V. United States, 116 U.S. 616 (1885). See also Sippit Cups v.M ichae l ' s Crea t ions , 189 F. Supp . 58 (E .D .N .Y. I960 ) . "

Thereafter the claimant moved for partial summary judgment to thee f f e c t t h a t t h e n a m e " D u r a s t r e s s " d i d n o t i n a n d o f i t s e l f r e p r e s e n t ,infer, or suggest any false claim for vitamins. The court granted thec l a i m a n t ' s m o t i o n a n d a l s o g r a n t e d t h e c l a i m a n t ' s r e q u e s t t o w i t h d r a was a claimant. Following the claimant's withdrawal and consent to thedestruction of the article, the article was ordered condemned andd e s t r o y e d . ( 5 9 )

Kelp tablets, at Cincinnati, S. Dist. Ohio.Charged on or about 1-8-68: while held by Spatz Health Foods, Cincinnati, Ohio, after repacking, the article contained the nonconforming foodadditive iodine, and its labeling lacked required information concerningits purported special dietary uses; 402(a)(2)(C), 403(j). Default decreeordered des t ruc t ion . (80 )

Nu Youth Gland Food vitamin capsules, at Marion, N. Dist. Ohio.Charged 2-9-68: while held by Nu-Youth Products Co., Marion, Ohio,a f t e r t he a r t i c l es ' manu fac tu re f r om ac t i ve i ng red ien t s sh i pped i n i n t e rstate commerce, the dealer's label statement "Nu-Youth Gland FoodVitamin Formula #10 with choline, inositol, iron, liver, minerals, andrutin" was false and misleading in representing and suggesting thatthe article had some special or unusual effect on glands, and thedealer's accompanying printed promotional cards, letters, leaflets, andfolders contained false and misleading claims, including claims forlonger life, regaining sexual powers, and revived energy; 403(a). Defaultdecree ordered des t ruc t ion . (81)

DRUGS / Human Use

Absopure distilled water, U.S.P,, at Mogadore, N. Dist. Ohio.Charged 2-21-68: when shipped by Absopure Water Co., Detroit, Mich.,t h e a r t i c l e c o n t a i n e d b a c t e r i a l fi l t h a n d i t w a s n o t p a c k a g e d a s p r escribed in the U.S.P., in that it is not preserved in tight containers;402(a)(3), 501(a), 502(g). Default decree ordered destruction. (82)

Ahead Hair Restorer cream, at Pittsburgh, W. Dist. Pa.Charged 6-14-67: when shipped by Kelly Products, Inc., Royal Oak, Mich.,the article was a new drug without an effective approved Ne\v DrugApplication, the label lacked the established name of each active ingredient, and the article had been processed in an unregistered establishment; 505(a), 502(e)(l)(A)(ii), 502(o). Default decree ordered destruct i o n . ( 8 3 )

Alerglmlst Intranasal solutions A and B, at Charlotte, W. Dist. N.C.Charged 9-3-65: when shipped by Brunson Corp., Miami Springs, Fla.,the articles were new drugs without effective approved New Drug Applications; 505(a). The shipper requested transfer of the action to theMiddle District of North Carolina. Since it appeared to the court thatcondemnation was sought on new drug charges and that this sort ofproceeding .had not been among those designated by Congress as removable, the court denied the shipper's request. The court also orderedthat the shipper answer the charges or the court would condemn thedrugs. The shipper failed to answer and the court condemned the drugsand ordered them dest royed. (84)

Amphetamine and barbiturate drugs, at Denver, Dist. Colo.Charged 11-28-67: while held by James H. Dickson, D.O., Denver, Colo.,complete and accurate inventory records and receipt and dispositionrecords of all such drugs were not prepared and kept; 301(q)(4). Defau l t dec ree o rdered des t ruc t ion . (85 )

Amphetamine, barbiturate, and other depressant or stimulant drugs, at Baltimore, Dist. Md.Charged 11-30-67: while held by Louis J. Glass, M.D., Baltimore, Md.,

FDA Papers / March 1969 / 33

complete and accurate receipt and disposition records were not prepared and kept; 301(q)(4). Default decree ordered destruction. (66)

Amphetamine, barbiturate, and other depressant or stimulant drugs, atBrooklyn, E. Dist. N.Y.Charged 1-4-68: while held by Mellor's Drug Store, Brooklyn, N.Y., complete and accurate receipt and disposition records were not preparedand kept; 301(q)(4). Default decree ordered destruction. (67)

Amphetamine, barbiturate, and other depressant or stimulant drugs, at Denver, Dist. Colo.Charged 11-27-67: while held by Hahn Pharmacy, Denver, Colo., complete and accurate inventory records and receipt and disposition records of all such drugs were not prepared and kept; 301(q)(4). Defaultdecree ordered des t ruc t ion . (68)

Amphetamine, barbiturate, and other depressant or stimulant drugs, at Denver,D i s t . C o l o .Charged 12-8-67: while held by T. K. Pharmacy, Inc., Denver, Colo.,complete and accurate receipt and disposition records of all such drugswere not prepared, obtained, and kept; 301(q)(4). Consent decree authorized release to dealer for preparation of records. (69)

Amphetamine , barb i tu ra te , and o ther depressan t o r s t imu lan t d rugs , a t Denver, Dist. Colo.Charged 1-4-68: wh i le he ld by Nor th Drug Co. , t /a Hatch 's Drugs, Denv e r, C o l o . , c o m p l e t e a n d a c c u r a t e i n v e n t o r y r e c o r d s a n d r e c e i p t a n ddisposition records of all such drugs were not prepared, obtained, andk e p t ; a n d t h e d e a l e r ' s e s t a b l i s h m e n t w a s a t t h a t t i m e n o t r e g i s t e r e dfor d is t r ibut ing such drugs; 301(q)(4) . 301(p) . Consent decree author izedre lease t o dea le r f o r p repa ra t i on o f r eco rds . ( 70 )

Amphetamine, barbiturate, and other depressant or stimulant drugs, at Glen-dale, C. Dist. Calif.Charged 12-5-67: while held by Fred 0. Caller, M.D., Glendale, Calif.,complete and accurate inventory records and receipt and dispositionr e c o r d s w e r e n o t p r e p a r e d a n d k e p t ; 3 0 1 ( q ) ( 4 ) . C o n s e n t d e c r e e a uthorized release to dealer for preparation of records. (71)

Amphetamine, barbiturate, and other depressant or stimulant drugs, at HazelPark, E. Dist. Mich.Charged 1-3-68: while held by Victor Drugs, Hazel Park, Mich., completeand accurate inventory records and receipt and disposition recordsof all such drugs were not prepared and kept; 301(q)(4). Consent decreeauthorized release to dealer for preparation of records. (72)

Amphetamine, barbiturate, and other depressant or stimulant drugs, at IslandPark, E. Dist. N.Y.Charged 2-2-68: while held by Austin Pharmaceuticals, Inc., Island Park,N.Y., complete and accurate inventory records and receipt and disposition records of all such drugs were not prepared, obtained, and kept;301(q)(4). Default decree ordered destruction. (73)

Amphetamine, barbiturate, and other depressant or stimulant drugs, at Kansas City, W. Dist. Mo.Charged 12-7-67: while held by Santa Fe Drug Co., Kansas City, Mo.,complete and accurate inventory records and receipt and dispositionrecords of all such drugs were not prepared and kept; 301(q)(4). Default decree ordered destruction. (74)

Amphetamine, barbiturate, and other depressant or stimulant drugs, at Littleton, Dist. Colo.Charged 12-5-67: while held by Zemel's Rexall Drug Store, Littleton,Colo., complete and accurate inventory records and receipt and disposition records of all such drugs were not prepared and kept; 301(q)(4).Default decree ordered destruction. (75)

Amphetamine, barbiturate, and other depressant or stimulant drugs, at LovesPark, N. Dist. III.Charged 12-12-67: while held by Mauco, Inc., Loves Park, Ml., completeand accurate inventory records and receipt and disposition records ofall such drugs were not prepared and kept; 301(q)(4). Consent decreeauthorized release to dealer for preparation of records. (76)

Amphetamine, barbiturate, and other depressant or stimulant drugs, atOklahoma City, W. Dist. Okla.Charged on or about 12-19-67: while held by Heritage Prescription &Supply Co., complete and accurate inventory records and receipt anddisposition records of all such drugs were not prepared and kept;301(q)(4). Default decree authorized release to public institution. (77)

Amphetamine, barbiturate, and other depressant or stimulant drugs, at SantaMonica, C. Dist. Calif.Charged 12-18-67: while held by Central Pharmaceutical Co., SantaMonica, Calif., complete and accurate inventory records and receiptand disposition records were not prepared and kept; 301(q)(4). Defaultdecree ordered destruction. (78)

Amphetamine, barbiturate, and other depressant or stimulant drugs, at Sheffield, N. Dist. Ala.Charged 1-16-68: while held by Sheffield Pharmacy, Sheffield, Ala.,complete and accurate inventory records and receipt and dispositionrecords were not prepared and kept; 301(q)(4). Consent decree authorizedrelease to dealer for preparation of records. (79)

Amphetamine, barbiturate, and other depressant or stimulant drugs, at Tulsa.N . D i s t . O k l a .Charged 8-7-67: while held by Kay Pharmacal Co., Tulsa, Okla., completeand accurate receipt and disposition records of all such drugs werenot prepared and kept, and a portion of such articles had been soldand delivered outside the ordinary and authorized course of the dealer'sbusiness; 301(q)(4), 301(q)(2). Consent decree authorized release todealer for preparation of records. (80)

AmphjBtamine, barbiturate, and other depressant or stimulant drugs, at Waco,Charged 11-22-67: while held by B & B Drug Store, Waco, Tex., complete and accurate inventory records and receipt and disposition recordsof all such drugs were not prepared and kept; 301(q)(4). Default decreeordered destruction. (81)

Amphetamine sulfate tablets and capsules, and amphetamine and desoxyephed-rine hydrochloride tablets, at Rochester, W. Dist. N.Y.Charged 1-31-68: while held by Frederick F. Offenberger, M.D., Roches-ter, N.Y., complete and accurate receipt and disposition records of allsuch drugs were not prepared, obtained, and kept; 301(q)(4). Defaultdecree ordered destruction. (82)

Amphetamine, barbiturate, and methamphetamine, and combinations of am

phetamines, barbiturates, and methamphetamine, at San Gabriel, C. Dist.C a l i f .Charged 10-27-67: while held by S. Philip Meyers, M.D., at San Gabriel,Calif., complete and accurate inventory records and receipt and disposit ion records were not prepared and kept ; 301(q) (4) . Consentdecree authorized release to dealer for preparation of records. (83)

Aspirin tablets, U.S.P., at Auburn, N. Dist. N.Y.Charged 1-5-68: while held by Jenkins Labs., Inc., Auburn, N.Y., afterhaving manufactured the article from ingredients shipped in interstatecommerce, the circumstances of the article's manufacture, processing,packing, and holding lacked conformity with current good manufacturingpractice; the quality of the article fell below U.S.P. standards, sincethe article failed the U.S.P. disintegration test; the label lacked theestablished name of the article, and the labeling lacked adequate directions for use and adequate warning against accidental ingestion oroverdose by children; 501(a)(2)(B), 501(b), 502(e)(l)(A)(i), 502(f)(1), 502(f)(2). Default decree ordered destruction. (84)

Aspirin tablets, enteric coated, U.S.P., at New Castle, S. Dist. Ind.Charged 2-1-68: when shipped by Plymouth Laboratories, Inc., Plymouth,Mich., the article's quality fell below, and the article's strength differed from, U.S.P. standards with respect to potency and disintegration;501(b). Default decree ordered destruction. (85)

Bacitracin ointment, U.S.P., at Canton, Dist. Mass.Charged 1-4-68: when shipped by McKesson Laboratories, Bridgeport,Conn., the article's strength differed from U.S.P. standard since thearticle was deficient in bacitracin, and the article was not from acertified batch or exempt from antibiotic certification; 501(b), 502(1).Default decree ordered destruction. (86)

Bandage, adhesive, Elastoplast, U.S.P., at Boston, Dist. Mass.Charged 11-16-67: when sh ipped by Duke Labora tor ies , Inc . , South Nor -walk, Conn., the article's quality fell below the U.S.P. standards, andthe label statement "Sterilized" was false and misleading as applied toa product in wrappers which were not completely sealed, and the articlewas no t packaged as p resc r ibed by the U .S .P. ; 501(b ) , 502(a ) , 502(g ) .Defau l t decree ordered dest ruct ion. (87)

Chemicr ine #2 tab le ts and Chemi lo id #6 tab le ts , a t Gardena, C . D is t . Ca l i f .C h a r g e d 2 - 1 4 - 6 8 : w h i l e h e l d b y C h e m i c o o f G a r d e n a , I n c . , G a r d e n a ,C a l i f . , a f t e r h a v i n g r e p a c k e d a n d r e l a b e l e d t h e a r t i c l e s , t h e l a b e l i n gconta ined fa lse and mis lead ing c la ims for increas ing ce l lu lar metabol ism,a n d a s a n a d j u n c t i n t h e t r e a t m e n t o f c o n s t i t u t i o n a l o b e s i t y ; t h elabel lacked the name and place of business of the manufacturer, packer,or distributor, an accurate statement of quantity of contents, theestablished name of the^ drug, and the established name and quantityof each active ingredie^nt; the articles were prescription drugs andf a i l e d t o b e a r t h e p r e s c r i p t i o n l e g e n d ; a n d t h e C h e m i l o i d # 6 w a sdangerous to health when used in the dosage or with the frequencyand duration prescribed in its labeling; 502(a), 502(b)(1), 502(b)(2),502(e)(l)(A)(i), 502(e)(l)(A)(ii), 503(b)(4), 502(]). Default decree orderedd e s t r u c t i o n . ( 8 8 )

Compound ca tha r t i c p i l l s , N .F. X I , a t A t l an ta , N . D i s t . Ga .Charged 12-18-67: while held by R. G. Cunwody & Sons, Atlanta, Ga.,a f t e r r e p a c k i n g t h e a r t i c l e i n p a r t f r o m b u l k , t h e r e p a c k l a b e l l a c k e dthe es tab l i shed name o f each ac t i ve i ng red ien t , and s ta temen ts o f t heq u a n t i t y o f t h e c a l o m e l i n g r e d i e n t a n d w h e t h e r t h e c a l o m e l w a s aderivative or preparation of mercury; 502(e)(l)(A)(ii). Default decreeorde red des t ruc t i on . ( 89 )

Da Costa tablets, at Buffalo, W. Dist. N.Y.Charged 1-29-68: when the article was shipped by Richlyn Laboratories,I n c . , P h i l a d e l p h i a , P a . , a n d w h i l e i t w a s h e l d b y D i r e c t L a b o r a t o r i e s ,Inc., Buffalo, N.Y., after such firm had labeled a portion of the article,the labeling lacked adequate directions for use and did not complywith the Rx drug exemption requirement for disclosure of information;5 0 2 ( f ) ( 1 ) . C o n s e n t d e c r e e a u t h o r i z e d r e l e a s e t o s h i p p e r f o r r e l a b e ling. (90)

Depressant or stimulant drugs, at Los Angeles, C. Dist. Calif.Charged 4-24-67: while held by John C. Wahl, t/a Lazelle Labs., LosAngeles, Calif., the wholesaler, jobber, and distributor of said drugsh a d s o l d a n d d i s p o s e d o f t h e m o t h e r t h a n i n t h e u s u a l c o u r s e o f h i sbusiness; 301(q)(2). Default decree ordered destruction. (91)

Depressant, stimulant, and other prescription drugs, at Pembroke, S. Dist. Ga.Charged 11-9-67: while held by Pembroke Drug Co., Pembroke, Ga., thedepressant and stimulant drugs were in the possession of the dealerwho was not in compliance with local laws regulating the practice ofpharmacy; complete and accurate inventory and receipt and dispositionrecords for certain depressant and stimulant drugs were not prepared,obtained, and kept; and the labeling of the other prescription drugs,which had been shipped in interstate commerce into Georgia, lackedadequate directions for use and was not exempted therefrom, sincethe drugs were in the possession of the dealer who was not lawfullyengaged in dealing in prescription drugs; 301(q)(3), 301(q)(4), 502(f)(1). Consent decree authorized release to William Eugene Smith,M.D., owner of Pembroke Drug Co., for preparation of required records.(92)

Fade antacid tablets, at Jacksonville, M. Dist. Fla.Charged 2-23-68: when shipped by an unknown shipper, giving a fictitiousaddress in Oaklawn, III., the label statement "Fade Pain Fast" wasfalse and misleading, since the article could not relieve pain, and thelabel lacked the name and place of business of the manufacturer, packer,

o r distributor; 502(a), 502(b)(1). Default decree ordered destruction.Femicin salicylate and phenacetin combination tablets, at Denver, Dist. Colo.

Charged 12-22-67: when shipped by Thayer Laboratories, Div. of ThayerKnomark, Inc., Metuchen, N.J., the labeling lacked warning as to possible damage to kidneys when used in large amounts or for a longperiod of time; 502(f)(2). Default decree ordered destruction. (94)

Lipo-K lipotropic factor combination tablets, and other drugs, at Philadelphia,E . D i s t . P a .Charged 7-27-67: when shipped by Marcen Labs., Inc., New Rochelle,N.Y., the Lipo-K tablets, capsules labeled in part "Lipo-K . . . Pancreatic Lipotropic Factor . . . Quaker City Pharmacal Co. Philadelphia,"and tablets and injectables labeled in part "Normotensin . . . HypopieticPancreatic Factor . . . Quaker City Pharmacal Co. Philadelphia" werenew drugs without effective approved New Drug Applications; 505(a).Default decree ordered destruction. (95)

Lithium carbonate tablets, at Omaha, Dist. Nebr.

34 j March 1969 / FDA Papers

Charged 2-13-68: when shipped by Paul B. Elder Co., Bryan, Ohio, thearticle, labeled "Tablets Lithium Carbonate 300 mg. Not for humanconsumption for Laboratory use only. Distributed by the BernardCo., Omaha, Nebraska," was a new drug without an effective approvedNew Drug Application and was not exempt from such requirement; 505(a).Default decree ordered destruction. (96)

Liver injection, N. F., at Whittier, C. Dist. Calif.Charged 1-18-68: while held for sale, the article's strength differedfrom N. F. standard, since the article was deficient in vitamin B ,potency; 501(b). Default decree ordered destruction. (97)

Mammary substance tablets, at St. Louis, E. Dist. Mo.Charged 2-14-68: while held by Knight Drug Co., St. Louis, Mo., thelabeling lacked adequate directions for use, and adequate directionscould not be written for drug use, since mammary substance is aninert glandular substance; 502(f)(1). Default decree ordered destruction.(98)

Novopin bath salts, at Los Angeles, C. Dist. Calif.Charged 11-9-67: when shipped by Pacific Trading Co., Ltd., Yokohama,Japan, the label contained false and misleading claims for bloodcirculation, women's diseases, rheumatism, and other therapy; andthe label lacked the established name of each active ingredient; 502(a), 502(e)(l)(A)(ii). Default decree ordered destruction. (99)

Oti-Fungal ear preparation, at Jacksonville, M. Dist. Fla.Charged 2-15-68: when shipped by Robert Lloyd Co., Greenville, S.C.,the article was a new drug without an effective approved New DrugApplication; 505(a). Default decree ordered destruction. (100)

Reserpine tablets, U.S.P., at Grand Rapids, W. Dist. Mich.Charged 12-26-67: while held by The Pill Mill, Inc., Grand Rapids, Mich.,after manufacture from reserpine alkaloid shipped in interstate comm e r c e , t h e a r t i c l e ' s s t r e n g t h d i f f e r e d f r o m U . S . P. s t a n d a r d , s i n c e i tw a s d e fi c i e n t i n r e s e r p i n e ; 5 0 1 ( b ) . D e f a u l t d e c r e e o r d e r e d d e s t r u c t i o n .(101)

Romycin capsules, at Phoenix, Dist. Ariz.Charged 2 -9 -68 : wh i le he ld fo r sa le , the a r t i c le was composed o f te t racycline hydrochloride and lacked an effective antibiotic certificate orr e l e a s e a n d w a s n o t e x e m p t e d f r o m s u c h r e q u i r e m e n t ; 5 0 2 ( 1 ) . D e f a u l tdecree ordered des t ruc t ion . (102)

Amphetamine, thyroid, and phenobarbital combination capsules, Rotrim, atPhoenix, Dist. Ariz.Charged 2-13-68: while held by Rocky Mountain Pharmacal Co., Phoenix,Ariz., the article's labeling contained false and misleading claims forsa fe and e f f ec t i ve t r ea tmen t o f obes i t y and l acked adequa te d i r ec t i onsf o r u s e a n d d i d n o t c o m p l y w i t h t h e R x d r u g e x e m p t i o n r e q u i r e m e n tfor disclosure of information; 502(a), 502(f)(1). Default decree ordereddes t ruc t i on . ( 103 )

Sanestro tablets, at Albuquerque, Dist. N. Mex.Charged 12-4-67: when shipped by Arizona Laboratories, Inc., Phoenix,Ariz., the strength of the article was deficient and the label was falseand misleading, since the article was deficient in estrone (approx. 18percent) and in estradiol (approx. 21 percent); 501(c), 502(a). Defaultdecree ordered des t ruc t ion . (104)

Solfoton-phenobarbital combination capsules, at Richmond, E. Dist. Va.Charged 1-4-68: while held by William P. Poythress & Co., Inc., Richmond, Va., after having manufactured the article from an ingredient(lactose powder) shipped in interstate commerce, the article containeda viable mold; 501(a)(1). Default decree ordered destruction. (105)

Sulfisoxazole tablets, U.S.P., and sodium butabarbital tablets, N.F., 2 seizureactions at Maryland Heights, E. Dist. Mo.Charged 1-18-68 and 2-1-68: while held by Shaw Pharmacal Co., Maryland Heights, Mo., which manufactured the articles from ingredientsshipped in interstate commerce, the strength of the articles differedfrom U.S.P. and N.F. standards, since the articles were deficient insulfisoxazole and sodium butabarbital (approx, 5 percent); 501(b). Defau l t decrees ordered dest ruc t ion . (106)

Thyroid-digitoxin combination tablets, at Farmingdale, E. Dist. N.Y.Charged on or about 2-27-68: when shipped by Seaway Pharmacal Corp.,Muskegon Heights, Mich., the labeling contained false and misleadingweight reduction and other therapeutic claims, the labeling lackedadequate directions and did not comply with the Rx drug exemptionrequirement for disclosure of information, and the article was dangerousto health when used in the dosage and with the frequency and durationprescribed in the labeling; 502(a), 502(f)(1), 502(j). Default decree ordered des t ruc t i on . (107 )

Triple obesity amphetamine compound tablets, at Dayton, S. Dist. Ohio.Charged 1-2-68: when shipped by Shaw Pharmacal Co., Maryland Heights,Mo., and while held for repacking by Halsom Drug Co., Dayton, Ohio,the labeling contained false and misleading claims for safe and effectivetreatment of obesity and lacked adequate directions for use and didnot comply with the Rx drug exemption requirement for disclosure ofinformation; 502(a), 502(f)(1). Default decree ordered destruction. (108)

Vasatrate pentaerythritol tetranitrate tablets, at Springfield, W. Dist. Mo.Charged 2-8-68: while held by Burt Krone Co., Springfield, Mo., afterrepacking, the strength of the article was deficient, and the labelingwas false and misleading, since the article was deficient in totalnitrate (approx. 24 percent); 501(c), 502(a). Default decree orderedd e s t r u c t i o n . ( 1 0 9 )

Zero aerosol coolant, at Tucker, N. Dist. Ga.Charged 1-30-68: when shipped by Hysan Products Co., Chicago, III.,the article, labeled "Kem Non-Toxic Zero Immediate relief from painand swelling caused by sprains, bruises, or strains . . . Kem Manufacturing. Corporation, Tucker, Georgia," was a new drug without anapproved effective New Drug Application; 505(a). Default decree orderedd e s t r u c t i o n . ( 11 0 )

DRUGS / Veter inary

Bio-flavonoid B-complex vitamin tonic for animal use, at El Paso, W. Dist.

Charged 2-23-68: when shipped by Teknol Laboratories, Inc., Sun Valley, Calif., the article, labeled in part "Scott's Flavonoid B Tonic . . .Distributed by Scott Pharmaceuticals, Inc., El Paso, Texas," containedfalse and misleading blood building and other therapeutic claims; 502(a). Consent decree authorized release to Scott Pharmaceuticals, Inc.,to bring the article into compliance with the law. (Ill)

Glo-Vet Tri-Biotic syringe for bovine mastitis, at Tempe, Dist. Ariz.

Charged 1-11-68: when shipped by Globe Veterinary Supply, Artesia,Calif., the article was a new drug without an effective approved NewDrug Application, and the article was a nonconforming food additive;505(b), 402(a)(2)(C). Default decree ordered destruction. (112)

Oxcin posterior pituitary injection, U.S.P., at Shawnee, Dist. Kans.Charged 3-7-68: when shipped by Maurry Biological Co., Inc., Los Angeles, Calif., the article's strength differed from U.S.P. standard, andthe labeling was false and misleading, since the article was deficientin oxytocic activity (approx. 34 percent); 501(b), 502(a). Default decreeo r d e r e d d e s t r u c t i o n . ( 11 3 )

M E D I C A L D E V I C E S

Air-Way 88 Sanitizor vacuum cleaner, at Minneapolis, Dist. Minn.Charged 1-16-68 : when sh ipped by A i r -Way San i t i zo r, Inc . , To ledo, Oh io ,a n d w h i l e h e l d b y C . A . S c h m i t z & C o . , I n c . , M i n n e a p o l i s , M i n n . , t h el a b e l i n g c o n t a i n e d f a l s e a n d m i s l e a d i n g c l a i m s f o r a s t h m a , s i n u st r o u b l e s , a n d p r e v e n t i o n o f t u b e r c u l o s i s a n d r e s p i r a t o r y i n f e c t i o n s ;502(a) . Consent decree au thor ized re lease to C. A . Schmi tz & Co. , Inc . ,f o r r e l a b e l i n g . ( 11 4 )

Cont rex e lec t ron ic exerc ise r, a t Tu lsa , N . D is t . Ok la .Charged 1-24-68: when shipped by International Contrex Corp., Dallas,Te x . , t h e a r t i c l e ' s l a b e l i n g c o n t a i n e d f a l s e a n d m i s l e a d i n g w e i g h t -control claims—502(a); and while held by Contrex of Tulsa, Tulsa, Okla.,the article's labeling lacked adequate directions for use for the condit i o n s r e p r e s e n t e d i n a d v e r t i s e m e n t s p l a c e d b y t h e d e a l e r i n a l o c a lnewspaper ; 502( f ) (1) . Defaul t decree ordered destruct ion. (115)

Cristofv Anti-Fatigue device, at Columbus, S. Dist. Ohio.Charged 1-29-68: when shipped by Electrogen Industries, Inc. (AF Elec.),Westbury, N.Y., and while held by J. H. Furber Co., Columbus, Ohio,the labeling contained false and misleading therapeutic claims; 502(a).D e f a u l t d e c r e e o r d e r e d d e s t r u c t i o n f o r a l l d e v i c e s , e x c e p t t w o , w h i c hwere turned over to FDA. (116)

Electric Exerciser, at Sacramento, E. Dist. Calif.Charged 1-24-68: when shipped by International Contrex Corp., Dallas,Tex., the labeling contained false and misleading weight control claims—502(a); and while held for sale, the labeling lacked adequate directionsfor use for purposes of figure improvement as advertised in the localnewspaper from mats supplied by the shipper—502(f)(1). Default decreeo r d e r e d d e s t r u c t i o n . ( 11 7 )

Filter Queen vacuum cleaner, at Kansas City, W. Dist. Mo.Charged 7-16-65: when shipped by Health-Mor, Inc., Chicago, III., andwhile held by Filter Queen of Greater Kansas City, Inc., Kansas City,Mo., the shipper's sales manuals for the device (a conventional vacuumcleaner with vibrator, hair-dryer, and vaporizer attachments) containedfalse and misleading therapeutic claims, including claims for sore feet,muscular aches and pains, asthma, allergies, the promotion of circulation in the scalp, and the removal of 99.99 percent of the pollen fromthe air of a room; and the labeling lacked adequate directions foruse for colds, lung cancer, sinus congestion, asthma, back trouble,weight reduction, and other therapy for which the device was recommended by Don Hopkins and Claude Adams, dealer salesmen; 502(a),502(f)(1). Consent decree authorized release to shipper for relabeling.(118)

Mity-Mite bath aerator, at Los Angeles, C. Dist. Calif.Charged 1-31-68: when shipped by Splendour Products, St. Petersburg,Fla the labeling contained false and misleading claims for treatmentof arthritis and stimulation of circulation; 502(a). Default decree orde red des t ruc t i on . (119 )

Ped-A-Massage device, at Wichi ta, Dist . Kans. r * ■ «Charged 2-12-68: when shipped by Posture Massage Manufacturing Co.,Oklahoma City, Okla., and while held by Midwest Massage of Kansas,Inc., Wichita, Kans., the labeling contained false and misleading claimsto relieve nervous tensions and stress, stimulate circulation, and relieve painful and disabling pain of arthritis, bursitis, and rheumatism,and the labeling lacked adequate directions for use and adequatewarnings against misuse; 502(a), 502(f)(1), 502(f)(2). Default decreeordered some of the devices delivered to FDA and the rest destroyed.(120)

Rexair Rainbow vacuum cleaner, at Great Falls, Dist. Mont.Charged 11-12-65 and amended 11-17-65: while held by Winston Baer,t/a Rainbow Rexair Sales & Service, Great Falls, Mont., the labelinglacked adequate directions for use for colds, flu, sinus, bronchial congestion, asthma, hay fever, pneumonia, "physical ailments of all sorts,eliminating bacteria, removal of poisonous gases, and removal of germs,for which uses the article was offered; 502(f)(1). Consent decree authorized release to the dealer for compliance operations and permanently enjoined the dealer from offering, suggesting, or representingin any manner, whether orally or in writing, that the device underseizure or any similar device was adequate or effective for the treatment, prevention, or elimination of any disease, physical ailment, orc o n d i t i o n . ( 1 2 1 )

Spectrowave radio-frequency generator, 2 seizure actions at New Baltimore, E. Dist. Mich., and Stanwood, W. Dist. Mich.Charged 10-15-64 and 8-5-66: when shipped by Cameron-Miller SurgicalInstruments Co., Chicago, 111., the labeling of the G5 model device atStanwood contained false and misleading claims for otitis media, sinusitis, pelvic inflammatory disease, bone and tissue healing, certainulcers, bursitis, dysmenorrhea, low back pain, whiplash, neurologicaldiseases, and other therapy, and its labeling lacked adequate directionsfor its intended uses—502(a), 502(f)(1); and when shipped by Bio-tronics Corp., Des Plaines, III., the labeling for the G6 model deviceat New Baltimore contained false and misleading claims for certainulcers, bursitis with calcification, sinusitis, pelvic inflammatory disease,low back pain, acceleration of tissue healng, and other therapy—502

^ Spectrowave Corp., Chicago, 111., claimed the G5 device and denied thecharges. Subsequently, Biotronics, Des Plaines, 111., was substituted asclaimant. Meanwhile, Biotronics Corp., (whose name had been changedto Biocytronics Corp.) and Dr. Edward H. Thomas, New Baltimore, Mich.,c l a i m e d t h e 0 6 m o d e l d e v i c e a n d d e n i e d t h e c h a r g e s . P u r s u a n t t ostipulation, the Eastern District case was transferred and consolidatedw i t h t h e W e s t e r n D i s t r i c t c a s e . I n t e r r o g a t o r i e s w e r e fi l e d b y t h eparties and depositions noticed. The claimants moved that the deposition of Donald I. Genser, executive vice president of BiocytronicsCorp., be not taken, stating that Genser had answered a number ofinterrogatories, a number of actions concerning discovery, and thepreparation of the actions for trial had already been taken, that the

FDA Papers / March 1969 / 35

subpoena served with the notice of deposition required large amountsof documents relating back many years concerning the inventory,development, characteristics, and uses of the devices seized and theirpredecessor, the Gonsertron, that Mr. Gonser's assistance in defendingthe actions placed great demands upon his time, and that to requirethe disposition would be oppressive, burdensome, and unfair andwould materially interfere with claimants' attempts to prepare fort r i a l . T h e c o u r t d e n i e d t h a t c l a i m a n t s ' m o t i o n . T h e r e a f t e r t h e c l a i mants moved to withdraw their claims and answers, but not to withdrawtheir appearances. The court granted the claimants' motion to withd r a w . A d e f a u l t d e c r e e c o n d e m n e d t h e d e v i c e s a n d o r d e r e d t h e i rrelease to FDA. (122)

Spectrowave radio-frequency generator, at Harsens Island, E. Dist. Mich.Charged 3 -28-68 : when sh ipped by Cameron-Mi l l e r Surg ica l Ins t rumentsCo., Chicago, III., the labeling of the device contained false and misleading claims for arthritis, bursitis, hypertension, fractures, prostatitis,d y s m e n o r r h e a , a n d o t h e r t h e r a p y ; 5 0 2 ( a ) . D e f a u l t d e c r e e o r d e r e d d el ivery to FDA for exhibi t / test ing. (123)

Vi ta Master bel t massager, and Vi ta Master exerc ise b icycle, at Des Moines,S . D i s t . I o w a .C h a r g e d 1 - 1 7 - 6 8 : w h e n s h i p p e d b y T. J . T h o m a s C o . , I n c . , B r o o k l y n ,N . Y. , t h e a r t i c l e s ' ( b e l t m a s s a g e r a n d b i c y c l e e x e r c i s e r ) l a b e l i n g c o ntained false and misleading weight-reduction and other therapeuticclaims—502(a); and the belt massager's labeling lacked adequate warnings—502(f)(2). Consent decree authorized release to Ardan Wholesale,Inc., Des Moines, Iowa, for relabeling. (124)

N O T I C E S O F J U O G M E N T o n C r i m i n a l C a s e s

Arnold L Adams, t/a Arnold L. Adams Wholesale Co., Rocky Mount, E. Dist.N . C .Charged 3-8-68: corn muffin mix, flour, and candy bars were held ina b u i l d i n g a c c e s s i b l e t o i n s e c t s a n d w e r e c o n t a m i n a t e d w i t h i n s e c tfilth; 402(a)(3), 402(a)(4). Guilty plea; imprisonment suspended, fine,and p roba t ion . (125)

Farmington Cooperative Creamery Association, Inc., Farmington, S. Dist.I o w a .Charged 2-5-68: when shipped. Tiger butter contained insects andi n s e c t f r a g m e n t s , a n d t h e c r e a m u s e d t h e r e i n c o n t a i n e d i n s e c t fi l t hand was moldy and yeasty; 402(a)(3), 402(e). Guilty plea; fine. (126)

New Mill Noodle and Macaroni Co., Inc., and Andrew J. Russo, president,Chicago, N. Dist. III.Charged 5-20-68: when shipped. Polka and Kluski egg noodles contained insect and rodent filth and had been prepared and packed underinsanitary conditions; 402(a)(3), 402(a)(4). Guilty plea by corporation;fine. Guilty plea by individual; fine and probation. (127)

Ostrofsky's Miami Bagel Bakery, Inc., and Al Ostrofsky, president, Miami, S.D i s t . F l a .Charged 4-11-68: when shipped, Biagly bagels contained insect androdent filth and had been prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Guilty pleas; fines. (128)

Don Swann Sales, Inc., and Donald M. Swann, president, Atlanta, N. Dist.G a .Charged 8-10-67: seasoned breading mix was held under insanitary conditions in a building accessible to rodents; 402(a)(4). Nolo contenderep l e a s ; fi n e s . ( 1 2 9 )

Tower Hill Bakery Corp., and Andrew J. Puglise, president, Lawrence. DistM a s s .Charged 4-26-68 by grand jury: when shipped, bread and rolls containedinsect filth and had been prepared under insanitary conditions; 402(a)(3),402(a)(4). Guilty plea by corporation; fine. Guilty plea by individual;imprisonment suspended and probation. (130)

Abbott Laboratories, Chicago, N. Dist. III.Charged 9-19-66: when shipped, the labeling of Eutonyl pargyline hydrochloride tablets lacked adequate directions for use and was not exempted therefrom, since It was a prescription drug which was a newdrug and its labeling, namely, the defendant's Eutonyl monograph inthe 1965 edition of the Physicians' Desk Reference, was not substantially the same as the labeling authorized by the drug's approved NewDrug Application; 502(f)(1).The defendant moved to dismiss the case on the grounds that theinformation failed to contain a plain, concise, and definite writtenstatement of the essential facts constituting the offense charged, andthat the defendant had not been given the notice and opportunity fora hearing pursuant to section 305 of the Act (21 U.S.C. 335) on thealleged defects of its Eutonyl monograph in Physicians' Desk Reference (PDR). After considering the parties' briefs and hearing oral argument, the court denied the defendant's motion to dismiss.

Subsequently the defendant moved to dismiss the case on the groundsthat FDA had initiated an administrative action against the defendantconcerning its labeling of Eutonyl, that such administrative action duringthe pendency of the criminal action placed the defendant in an untenable position, and that the regulation, 21 CFR 1.106(b)(4)(i), pursuantto which this information had been filed, was arbitrary, capricious, notin accord with the law, and constituted a promulgation without statutoryauthority and in contravention of the statutory scheme of the new drugsection of the Act. Thereafter, the difficulties created by the administrative action were resolved and a stipulation relevant to the administrative action was filed in the criminal action.

In denying the defendant's second motion to dismiss, the court didnot agree with the defendant's contentions, and said: that 502(f)(1)did apply to prescription drugs; that the prescription legend Itself did notconstitute adequate directions for use; that the phrase "substantially

21 CFR 1.106(b)(4)(i) and the phrase "material change" ofprovided a meaningful standard that was neither vagueand indefinite nor incapable of compliance; and that the scope of the

exemption from adequate directions, where not necessary for the protection of the public health, did extend to exemptions for prescriptiondrugs, and was conditioned on compliance with terms designed to ensure such protection; and that such terms were a reasonable conditionfor exemption from adequate directions for use. The defendant alsocontended that the regulation's definition of adequate directions for useas meaning "directions under which the layman can use a drug ordevice safely and for the purposes for which it is intended" made it

h e c o u r t d i dhat 502(f)(1)i tse l f d id not'substant ia l lyI change " o f

impossible for prescription drugs to comply with the provisions of 502(f)(1) and was therefore contrary to the intent of Congress. In rejectingthis contention, the court said:

"The Court does not view Section 502(f)(1) as incapable of compliance. Under its provisions, a drug must either bear adequate directionsfor use or meet the conditions for exemption specified in the regulations.The Court agrees that in the case of prescription drugs they will almostalways need to seek exemption because they cannot comply with thedefinition of adequate directions for use set out in the regulations.B u t t h e C o u r t c o n c l u d e s t h a t t h i s i s n o t c o n t r a r y t o t h e i n t e n t o fCongress.

"The intent of Congress must be presumed to be to protect thepublic from harmful consequences in connection with the use of drugs.The obvious dangers inherent in the lay use of prescription drugscoupled with the apparent difficulties involved in providing adequated i r e c t i o n s f o r t h e i r u s e l e a d s t h e C o u r t t o t h e l o g i c a l c o n c l u s i o n t h a tCongress intended prescription drugs to be marketed only by way ofexemption from the requirement of adequate directions for use. In sodoing. Congress intended that the public health be protected throughregulations promulgated by the Food and Drug Administration."

T h e d e f e n d a n t p l e a d e d n o t g u i l t y , a n d t h e c a s e w a s t r i e d b y t h ec o u r t . T h e c o u r t f o u n d t h e d e f e n d a n t n o t g u i l t y. ( 1 3 1 )

John Andreadis, a/k/a John Andre, and Drug Research Corp., Brooklyn, E.D i s t . N . Y .C h a r g e d 1 - 2 3 - 6 4 b y g r a n d j u r y : w h e n s h i p p e d w i t h i n t e n t t o d e f r a u dand m is l ead , t he l abe l i ng o f Reg imen t ab le t s con ta i ned f a l se and m islead ing weight - reduct ion c la ims and, in the cases o f 2 sh ipments , fa i ledt o b e a r a d e q u a t e d i r e c t i o n s f o r u s e f o r t h e p u r p o s e s f o r w h i c h t h etablets were intended; 502(a), 502(f)(1). Not guilty pleas. Defendantsm o v e d t o s u p p r e s s i n t r o d u c t i o n i n t o e v i d e n c e i n t h i s c a s e o f t h e i rpleas of guilty in a State case relating to Regimen tablets and themotion was denied (238 F. Supp. 802). The case was tried and thejury returned a verdict of guilty with respect to one of the alleged shipments. The court imposed a fine against each defendant and also asentence against the individual of imprisonment for 18 months to runconcurrently with sentences imposed upon conviction for violations involving mail and wire fraud. Upon appeal the judgments of convictionwere affirmed. (366 F.2d 423; cert, denied 385 U.S. 1001). (132)

Ronald C. Michelson, pharmacist, t/a Don Drug Co., Santa Monica, S. Dist.C a l i f .Charged 9-15-66: meprobamate tablets were dispensed without prescription; 503(b)(1). Nolo contendere plea; probation. (133)

White Drug Store, Inc., Garrett P. Conway, president, and William H. White,treasurer, at Jackson, E. Dist. Mich.Charged 9-26-66: Enovid tablets, Parafon tablets, penicillin tablets,and Librium capsules were dispensed without a prescription; 503(b)(1).Nolo contendere pleas; fines. (134)

Dean Rubber Manufacturing Co., and Wilbur L. Dean, North Kansas City.W . D i s t . M o .Charged 11-27-63: when shipped, the quality of "Peacocks" rubberprophylactics was deficient and the labeling false and misleading,since the articles contained holes (1.04 percent to 2.54 percent); 501(c), 502(a). Not guilty pleas. Defendants moved to dismiss and for a billof particulars. On 2-17-64, the district court denied the motion to dismiss, but granted, in part, the motion for a bill of particulars, sayingthat 501(c) applied to devices; the words "aid in preventing venerealdisease" were a representation of quality; the Government must givethe citation to all statutes, rules, and regulations alleged violated-the Government must give the percentage of devices tested and thepercentage found defective; that "on or about" a specific date wassufficiently particular; and the Government did not have to give thenumber, size, and location of the holes in the articles.Defendants again moved to dismiss, but on 3-27-64, the court deniedthis motion saying that the percentage of defective devices was notde minimis when such devices were intended to prevent disease.

After trial by jury, the Dean Rubber Manufacturing (Do. was foundguilty of shipping articles deficient in quality; and found not guiltyof shipping articles whose labeling was false and misleading Wilbur LDean was found not guilty on all charges. Following the verdict o'fthe jury, the defendant filed a motion for judgment of acquittal whichwas demed, and in accordance with an opinion rendered on 9-13-64the court assessed certain costs against the company. A fine was there-

against the company and an appeal was then taken to

conviclioJ O'sTfThe court held that the label statement "an aid in prevention of

venereal disease" was a claim of "quality" within the meaning of 501(c); that 501(c) applies to devices as well as drugs; that the adoptionin 1957 of a working tolerance of 1 percent defective prophylacticsand the prosecution thereafter of interstate shippers only for thoseshipments in excess of such tolerance did not render the Act unconstitutional as so enforced; and that the evidence of record, includingthat relating to the Government's use of a water test for determiningthe presence of holes in prophylactics, and that relating to the pro-th d °t 7 'It (135)" shipments, was sufficient to support

Notices of Judgment are given pursuant to section 705 of the FederalFood, Drug, and Cosmetic Act and section 13 of the Federal HazardousSubstances Act. Notices of Judgment report cases involving seizureproceedings, criminal proceedings, and injunction proceedings. Seizureproceedings are civil actions taken against goods alleoed to be iniroceeomgs are civil actions taken against goods alleged to be ilolation, and criminal and injunction proceedings are against firms cindividuals charged to be responsible for violations. The cases generallinvolve foods, drugs, devices, cosmetics, or hazardous substances whicvvere alleged to be adulterated or misbranded or otherwise violative cthe law when introduced into and while in interstate commerce, or whil

eld for sale after shipment in interstate commerceCase summaries are prepared by Food, Drug, and Environmental Healt

hvision. Office of the General Counsel, DHEW.F^ublished by direction of the Secretary of Health, Education, an

Case summaries are pDiv is ion , Office o f the G

P u b l i s h e d b y d i r e c t i oW e l f a r e .

Herbert L. Ley, Jr., Commissioner of Food and Drugs

Washington, D.C., March 1, 1969

36 / March 1969 / FDA Papers

☆ u.S. GOVERNMENT PRINTING OFFICE; 1969 342-4

Maximum Benefits toAnimal Owners Consistent

With Maximum PublicHealth Protection

Bureau of Veterinary MedicineNAS/NRC-FDA Veterinary Drug

Efficacy Review of Over 700 DrugsMarketed Before 1962

The 1962 Drug Amendments to the Food, Drug, and Cosmetic Act requirethat all drugs—for human and for veterinary use—must not only be safe, bute f f e c t i v e a s w e i i .

The National Academy of Sciences/National Research Council and theFDA are now reviewing all veterinary drugs marketed between 1938 and1962 for efficacy.

Final evaluations are published in the Federal Register as they arecompleted.

Any manufacturer, packer, distributor, or other interested person mayobtain a copy of a NAS/NRC report by writing to the Food and DrugAdministration, Press Relations Office, CE-300, 200 "C" Street, S.W.,Washington, D.C. 20204.

UNITED S ta tesG o v e r n m e n t P r i n t i n g O f fi c e

D I V I S I O N O F P U B L I C D O C U M E N T S

WASHINGTON, D. C. 20402

POSTAGE AND FEES PAIDU. S. GOVERNMENT PRINTING OFFICE

OFFICIAL BUSINESS

DRUG INDUSTRY TRAINING FILM TheFood and Drug Administration's colormotion picture, "Good Drug Manufacturing Practices: No Margin for Error,"has proved to be a highly popular employee training and motivational toolsince it was introduced in January 1968.To i n c r e a s e t h e v a l u e o f t h i s m o v i e a s a

training aid, FDA has issued a discussion guide containing some suggestionsfor management and employee discussion sessions in your training programusing the FDA film. Stat ist ics compiledfrom industry and FDA Districts' reportso n t h e fi l m ' s u s e s h o w t h a t a t o t a l o f

21,671 persons viewed the film at 607showings las t year. The Government 'scontractor sold 99 prints to industry purchasers for continuing use. Even thesefi g u r e s d o n o t r e fl e c t t h e fi l m ' s t o t a laudience, since they do not include complete data on loans from FDA Districtsor v iew ings a t FDA workshops dur ingthe entire year.

T h e fi l m i s a v a i l a b l e f o r f r e e s h o r t -term loan (up to 2 weeks) from: Bureauof Compl iance, Food and Drug Administration, 200 C Street, S.W., Washington , D .C. 20204 , o r the neares t FDADistrict office. Information concerningpurchase of the fi lm a lso may be obtained from the Bureau of Compliance.

C O N F E R E N C E - W O R K S H O P P R O G R A MIndustry acceptance and participation inFDA's conference and workshop program continued to accelerate in 1968. Asa result, FDA expanded its efforts to assist particular industries in identifyingand solving specific compliance problemsof major health significance to consumers. A total of 138 District workshopsand 14 national or regional conferenceswere held and were focused on thesecritical problem areas, as shown in thetable at the right.

These FDA-industry meetings concentrated on major problems in each of theproject areas, such as Salmonel la andBotul ism in smoked fish; bacterial contamination in convenience foods, shelledpecans, and shellfish; and pesticide residues in dairy products.

The increasing importance of a f reeexchange of ideas, suggestions, and solutions to these problems attracted skilledspecialists from industry, universities,FDA, and other State and Federal agencies to participate in the programs. Morethan 13,500 professional and management personnel, representing over 6,700firms, par t ic ipated in the var ious seminars, conferences, and workshops during1968.

AnnouncementsFDA INDUSTRY WORKSHOPS During April and May, FDA Districts will conduct a

series of workshops and regional conferences on specific compliance problems ofmajor health significance. These problems deal with drugs (good manufacturingpractices (GMP)), foods (microbiological contamination, chemical residues,and sanitation), and labeling of hazardous household substances. Anyone desiring to attend should contact the nearest District.

SCHEDULE OF FDA WORKSHOPS AND REGIONAL CONFERENCESA P R I L & M AY 1 9 6 9

F D A D i s t r i c t

B a l t i m o r e

B u f f a l o

April 8

April 29

L o c a t i o n

Virginia

Virginia

Syracuse, N.Y.Buffalo, N.Y.

Subject AreaBacteriological-

C r a b

Bacteriological-C o n v e n i e n c e F o o d s

GMP—DrugsGMP—Drugs

STATISTICAL SUMMARY OF INDUSTRY PARTICIPATION IN FDA WORKSHOPS,SEMINARS, AND CONFERENCES / JANUARY THRU DECEMBER 1968

District Workshops

A T T E N D A N C E

G M P—Drugs—H u ma nDrugs—In Plant—for EmployeesG M P—Drugs—Veteri na ryFoods—Bacter ial Contaminat ionFoods—Chemical Contaminat ionF o o d s — S a n i t a t i o nH a z a r d o u s S u b s t a n c e s

To t a l

People1901275

10673481

3542973

16510216

Seminars and Conferences

ATTENDANCE

Hazardous Substances SeminarDrugs—GMPDrugs—DACAGeneral—FDLI National ConferenceTherapeutic DevicesC o s m e t i c sFoods—Chemical

To t a l

*Hospital Representatives.

People6686 9 0

5 0753193700300

3 3 5 4