Professor Heath Fall 1999

FOOD AND DRUG LAWI. Historical Background

A. Why have the FDA?

To ensure that the products it regulates are safe and truthfully labeled…

25 cents of every consumer dollar goes to a product that falls under FDA regulation…

1. To ensure universality and uniformity of action 2. To protect the gullible consumer

B. Two major concerns of the FDA

1. Adulteration – addition that changes the quality level – makes impure.2. Misbranding – product is not truthfully labeled.

C. FDA Mission

To ensure that…

(1) food is safe, pure, and wholesome;(2) cosmetics are safe;(3) human and animal drugs biological products, and therapeutic devices

are safe and effective; and (4) radiological products and use procedures do not result in unnecessary

exposure to radiation.

D. Chronological Backdrop

1902 Biologics Control Act: Result of distribution in St. Louis of tetanus- infected diphtheria antitoxin that resulted in the death of several

children. The law requires that biological drugs sold in interstate commerce be licensed and produced in licensed establishments.

1906 Federal Food & Drugs Act of 1902: First federal statute broadly prohibiting interstate commerce in misbranded or adulterated food or drugs. See pages 9-10 in CB for details of the Act.

1938 Food Drugs & Cosmetics Act of 1938: Legal framework controlling the activities of producers of food, drugs, cosmetics,

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and medical devices. Catalogue of definitions elaborating two basic concepts: “adulteration” and “misbranding”. Several Post- 1938 Amendments were enacted…primarily to curtail FDA power. Ex. Vitamin-Mineral Amendments of 1976 – FDA cannot regulate the composition and promotion of dietary supplements. See pages 13-14 in CB.

1962 In response to the European morning sickness drug, must now prove that drug is “safe and effective”.

1976 Medical Devices Amendment Act.

1988 Congress created the FDA by statute.

1999 The current Commissioner of the FDA is Jane Henney.

E. Enforcement by FDA

1. Principal Statutorily Authorized Sanctions (FD&C Act 1938)

a. Criminal prosecution of individuals and firms guilty of prohibited acts

b. Injunction against such actsc. Seizure of adulterated or misbranded goods (most common)

2. Non-Statutorily Authorized Sanctions

a. publicityb. recallsc. regulatory letters

II. Food

A. Definition of “Food”

1. Whether a product is a food, drug, or cosmetic will be construed based upon the use to which the product is put. The use will determine which category it falls within. The categories are not, however, mutually exclusive. So why worry about the distinctions?…Because they are regulated differently.

2. § 321(f): The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

3. Food: No FDA approval process necessary…simply market it. Drugs

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require a NDA (New Drug Application) pursuant to 21 U.S.C. § 355 whereby the FDA “clears” the drug for market (do not “approve” the drug).

4. Nutrilab, Inc. v. Schweiker 7th Circ. 1983

FACTS: Ps manufacture starch blockers that aid in controlling weight. FDA classified starch blockers as drugs and required that all such products be removed from the market until FDA approval was received. Ps argue that starch blockers are food because they are derived from kidney beans which are food.

ISSUE: Are starch blockers food or drugs under the FD& C Act?

COURT: Starch blockers are drugs. § 321(g)(1)(C) provides that “drug” means “articles (other than food) intended to affect the structure or any function of the body of man or other animals…” Although the definitions of food and drugs are not normally mutually exclusive, under this definition they must be. A mfc. cannot claim that it intended the product to be a food because “intent” is not within the statutory language of § 321(f). The ordinary way that most people use food is primarily for taste, aroma, or nutritive value (common sense reading of § 321(f)(1)). Since this is not the case with starch blockers, and they are not chewing gum or components of food, starch blockers are not food and fall within § 321(g)(1)(C) as a drug.

CLASS: If coffee were used primarily as a stimulant and not for taste and

aroma, it would not be a food. Dual classification: An article affects the bodily structure or

function by way of its consumption as a food, but a manufacturer represents the article to have physiological effects, making it a drug according to American Health Prods. Co.

5. National Nutritional Foods Ass’n v. Mathews 2nd Circ. 1977

FACTS: The FDA generally characterizes vitamin and mineral products as foods unless therapeutic claims are made for them. The FDA classified preparations of Vitamins A and D in excess of 10,000 IU per dosage unit and 400 IU per dosage unit, respectively, as “drugs” under § 321(g)(1), restricting the producers to prescription sales under § 353(b)(1).

ISSUE: Are Vitamins A and D at these dosage levels considered “drugs” because of an intended therapeutic use?

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COURT: The FDA may look for actual therapeutic intent on the basis of objective evidence from either the manufacturer or by other persons. Commissioner provided evidence of public promotion of vitamins for treatment, lack of recognized nutritional usefulness, and potential for toxicity at such high dosage levels. The court dismisses this evidence (no statutory language relating to toxicity) and states that it is important to assess whether third party promotion of a therapeutic use establishes intent. Commissioner must show that at these dosages, the vitamins were taken “almost exclusively” for therapeutic purposes. Mere inclusion in the USP or NF is insufficient for drug classification (§ 321(g)(1)(A)).

CLASS: Commissioner failed to show third party intent…could have been

that the third parties believed that higher dosages were better. Neptone: Green mussel product that was high in

mucopolysaccharides, which were claimed in advertising to help prevent diseases commonly associated with aging, such as arthritis and hardening of the arteries.

Selling drugs in interstate commerce without FDA approval is illegal. Since clinical trials are needed for approval, a manufacturer may file an Investigational Exemption for New Drug (IND) to conduct the research around the country and to continue selling it as a food until clinical research complete and approved.

If there is a third party widespread notion that Grapenuts cures AIDS, and Post knows that people are buying it to cure AIDS, Post has exhibited intent. The company has an obligation to conduct studies for safety and efficacy. Most companies will not acknowledge that they know people are using the product for such purposes.

Cultural influences on food regulation.

B. Scope of “Labeling”

1. 21 U.S.C. § 343 Misbranded food(a) False or misleading

Only health, not therapeutic claims may be made… Validated by a qualified expert. In combination with total dietary health. Uniform for all types of product (not specific to that brand). No dietary power races.

Note: Look to § 350 and § 350(b)(2).

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(c) Imitation of another food(e) Package form(g) Representation as to definition and standard of identity(h) Representation as to standards of quality and fill of container

2. Food Advertising: FTC Food Labeling: FDA

3. 21 U.S.C. § 321 (k) and (m):

“Label” – display of written, printed, or graphic matter upon the immediate container of any article…

“Labeling” – all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

4. Kordel v. United States US SC 1948

FACTS: Kordel markets his own health food products by shipping both the drugs and the literature into interstate commerce. A portion of the shipments had the drugs and the literature shipped in the same carton, while the other shipments had the drugs and the literature shipped at different times. The FDA charged Kordel with introducing misbranded drugs into interstate commerce.

ISSUE: Does the separate shipment of the literature save the drugs from being misbranded?

COURT: The products and the literature are interdependent, regardless of whether they were shipped together or not because of the drug usage explanation. The purpose of the Act is to protect consumers, so “accompanying such article” (§ 321(m)(2)) is not restricted to labels that are on or in the article or package that is transported. The textual relationship (supplementing and explaining) is important. Physical attachment or contiguity is unnecessary under § 321(m)(2).

CLASS: Why is it labeling and not advertising being sent? The directions

for use characterize the literature as labeling. Urbuteit - The movement of medical devices and leaflets in

interstate commerce were a single interrelated activity, not separate or isolated ones. The prevention of misbranding is for the purpose of consumer protection.

5. United States v. 24 Bottles “Sterling Vinegar & Honey”, Etc. 2nd Circ. 1964

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FACTS: The vinegar and honey product and books on folk medicine and the remedy of a vinegar and honey mixture were sold in the same store. The FDA seized the products, claiming the books constitute “labeling” which is misleading, and therefore, the product in misbranded.

ISSUE: Does a book that is sold in the same store as a product it makes claims about (about the mixture, not about the product itself) constitute labeling?

COURT: Every writing which bears some relation to the product is not labeling. The function of the writing must be assessed. A label varies from advertising in that it is “presented to the customer in immediate connection with his view and his purchase of the product”. In this case, there is no evidence of joint promotion. There was no correlation between the number of books sold and the number of bottles of the product sold.

CLASS: Did the book accompany the product? Not if vinegar and honey

cured cancer. So, why not go after the author? Author is protected by the First Amendment. Consumers, however, could sue the author for fraud. Consumer protection does not override an author’s First Amendment right.

The FDA cannot seize the book because the FD&C Act was not intended to deal generally with misleading claims. The FDA can only seek and injunction to halt the misuse of the book.

6. United States v. Articles of Drug…Century Food Co. S.D. Ill. 1963

FACTS: The FDA is alleging that vitamin and mineral products are misbranded because of a book accompanying the product that contains false and misleading information as to medical guidance for their use. The author book claims claims he had no knowledge that the book was being used to sell or promote the vitamins.

ISSUE: Does a book on the market promoting a product constitute misbranding even if the author has no knowledge of and does not authorize its use in such a capacity?

COURT: Knowledge of the book use to promote the product is irrelevant. The mere fact that the books were used as false labeling for the products is sufficient for seizure. The seizure does not condemn the book from sale in food stores. The book simply may not be offered in conjunction with the product as a label for the product.

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CLASS: US v. 8 Cartons, etc., Molasses: The book condemnation is only to

the extent that it was used as a label that was misleading. The First Amendment does not prohibit such seizures.

Government regulation of commercial speech:Current SC test to determine whether the speech is protected by the First Amendment:1. Must concern lawful activity and not be misleading2. Is the asserted government interest substantial?

If positive on the above two…3. Does the regulation directly advance the governmental

interest?, and4. Is the regulation more extensive than necessary to serve that

interest?

C. Labeling Requirements of Section 343

1. Prohibited Representations

a. United States v. Ninety-Five barels of Apple Cider Vinegar SC 1924

FACTS: The FDA sought to condemn 95 barrels of vinegar because it was misbranded. The vinegar was made from dried and evaporated apples, but was called “apple cider vinegar made from selected apples”, a name that was stipulated to involve unevaporated apples.

ISSUE: Does “made from select apples” on a dehydrated apples product constitute misbranding?

COURT: The product is misbranded by the label despite the fact that “selected apples” could mean dehydrated selected apples. A consumer associates such labeling with the guarantee that the apples were picked with special regard to their fitness for apple cider vinegar. The consumer is, therefore, mislead into believing that the product is made from real apples.

CLASS: § 343(a): False or misleading label

If (1) its labeling is false or misleading in any particular, or (2) in the case of food to which section 350 of this title applies, its advertising is false or misleading in a material respect or its labeling is in violation of section 350(b)(2) of this title.

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- “Different” is all that matters for a label to be false or misleading. Note that it can be “in any particular”. There is no materiality requirement. The standard, therefore, is stricter than for advertising.

§ 343(b): Offer for sale under another name: If it is offered for sale under the name of another food.

- May apply to the apple cider vinegar product.

b. United States v. 432 Cartons…Candy Lollipops SD NY 1968

FACTS: The government contends that the lollipop labeled with different liquors have false and misleading labels because they imply and represent that the product is flavored with liquor, which it is not. The outside box clearly says “candy” and lists the ingredients.

ISSUE: If a true statement on the outside clarifies a false statement on the inside, does the true statement neutralize the false statement?

COURT: A true statement will not necessarily cure or neutralize a false one contained in the label. The statute reads “false or misleading”, so that while purchasers have not been misled, the statement is still false “in any particular” (strict standard). The “misleading” issue is for a jury to decide (whether they would be confused). No summary judgment will be granted for the government.

CLASS: Oral misrepresentations can constitute misbranding. Disclaimers have been held insufficient to cure otherwise

misleading labeling. Courts are reluctant to force the abandonment of misleading brand

names.

c. United States v. “Manischewitz”…Diet Thins ED NY 1974

FACTS: The FDA claims that the name “Diet Thins” on the box implies lower calories matzos than those in other matzos useful in weight control diets. The company argues that the product has several other dietary uses other than weight control.

ISSUE: Will the consumer believe that the “Diet Thins” are lower in calories than ordinary matzos?

COURT: The standard is not one of a “reasonable consumer”, but of “the ignorant, the unthinking and the credulous”. Purchasers of

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diet products are often “pathetically eager” to lose weight. The use of any one statement may be misleading in any particular to violate the statute.

CLASS: Should the “gullible consumer” or “reasonable consumer”

standard apply?

- Most courts go for the “reasonable consumer” standard. “Reasonable” is important throughout the statute, as in § 341 for reasonable standards of identity, reasonable standards of quality, reasonable standards of fill of container, etc.

- The gullible standard may apply because the FDA is concerned with consumer protection.

There is no FDA regulation of sell or use dates.

d. Special Labeling Issues

USDA Food Grade Labeling Kosher Labeling : § 343(a) applies. “Kosher” only if it meet the

religious dietary requirements. “Kosher style” discouraged by FDA because misleading.

Food Origin Labeling : No FDA regulation today.

e. “Natural” and “Organic” Food Claims

FDA: “natural” must not contain artificial color, flavor, or synthetic ingredients such as chemical additives.

FTC: “natural” if not undergone more than “minimal processing” after harvest or slaughter and contained no artificial flavor, color additive, chemical preservative, or other artificial or synthetic ingredient. “Minimal processing” uncertain, so entire regulation abandoned.

USDA: Brief statement accompanying product as to what was meant by “natural” in requirement in policy memorandum. USDA must establish national standards for certification of foods as “organic”.

BATF: alcohol beverages are “natural” is they have been minimally processed and contain no artificial additives.

2. Affirmative Disclosures

a. Mandatory Disclosure of Five types of Information on Every Food Label

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1. Name of the food2. Name and place of business of the manufacturer3. Statement of ingredients (in order of prominence and for

ingredients comprising less than 2% of the product, the list may be in any order in one group).

4. Net quantity of contents5. Nutrient content

b. Failure to Reveal Material Facts

§ 321 (n): To determine whether labeling is misleading, not only representations made about the product are taken into account, but also

“the extent to which the labeling or advertising fails to reveal facts material in light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual”

Ex. Diet Coke states “Contains PKUs”.

c. Prominence of Information on Label

§ 343 (f) - Need “conspicuousness”- Must be “in such terms as to render it likely to be read and

understood by the ordinary individual under customary conditions of purchase and use”.

d. Principal Display and Information Panels of Package Form Food

21 CFR § 101.1 – Pages 61 to 63

Note: Is the “no less than one-sixteenth inch in height” specificity necessary? FDA: Consumer information that is conspicuous does not serve its purpose.

3. DEBATE: Should the FDA be required to approve all food labeling prior to marketing?

PROS CONS

* Consumer Protection * Self-regulation for fear of

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civil liability* Fear of drugs being marketed * Cost-prohibitive and inefficient as foods * Price of food increases

Note: may also have to get FTC approval for marketing. Companies say this is too time consuming and inhibits the entry of the product into the market. Given the race to get to market, required approval would cause companies to lose money to competitors. Mantra: It is easier to ask forgiveness than it is to ask permission.

D. Regulation of Food Identity and Quality

1. Premises of Regulation

a. Carolene Products Co. v. United States SC 1944

FACTS: FDA claims that Carolene Products (CP) violated 21 USCA § 62, the Filled Milk Act, stating that any milk blended or compounded with any fat or oil other than milk fat, the resulting product being in semblance of milk, cannot be manufactured or shipped in interstate or foreign commerce. The filled milk is said to be adulterated and injurious to public health, and sale of it is fraud to the public. CP makes a product that is skim milk with oil sold in cans that are the same size and shape as those for evaporated milk, but are labeled truthfully. CP argues that the product is still wholesome and not “injurious to public health” (§ 62 language).

ISSUE: Is the CP product covered by the Filled Milk Act?

COURT: The court notes that the congressional intent of the act was to keep bad milk out of interstate commerce and that there was no irrational basis for the law. The labeling was misleading because looked like that of evaporated milk, and consumers may believe the quality to be better than it really is. CP argues that the law is unconstitutional. The court rejects this argument, stating that since there is no irrational basis for the law, it is constitutional.

CLASS: § 343(c): Imitation of another food

A food is misbranded if it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated.

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2. Economic Adulteration

a. United States v. 88 Cases…Bireley’s Orange Beverage 3rd Circ. 1951

FACTS: Bireley’s Orange Beverage was allegedly adulterated under § 343(b)(4) stating that:

A food shall be deemed to be adulterated if any substance has been added thereto to mixed or packaged therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.

The beverage had yellow coal tar dyes, sugar, lactic acid, and orange oil. The bottle label read “Enjoy Real Fruit Taste”.

ISSUE: Would the ordinary consumer confuse the inferior diluted orange juice with a superior undiluted orange juice, thereby allowing § 343(b)(4) to apply to Bireley’s Orange Beverage?

COURT: Economic adulteration occurs in cases where the product is recognized as wholesome, but is excluded from commerce because of the danger of confusing it with something else which is defined, familiar, and superior. A product cannot appear “better than it is” without a finding that the marketable inferior product is likely to be confused with a specified superior counterpart. § 342(b)(4) does not apply if the allegedly adulterated food is its only standard (brought about need for standards of identity). The standard of “ordinary customer” should be instructed to the jury. This test is explicit in § 343(f), so Congress must have intended it to apply to § 342(b)(4) as well. The beverage is a “food” due to the broad and non-technical language of the statute.

CLASS: § 343(b): Absence, substitution, or addition of constituents. Bred Spread: A spread containing less than half the

strawberries found in traditional strawberry jam is not adulterated.

Chip Steak Co.: The USDA said preservatives in cooked sausage make the food adulterated because the additives “conceal inferiority and damage and make the product look better than it actually is”.

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3. Food Standards of Identity

a. The 1906 Act did not provide for mandatory standards of identity and quality for food, which would have the force of law in prosecutions for adulteration and misbranding. Standards were promulgated for caned foods in the McNary-Mapes Amendment of 1930.

b. Under the 1938 Act, the Secretary must publish a proposal in general terms for a standard of food, along with notice of hearing pursuant to § 371 Regulations and hearings.

c. Operation of Food Standards

Federal Security Adm’r v. Quaker Oats Co. SC 1943

FACTS: Quaker Oats manufactures a wheat product used in cereal foods consisting of farina with vitamin D added. The Federal Security Administrator has established a standard of identity that permits only “enriched farina” to have vitamin D, in addition to Vitamin B, riboflavin, nicotinic acid and iron. QO’s labeling reads “Quaker Farina Wheat Cereal Enriched with Vitamin D”. The FSA says the product cannot be marketed as “farina” because of the vitamin D content or as “enriched farina” because of the lack of Vitamin B, riboflavin, nicotinic acid and iron.

ISSUE: Are the farina standard of identity regulations valid as applied to the QO product?

COURT: The answer must turn upon (1) whether there is substantial evidence that the enrichment would confuse consumers, (2) if so, the Administrator has the authority to adopt a standard of identity for the interest of the consumer, and (3) whether the Administrator’s “farina” “a reasonable definition and standard of identity” pursuant to § 341.

- Evidence and findings from the public revealed that there is a demand for vitamin-enriched foods and variable vitamin composition and dietary value, but there is a general lack of consumer knowledge as to these values. This supports a “rational probative force” to support that absent a standard of identity, consumer confusion would ensue.

- Standards of identity are promulgated to prevent economic adulteration.

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- Purpose of standards of identity: To reflect a recognition by Congress of the inability of consumers in some cases to determine, solely on the basis of informative labeling, the relative merits of a variety of products superficially resembling each other.

- § 341 does allow the exclusion of wholesome ingredients from a definition, such as vitamin D. The Administrator has the judgment, and judiciary will not substitute its own. The Administrator did not establish an unreasonable definition and standard of identity (“farina” = no additives; “enriched farina” = additives).

CLASS: § 341 Definition and standards for food

Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of the consumer, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so long as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container…

Columbia Cheese Co. v. McNutt 2nd Circ. 1943

FACTS: Petitioners seek to have the standard of identity for cream cheese to not require that a substantial portion of the cheese manufactured by them must be designated as neufchatel cheese (lower fat content, higher moisture content), but rather as a Grade B or No. 2 cream cheese. Petitioners oppose this because without the designation, they could sell the low fat, high moisture cream cheese cheaper. The Administrator, however, found that consumers were confused.

ISSUE: Should lower fat, higher moisture cream cheese be allowed to be sold as cream cheese or as the more closely akin neufchatel cheese?

COURT: The court will not substitute its judgment for the Administrator’s. The decision will not create a monopoly because the manufacturers are free to comply with the standards of identity for cream cheese to market it.

DISSENT: It is not confusing to use the common name, cream cheese, with adjective designations such as light cream cheese or

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heavy cream cheese. It is more confusing to deprive the public of the commonly used name.

d. “Recipe Concept”

To avoid consumer deception To curtail the use of chemical additives whose safety had not

been determined. § 343(g): An expansive reading of “purports to be or is

represented as” contributed to homogeneity in the food markets for which standards of identity had been adopted.

Given the broad reading of § 343 (g), a manufacturer is only safe if he discloses all the ingredients and declares that the product fails to meet the FDA standard of identity in some respect, the substitute would not be deemed as confusing to the customer.

FDA cannot establish multiple standards of quality, but have circumvented the rule by establishing “grades” and “neufchatel”.

e. Standardized and Non-standardized Foods

§ 343 (g): Representation as to definition and standard of identity

Standardized: The label must bear only the common name of each optional ingredient (other than spices, flavoring, and coloring) included in the definition and standard of identity a specifically designated in the standard to be named on the label. Failure to comply is a § 343(g) misbranding violation because it “purports to be or is represented as a food for which a definition and standard of identity has been prescribed”.

TODAY: 1990 Nutrition Labeling and Education Act amended § 343(g) to require the declaration of all ingredients (with less than 2% in one group) in standardized foods.

Rigid standards of identity provide little differentiation between similar food items. Instead of differentiating by improving quality, manufacturers have turned to advertising to promote what little differentiation exists.

FDA provides temporary permits for test marketing products awaiting amendment to a standard of identity.

f. DEBATE: Should food standards of identity be abolished?

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PROS: Costs reduced. Constrains on improvements, creativity, little product

differentiation, etc. Economic argument: barrier to entry: no differentiation,

so no niche. Consumer choice should be market driven, but labeling

requirements still exist.

CONS: Minimizes consumer confusion. Consumers can rely on FDA standard to know what

they are getting.

E. “Imitation” Labeling

1. 62 Cases of Jam v. United States SC 1951

FACTS: The FDA has promulgated a standard of identity for fruit jam. “Delicious Brand Imitation Jam” “purports” to be fruit jam. The specified ingredients in the standard of identity must be in the prescribed proportions. The jam, however, is labeled as imitation.

ISSUE: Is the jam “imitation” pursuant to § 343(c), and therefore, misbranded?

COURT: Congress did not give an esoteric meaning to “imitation”. It left it to the understanding of ordinary English speech. “Imitation” is meant to mean different, inferior, and not conforming to the defined standard of identity. By contrast, § 343 (g) was designed to protect the public from inferior foods resembling standard products, but marketed under distinctive names. The use of the word “imitation” on the label, as required by § 343(c), eliminates any confusion on the part of the consumer. The product is not misbranded.

CLASS: Imitation: nutritionally inferior to the traditional food.

“Nutritionally inferior” is reduced of 2% or more of proteins, etc. but not of calories or fat.

2. United States v. 651 Cases…Chocolate Chil-Zert ND NY 1953

FACTS: Chil-Zert is a frozen dessert that contains chocolate-flavored ice cream and soy fat and soy protein instead of milk fat and milk protein. The product is labeled “not an ice cream” and “contains no milk or milk

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fat”. The product is similar in taste and appearance to ice cream, and the carton is the same size, shape, and description as those used to sell ice cream. The FDA claims that it is imitation pursuant to § 343(c), and therefore, it is misbranded. The claimant contends that the product is new, there is no standard of identity for ice cream, and there is no deception since the labeling is truthful.

ISSUE: Is Chil-Zert an imitation of ice cream, and therefore, misbranded even though it is truthfully labeled and there is no standard of identity for ice cream?

COURT: Although resemblance alone is not enough to constitute imitation, the composite effect of similar elements is enough under the ordinary meaning of imitation. Truthful labeling of Chil-Zert does not exempt it from the requirement of the statute that it put “IMITATION” on the label. Neither deception nor intent to mislead is necessary to establish that a product is imitation. Non-standardized food can be imitation…inferiority and differences are key.

CLASS: The company did not put “imitation” on the label because they did

not want the product to seem inferior. Coffee-Rich: Courts have refused to suppress the marketing of

such products when truthfully labeled. This case is distinguishable from Chil-Zert because the two products had no similarities, were marketed differently, etc.

Organoleptically similar products are more likely to be deemed imitation.

F. Regulation of the Nutrient Content of Food

Should the government ensure that everyone is eating above the malnutrition level?

Sodium Labeling: If a food is represented as a means of regulating sodium intake, it must be labeled for the special dietary use or it is misbranded under §343(j).

Hypoallergenic claims must be supported by a convincing body of evidence.

G. Disease Prevention Claims

Disease Prevention Claims have been classified as drug claims to allow enforcement actions under the generally recognized as safe and effective requirement.

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Must show generally recognized as safe (GRAS) and generally recognized as effective (GRAE). If the manufacturer cannot show this, they must go through the NDA process or stop making the false or misleading claim or risk being removed from the market.

The food products for which health claims are made could be treated as “quasi-drugs” for which adequate well controlled studies are needed, instead of just a consensus in the medical community as to the accurateness of the claim.

The problem arises when there are no explicit disease prevention claims. The traditional ban on specific disease prevention claims for food has been reconsidered.

The government became concerned by the relationship between diet and disease, and installed research and studies on human nutrition, as well as programs for the dissemination of information respecting human nutrition to health professionals and the public. This led to the National School Lunch Act of 1946 and the Child Nutrition Act of 1966, providing statutes for the use of food to prevent or treat disease.

1. Health Claimsa. Implicit – nutrient contents - APPROVEDb. General – statements that food is nutritious or good for you -

APPROVEDc. Explicit – statements that a food will help to prevent a specific

disease – CONTROVERSY because of fear of fraud.

The prohibition of explicit health claims led to the public receiving this information from other unreliable sources (books, newspapers, TV, etc.). The FTC concluded that explicit health claims for food should be permitted where they are accurate and truthful.

Consequently, the FDA agreed to allow explicit health claims as part of the disease prevention movement so long as it could regulate against fraud.

Six Circumstances Under Which Food Manufacturers Can Make Explicit Disease Prevention Claims:

1. If it is based upon a consensus of medical and scientific information. There must be little to no disagreement in the medical community.

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2. If it emphasizes that good nutrition is a function of total diet.

3. If the wording of the health claim is reasonably uniform from product to product in order to make it more understandable and less confusing to consumers. In other words, different brands of the same product cannot have widely different claims such that the claims are for mere promotion or competition.

4. Dietary “power races” should be prevented. Manufacturers should not start adding items to their products just to claim they are healthier.

5. The label information must be truthful and not misleading. The label should not imply that the food is a treatment for the disease. Any food that makes a health-related claim triggers the FDA’s nutrition labeling requirements.

6. The explicit health claim will not be allowed if the food contains any nutrient at a level the FDA has determined increases the risk of disease, unless specifically authorized by the FDA. If the FDA authorizes it, the label will most likely have to say something about the problematic nutrient.

Seven Areas of Such Claims:

1. Calcium and a lower risk of osteoporosis2. Fat and a greater risk of cancer3. Saturated fat and cholesterol and a greater risk of

coronary heart disease4. Fiber-containing grain products, fruit, and vegetables

and a reduced risk of cancer5. Fiber-containing grain products, fruit, and vegetables

and a reduced risk of coronary heart disease6. Sodium and a greater risk of high blood pressure7. Fruit and vegetables in general and a reduced risk of

cancer

H. Food Labeling

1. FTC and Food Advertising

a. Wheeler-Lea Amendments of 1938: may not be “misleading in a material respect”.

b. Illegal if substantial consumer injury, violates public policy, or constitutes unethical or unscrupulous conduct from a

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“reasonable consumer” standpoint. The FDA has a stricter standard of “scientific proof” for labeling claims.

c. Public faith in food labeling is higher than that of food advertising.

2. The use of the food label is to convey information and the relationship between diet and certain diseases.

This goal is achieved through:

a. Nutrition Labeling:

Should vitamin information be voluntary since the concern today has shifted to fat and cholesterol?

Manufacturers are against it because:- Consumers are conscious and manufacturers do not

want to divulge unfavorable information.- Increased costs for determining the amounts.- Want flexibility to switch ingredients and nutrients.- Do not want “negative labeling” because if it is

mandatory to list the amount of a nutrient and the product does not contain it, a “0” must be listed.

b. Nutrient Label Format

Is the current format optimal for conveying usable information to consumers?

c. Ingredient Labeling

In order of prominence with those ingredients constituting less than 2% of the total product being grouped together with no order requirements.

d. Descriptions of Food

Names established by standards of identity Common or usual names Imitation or substitute foods Descriptor labeling such as “low calorie”; §343 (r); Must

be accompanied by “See side panel for nutritional information”.

e. Health Claims

3. The Nutrition Labeling and Education Act of 1990

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Nutritional information is mandatory for virtually all foods. Labeling rules do not apply to:

- Foods sold in restaurants and other food service establishments.

- Foods prepared in retail stores for consumption off premises.

- Infant formula.- Medical foods.- Foods sold in small packages.- Foods containing insignificant amounts of all mandatory

nutrients and making no nutrition claims.- All food sold by small businesses (less than $500,000 per

year gross sales or $50,000 per year food sales and no nutrition claims).

- Foods sold by a distributor to restaurants or other food service establishments.

RDIs replaced by RDAs Prescribed labeling of items on Pages 200 and 201 “Nutrition profile” table may be shown showing the percent of

a “daily reference value” (DRV) for fat, saturated sat, cholesterol, carbohydrate, fiber, and sodium.

Must show serving size and number of servings per container.

- Must be the amount customarily consumed, expressed in a common household measure appropriate to the food. This ensures that a manufacturer cannot get rid of problem nutrient by having a small serving size (21 CFR § 101.9(b)).

- The FDA established standards for serving sizes of foods.

The FDA may not prohibit the voluntary declaration of a nutrient.

The FDA may require certain information to be highlighted, bold, large type, contrasting color, etc.

§ 343 (q): Nutrition Information 21 CFR 101.9 § 343 (r): Nutrition levels and health-related claims

- Nutrient Descriptors- A food bearing a claim that meets the requirements of §

343 (r) is excluded from the statutory definition of a drug.

4. Nutrient Labeling Handout

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a. 21 CFR § 101.13 Nutrition content claims – general principles

- A claim that expressly or implicitly characterizes the level of a nutrient (nutrient content claim).

- Expressed = direct statement about the level of a nutrient in the claim. Ex. “low sodium” or “contains 100 calories”.

- Implied = (i) describes the food or an ingredient therein in a manner that suggests that a nutrient is absent or present in a certain amount (“high in oat bran”); or (ii) suggests that the food, because of its nutrient content, may be useful in maintaining healthy dietary practices and is made in association with an explicit claim or statement about a nutrient (“healthy, contains 3 grams of fat”).

- § 101.13 (g) – prominently and in immediate proximity to the nutrient content claim, it must say “see --- for nutritional information”

- § 101.13 (g)(3) – If multiple nutrient content claims, one referral is acceptable so long as it is adjacent to the claim printed in the largest type on the panel.

b. Wheatena

The “high in fiber” claim must be 20% or more of the RDI or DRV reference amount customarily consumed.

c. 21 CFR § 101.14 health claims: general requirements

A health claim means any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including “third party” references, written statements, symbols, or vignettes, characterizes the relationship of any substance to a disease or health-related condition.

I. Regulation of Vitamin-Mineral Supplements

1. Deceptive Marketing Practices

a. V.E. Irons, Inc. v. United States 1st Circ. 1957

FACTS: Vit-Ra-Tox (raw veal bone, defatted wheat germ, and the concentration of juices) was misbranded according to the FDA under §343(j) because it was represented as a food for special dietary uses and failed to bear vitamin and mineral content necessary to inform the purchaser as to their value for such uses. The FDA also claims that the product was misbranded under

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§352(a) because of false and misleading leaflets about malnutrition in the country. The FDA also claimed it was misbranded under §352(f)(1) for failing to provide adequate directions for use. All of these counts are based on the claim that the product is a drug under §321(g) for claims made of intent to cure malnutrition and affect the structure and function of the body.

ISSUE: Can a dietary supplement ever make a health-related claim?

COURT: Prospective purchasers and actual customers are not special experts or unduly cautious. Under §343(r)(6), the statements for dietary supplements must be substantiated as truthful and not misleading by the manufacturer. The statements made by the company could be false and misleading to a lay jury, and therefore, are most likely to the general consumer as well.

CLASS: To protect the pathetically eager. §343(r)(6)

- Need overwhelming scientific proof for a dietary supplement to make a health-related claim, but need only “reasonable basis” proof for manufacturer substantiation.

- Example of a classical nutrient deficiency is calcium relating to osteoporosis today.

- For describing the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, an example is “milk for healthy teeth and bones”.

2. United States v. “Vitasafe Formula M” NJ 1964

FACTS: The FDA alleges that the Vitasafe capsule, as an article of food under §321(f) is misbranded under §343(a) because of its false distinctions between the nutritional needs for men and women and as to its representations that the presence of certain ingredients enhances the nutritional value of Vitasafe. The FDA also states that Vitasafe is misbranded as a drug (§321(g)) under §352(a) because of false and misleading representations that the article is adequate and effective treatment for a number of conditions and diseases.

COURT: The article is misbranded as a food and as a drug. There are no different nutritional need between men and women. The ingredients add no nutritional value and are in minute quantities. The statement that the capsule provides the same amount of vitamins and

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minerals as a variety of foods is false and misleading because the variety in fact provide more than one capsule. The article is also misbranded as a drug because people with the symptoms that Vitasafe claims to cure may rely on the product for a cure.

CLASS: The dietary supplement industry has great lobbying groups to have

them not treated as drugs.

3. Vitamin-Mineral Regulations: 1966: Final revision of the special dietary food regulations.

% RDA Required. Myths eliminated – malnutrition, soil enriched with minerals, etc. Standards of identity for vitamins and minerals. Vitamin and mineral manufacturers upset because the FDA set a

50% RDA floor and a 150% RDA ceiling for vitamins and minerals.

“Crepe” label eliminated – food are the an abundant source of vitamins and minerals, and except for persons with special medical needs, there is no scientific basis for recommending routine use of dietary supplements.

4. National Nutritional Foods Ass’n v. FDA 2nd Circ. 1974

FACTS: The FDA’s authority to set standards of identity for vitamin and mineral supplements sold as foods under §341 and §343(j) is challenged.

ISSUE: Can the FDA set standards of identity for vitamin and mineral supplements and are these standards supported by substantial evidence?

COURT: The FDA can set standards of identity for vitamin and mineral supplements, but it must consider applications for increases on upper limits and balance consumer confusion. The maximum amounts set by the FDA were rejected because of inaccuracies. Proper maximums were to be determined. Setting maximums is acceptable, but people will consume more pills to exceed the maximum regardless. The FDA cannot classify vitamins and minerals above a certain dosage level as drugs.

CLASS: NNFA lobbied for the 1976 Health Research and Health Services

Amendment…

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§350 Vitamins and minerals

cannot set maximum potency levels cannot deem V/M a drug because it exceeds a level of potency

that the Secretary determines to be nutritionally rational or useful. UNLESS IT STATES A HEALTH-CLAIM.

Minimums may be set. May not limit the combination of vitamins, mineral, or other food

ingredients within a food to which the section applies. None of these requirements are applicable the V/M is represented

for use by individuals in the treatment or management of specific diseases or disorders, by children (under 12), or by pregnant or lactating women.

5. Statutes

§321(ff): Definition of a dietary supplement. §342(f): Dietary supplement or ingredient: safety §343(r)(5)(D): Procedure and standards for validity of claims §343(r)(6): Requirements for a statement for a dietary supplement §343(s): Dietary supplement label requirements §343-2: Dietary Supplement labeling exemptions

J. Aesthetic Adulteration

…As opposed to economic adulteration which involves the manufacturer attempting to make the product better than it is (§ 342(b)(4))…cheapening the product. Aesthetic adulteration refers to food taste, smell, etc. not being as good as it appears.

1. Filth

a. United States v. 484 Bags, More or Less 5th Circ. 1970

FACTS: Coffee was imported from Brazil and stored in the US in a warehouse where water damage caused the coffee to mold. The FDA says the food is adulterated pursuant to under § 342(a)(3), which states that a food is adulterated if “it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food”.

ISSUE: Is the coffee adulterated pursuant to § 342(a)(3)?

COURT: A food is not a filthy, putrid, or decomposed substance only if it is unfit for food. The two clauses of the statute are independent. The first clause could be applied to almost any

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article in interstate commerce if the scientist has a microscope. The Secretary, therefore, may adopt administrative tolerance and impose a de minimis qualification on the statute. The tolerance is 10% moldy beans in coffee, and the beans here had 15.1%. The claimant argues that such unpublished standards cannot be enforced. The court agrees. The court also notes that the court may apply a stricter standard, holding that a food is adulterated even though it falls within the Secretary’s tolerance.

CLASS: The FDA may set “tolerances” or “defect action levels”.

Tolerances are for added impurities in foods – must get approval for the additives. DALs are set by the FDA as levels for natural or unavoidable defects in the foods. Falling below the level is acceptable, but above equates to adulteration.

A strict standard in interpreting § 342(a)(3) is advantageous because it sets the floor above what may be dangerous to the public. The downside, however, is that it could ban all processed food from interstate commerce.

US v. Tomato Paste: Claimant argues that the statute applies only to filth that is perceptible by the consumer. The court says such a reading would deprive the public of the protection it cannot afford itself…foods where the filth cannot be detected by the human eye.

§342(a)(4): Adulterated if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated by filth, or whereby it may have been rendered injurious to health.

37 Federal Register § 128.10: Natural or unavoidable defects in food for human use that present no health hazard. There is a maximum level of defects under the Good Manufacturing Practices. Manufacturers must still meet the §342(a)(4) requirement.

Should the public be aware of the “filth guidelines”? Tolerances may have a chilling effect on technological

advances that eliminate insect fragments, etc. Should there be Grades for levels of adulteration?

2. United States v. Capital City Foods, Inc. Dist. ND 1972

FACTS: The food was claimed to be adulterated because of a filthy substance, namely insect fragments. The FDA has not set a tolerance for butter. The court questions whether no tolerance means zero allowance of foreign matter, whether such a tolerance is reasonable, and whether the FDA can show foreign matter above the de minimis allowable amount.

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ISSUE: Are de minimis amounts of foreign matter in butter acceptable?

COURT: De minimis filth is allowed because otherwise, every manufacturer in the country would be subject to prosecution. Since no standard had been set, and there was no showing that the fragments could have been eliminated in the manufacturing process, the de minimis filth is acceptable.

CLASS: Predaceous insects are subject to food additive regulations.

b. Decomposition

1. United States v. An Article of Food…915 Cartons of Frog Legs SD NY 1981

FACTS: FDA organoleptic examiners conducted an analysis of 18 subsamples to determine whether the shrimp were “decomposed”. The FDA set tolerances based on the analysis.

ISSUE: Are the shrimps adulterated due to decomposition, or is the decomposition merely de minimis?

COURT: Decomposition is “a bacterial separation or breakdown in the elements of the food so as to produce an undesirable disintegration or rot”. Organoleptic analysis, based upon the sense of smell to detect different types of offensive food, if honestly administered, is a valid scientific test for decomposition. The shrimp are adulterated under §342(a)(3).

CLASS: Bruce’s Juices, Inc.: decomposition is “not a matter cognizable by

the senses”.

c. Insanitary Conditions

1. United States v. 1200 Cans…Pasteurized Whole Eggs, Etc. ND Ga. 1972

FACTS: Golden Eggs Products, Inc. introduced adulterated pasteurized frozen whole eggs and sugar yolks into interstate commerce according to the FDA. The FDA claims the eggs were adulterated under §342 (a)(1), (a)(3), and (a)(4).

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ISSUE: Are the eggs adulterated?

COURT: The eggs are adulterated. They are “poisonous and deleterious”, rendering them “injurious to health” based upon the salmonella finding. The FDA argues that the test for decomposition is simply to count the live and dead bacteria. GE argues that an acid test is necessary. The court states that both tests are needed for determining decomposition because the acid test measures the lactic acid produced by live bacteria. The FDA claims the food was packed and held under insanitary conditions, rendering it injurious to health. The court agrees that a FDA and National Health Safety Board Inspection revealed no sanitary conditions.

K. The Issue of “Blending”

1. Section 110.99(d) of FDA’s Regulations

The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the final food unlawful regardless of the defect level of the final food.

2. Sugarman v. Forbragd ND Calif. 1967

FACTS: A fire aboard the ship that coffee beans were being transported on caused the beans to be blackened, heated, and in a steaming condition. The beans were purchased to be ground and blended with other ground coffee. The FDA objected to the “blending”.

ISSUE: Were the beans “blended” under the Regulation’s definition?

COURT: The “blending” of charred coffee beans with genuine coffee beans, or of used coffee beans with freshly ground coffee, would enable a coffee producer to palm off the finished product on an unsuspecting public as coffee. The salvaged portion may be used by either extracting the caffeine or by processing it into soluble coffee without blending.

CLASS: There is a tolerance for burnt coffee beans because of ordinary

roasting. Aflatoxin and animal feed (non-contaminated corn) may be

blended so that it is below one of the action levels for animal feed. If blending is safe, why not allow it? It is cheaper to blend, so

manufacturers would always blend and consumers would never have pure foods. There would also be sanitation problems.

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L. Pathogenic Microorganisms

With rare exceptions, the FDA takes regulatory action against any food containing any detectable level of pathogenic microorganisms.

§342(a) is how the FDA gets to these situations.

M. Good Manufacturing Practice

a. Efforts To Enforce §342(a)(4)

Plant Evaluation System (PEV)- Standardized forms focusing on sanitation practices.

Good Manufacturing Practice Guidelines- To interpret the “insanitary conditions” of §342(a)(4).

GMP Regulations – 21 CFR §110 GMP Regulations for specified food commodities.

b. United States v. Nova Scotia Food Products Corp. 2d Circ. 1977

FACTS: The FDA wants the processing of hot smoked whitefish to be in accordance with time-temperature-salinity (T-T-S) regulations. NSFP claims that the plant was not processing whitefish under any “insanitary conditions”, and that the requirements of T-T-S could not be met if a marketable white fish was to be produced. The FDA argues that T-T-S assures sanitary conditions and that §342(a)(4) will be met.

ISSUE: Is it beyond the FDA’s statutory authority under §342(a)(4) to require T-T-S?

COURT: Although there is no statutory authority for the FDA to regulate the number of microorganisms under §342(a)(4), the larger public interest purpose will not allow the requirement to be invalidated because of lack of statutory authority.

CLASS: The FDA should have argued §342(a)(1) – poisonous or

deleterious substance injurious to health. §342(a)(1): For added substances, it is adulterated if it may be

injurious to health. For non-added substances, it is not injurious if it does not ordinarily render it injurious to health.

c. Current Good Manufacturing Practice (CGMP)

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1. §371(a) Regulations and hearings: Gives the FDA authority to promulgate regulations in this area.

2. Ensure that (1) food is manufactured. Processed, packed, and held under conditions that are sanitary, and (2) that such food is safe, clean, and wholesome.

3. 21 CFR § 110 – Recordkeeping requirements, etc.

N. Safety of Food Constituents

1. Poisonous or Deleterious Substances

§ 342(a): A food is adulterated if…

(1) If it bears or contains any poisonous or deleterious substance…

Added: that may render the food injurious to healthNon-added: if the quantity of such substance in such food does not ordinarily render it injurious to health.

“Non-added” is defined in 21 CFR §109.3 as a natural part of the food.

§ 346: Allows the FDA to set tolerances for poisonous or deleterious substances in food. Action levels (DAL) with respect to a natural defect.

§ 346a: Tolerances for pesticide chemicals on or on raw agricultural commodities.

a. Added Substances

United States v. Lexington Mill & Elevator Co. SC 1914

2. Food Additives Amendment

§ 348: Food additives

§ 321(s): Definition of “food additive”

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II. Human Drugs

A. Historical Background

1. Act of June 26, 1948: To prevent the importation of “adulterated and spurious drugs and medicines”.

- Must be examined and appraised…in reference to quality, purity, and fitness for medical purposes, as to their value and identity specified in the invoice.

2. 1906 Food and Drugs Act

- Development of control of drugs

B. General Requirements for Drugs

1. Statutory Definition of “drug”

§321(g): The term “drug” means

(A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and

(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and

(D) articles intended for use as a component of any article specified in clauses (A), (B), or (C) of this paragraph.

2. United States v. 46 Cartons…Fairfax Cigarettes DIST CT NJ 1953

FACTS: The claimant sells cigarettes that are represented to prevent respiratory and circulatory conditions in accompanying leaflets. Claimant admits that the product has none of the curative or preventive powers implied in the leaflet (false and misleading = misbranding).

ISSUE: Is the leaflet evidence of intent to use the article to cure, mitigate, treat, prevent disease in man?

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COURT: Despite claimant’s admission that the leaflet was false and misleading, the clear import of it was that smoking the cigarettes will make cold and viruses less likely, bringing it within the statutory meaning of a “drug”.

CLASS: The FDA seeks to regulate nicotine as a dug and tobacco as a

device.

3. Action on Smoking and Health v. Harris US CT of App. DC 1980

FACTS:

ISSUE:

COURT:

CLASS:

4. United States v. An Article of Drug…Ova II DIST CT NJ 1975

FACTS:

ISSUE:

COURT:

CLASS:

C. Adequate Directions For Use

1. Alberty Food Products Co. v. United States 9th Circ. 1950

FACTS:

ISSUE:

COURT:

CLASS:

2. United States v. Article of Drug…Designated B-Complex Cholinos Capsules 3rd Circ. 1966

FACTS:

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ISSUE:

COURT:

CLASS:

D. Prescription Drug Labeling

1. Limitation to Prescription Sale

Import Drugs Act of 1848, Biologics Act of 1902, and the Food and Drug Act of 1906 left the status of drug as either prescription or non-prescription entirely up to the manufacturer.

Harrison Narcotic Act of 1914: Congress specifically designated certain drugs as available only on the prescription of a licensed physician.

Regulations promulgated in 1938 were the first to introduce the concept of mandatory prescription status.

- Shipment or delivery of a drug or a device was exempt from the § 352(f) – adequate directions for use – requirement.

- Drugs sold by prescription were exempt from the labeling requirement.

- The drug companies could decide which were to be prescription, but the FDA to get to them as mislabeled if they disagreed with the decision. The consumers are passive recipients of the decision.

- The Durham-Humphrey Amendment was considered in 1951 to create uniformity in designating drugs to require prescriptions…if “its toxicity or other potentiality for harmful effect…has been determined by the Federal Security Administrator, on the basis of opinions generally held among experts...to be safe and efficacious for use only after professional diagnosis”.

a. United States v. El-o-Pathic Pharmacy 9th Circ. 1951

FACTS: The FDA claims that certain hormones introduced into interstate commerce are misbranded in that they fail to bear adequate directions for use for efficacious remedies for many conditions that are not mentioned in the labeling or directions for use. The hormones are also said to be inherently dangerous in that it may cause infertility and make dormant cancer active.

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ISSUE: Does the danger of the hormones justify deeming the hormones misbranded because they are only labeled “a physician should be consulted”?

COURT: The label direction that “a physician should be consulted” does not constitute adequate directions for use when the drug is inherently dangerous except under the supervision of a physician. Adequate directions for unsupervised lay use cannot be written. The FDA says that the only adequate label would be one that says the drug should only be used under the prescription of a physician. The FDA may exempt the requirement for directions for use if it is not necessary for public health, but only if the drug complies with the regulation requiring the label to provide that drugs be sold only under prescription of a physician. The regulation is not contrary to law, arbitrary, or capricious.

CLASS: §353(b): Prescription by physician; exemption from labeling and

prescription requirements; misbranded drugs; compliance with narcotic and marihuana laws. – Requires certain drugs to be prescribed, either in writing or orally.

§352(d): Habit forming substances

Misbranded if…- Contains certain quantities of certain substances, OR- Secretary’s investigation and by regulation reveal it is habit

forming, UNLESS- The label bears the quantity or proportion of such substance or

derivative AND in juxtaposition therewith the statement “Warning – May be habit forming”.

Violation of §333(e): Prohibited distribution of anabolic steroids is a violation of the Controlled Substances Act.

b. United States v. Article of Drug…”Decholin” ED Mich. 1967

FACTS: The government condemned Decholin as misbranded while held for sale because it was being sold without prescription. The FDA believes that the drug is unsafe and this raises a toxicity issue of the patient experiencing the indications set out on the label having an aliment that Decholin cannot cure and postponing a visit to the doctor because of reliance on the OTC drug, or the “collateral measures” question.

ISSUE: Is Decholin unsafe as a drug intended for human use without a prescription?

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COURT: There must be a showing of evidence to show how a lay person seeking medicine may be affected by Decholin. The factors for the drug being unsafe for unsupervised lay use include:

1. Seriousness of effect of delayed doctor visit – inconvenience or actual harm.

2. How much of a delay will be detrimental.3. Quality of advise on the label cautioning users to

consul a doctor if certain symptoms develop.4. If the indications are eliminated by the OTC drug,

will the patient believe they are cured.5. Meaning of “safe” as connected with the toxicity

issue.

The government contends that while the drug may relieve symptoms, self-medication may actually be harmful to the patient. The company argues that the if the patient has a major ailment, Decholin will not help them and they will seek medical attention in the end. It is counterintuitive to deem every drug that cannot cure every possible disease as requiring prescription.

c. Switch from Prescription Drugs to OTC pursuant to §353(b)(3) (prescription requirement removed if not necessary for the protection of the public health).

1. Holder of the NDA or ANDA (abbreviated NDA when it goes off patent) or the supplemental NDA (submitted to change the NDA).

2. Anybody can petition the FDA for the switch. For example, a generic holder of an ANDA may want to go OTC. The NDA holder may not block such a switch. But it is rare to force the manufacturer to go OTC while they still hold the patent.

3. OTC Drug Review Process: Amendment to OTC “monograph”, which is a description of classes of OTC drugs. Such a monograph is expanded to include prescription so that the prescription can be sold OTC.

d. Third Class of Drugs

All OTC drugs with warning labels should be sold only through pharmacies – do not need a prescription though.

2. Warnings for Prescription Drugs

a. §352(f)(2): Misbranded Because No Adequate Warnings

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“such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application,…as are necessary for the protection of users”

b. Stottlemire: No need to warn to the general public about dangerous possibilities of a prescription drug that requires a doctor visit.

c. Magee: THE “LEARNED INTERMEDIARY” DOCTRINE: A manufacturer of a prescription drug need not also insure that warnings also reach the patients for whom the drug is prescribed.

d. The warnings that a manufacturer supplies with a new prescription drug when it is first marketed are specifically prescribed by the FDA in the physician package insert that is part of the approval of the NDA. If new information about a dug already widely prescribed by physicians is discovered, the manufacturer should provide additional warnings to physicians (even if before FDA approves or requires them).

e. Sterling Drug, Inc. v. Yarrow 8th Circ. 1969

FACTS: A South Dakota housewife sued Sterling, manufacturer of Aralen for rheumatoid arthritis, for failing to warn the public, herself, her physician, and retail drug dispensaries from which she purchased the drug, of the potential danger to “eyesight and vision” from the use of the drug. While the effects on the retina were published in reports, the information was never brought to the attention of physicians and customers through detail men. The warnings were in the PDR and a letter to provide additional information of the drug.

ISSUE: Is the medical literature and the letter sufficient to warn physicians of the additional information regarding retinal damage?

COURT: Detail men present the most effective method of warning the doctor. Doctors rely on them for personal calls, special experience, training and literature, and to promote the sale of the drug. The medical literature presented to doctors is too much for them to read all of it. The manufacturer argues that it is an unreasonable duty for drug manufacturers to personally notify doctors through detail men. The court stated that it is the exercise of reasonable care for the detail men to warn physicians whom they regularly call on.

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CLASS: The FDA today does not require the use of detail men, but

since literature can be abundant, the envelope size and type is required, with “Important Drug Warning” printed on it.

f. MacDonald v. Ortho Pharmaceutical Corp. Mass. 1985

Massachusetts: In light of oral contraceptive injuries, the courts have narrowed the “learned intermediary” doctrine and enunciated a general rule that FDA-mandated warnings present the minimum, and not necessarily appropriate, warnings for a prescription drug.

FACTS: Since doctors play a passive role in the prescription of the pill, and patients play a more active role in the decision, the manufacturers have a common law duty to warn the users directly of the associated risks.

ISSUE: Should users of oral contraceptives be warned directly by the manufacturer due to the risks of such drugs?

COURT: The manufacturer has an obligation to warn users of oral contraceptives directly of any risks. The warning should be written, conveying reasonable notice of the nature, gravity, and likelihood of known or knowable side effects, and advising the consumer to seek fuller explanation from the prescribing physician or other doctor of any such information of concern to the consumer. FDA requirements are the floor, and the state may impose stricter duties to warn. The common law duty to warn necessitates a “lay person” understanding standard.

DISSENT: A manufacturer’s duty to warn is fulfilled by complying with applicable FDA regulations and adequately informing physicians of the risks associated with its products.

CLASS: All prescription drugs, as well as aspirin and a relatively small

number of other nonprescription drugs must have “child-restraint” packaging.

The “learned intermediary” is beneficial because it puts some obligations on the doctor.

Patient Package Inserts alone and no “learned intermediary”:

Downside:1. Patients stop taking because scared of the side effects.

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2. Develop side effects because suggestable.3. Pharmacist will charge more because of the cost of

insert dissemination.4. Liability Exposure: If no learned intermediary defense,

manufacturers will be discouraged from drug innovation and introduction. At the very least, the manufacturers would be slower introducing helpful drugs or more willing to pull helpful drugs from the market.

Physician Package Inserts required for:

1. Oral contraceptives2. IUDs3. Estrogen-containing drugs4. Pro-gestational drugs

g. Restatement (Third) of Torts

Three areas of defects with respect to products:1. Manufacture – the product was not as manufacturer intended it

to be.2. Design – As intended, but all are dangerous.3. Warning – Must warn about a particular risk, or gave warning,

but it was inadequate (§321(n)).

History: Restatement (Second) of Torts:

Strict Liability: No examination of unreasonably dangerous…simply had to cause harm.

§402(a)

Comment K: Some products are unavoidably unsafe. Due to the benefit to society, no strict liability will be applied, only liability for negligence. Pharmaceutical industry manufacturers benefit from this standard.

Prescription Drugs:

If a product is more beneficial than harmful in the overall scheme, then the product is not a defectively designed pharmaceutical drug.

This negligence standard is applied to:

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1. Protect against the high cost of drugs due to increased liability exposure.

2. Prevent the slowing or stopping of drug introduction.3. As a result of Pharmaceutical and Research Manufacturers

Association (PhRMA) strong lobbying group.4. Since the process to ensure safety is so involved (13 years), no

need to apply strict liability.

Some courts do say that drugs are like lawnmowers and people should be able to sue and recover.

Restatement (Third) of Torts

Very Pro-defendant §6(c): Not liable for a design defect if it is a benefit to any

class of patients…if reasonable healthcare provider, knowing of such foreseeable risks and therapeutic benefits, would prescribe the drug or medical device for any class of patients.

Reasonable: objective, medical malpractice standard.

This provides for the Super Negligence standard of Schwartz.

h. §321(n)

1. Statutory Authority for FDA to require manufacturer to provide adequate warnings. §352(f)(2).

2. Civil Obligation: Failure to Warn Suit.3. Statutory Authority for FDA to require manufacturer to avoid

the “failure to reveal facts material in light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising related under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual” which means it is misbranded. §321(n).

If a drug is marketed for hypertension, but a medical expert says in JAMA that it is good for congestive heart failure, and most of medical community does not believe this, the manufacturer should not remove any warnings for congestive heart failure uses because of §321(n).

Cannot disclaim or qualify a warning with respect to disclamatory opinions (Cannot say “Some doctors say this is acceptable”). Why? Because not beneficial for

39

upholding public health , etc. Can write: “May be harmful for congestive heart failure”.

Differences in medical opinion son the warning would render the label confusing and misleading, making it misbranded within the meaning of §343(a).

i. “Class Labeling” through the DESI program has been abandoned for the achievement of uniformity through the NDA process.

j. If the manufacturer has done the study and has knowledge of a side effect, it must put a full warning or the drug is misbranded. Attorneys often end up negotiating with the advertising departments about what to include on the label.

3. Patient Labeling for Prescription Drugs

a. Patient Package Inserts (PPIs)

b. Oral Contraceptives and PPIs

Opposed because:1. Interferes with the physician-patient relationship.2. Confuses and alarms the patient.3. Cannot provide all the needed information.4. Physician is the proper person to dispense the

information.5. Should not control what information the physician

gives.

Favored because:1. Patient allowed to make a conscientious choice.2. Assures informed consent

35 Federal Register §130.45: PPIs allowed for oral contraceptives with printed information: “Do Not Take Drug Without Your Doctor’s Continued Supervision” and that safe use of the drug requires a careful discussion with your doctor.

c. Pharmaceutical Manufacturers Ass’n v. FDA Del. 1980

FACTS: The FDA required that PPIs be dispensed or administered to patients using conjugated estrogens due to an increased risk of endometrial cancer. The manufacturers argue that the FDA lacks statutory authority because the Acts says nothing about PPIs, and that the requirement is unconstitutional

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because it infringes upon a doctor’s right to exercise professional judgment.

ISSUE: Does the FDA have statutory and constitutional authority to require PPIs for estrogen drugs?

COURT: The FDA’s authority comes from the objective of §321(n) being met through PPI labeling. The requirement is not unconstitutional because it does not prevent physicians from prescribing the drugs, but rather, encourages patients to have open discussions with their doctors. Another objective is that labeling should be truthful and complete. Physicians do not have the right to control a patient’s access to information. Furthermore, the right to privacy is upheld by the right to make an important decision for themselves.

CLASS: 321(n) does not say that the material facts must be revealed

to “users of drugs”. The court interprets the statute liberally to protect patients.

PPIs put patients on notice of off-label uses and leads to informed consent. Also, some of the warnings are still applicable even though it is an off-label use.

d. Prescription Drug Products: Patient Labeling Requirements1979 – Agency for PPIs

Patients know about the benefits, risks, and directions for use of the products, which leads to more safe and effective use.

Fewer liability actions. Patients understand the risks, and assume the risks. This leads to support from doctors (fewer malpractice suits) and manufacturers.

1982 - Revocation of PPIs

Private sector has taken over the initiative. The FDA has only mandated PPIs for 10 products. Manufacturers plan to have PPIs for many more drugs.

Voluntary PPIs: Promoted innovation in delivery systems – AMA, AARP, inexpensive books of information.

The change came about with the Reagan Administration: Pharmaceutical industry allied with the Administration.

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1995 – Federal Register Requirements – Clinton Administration

If 75% of the people who get prescriptions by 2000 get the useful information, then PPIs will not be mandatory. If 95% by 2006, then not mandatory.

60 Federal Register §208.1(c): Determination of useful information will be based on scientific accuracy, consistency with the format in §208.22, nonpromotional tone and content, specificity, comprehensiveness, understandable language, and legibility.

The data guidelines are in place to get the pharmaceutical companies to meet the goals.

E. Prescription Drug Promotion

a. Generic Drug Disclosure

1. §352(e): A drug for which the manufacturer does not disclose the generic name of the active ingredient of their product in labeling and in advertising is misbranded. The disclosure of the established name was to be made each time the trade name was used.

2. 21 CFR §201.10(g): Requires that the generic name appear, in type that is at least half the size as the brand name, whenever the brand name is “featured,” and at least once when the brand name is used “in the running text”.

3. §352(n): Fleshes out the CFR regulations.

F. Prescription Drug Advertising to Professional

FDA regulates the advertising of prescription drugs. The FTC regulates the advertising of prescription drugs.

a. 21 CFR §202.1(e)(6): An advertisement for a prescription drug is false, lacking in fair balance, or otherwise misleading, or otherwise violative of §352(n) if…

§202.1(l)((1): Newspaper, TV, and magazine prescription drug ads are considered advertising. Advertisements must include a “brief summary relating to side effects, contraindications, and effectiveness”.

§202.1(l)(2): Everything else is labeling. Brochures, file cards, calendars, exhibits, PDR, etc. is all labeling.

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“Fair Balance”: If an advertisement stresses the drug’s benefits, it must stress the risks with equal weight, to permit a balanced evaluation.

§202.1(e)(7)(vii): False, lacking in fair balance, or otherwise misleading if…fails to provide sufficient emphasis for the information relating to the side effects and contradictions, when such information is contained in a distinct part of an advertisement, because of repetition or other emphasis in that part of the advertisement of claims for effectiveness or safety of the drug.

§202.1(e)(7)(viii): False, lacking in fair balance, or otherwise misleading if…fails to present information relating to side effects and contraindications with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug, taking into account all implementing factors such as typography, layout, contrast, headlines, paragraphing, white space, and any other techniques apt to achieve emphasis.

§202.1(e)(6)(xi): Uses, literature, quotations, or references for the purpose of recommending or suggesting conditions of drug use that are not approved or permitted in the drug packaging labeling.

Mfc. Cannot do “off-label” promotions because not keeping with the drug packaging labeling.

Advertisement is violative if the manufacturer uses literature to recommend or suggest a drug use that is not approved in the drug packaging labeling.

As of the Food and Drug Modernization Act of 1997, 21 USCA §360aaa, “enduring materials” may be disseminated to ensure that doctors receive the information. Despite the prohibition in (xi), Congress said dissemination is allowed, but need:

1. Disclaimer2. Not in keeping with drug labeling statement3. “There are approved drugs” for the condition.4. Supplemental NDA – seeking approval through

studies, etc. If it does not make economic sense to invest in the studies, the manufacturer does not have to file a supplemental NDA.

b. Reminder Advertisements

Call attention to the name of the drug product, but do not

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include indications or dosage recommendations.

No need for side effects or contraindications unless FDA requires a boxed warning for serious hazards associated with its use.

c. Medicare/Medicaid Fraud and Abuse

It is a felony to solicit or receive any remuneration for purchasing any product for which payment may be made under Medicare or Medicaid.

Manufacturers cannot give doctors anything to influence them to buy their products if they are reimbursable by Medicare or Medicaid.

In addition, AMA has a GUIDELINE that a doctor cannot give or receive a gift worth more than $100.

d. Overpromotion

Love v. Wolf Cal. 1964

The company’s heavy promotion of the drug effectively submerged its own warnings about the hazards.

e. Dissemination of Scientific Information

Promotional regulations restrictions cannot restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings and scientific or lay media.

So long as the information is complete and balanced, the FDA will refrain from regulation generally. The concern is with First Amendment violations.

An independent article about a prescription drug is not to be considered advertisement or labeling of the drug, so long as the manufacturer made no contribution to the article and does not use the article for promotional purposes.

G. Direct to Consumer Advertising of Prescription Drugs

1. 1983: Voluntary Moratorium of DTC Ads to permit time for a reasoned assessment of the complex issue. Before DTC, the FDA limited ads to price ads.

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2. 1985: Moratorium withdrawn. The current regulations were sufficient safeguards to protect consumers.

3. The FDA now requires ads to contain: name, indication, fair balance, mechanism for consumers to get brief summary (toll free number or reference to an ad).

4. DTC Advertising

ADVANTAGES DISADVANTAGESInformed Patient. Interferes with Doctor-Patient

Relationship.Patient participation in their own care leads to more business for manufacturer.

Unreasonable expectations.

Increased competition that leads to decreases in costs.

Emphasis on taking drugs as treatments (pharmacological treatments).

Makes doctors more aware of costs. Those without insurance will ask for the lower priced drugs.

Increased cost of drugs.

Provides health information.Patient may ask for an inappropriate treatment that the doctor will have to spend time explaining.

Seek treatment for conditions that may otherwise go untreated.

Scared and confused into noncompliance (unnecessary use).

5. Kessler Article

The FDA can seize a drug and the manufacturer can be subject to criminal prosecution, but the FDA usually just writes a letter. The company usually comes into compliance because it wants a good relationship with the FDA. The FDA may hold up NDAs on new products in the future – Extortion.

Ads and other promotional materials are recommended to be approved by the FDA, although not required. Some companies have raised First Amendment issues, but most do not because they want a good relationship with the FDA.

H. Drug Product Sanitation and Integrity

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1. §351(a)(2)(B): A drug is adulterated if it is not manufactured “in conformity with current good manufacturing practice”.

2. United States v. An Article of Drug…White Quadrisect 7th Circ. 1973

FACTS: WQ was condemned because its production procedure violated the cGMP and §351(a)(2)(B). WQ argues that the provision is unconstitutional because it is vague as to its definitions of “current” and “good”.

ISSUE: Is §351(a)(2)(B) unconstitutional for vagueness?

COURT: “Current: refers to the regulations in place at the time of production of the drug. “Good” is defined as in the dictionary, and therefore, is capable of being objective. The Constitution only requires a reasonable degree of certainty as to the statutory language. WQ manufacturer violated a reasonably certain statute.

CLASS: Footnotes 4 and 5 on Page 469.

I. FDA Licensure of New Drugs

1. Background

As of 1962, drugs must be safe and effective with substantial evidence – through adequate and well-controlled studies.

“New Drug” §321(p)(1) Not generally recognized as safe and effective(2) Through investigations, has been demonstrated to be safe and

effective, but not to a material extent (not widely distributed) or for a material time.

Can have an old drug that becomes a new drug because it is used for a new use.

Safe is not enough because the media will exploit the fact that the drug is not effective and $ is being spent on it.

“IND” needed to send the drug across state lines for clinical investigations.

§355 New Drugs

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United States v. An Article of Drug…Diso-Tate ED La. 1976

FACTS: Dr. Evers was prescribing EDTA, a drug used for treatment of heavy metal poisoning, for the treatment of arteriosclerosis and other circulatory diseases. The FDA seeks to seize AND enjoin administration of the drug. The product as misbranded because it bears inadequate directions for use (§352(f)(1)) and because it is specifically contraindicated for cardiovascular treatments. The doctor continued to distribute promotional literature advocating EDTA for cardiovascular treatment.

ISSUE: Is EDTA misbranded and is the enjoining of the administration of the drug unwarranted interference with the practice of medicine?

COURT: The requested injunction is the only means of removing the misbranded drug from interstate commerce. Since the FDA is charged with removing misbranded drugs from interstate commerce, there is no unwarranted interference with the practice of medicine. The doctor could have used the drug for experimental or investigational uses if he had followed the §355(i) procedures.

CLASS:

United States v. Evers Alab. 1978

FACTS: Dr. Evers is promoting and administering calcium disodium versenate for arteriosclerosis. The allegations include using the drug for a use not indicated on the package insert, patients are subject to grave injury or death, and that promoting and administering the drug after it has been shipped through interstate commerce is prohibited and amounts to misbranding pursuant to §§ 331(k) and 352(f)(1), respectively. The doctor argues that physician judgment should be

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upheld and that the FDA does not prohibit a licensed physician from using a drug in any manner that is not contraindicated on the package insert.

ISSUE: Can a licensed physician be enjoined from prescribing for his patient a drug which the package insert is silent as to whether the drug is indicated or contraindicated for the patient’s illness?

COURT: Since patients have a remedy in malpractice, once a drug is in a local pharmacy, the FDA will not interfere with a licensed physician prescribing various dosages or for different conditions. Unapproved uses are outside of federal jurisdiction once interstate commerce is completed. Since FDA approval requires the submission of evidence supporting the new use, and new discoveries are often first printed in medical journals and meetings, the FDA will not interfere with a physician prescribing according to his best judgment. The drug, therefore, is not misbranded.

CLASS:

United States v. Evers 5th Circ. 1981

FACTS: The FDA claims that Dr. Evers has violated §331(k) by his failure to provide “adequate directions for use” pursuant to § 352(f)(1). The government is concerned with the promotion and advertising of the chelating drug (not accepted by medical profession), not with the actual prescribing. The FDA claims he “misbranded” the drug when he advocated the chelating drug for an unapproved purpose without providing “adequate directions” for such a use.

ISSUE: Has Dr. Ever’s promotion of the drug deemed the drug misbranded?

COURT: The FDA seeks to prove that adequate directions for use by physicians were not provided, and at the same time, that the sale of the drug was prohibited to patients. The court says this is nonsensical. Dr. Evers was the only physician who needed to provide adequate directions for use to himself. In addition, he was merely distributing the drugs to his own patients. He has no obligation to disclose the adeqaute dorections for use to physicians who are not distributing the drug.

CLASS: §331(k): Prohibits the misbranding of a drug which is held for sale

after shipment in interstate commerce. What about the misbranding through the promotions to other

physicians where no adequate directions for use were provided? A doctor who merely advocates to other doctors a lawful

prescription drug for a use not approved by the FDA, and does not distribute that drug to other doctors, is not holding that drug for sale within the meaning of §331(k).

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Physician Civil Liability for Deviating From the Package Insert

Deviation from approved labeling is generally per se N. The question is whether the package insert is admissible in court,

and if so, what kind of evidence does it constitute…

- Appropriate standard of care- Prima facie evidence of the standard of care

The doctor may provide reasons for deviating from the procedures recommended, and it for the jury to decide whether the deviation was justified.

III. Devices

A. Historical Background

1. Enactment of 1938 Act to curtail the growing number of fraudulent devices being marketed during the 1930s.

a. By 1937, there were 436 manufacturers of surgical, medical and dental instruments and supplies, and the value of their shipment was a little over a million dollars. By 1947, the number rose to $327 million.

2. Medical Device Amendments of 1976

B. The 1938 Act Definition of “Device”

1. United States v. 23…Articles 2nd Circ. 1951

FACTS: The government sought seizure and condemnation of phonographic records entitled “Time To Sleep” pursuant to § 321(h).

ISSUE: Are the records intended (1) for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (2) to affect the structure or any function of the body of man or other animals?

COURT: The experts testified that insomnia is not a disease, but a symptom of a disease (usually neurological) or of an emotional disturbance of some kind. The experts do state, however, that sleep is a function of the body. The records do involve “devices”

CLASS: §321(h): Definition of device.

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2. United States v. Undetermined Quantities of Article of Device WD Mich. 1982

FACTS: The government seeks to condemn 32 different tapes related to health or medical problems, listed as the “Health Series”, marketed by Potentials Unlimited.

ISSUE: Are the tapes medical devices within the meaning of the FD&C Act?

COURT: “Medical devices” should be regulated by the FDA for the protection and benefit of the consumer seeking medical treatment, and courts will adopt a broad definition of “medical device” to effectuate that purpose. The liberal interpretation of the statute must yield when it comes in conflict with the First Amendment. The legislature did not intend for the FDA to regulate the dissemination of health information through the devices statute. The Act does, however, apply is the manufacturer had a therapeutic intent. The tapes are accompanied by therapeutic claims in the introduction, used to treat disease or affect body function.

CLASS:

3. United States v. An Article of Drug…Bacto-Unidisk SC 1969

FACTS: Antibiotic sensitivity discs were used as a screening test to determine what the proper antibiotic drug was to administer to patients.

ISSUE: Is the product a “drug” and subject to pre-market approval pursuant to § 357, or a “device” for which no pre-testing or approval is required before marketing?

COURT: Courts will give the definition of “drug” a liberal interpretation in order to protect the public health, and more specifically, to ensure that antibiotic products marketed serve the public with “efficacy” and “safety”. While the difference between a drug and a device according to the statute comes down to whether it is an “article” or “an instrument, apparatus, or contrivance”, the more natural way to distinguish the two is as to the statutory purpose of protecting public health.

CLASS: In-vitro diagnostic products do not require NDAs, but are subject

to detailed labeling requirements. Cancer and gonorrhea diagnostic tests do require NDAs.

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“Grey area” products as to whether drugs or devices receive complete agency discretion

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