llnsubstantiat0d~fai1ii's ,~ and · dietary supplements: a review of current promotional...

llnsubstantiat0d~fai1ii'S and ,~ .

Unsubstantiated Claims and

Documented Health Hazards in the

Dietary Supplement Marketplace

Department of Health and Human Services Public Health Service

Food and Drug Administration

July 1993

Table of Contents

Introduction ..................................................................................................... iv

Dietary Supplements: A Review of Current Promotional Literature Available to Consumers in the Marketplace Related to Specific Illnesses ............ 1

Unsubstantiated Claims-Immune Systems .................................................................... 2

Unsubstantiated Claims-Arthritis .................................................................................. 9

Unsubstantiated Claims-Cardiovascular Systems ........................................................ 12

Unsubstantiated Claims-Diabetes ............................................................................... 23

Unsubstantiated Claims-Honn ones ............................................................................. 28

Unsubstantiated Claims-Cancer .................................................................................. 30

Unsubstantiated Claims-Otller .................................................................................... 36

Dietary Supplements: Examples of Recent Regulatory Actions (Seizures and Wanting ~tters) ........................................................................ 41

Cardiovascular System Claims ...................................................................................... 42

Multiple Disease ClaiJns ............................................................................................... 44

ltnmune System Claims ................................................................................................ 61

Otlter Claims ............................................................................................................. _. 63

Dietary Supplements: Examples of Current Oral Claims Made by Health Food Store Employees for Specific Illnesses ........................... 69

High Blood Pressure ..................................................................................................... 70

ltnmune System ............................................................................................................ 81

Cancer .......................................................................................................................... 90

Illnesses and Injuries Associated with the Use of Selected Dietary Supplements ............................................................. 100

Herbals ....................................................................................................................... 100

Amino Acids .............................................................................................................. 103

Vitamins and Minerals ................................................................................................ 1 ()4

Other Products Marketed as Dietary Supplements ....................................................... 105

iii

Introduction

This repon demonstrates the pervasiveness of unsubstantiated claims cmrently being made for dietary supplements in the U.S. marlcetplace and reviews health bawds associated with dietary supplements.

FDA is issuing this report so that oonsmners have accurate information about the dietary supplement marlcetplace. The report has four sections: • a list, with more than 500 entries, of dietary supplement products and the unsubstantiated claims currently being made for those products • a ~tative list of recent FDA enforcement actions against dietary supplements • a list of oral representations made for specific products for hypertension, immune system problems, and cancer by employees of stores selling dietary supplements • a narrative report desaibing serious adverse reactions associated with selected ingredients marlceted as dietary supplements.

Products with Umubstantiated Claims To gain an understanding of the current dietary

supplement marlcetplace, FDA has compiled examples of dietary supplements and the claims being made for those products. Only printed claims have been included in this list: Pamphlets and brochmes, leaflets, point-of-purchase materials, and product advertisements were the primary sources of the claims.

Whenever ~ible, each dietary supplement product on the list is classified according to the following code: {AA} signifies an amino acid product; { G} signifies a glandular product; {H} signifies an herbal product; { Combo H) signifies a combination herbal product; {M} signifies a mineral product; and {V) signifies a vitamin product

Each product makes at IC$t one unsubstantiated claim; most make several. The claims range from treatment of such chronic diseases as cancer, emphysema and multiple sclerosis to the elimination of such disorders as incontinence and varicose veins. Some promise prevention of heart disease and cataracts. Others promise cures: ''removal of kidney and gallstones." Some claim very specific outcomes, such as the product that "inhibits platelet aggre-

iv

gation" or the one that works against "diabetic vascular damage." Others promise relief from "infection."

Unsubstantiated claims being made for dietary supplements in the United States today include claims for treatment of such infectious diseases as AIDS, chickenpox, cholera, and dysentery; they range from the general ("infection" and "senility") to the specific ("ringworm" and "impetigo'').

These products may be making a wide variety of claims, but they have one thing in common: Not one of the claims has been substantiated by FDA before their appearance in the marketplace.

FDA Enforcement Actions, November 1990 through June 1993

Because of the current legal and regulatory frameworlc, FDA exercises oversight on the dietary supplement industry on a case-by-case basis. F.ach case is extremely resource-intensive. This section of the report lists representative FDA regulatory actions, between November 1990 and June 1993, against 188 dietary supplement products that made unsubstantiated claims about serious medical conditions. It includes only actions taken under the drug provisions of the Federal Food, Drug, and Cosmetic Act by FDA's health fraud program. Items in this section marked by an asterisk are product seizures; all other listings are warning letters. As the other sections of this report make clear, this investment of resources has failed to stem the tide of unsubstantiated claims.

Oral Claims for Dietary Supplements As the long list of printed claims shows, unsubstan

tiated claims currently are pervasive in the dietary supplement industry. No pictw'e of the current situation would be complete, however, without an understanding of oral representations being made about these products. To complete this picture, earlier this month personnel in each of FDA' s 21 district offices across the nation inf onnally visited local stores that sell dietary supplements.

During their visits, they asked salespeople the following questions about the use of dietary supplements for specific serious and life-threatening diseases:

• "What do you sell to help high blood pressme?" • "Do you have anything to help fight infection or help my immune system?,. • "Do you have anything that works on cancer?''

The results of those visits are presented by disease category. Of the 129 requests for information summarized in this section, 120 resulted in recommendations of specific dietary supplements. In three instances, store employees declined to make recommendations. On six occasions, employees merely provided references from reading material on dietary supplements.

The oral representations of dietary supplements demonstrate the pervasiveness of unsubstantiated claims for serious diseases being made for these products aaoss the nation.

Health 1187.ards Associated with Dietary Supplements Unsubstantiated claims now being made for dietary

supplements represent only part of the pictme: In addition, some of these products present health hazards that can be serious and are sometimes fatal.

The report on health hazards focuses on selected ingredients currently available in dietary supplement products: nine herbal substances, two amino acids, four vitamin and mineral products that can be toxic at higher doses, and one other product. This list is not intended to be all-inclusive.

Conclusions Roughly 80 percent of the dietary supplement market

place consists of vitamins and minerals that are marketed at reasonable potencies and make no unsubstantiated health claims. The conclusions of this report do apply, however, to the other 20 percent of the marketplace: those dietary supplement products that present safety concerns or make unsubstantiated claims.

Thousands of unsubstantiated claims are being made about hundreds of dietary supplements. Some ingredients marketed as dietary supplements have demonstrated serious and even life-threatening hazards.

As a result, millions of Americans are spending billions of dollars every year on dietary supplement products,

V

many of which have shown little or no evidence of either safety or effectiveness. In this blizzard of claims for dietary supplement products, valid claims are currently indistinguishable from invalid claims. Moreover, people may be replacing legitimate treatments of demonstrated effectiveness with unproven and questionable remedies. For example, high blood pressure is a well-understood condition that is readily treatable. Left untreated, or improperly treated, it can be life-threatening.

This report suggests that the success of FDA's rather modest enforcement actions of the past few years has been limited. The samples collected-along with oral representations of uses for dietary supplemenl.,_show that in nearly all cases unsubstantiated claims are moving off the product label and into catalogues, brochures, and oral sales pitches.

The history of health quackery in this century demonstrates that enforcement actions may cause manufacturers to remove claims from the label-but the products stay on the market Even without claims on the label, sales litera• tme and salespeople continue to make unsubstantiated claims. Moreover, products continue to be bought and used because of the original unsubstantiated claims made on their behalf.

The bottom line is this: The marketplace has changed little over the years despite fDA's efforts. If anything, unsubstantiated claims are becoming more exaggerated, more products of unknown effect are available, and their use is escalating.

When it comes to dietary supplements, the position of the Food and Drug Administration is straightforward: Dietary supplements should be safe, and any health claim on their labels or in promotional literature should be scientifically valid.

Many of these products can be beneficial. FDA has prepared this report so that consumers will have infonnation about the broad range of claims being made for them. We will have learned little from the tum-of-the•century days of the traveling medicine show if the proliferation of unsubstantiated claims for dietary supplements is allowed to continue.

Dietary Supplements: A Review of Current Promotional Literature Available to Consumers

in the Marketplace Related to Specific Illnesses

1

I UNSUBSTANTIATED CLAIMS - IMMUNE SYSTEMS I PRODUCT FIRM CLAIM

AUNTIE VI HERBS FOR KIDS ANTIVIRAL FORMULA TO PREVENT AND {COMBO-H} INHIBIT COMMON CHILDHOOD VIRAL

ILLNESSES

FLORA BALANCE BIO-GENESIS CORP HEALTHY IMMUNE SYSTEM RESTORED {H}

L-CYSTINE {AA} COUNTRY LIFE STIMULATE WHITE BLOOD CELL ACTIVITY REQUIRED TO FIGHT DISEASE

SWEET ECHINACEA HERBS FOR KIDS IMMUNE SYSTEM ENHANCER, USED FOR {H} SYMPTOMS OF COMMON BACTERIAL OR

VIRAL ILLNESSES

CO-ENZYME Q-10 LIFE EXTENSION BOOSTS IMMUNITY FOUNDATION

ECHINACEA {H} INDIANA BOTANIC BOOSTS IMMUNE SYSTEM GARDENS

LYSINE {AA} CRYSTAL STAR HERPES VIRUS; OSTEOPOROSIS HERBAL NUTRITION

VITAMINC LIFE EXTENSION IMPROVE THE IMMUNE SYSTEM (ASCORBIC ACID) FOUNDATION POWDER

CLEANZE NATIONAL STRENGTHEN THE IMMUNE SYSTEM {COMBO-V+M+H} HEALTH

PRODUCTS

CO ENZYME Q-10 BOOK BY EMILE G STRENGTHEN HEART, BOOST IMMUNE {AA} BLIZNAKOV ,M.D./ SYSTEM

GERALD L.HUNT

BEE POLLEN {H} HEALTH CENTER HELPS THE IMMUNE SYSTEM; BUILDS FOR BETTER RESISTANCE TO DISEASE LMNG

L-LYSINE 1000 MG SUNDOWN REDUCTION OF THE INCIDENCE OF {AA} HERPES-SIMPLEX INFECTION

CRYSTAL STAR CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & ANTI-BIO CAPS OR HERBAL ARC; AIDS RELATED COMPLEX EXTRACT{H} NUTRITION

NATUR-EARTH {H} LIFELINE INC AIDS, CANCER

CRYSTAL STAR CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & DETOX {H} HERBAL ARC; AIDS RELATED COMPLEX

NUTRITION

2


GARLIC {H} THE HERB NOOK BACTERIAL AMD VIRAL INFECTIONS

PAU D'ARCO {H} INDIANA BOTANIC IMMUNE SYSTEM RELATED PROBLEMS GARDENS

RED CLOVER {H} INDIANA BOTANIC IMMUNE SYSTEM ENHANCER GARDENS

CALF THYMUS {G} COUNTRY LIFE IMMUNE SYSTEM TO PROVIDE ANTIBODIES TO FIGHT OFF BACTERIA AND VIRUS

IMMUNE BOOSTERS SOLSTICE HELPS TO RESTORE YOUR IMMUNE SYSTEM

IMM-C {H} THE HERB NOOK STIMULATES IMMUNE RESPONSE

BIOTEC CELL CRYSTAL STAR PREVENTION OF AIDS, CANCER, HERPES GUARD HERBAL ASTRAGALUS {H} NUTRITION

HRP-C THE HERB NOOK SHINGLES, VIRUSES,AIDS,CANCER

PYCNOGENOL {AA} CRYSTAL STAR PREVENTION OF AIDS, CANCER, HERPES HERBAL NUTRITION

A C & POTASSIUM ENZYMATIC ESSENTIAL FOR PROPER IMMUNE FUNCTION COMPLEX THERAPY

IMMUNE FOCUS {H} GERO VITA IMMUNE-STIMULATING AGENTS, ARREST OR INTERNATIONAL LIMIT TUMOR GROWTH IN AIDS

ADVANCED 1991 RAINBOW NOURISH THE IMMUNE SYSTEM AND DEFENSE SYSTEM LIGHT SUPPORT LONG LIFE PLUS NUTRITIONAL

SYSTEMS

ARTHEEZ {V+AA} THE ROCKLAND ENHANCE IMMUNE SYSTEM CORPORATION

HONEYBEE GOLDEN STRENGTHEN IMMUNE SYSTEM PROPOLIS PRIDE/RA WLEIGH (FORMULA#4) {M}

NATURAL VITAMIN VITAMIN WORLD STRENGTHENS THE IMMUNE SYSTEM C {V}

PANTETHINE THE ATKINS AUTO-IMMUNE PROCESSES COMPLEX {AA} CENTERS FOR

COMPLEMENTARY MEDICINE

YERBAMATE INDIANA BOTANIC STRENGTHENS AUTO-IMMUNE SYSTEM {COMBO-H, V ,M} GARDENS

3


CANDIDA GUARD GERO VITA YEAST INFECTION; SUPPORTS BODY'S {H} INTERNATIONAL IMMUNE SYSTEM

ACUTE INFECTION THE ATKINS SUPPORT FOR THE IMMUNE SYSTEM FORMULA (AI#6) CENTERS FOR


BIO-OXY {M} BIO-LIFE ENHANCES IMMUNE SYSTEM INTERNATIONAL CORP.

NUTRA CLEANSE + ESPIAL INC INCREASES EFFECTIVENESS OF IMMUNE {COMBO V+M} SYSTEM

BIOTEC EXTRA CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & ENERGY ENZYMES HERBAL ARC; AIDS RELATED COMPLEX {M} NUTRITION

HYDROGEN CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & PEROXIDE,FOOD HERBAL ARC; AIDS RELATED COMPLEX GRADE PEROXY GEL NUTRITION

ECHINACEA ROOT HOUSE OF ANTI-VIRAL & ANTI-BACTERIAL; BOOST THE {H} HEZEKIAH IMMUNE SYSTEM; INCREASES WHITE BLOOD

CELLS

RAINBOW LIGHT CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & DETOX-ZYME {M} HERBAL ARC; AIDS RELATED COMPLEX

NUTRITION

TIGRESS CAPSULES QUAN YIN STRENGTHENER OF IMMUNE SYSTEM; FORMULA ill {H} TIGRESS REGULATEBLOODSUGARBALANCE

ESTER C POWDER CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & {M} HERBAL ARC; AIDS RELATED COMPLEX

NUTRITION

TIGER CAPSULES TIGER STRENGTHENER OF IMMUNE SYSTEM FORMULA IV {H}

SHARK LIVER OIL CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & {G} HERBAL ARC; AIDS RELATED COMPLEX

NUTRITION

BARLEY GREEN CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & MAGMA {H} HERBAL ARC; AIDS RELATED COMPLEX

NUTRITION

IMMUNENE PHYSIOLOGICS ANTIVIRAL,IMMUNE {COMBO-H}

4


ORGANIC PHYSIOLOGICS IMMUNE FUNCTION AID, ANTI-VIRAL GERMANIUM SESQUIOXIDE (GE-132){H}

HEZEKIAH'S OWN HOUSE OF GIVE SUPPORT TO THE IMMUNE SYSTEM FORMULA'S HEZEKIAH HERB-IMMUNE{H}

SUMA {H} HOUSE OF STRENGTHENS THE IMMUNE SYSTEM; HEZEKIAH REDUCES TUMORS AND CANCERS

CRYSTAL STAR CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & ENERGY GREEN {H} HERBAL ARC; AIDS RELATED COMPLEX

NUTRITION

PAU D'ARCO {H} BIORGANIC STRENGTHEN THE IMMUNE SYSTEM BRANDS, INC.

HRPZ {H} HERBLEX RELIEF FROM CHRONIC VIRAL SKIN COMPANY ERUPTIONS; FIGHTS THE VIRUS

LYMPHATONIC {H} SANTA FE DEEP-ACTING IMMUNE SYSTEM BUILDER BOTANICAL

LIQUID LIVER WITH CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & SIBERIAN GINSENG HERBAL ARC; AIDS RELATED COMPLEX {H} NUTRITION

ECHINACEA CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & EXTRACT {H} HERBAL ARC; AIDS RELATED COMPLEX

NUTRITION

ST JOHN'S WORT CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & EXTRACT {H} HERBAL ARC; AIDS RELATED COMPLEX

NUTRITION

SUN CHLORELLA CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & {H} HERBAL ARC; AIDS RELATED COMPLEX

NUTRITION

ANEMIGIZE CAPS CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & {H} HERBAL ARC; AIDS RELATED COMPLEX

NUTRITION

LIV-ALIVE CAPS OR CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & TONIC EXTRACT {H} HERBAL ARC; AIDS RELATED COMPLEX

NUTRITION

ADRN ALIVE CAPS CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & OR EXTRACT {H} HERBAL ARC; AIDS RELATED COMPLEX

NUTRITION

5


AWE VERA {H} CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & HERBAL ARC; AIDS RELATED COMPLEX NUTRITION

ASTRAGALUS {H} HOUSE OF DEEP IMMUNE SYSTEM TONIC, INCREASES HEZEKIAH PRODUCTION OF INTERFERON AND

RESISTANCE TO VIRAL INFECTIONS

COQ 10 30 {M} CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & HERBAL ARC; AIDS RELATED COMPLEX NUTRITION

CHAPARRAL{H} HOUSE OF IMMUNE SYSTEM; ANTI-TUMOR AGENT HEZEKIAH

IMMUNOTONIC {H} SANTA FE FIRST-LINE IMMUNE SYSTEM ACTIVATOR BOTANICAL

GERMANIUM {M} CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & HERBAL ARC; AIDS RELATED COMPLEX NUTRITION

COUNTRY LIFE CRYSTAL STAR AIDS; ACQUIRED IMMUNE DEFICIENCY & ENERGIX {H} HERBAL ARC; AIDS RELATED COMPLEX

NUTRITION

FRESH ROYAL JELLY HOUSE OF ENHANCES THE IMMUNE SYSTEM {H} HEZEKIAH

PROPOLIS J.P. WYNNE STIMULATING ONE'S IMMUNITY SYSTEM COMPANY

ECHINACEA {H} PHYSIOLOGICS HELPS THE IMMUNE SYSTEM

CRYSTAL STAR FEEL CRYSTAL STAR PREVENTION OF AIDS, CANCER, HERPES GREAT TEA & CAPS HERBAL {H} NUTRITION

ZAND HERBAL CRYSTAL STAR PREVENTION OF AIDS, CANCER, HERPES INSURE EXTRACT & HERBAL CAPSULES {H} NUTRITION

CRYSTAL STAR CRYSTAL STAR PREVENTION OF AIDS, CANCER, HERPES SUPER LICORICE HERBAL EXTRACT {H} NUTRITION

CRYSTAL STAR CRYSTAL STAR PREVENTION OF AIDS, CANCER, HERPES HERBAL DEFENSE HERBAL TEAM CAP {H} NUTRITION

SUPER A CAPS PLUS LIFE EXTENSION IMMUNE SYSTEM CAROTENE {V} FOUNDATION

6

I UNSUBSTANTIATED CLAIMS - IMMUNE SYSTEMS I PRODUCT FIRM CL.AIM:

BARLEY GREEN {H} THE HERB NOOK IMMUNE BUILDER

SUN CHLORELLA {H} CRYSTAL STAR PREVENTION OF AIDS, CANCER, HERPES HERBAL NUTRITION

RAW THYMUS {G} CRYSTAL STAR PREVENTION OF AIDS, CANCER, HERPES HERBAL NUTRITION

CO QlO {AA} CRYSTAL STAR PREVENTION OF AIDS, CANCER, HERPES HERBAL NUTRITION

ENER B INTERNASAL CRYSTAL STAR PREVENTION OF AIDS, CANCER, HERPES GEL {V} HERBAL

NUTRITION

MEZOTRACE CRYSTAL STAR PREVENTION OF AIDS, CANCER, HERPES MINERAL COMPLEX HERBAL {M} NUTRITION

CALCIUM LIFE EXTENSION IMMUNE SYSTEM ENHANCEMENT ASCORBATE FOUNDATION POWDER {V}

GARLIC-4000 {H} PHYSIOLOGICS INHIBIT THE GROWTH OF VIRUSES, NULLIFIES TOXINS THAT IMPAIR THE IMMUNE SYSTEM

COGNITEX LIFE EXTENSION HELPS ALZHEIMER'S PATIENTS, IMMUNE {COMBO-V ,AA} FOUNDATION SYSTEM ENHANCEMENT

GOLDEN SEAL ROOT THE HERB NOOK INFECTION {H}

CONEFLOWER ENZYMATIC ANTIBODY MEDIATED IMMUNITY EXTRACT {V + H} THERAPY

VIRA-PLEX NO. 135 ENZYMATIC ANTIBODY MEDIATED IMMUNITY {V+M+H+G+AA} THERAPY

NATREN LIFE START CRYSTAL STAR PREVENTION OF AIDS, CANCER, HERPES {M} HERBAL

NUTRITION

SUBLINGUAL C & SUBLINGUAL ENHANCES EVERY PART OF THE IMMUNE NIACIN {V} SYSTEM; RAISED BLOOD LEVEL OF

INTERFERON

PAUD' ARCO INTERNATIONAL TO STRENGTHEN THE IMMUNE SYSTEM MARKETING COMPANY

7


THE IMMUNIZER NATURE'S PLUS BOOST THE IMMUNE SYSTEM PAK {COMBO H+V+M+AA}

HYDRASTINE ENZYMATIC IMMUNE SYSTEM {COMBOV+H} THERAPY

THYMUPLEX ENZYMATIC ESSENTIAL FOR PROPER IMMUNE FUNCTION {COMBO THERAPY V+M+AA+H}

8

I UNSUBSTANTIATED CLAIMS -ARTHRITIS I PRODUCT FIRM CLAIM

YUCCA {H} BIORGANIC HELPS ARTHRITIC AND GOUT CONDmONS BRANDS, INC.

CHAPARRAL {H} HEALTH CENTER ARTHRITIS FOR BETTER LMNG

CHAPARRAL {H} BIORGANIC FOR ARTHRITIC CONDITIONS BRANDS, INC.

SAFFRON {H} HEALTH CENTER CAN RELIEVE GOUT AND ARTHRITIS FOR BETTER LMNG

FEVERFEW HERB HEALTH CENTER HELPS REDUCE INFLAMMATION IN {H} FOR BEITER ARTHRITIC JOINTS, RESTORES LIVER

LMNG FUNCTION

BETTER LIVING HEALTH CENTER ARTHRITIS {COMBO-H} FORM. N0.6 FOR BEITER ARTHR/RHEUM LMNG

BURDOCK {H} HEALTH CENTER ARTHRITIS AND REMOVING TOXINS FROM FOR BEITER THE BODY LMNG

PRICKLEY ASH {H} HEALTH CENTER ARTHRITIS FOR BETTER LMNG

RAW ADRENAL {G} CRYSTAL STAR ARTHRITIS;ULCERS;HYPOGLYCEMIC HERBAL NUTRITION

VALERIAN ROOT INDIANA BOTANIC NERVE TONIC FOR EPILEPTIC FITS AND {H} GARDENS HYSTERIA

ALFALFA {H} INDIANA BOTANIC ARTHRITIS GARDENS

SAFFRON FLOWERS INDIANA BOTANIC HELP ARTHRITIS AND GOUT {H} GARDENS

DEVILS CLAW {H} INDIANA BOTANIC RELIEVE SYMPTOMS OF ARTHRITIS GARDENS

HISTIDINE {AA} CRYSTAL STAR ARTHRITIS FIGHTER HERBAL NUTRITION

YELLOW DOCK {H} INDIANA BOTANIC ARTHRITIS GARDENS

9

I UNSUBSTANTIATED CLAIMS - ARTHRITIS I PRODUCT FIRM CLAIM

VITAMINB-5 CRYSTAL STAR ARTHRITIS PANTOTHENIC ACID HERBAL {V} NUTRITION

COPPER {M} CRYSTAL STAR ARTHRITIS, HIGH CHOLESTEROL, HEART HERBAL ARRHYTHMIAS NUTRITION

VITAMIN B-12 CRYSTAL STAR OSTEOARTHRITIS COBALAMIN{V} HERBAL

NUTRITION

DANDELION {H} INDIANA BOTANIC IMPROVE ARTHRITIS GARDENS

PERVIAN BARK {H} HEALTH CENTER HAS GREAT HEALING INFLUENCES ON THE FOR BETTER LUNGS,NERVOUSSYSTEM LIVING

COMFREY {H} INDIANA BOTANIC ARTHRms GARDENS

IMPROVED ARTHRIL GERO VITA ARTHRITIS RELIEF {V,M} INTERNATIONAL

ART-A {COMBO-ff} THE HERB NOOK ARTHRITIS, GOUT

TWINEPA CAPSULES LIFE EXTENSION HELPFUL AGAINST ARTHRITIS, HELP {EPA&DHA} FOUNDATION ELEVATE HDL LEVELS

YUCCA {H} THE HERB NOOK ARTHRITIS

CRYSTAL STAR CRYSTAL STAR CEREBRAL PALSY RELAX CAPSULES HERBAL {H} NUTRITION

LEXON SUPREME B CRYSTAL STAR CEREBRAL PALSY BLEND {V} HERBAL

NUTRITION

A & R CAPSULES UCHUNGYUN ARTHRITIS FORMULA #7 {H}

ALTA HEALTH SIL-X CRYSTAL STAR ARTHRITIS SILICA EXTRACT {H} HERBAL

NUTRITION

LIV ALIVE AND CRYSTAL STAR ARTHRfflS ADRN-ALIVE CAPS HERBAL {H} NUTRITION

HYDRANGEA {H} THE HERB NOOK ARTHRITIS

10

I UNSUBSTANTIATED CLAIMS -ARTHRITIS I PRODUCT FIRM CLAIM

DR. CLAYTON'S L&H VITAMINS FOR ARTHRITIS RELIEF ARTH-HERBS {H}

PLS II { COMB-H} THE HERB NOOK ARTHRITIS

ARTHROTONIC {H} SANTA FE REDUCES JOINT INFLAMMATION; RELIEVES BOTANICAL GOUT

B-6 (PYRIDOXINE) NATURE'S PLUS, ARTHRITIS {V} THE ENERGY

SUPPLEMENTS

CRYSTAL STAR RTH CRYSTAL STAR ARTHRITIS EASE CAPS {H} HERBAL

NUTRITION

COUNTRY LIFE CRYSTAL STAR ARTHRITIS LIGATEND {M} HERBAL

NUTRITION

ENZYMATIC CRYSTAL STAR ARTHRITIS THERAPY ADRENAL HERBAL COMPLEX {G} NUTRITION

PREMIER 1 OR YS CRYSTAL STAR ARTHRITIS ROY AL JELLY {H} HERBAL

NUTRITION

BIOTEC EXTRA CRYSTAL STAR ARTHRITIS ENERGY S.O.D. {M} HERBAL

NUTRITION

BOSWELLA {H} LIFE EXTENSION ANTI-ARTHRITIC ACTION IN ACUTE/CHRONIC FOUNDATION MODELS OF IMFLAMMATION

CHAPARRAL {H} THE HERB NOOK ARTHRITIS

ANTI-ARTHRITIC THE ATKINS ARTHRITIS FORMULA (AA#5){IE} CENTERS FOR


SO LARA Y CAL/MAG CRYSTAL STAR ARTHRITIS W/BORON & D {M} HERBAL

NUTRITION

ANTI-SPAZ CRYSTAL STAR CEREBRAL PALSY CAPSULES {H} HERBAL

NUTRITION

11

UNSUBSTANTIATED CLAIMS - CARDIOVASCULAR SYSTEMS

PRODUCT FIRM CLAIM

HS II {COMBO-H} THE HERB NOOK HIGH OR LOW BLOOD PRESSURE

GREEN TEA {H} LIFE EXTENSION PROTECT AGAINST CARDIOVASCULAR FOUNDATION DISEASE

VITAMINE LIFE EXTENSION PREVENTS/DISSOLVES BLOOD CLOTS, CAPSULES FOUNDATION LOWERS RISK ISCHEMIC HEART DISEASE

GARLIC {H} THE HERB NOOK NORMALIZE BLOOD PRESSURE

CRYSTAL STAR CRYSTAL STAR CHOLESTEROL;HDL;LDL;TRIGLYCERIDES CHO-LO FIBER TONE HERBAL {H} NUTRITION

CHOL-EX CAPSULES CRYSTAL STAR CHOLESTEROL; HDL; LDL; TRIGLYCERIDES {H} HERBAL

NUTRITION

CAPSICUM {H} THE HERB NOOK STROKES, BLOOD PRESSURE EQUALIZER

HAWTHORN {H} THE HERB NOOK HARDENING OF ARTERIES, BLOOD PRESSURE

HS-C {H} THE HERB NOOK ANGINA PAIN, PALPITATIONS

MEAL SKIPPERS J.P. WYNNE BLOOD PRESSURE, HYPERTENSION COMPANY

GUGGACIN THE VITAMIN CHOLESTEROL CONTROL, FIGHT COMPLEX {H} SHOPPE CHOLESTEROL

GERIAFORCE {H} THE VITAMIN NORMALIZE HIGH BLOOD PRESSURE, SHOPPE DIABETIC VASCULAR DAMAGE

RICE BRAN OIL COUNTRY LIFE MANAGE CHOLESTEROL {COMBO-A, V}

HEART FOOD CAPS HEART FOODS LOWER BLOOD CHOLESTEROL; HELP {COMBO AA+H} COMPANY REGULATE BLOOD PRESSURE;

ANTI-COAGULANT AGENT

E-COMPLEX INTERNATIONAL REDUCING SERUM CHOLESTEROL LEVELS MARKETING COMPANY

CHOLESTAWAY HARMONY REDUCE THE CHOLESTEROL LEVELS HEALTH INC.

REFRESH SOLARAY, INC. REGULATING CHOLESTEROL METABOLISM, AND HORMONES

CALCIUM/ CRYSTAL STAR HEART ARRHYTHMIA; TACHYCARDIA MAGNESIUM/ HERBAL POTASSIUM CAPS NUTRITION {M}

12

I UNSUBSTANTIATED CLAIMS - CARDIOVASCULAR SYSTEMS I PRODUCT FIRM CLAIM

L-ASPARTIC ACID COUNTRY LIFE SUPPORTS THE CARDIOVASCULAR SYSTEM {AA}

CAPSICIUM/GARLIC/ THE HERB NOOK BLOOD PRESSURE, CHOLESTEROL PARSLEY {H-COMBO}

RESCUE ESTEEM HEART DISEASE, CANCER, HIGH BLOOD PRODUCTS, INC. PRESSURE, BROKEN DOWN IMMUNE SYSTEM

ORAL NUTRIENT ENZYMATIC ESSENTIAL FOR THE HEART AND VASCULAR CHELATES NO. 375 THERAPY SYSTEM FUNCTION {V+M+AA}

GUGUL PLUS NO. 860 ENZYMATIC ESSENTIAL FOR THE HEART AND VASCULAR P.S.E. {V+M+H} THERAPY SYSTEM FUNCTION

LIQUID CARNITINE CRYSTAL STAR HEART DISEASE {AA} HERBAL

NUTRITION

SAFFLOWERS {H} THE HERB NOOK GOUT, HELP REDUCE CHOLESTEROL

RAINBOW LIGHT CRYSTAL STAR HEART ARRHYTHMIA; TACHYCARDIA CALCIUM {M} HERBAL

NUTRITION

KYO-CHROME WAKUNAGAOF HELP TO REDUCE CHOLESTEROL LEVELS {COMBO-H,V,M} AMERICA CO.

LTD.,MAKERS OF KYOLIC

CHROMIUM LIFE EXTENSION HAS LOWERED BLOOD CHOLESTEROL; PICOLINATE FOUNDATION ENHANCES THE ABILITY OF INSULIN TO CAPSULES {M} LOWER BLOOD SUGAR LEVELS

APPLE PECTIN LIFE EXTENSION HELPFUL IN LOWERING CHOLESTEROL POWDER FOUNDATION

HAWTHORN {H} BIORGANIC FOR THE HEART AND BLOOD PRESSURE BRANDS, INC.

G.T.F. CHROMIUM INTERNATIONAL NORMALIZE CHOLESTEROL LEVELS, MARKETING TREATMENT OF DIABETES, ARTHRITIS COMPANY

COMPLEX CL-3 GERO VITA ANTI-HEART DISEASE BOTANICAL W/CHROMIUM INTERNATIONAL {COMBO-H,AA,V} PICOLINATE

HAWTHORNE CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION EXTRACT {H} HERBAL

NUTRITION

13


SOLARA Y SIBERIAN CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION GINSENG {H} HERBAL

NUTRITION

CRYSTAL STAR CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION RELAX CAPS {H} HERBAL

NUTRITION

CRYSTAL STAR CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION DIURCAPS{H} HERBAL

NUTRITION

ADRN ALIVE CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION CAPSULES OR HERBAL EXTRACT{H} NUTRITION

CO-ENZYME QlO LIFE EXTENSION LOWER RISK OF HEART DISEASE {AA} FOUNDATION

L-TAURINE POWDER LIFE EXTENSION TO PREVENT CERTAIN FORMS OF HEART {AA} FOUNDATION DISEASE AND CATARACTS

SOLARAY CRYSTAL STAR HEART ARRHYTHMIA; TACHYCARDIA CHROMIACIN {M} HERBAL

NUTRITION

BETTER LIVING HEALTH CENTER STRENGTHENS THE HEART, FOR FORM. N0.31 FORBETIER PALPITATION OF THE HEART HEART{COMBO-H} LIVING

BETIER LIVING HEALTH CENTER LOWER HIGH SERUM CHOLESTEROL; HELP FORM. N0.12 FOR BETTER PREVENT DEPOSIT OF DIETARY -CHOLESTEROL LIVING CHOLESTEROL {COMBO-H}

CHICKWEED {H} HEALTH CENTER DISSOLVES PLAQUE IN BLOOD VESSELS FORBETIER LIVING

CAYENNE{H} HEALTH CENTER FOR BLOOD PRESSURE AND CIRCULATORY FOR BETTER SYSTEM LIVING

BETIER LIVING HEALTH CENTER HERBAL FOOD FORMULA IS VERY EFFECTIVE FORM. N0.9 BLOOD FOR BETTER IN REGULATING THE BODY'S BLOOD PRESSURE LIVING PRESSURE {COMBO-H}

BETIER LIVING HEALTH CENTER LOWER HIGH BLOOD PRESSURE {COMBO-H} FORM.N0.34-HI FOR BETTER BLOOD PRESS. LMNG

BETTER LIVING HEALTH CENTER COMBATING VARICOSE VEINS {COMBO-H} FORM.N0.57- FORBETIER VARICOSE VEINS LIVING

14


GERO VITA (GH3) GERO VITA HEART DISEASE, ARTERIOSCLEROSIS {COMBO-V ,M,AA} INTERNATIONAL

MEGA-TAURINE LIFE EXTENSION PREVENT CERTAIN FORMS OF HEART CAPSULES {AA} FOUNDATION DISEASE AND CATARACTS

ANGELICA {H} HEALTH CENTER FOR DISEASES OF THE LUNGS AND HEART FOR BETTER LMNG

BAYBERRY {H} HEALTH CENTER VARICOSE VEINS FOR BETTER LIVING

CRYSTAL STAR HI CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION PRESSURE CARE {H} HERBAL

NUTRITION

EVENING PRIMROSE CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION {AA} HERBAL

NUTRITION

SUN CHLORELLA {H} CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION HERBAL NUTRITION

RAINBOW LIGHT CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION CALCIUM PLUS HERBAL CAPSULES {M} NUTRITION

VITAL HEALTH CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION ORAL CHELATION HERBAL {M} NUTRITION

COUNTRY LIFE CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION RELAXER W/GABA HERBAL {AA} NUTRITION

MEGA-TROPIC MUSCLE MASTERS CHOLESTEROL LOWERING AGENT (LEMON GRASS {COMBO-AA, V ,H} OIL-90% CITRAL)

ANTI- THE ATKINS BLOOD PRESSURE LOWERING HYPERTENSION CENTERS FOR FORMULA COMPLEMENT ARY (AH#3){COMBO} MEDICINE

ANTIOX GLOBAL HYPERTENSION; DIABETES; CANCER; {COMBO-V+M} PHARMACEUTICA CARDIOVASCULAR DISEASE (KOREAN LS TRANSLATION)

15


VITAL HEALTH CRYSTAL STAR HEART DISEASE ADVANCED HERBAL CHELATION NUTRITION FORMULA!

EVENING PRIMROSE CRYSTAL STAR HEART ARRHYTHMIA; TACHYCARDIA OIL {AA} HERBAL

NUTRITION

MEDICINE WHEEL CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION SERENE EXTRACT HERBAL {H} NUTRITION

SOLARAY CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION EUROCALM CAPS HERBAL {H} NUTRITION

CO Q 10 30 {AA} CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION HERBAL NUTRITION

SPORTS GINSENG LIFE EXTENSION ATHEROSCLEROSIS, HYPERTENSION AND {H} FOUNDATION HYPOTENSION, DIABETES MELLITUS,

DEPRESSION

HEALTH PLUS ORAL CRYSTAL STAR CHOLESTEROL;HDL;LDL;TRIGLYCERIDES CHELATION {M} HERBAL

NUTRITION

INOSINE CAPSULES LIFE EXTENSION MYOCARDITIS, MYOCARDIOSCLEROSIS, {AA} FOUNDATION CARDIAC ARRHYTHMIA, MYOCARDIAL

INFARCTION, BOOST THE IMMUNE SYSTEM

SUN CHLORELLA CRYSTAL STAR CHOLESTEROL;HDL;LDL;TRIGLYCERIDES TABS {H} HERBAL

NUTRITION

B6 CAPS LIFE EXTENSION PREVENTING ATHEROSCLEROSIS, LOWERING FOUNDATION CHOLESTEROL

HYLAND'S CALMS CRYSTAL STAR HIGH BLOOD PRESSURE; HYPERTENSION FORTE {H} HERBAL

NUTRITION

VITAMIN C LIFE EXTENSION LOWERING CHOLESTEROL AND PREVENTING (ASCORBIC ACID) FOUNDATION HEART DISEASE POWDER

B-12 (COBALAMIN) NATURE'S PLUS, PERNICIOUS ANEMIA, BRAIN DAMAGE {V} THE ENERGY

SUPPLEMENTS

16


GARLICIN HC {H + V} MADAUS HEALTHY HEART AND CIRCULATORY MURDOCK INC. SYSTEMS

ENHANCE{COMBO ENRICH NORMALIZE BLOOD PRESSURE H+M} INTERNATIONAL

INC.

PYCNOGENOL FOOD HORPHAG HELP ARTERY LINING, DIABETICS, STROKE, SUPPLEMENT OVERSEAS, LTD. ARTHRITICS {COMBO-V+H} (HOLDS

TRADEMARK)

STONEROOT {H} HEALTH CENTER VARICOSE VEINS CAN BE GREATLY HELPED FOR BETTER WITH THIS HERB LIVING

CALCIUM {M} NATURE'S PLUS, HEART DISEASE THE ENERGY SUPPLEMENTS

CHROMIUM {M} NATURE'S PLUS, ARTHEROSCLEROSIS; INTOLERANCE IN THE ENERGY DIABETICS SUPPLEMENTS

HEART SMART {H} HOUSE OF HEALTHY HEART AND CIRCULATION, HEZEKIAH STRENGTHEN THE HEART, BALANCE BLOOD

PRESSURE

E (TOCOPHEROL) {V} NATURE'S PLUS, HEART DISEASE THE ENERGY SUPPLEMENTS

INOSITOL {V} NATURE'S PLUS, HIGH CHOLESTEROL THE ENERGY SUPPLEMENTS

HEART EASE {H} HOUSE OF STABILIZING EFFECT ON BLOOD PRESSURE HEZEKIAH AND CHOLESTEROL CONTROL

CATHY'S EXTRA CATHY HIGH BLOOD PRESSURE, SENILITY, STRENGTH SUMMERLIN CONVULSIONS GUARANA {H}

CHROMATON ENRICH LOWERS CHOLESTEROL {COMBO M+H} INTERNATIONAL

INC.

CRYSTAL STAR CRYSTAL STAR VARICOSE VEINS VARI-VEIN TEA {H} HERBAL

NUTRITION

17


POTASSIUM {M} NATURE'S PLUS, CARDIAC ARREST; IRREGULAR HEARTBEAT; THE ENERGY RESPIRATORY FAILURE SUPPLEMENTS

BILBERRY CAPSULES BIOENERGY REVERSE DAMAGE CAUSED BY BLOOD {H} NUTRIENTS VESSEL DETERIORATION; HYPERTENSION;

INHIBITS DIABETES-INDUCED CATARACTS

CAYENNE{H} BIORGANIC HEART AND BLOOD PRESSURE BRANDS, INC.

SUPER BLUE GREEN NONE NOTED HIGH CHOLESTEROL, HYPOGLYCEMIA, ALGAE {H} ARTHRITIS

NUTRAPATHIC FAT PARAMETRIC CHOLESTEROL;TRIGLYCERIDES;BALANCE METABOLIZER ASSOCIATES INC. FAT & SUGAR REGULATING SYSTEMS {COMBO - ALL}

HAWTHORN BERRY HOUSE OF REDUCE CHOLESTEROL; HEART TONIC, {H} HEZEKIAH STRENGTHENER AND REGULATOR; LOWERS

BLOOD PRESSURE

SOLARA Y BRAND HEARTLAND REGULATING CHOLESTEROL METABOLISM REFRESH {H} HEALTH FOODS

KYO-CHROME KYOLIC, LTD. REDUCE CHOLESTEROL {COMBO-H+M}

GINKGO BILOBA {H} LI CHUNG YUN INHIBITS PLATELET AGGREGATION

SIBERIAN GINSENG HOUSE OF CIRCULATORY SYSTEM; LOWERING BLOOD {H} HEZEKIAH PRESSURE; REDUCING CHOLESTEROL

HEMA-CLEANSE TEA CRYSTAL STAR ARTERIOSCLEROSIS/ ATHEROSCLEROSIS {H} HERBAL

NUTRITION

CHINESE RED HOUSE OF NORMALIZE BLOOD PRESSURE; INCREASE GINSENG {H} HEZEKIAH CIRCULATION & REDUCE CHOLESTEROL;

SUPPORT IMMUNE SYSTEM

COUNTRY LIFE B-15 CRYSTAL STAR ARTERIOSCLEROSIS/ ATHEROSCLEROSIS {V} HERBAL

NUTRITION

RED RIVER TEA {H} HOUSE OF GENTLY LOWER BLOOD PRESSURE HEZEKIAH

PASSION FLOWER HEALTH CENTER BLOOD PRESSURE {H} FOR BETTER

LIVING

18


VITAL HEALTH CRYSTAL STAR ARTERIOSCLEROSIS/ ATHEROSCLEROSIS FORMULA 1 HERBAL CHELATION NUTRITION THERAPY

CRYSTAL STAR CRYSTAL STAR ARTERIOSCLEROSIS/ ATHEROSCLEROSIS CARDI-STRENGTH HERBAL CAPSULES {H} NUTRITION

DONG QUAI ROOT HOUSE OF NORMALIZE CHOLESTEROL AND {H} HEZEKIAH TRIGLYCERIDE LEVELS

DANDELION {H} HEALTH CENTER LOWERING BLOOD PRESSURE FOR BETTER LMNG

H.B.P. TONIX {H} SANTA FE ELEVATED BLOOD PRESSURE BOTANICAL

CHOLESTEROTONIC SANTA FE LOWERS ELEVATED CHOLESTEROL AND/OR {H} BOTANICAL TRIGLYCERIDE LEVELS

REISHI {H} HOUSE OF LOWERING OR RAISING BLOOD PRESSURE; HEZEKIAH MY ASTHENIA GRAVIS, MS, IMMUNE SYSTEM

CALCIUM {M} CRYSTAL STAR LOWERS BLOOD PRESSURE, PREVENT COWN HERBAL CANCER NUTRITION

PASSION FLOWER INDIANA BOTANIC HIGH BLOOD PRESSURE {H} GARDENS

KELP {H} INDIANA BOTANIC CHOLESTEROL & ARTERIOSCLEROSIS GARDENS CLEANSING; CLEANSES THE ARTERIES

LECITHIN INDIANA BOTANIC CHOLESTEROL & ARTERIOSCLEROSIS GRANULES {H} GARDENS CLEANSING

PSYLLIUM SEED {H} INDIANA BOTANIC CHOLESTEROL & ARTERIOSCLEROSIS GARDENS CLEANSING

WATERMELON SEED INDIANA BOTANIC HELP LOWER BLOOD PRESSURE {H} GARDENS

GOTU KOLA {H} INDIANA BOTANIC BLOOD PRESSURE GARDENS

FO-TI {H} INDIANA BOTANIC LOWERS BLOOD PRESSURE, ARTHRITIS, GOUT GARDENS

BEE-III (FORMULA#7) GOLDEN LOWER LDL; RAISE HDL; LOWER {COMBO-AA+H+M} PRIDE/RA WLEIGH TRIGLYCERIDES; CONTROL BLOOD CLOTTING

19

I UNSUBSTANTIATED CLAIMS - CARDIOVASCULAR SYSTEMS I PRODUCT FIRM CLAIM:

FORMULA#l GOLDEN COMBAT HARDENING OF ARTERIES; {COMBO-AA+V} PRIDE/RA WLEIGH DETOXIFY HEAVY METALS(PB); BALANCE

BLOOD PRESSURE

HERBAL FOOD INDIANA BOTANIC HIGH BLOOD PRESSURE, HIGH CHOLESTEROL, FORMULA GARDENS VARICOSE VEINS, ARTHRITIS (C04HIGH) {COMBO-H}

KOL-ESTER {H} INDIANA BOTANIC HIGH CHOLESTEROL GARDENS

VITAMIN B-3 NIACIN CRYSTAL STAR HIGH BLOOD PRESSURE; REDUCE SERUM {V} HERBAL BLOOD FATS AND CHOLESTEROL

NUTRITION

VITAMIN B-15 CRYSTAL STAR ATHEROSCLEROSIS, LIVER CIRRHOSIS, PANGAMIC ACID {V} HERBAL RHEUMATISM

NUTRITION

SODIUM {M} CRYSTAL STAR HIGH BLOOD PRESSURE HERBAL NUTRITION

COUNTRY LIFE CRYSTAL STAR HEART ARRHYTHMIA; TACHYCARDIA RELAXER CAPSULES HERBAL {M} NUTRITION

MEGACHEL THE HERB NOOK CHOLESTEROL {COMBO-ff}

CHOLINE {V} CRYSTAL STAR LOWER CHOLESTEROL HERBAL NUTRITION

TWIN LAB LIQUID K CRYSTAL STAR HEART ARRHYTHMIA; TACHYCARDIA (V} HERBAL

NUTRITION

HAWTHORNE LEAF CRYSTAL STAR HEART ARRHYTHMIA; TACHYCARDIA & FLOWER EXTRACT HERBAL {H} NUTRITION

LIPID FORMULA THE ATKINS CHOLESTEROL AND TRIGLYCERIDE (LIPID#18){AA} CENTERS FOR LOWERING EFFECTS


CRYSTAL STAR CRYSTAL STAR HEART ARRHYTHMIA; TACHYCARDIA CARDI-STRENGTH HERBAL CAPS {H} NUTRITION

20


TAURINE {AA} CRYSTAL STAR HYPERTENSION HERBAL NUTRITION

HYSSOP {H} INDIANA BOTANIC IMPROVE CIRCULATION TO PROMOTE GARDENS NORMAL BLOOD PRESSURE .

METHIONINE {AA} CRYSTAL STAR KEEP HIGH BLOOD PRESSURE AND HERBAL CHOLESTEROL DEPOSITS LOW NUTRITION

POTASSIUM SOURCE CRYSTAL STAR HEART DISEASE CAPS {M} HERBAL

NUTRITION

CALCIUM LIFE EXTENSION CHOLESTEROL ASCORBATE FOUNDATION POWDER {V}

TWINEPA CAPSULES LIFE EXTENSION HELPFUL AGAINST ARTHRITIS, HELP {EPA&DHA} FOUNDATION ELEVATE HDL LEVELS

DOCTOR'S BEST L&H VITAMINS CONTROL CHOLESTEROL AND BLOOD FATS, GUGGULOW {H} PREVENT ABNORMAL BLOOD CLOTS,

CHOLESTEROL LOWERING

BIOTEC EXTRA CRYSTAL STAR HEART DISEASE ENERGY ENZYMES HERBAL {AA} NUTRITION

CARNITINE {AA} CRYSTAL STAR REDUCE EXCESS TRIGLYCERIDES IN BLOOD, HERBAL VALUABLE TO DIABETICS NUTRITION

HAWTHORN BERRIES INDIANA BOTANIC BENEFICIAL IN AILMENTS CONCERNING THE {H} GARDENS HEART AND REGULATE BLOOD PRESSURE

ARGININE {AA} CRYSTAL STAR HERPES VIRUS, LOWER CHOLESTEROL FATS HERBAL NUTRITION

KYO-CHROM L&H VITAMINS REDUCE CHOLESTEROL {COMBO-H+V+M}

GABA {AA} CRYSTAL STAR HIGH BLOOD PRESSURE HERBAL NUTRITION

OCTACOSANOL {H} VITAMIN WORLD LOWER CHOLESTEROL LEVELS

TOP PRODUCT ENRICH NORMALIZE BLOOD PRESSURE REVIEW INTERNATIONAL,

INC.

21


GINKGO BILOBA {H} INDIANA BOTANIC REDUCE BLOOD CLOTIING GARDENS

CO-ENZYME Q-10 INDIANA BOTANIC NORMALIZES BLOOD PRESSURE, HEART (ANTI-AGING GARDENS PROBLEMS FORMULA) {M}

CHROMIUM NUTRITION 21 REDUCE ELEVATED CHOLESTEROL PICOLINATE

B3 (NIACIN) {M} COUNTRY LIFE MANAGE CHOLESTEROL LEVELS

HAWTHORNE {H} INDIANA BOTANIC PROMOTES HEALTHY BLOOD PRESSURE GARDENS LEVELS, LOWERS SERUM CHOLESTEROL

LEVELS

PHYTO-PLANKTON BIOTEC LOWERING CHOLESTEROL AND INTERNATIONAL {COMBO-AA,PLANKTON} GAMMA-LINOLENIC CENTER ACID

ALFALFA {H} INDIANA BOTANIC LOWER CHOLESTEROL, ELIMINATE GARDENS CARCINOGENS, SOFTEN HARD ARTERIES

22

I UNSUBSTANTIATED CLAIMS - DIABETES I PRODUCT FIRM CLAIM

CRYSTAL STAR CRYSTAL STAR DIABETES INSULFORM HERBAL CAPSULES {H} NUTRITION

CRYSTAL STAR LIV CRYSTAL STAR CIRRHOSIS OF THE LIVER TONIC EXTRACT {H} HERBAL

NUTRITION

WHITE OAK BARK HEALTH CENTER REMOVES KIDNEY STONES & GALLSTONES, {H} FOR BETTER EXCELLENT FOR VARICOSE VEINS, DOUCHE

LIVING FOR VAGINAL INFECTIONS

BARLEY GREEN CRYSTAL STAR CIRRHOSIS OF THE LIVER MAGMA {H} HERBAL

NUTRITION

SUN CHLORELLA {H} CRYSTAL STAR CIRRHOSIS OF THE LIVER, DIABETES, HERBAL HYPOGLYCEMIA NUTRITION

CRYSTAL STAR LIV CRYSTAL STAR CIRRHOSIS OF THE LIVER FLUSH TEA {H} HERBAL

NUTRITION

ALTA HEALTH CRYSTAL STAR DIABETES CANGEST {M} HERBAL

NUTRITION

GLUTATHIONE {AA} CRYSTAL STAR CHRONIC KIDNEY FAILURE HERBAL NUTRITION

ENER B B12 CRYSTAL STAR DIABETES INTERNASAL GEL HERBAL {V} NUTRITION

VITAMIN K {V} CRYSTAL STAR CIRRHOSIS & JAUNDICE OF LIVER; BLOOD HERBAL CLOTTING NUTRITION

TRYPTOPHANE {AA} CRYSTAL STAR RAISES ABNORMALLY LOW BLOOD SUGAR HERBAL NUTRITION

RAW PITUITARY {G} CRYSTAL STAR HYPOGLYCEMIA HERBAL NUTRITION

RAW OVARY {G} CRYSTAL STAR BLOOD GLUCOSE LEVELS HERBAL NUTRITION

23

I UNSUBSTANTIATED CLAIMS - DIABETES I PRODUCT FIRM CLAIM:

RAW KIDNEY {G} CRYSTAL STAR AIDS IN NORMALIZATION OF HERBAL KIDNEY/URINARY DISORDERS; BLOOD NUTRITION PRESSURE IMBALANCE; HYPERTENSION

LIQUID CRYSTAL STAR DIABETES LIVER/GINSENG HERBAL {COMBO H+G} NUTRITION

VITAMIN B-2 CRYSTAL STAR DIABETES,CATARACTS RIBOFLAVIN {V} HERBAL

NUTRITION

SOLARAY CRYSTAL STAR SUGAR REGULATION, DIABETES CHROMIACIN {M} HERBAL

NUTRITION

ENZYMATIC CRYSTAL STAR CIRRHOSIS OF THE LIVER THERAPY LIVA-TOX HERBAL {M} NUTRITION

BETTER LIVING HEALTH CENTER HERBS THAT HELP WITH DIABETES FORM.NO.22 - FOR BETTER {COMBO-ff} DIABETES LMNG

DAN-GAN-SIN-KU KISEIDO LTD. USA DIABETES {G} (KOREAN TRANSLATION)

CRYSTAL STAR CRYSTAL STAR DIABETES BODY REBUILDER HERBAL CAPS {H} NUTRITION

L-ISOLEUCINE {AA} COUNTRY LIFE HELPS REGULATE BLOOD SUGAR

PANCRAID {H} CRYSTAL STAR DIABETES HERBAL NUTRITION

DIABETES MELLITUS THE ATKINS TYPE II DIABETES FORMULA CENTERS FOR (DM#17){M} COMPLEMENTARY

MEDICINE

GOLDENSEAL ROOT INDIANA BOTANIC AIDS IN LIVER DISORDERS {H} GARDENS

NETTLE LEAF {H} INDIANA BOTANIC KIDNEY DISORDERS GARDENS

THISTLE (BLESSED) INDIANA BOTANIC LIVER, GALLSTONES, AND SPLEEN {H} GARDENS PROBLEMS; LIVER ABUSED BY ALCOHOL,

HEPATITIS

24


DANDELION ROOT INDIANA BOTANIC KIDNEY, LIVER, SPLEEN AND PANCREAS {H} GARDENS AILMENTS

BLUEBERRY LEAF INDIANA BOTANIC DIABETES AND HYPOGLYCEMIA {H} GARDENS

CHOLINE {V} NATURE'S PLUS, CIRRHOSIS; KIDNEY HEMORRHAGE; THE ENERGY BLEEDING ULCERS; HIGH BLOOD PRESSURE SUPPLEMENTS

SPORTS GINSENG LIFE EXTENSION DIABETES MELLITUS {H} FOUNDATION

DIATROL THE ROCKLAND NUTRITIONAL COMPLIMENT FOR DIABETES {COMBO-AA+H} CORPORATION AND OTHER CONDmONS

WATERMELON SEED INDIANA BOTANIC USEFUL IN KIDNEY DISORDERS AND HIGH {H} GARDENS BLOOD PRESSURE

LIV-C {H} THE HERB NOOK HEPATITIS

JP-X {H-COMBO} THE HERB NOOK KIDNEY INFECTION

YELLOW DOCK {H} THE HERB NOOK HEPATITIS

UVA URSI {H} THE HERB NOOK SPLEEN, BLADDER AND KIDNEY INFECTIONS, CYSTITIS, GONORRHEA, DIABETES

HYDRANGEA{H} THE HERB NOOK ARTHRITIS, GOUT, KIDNEY AND BLADDER PROBLEMS; DISSOLVE STONES

P-4 {COMBO-H} THE HERB NOOK DIABETES

BP-C {H} THE HERB NOOK HEPA fflIS, CIRRHOSIS

K-C {H} THE HERB NOOK NEPHRmS, EDEMA IN LUNGS

IF-C THE HERB NOOK HEPATITIS

HY-C {H} THE HERB NOOK DIABETES

PANTOTHENIC ACID NATURE'S PLUS, SENSITIVITY TO INSULIN, HYPOGLYCEMIA {V} THE ENERGY

SUPPLEMENTS

LIVER D-TOX GERO VITA INHIBITS ALCOHOL INDUCED FATTY LIVER {COMBO-H,AA} INTERNATIONAL DISEASE

COMFREY {H} HEALTH CENTER INFECTION FIGHTER, ELIMINATE BLOODY FORBETIER URINE, KIDNEY/BLADDER AILMENTS LMNG

GOLDEN SEAL {H} HEALTH CENTER BLADDERINFECTIONS,ULCERS FORBETIER LIVING

25

r \ \ ·.I\

I PRODUCT

POKE ROOT {H}

CHROMIUM {M}

FORMULAil GLYCEMIC FACTORS {COMBO-AA+V}

SUPER BLUE-GREEN ALGAE {H}

GINGKO BILOBA {H}

GOLDEN SEAL {H}

DANDELION {H}

NATREN LIFE START

SUN CHLORELLA GRANULES {H}

CRYSTAL STAR LIV-ALIVE CAPSULES {H}

LIQUID LIVER {G}

NUTRICOLOGY GERMANIUM SUBLINGUAL {M}

GUARGUM {H}

HYPO-ADE CAPSULES {AA}

CRYSTAL STAR HYPO-BLUES CAPS {H}

UNSUBSTANTIATED CLAIMS- DIABETES I FIRM CLAIM

HEALTH CENTER TO CLEAN SWOLLEN INFECTED GLANDS, FOR BETTER INFLAMED KIDNEYS LMNG

SCHIFF PRODUCTS REGULATE BLOOD GLUCOSE LEVELS

COUNTRY LIFE NUTRITIONAL AID FOR BLOOD SUGAR METABOLISM

KASRUTH LABS HYPOGLYCEMIA

HOUSE OF DIABETIC-RELATED VISION IMPAIRMENT HEZEKIAH

BIORGANIC FOR INFECTIONS AND KIDNEYS AND LIVER BRANDS, INC.

THE HERB NOOK HEPATITIS

CRYSTAL STAR HEPATITIS; JAUNDICE; LIVER MALFUNCTION HERBAL NUTRITION


CRYSTAL STAR HEPATms; JAUNDICE; LIVER MALFUNCTION HERBAL NUTRITION



CRYSTAL STAR HYPOGLYCEMIA/LOW BLOOD SUGAR HERBAL NUTRITION



26


ALTA HEALTH CRYSTAL STAR HYPOGLYCEMWLOW BLOOD SUGAR CANGEST OR HI-LO HERBAL BALANCE{M} NUTRITION

MEMBRANE INTERNATIONAL DIABETES, KIDNEY FAILURE, URINARY COMPLEX NUTRITION, INC. INFECTIONS

CO Q 10 {AA} CRYSTAL STAR HYPOGLYCEMIA/LOW BLOOD SUGAR HERBAL NUTRITION

ADRN-ALIVE CAPS CRYSTAL STAR HYPOGLYCEMIA/LOW BLOOD SUGAR OR ADRN EXTRACT HERBAL {H} NUTRITION

CRYSTAL STAR CRYSTAL STAR HYPOGLYCEMIA/LOW BLOOD SUGAR MIN-ZYME-MINOS HERBAL {COMBO-M+AA} NUTRITION

HI-POTENCY YS OR CRYSTAL STAR HYPOGLYCEMWLOW BLOOD SUGAR PREMIER 1 ROY AL HERBAL JELLY NUTRITION

COUNTRY LIFE CRYSTAL STAR HYPOGLYCEMIA/LOW BLOOD SUGAR MOOD FACTORS HERBAL CAPSULES {H} NUTRITION

27

I UNSUBSTANTIATED CLAIMS - HORMONES I PRODUCT FIRM CLAIM

DAY TIME GROWTH LIFE EXTENSION SUPERIOR GROWTH HORMONE RELEASER HORMONE FOUNDATION FORM.{COMBO-AA, V}

POWERMAKER II LIFE EXTENSION GROWTH HORMONE RELEASING FORMULA {COMBO-V,M,AA} FOUNDATION

NIGHTIIME LIFE EXTENSION GROWTH HORMONE RELEASER, IMPROVES GROWTH HORMONE FOUNDATION IMMUNE FUNCTION FORM. { COMBO-AA V}

GROWTH HORMONE LIFE EXTENSION GROWTH HORMONE RELEASER RELEASING FOUNDATION FORM.{COMBO-AAV}

DONG QUAI {H} HEALTH CENTER MENSTRUAL DISORDERS, FEMALE HORMONE FOR BEITER BALANCER LMNG

L-ARGININE HCL LIFE EXTENSION GROWTH HORMONE RELEASE {AA} FOUNDATION

ARGININE/ORNI- LIFE EXTENSION GROWTH HORMONE RELEASE THINE POWDER FOUNDATION {AA-COMBO}

GLYCINE POWDER LIFE EXTENSION GROWTH HORMONE RELEASE {AA} FOUNDATION

L-ORNITHINE LIFE EXTENSION GROWTH HORMONE RELEASING AMINO ACID CAPSULES {AA} FOUNDATION

.. DAMIANA {H} THE HERB NOOK HORMONE BALANCE, PARKINSON'S DISEASE

L-ORNITHINE HCL LIFE EXTENSION GROWTH HORMONE RELEASING AMINO ACID POWDER {AA} FOUNDATION

ARGININE FREE LIFE EXTENSION GROWTH HORMONE RELEASE BASE POWDER {AA} FOUNDATION

HORMOPLEX NATIONAL GROWTH HORMONE {COMBO-G+AA} HEALTH

PRODUCTS

GLYCINE & CRYSTAL STAR HYPOGLYCEMIA; MYASTHENIA GRAVIS, MD, DI-METHYL HERBAL GOUT, RELEASES GROWTH HORMONE GLYCINE B-15) NUTRITION {AA+V}

28

I UNSUBSTANTIATED CLAIMS - HORMONES I PRODUCT FIRM CLAIM

EXSTEROL NATIONAL INCREASE BODY'S PRODUCTION OF GROWTH {COMBO-G+AA+H+ HEALTH HORMONE M} PRODUCTS

HORSETAIL {H} HEALTH CENTER FRACTURED BONES WILL HEAL MUCH FOR BETTER FASTER, GLANDULAR DISORDERS LMNG

SAW PALMETTO HEALTH CENTER DISEASES OF BOTH MALE AND FEMALE BERRIES {H} FOR BETTER REPRODUCTIVE ORGANS CAN BE HELPED

LIVING WITH THIS HERB

L-ORNITHINE COUNTRY LIFE GROWTH HORMONE RELEASE

L-ARGININE COUNTRY LIFE PROMOTING THE RELEASE OF GROWTH HORMONE

29

I UNSUBSTANTIATED CLAIMS - CANCER I PRODUCT FIRM CLAIM

CRYSTAL STAR CRYSTAL STAR LEUKEMIA; BONE MARROW CANCER HIGHLY HERBAL ABSORBABLE IRON NUTRITION EX {M}

MEZOTRACE SEA CRYSTAL STAR LEUKEMIA; BONE MARROW CANCER MINERAL COMPLEX HERBAL {M} NUTRITION

FLORADIX LIQUID CRYSTAL STAR LEUKEMIA; BONE MARROW CANCER IRON {M} HERBAL

NUTRITION

ENZYMATIC CRYSTAL STAR LEUKEMIA; BONE MARROW CANCER THERAPY HERBAL LIVA=TOX NUTRITION {COMBO-AA+M}

ENER B INTERNASAL CRYSTAL STAR LEUKEMIA; BONE MARROW CANCER B12 {V} HERBAL

NUTRITION

LIQUID LIVER WITH CRYSTAL STAR LEUKEMIA; BONE MARROW CANCER GINSENG {COMBO HERBAL H+M} NUTRITION

BETA CAROTENE {V} CRYSTAL STAR LEUKEMIA; BONE MARROW CANCER HERBAL NUTRITION

SPIRULINA PACIFICA NORTHBEST LOWERS THE RISK OF LUNG CANCER, {V} NATURAL ANTI-TUMOR EFFECT

PRODUCTS

JWT BLEND {H} HOUSE OF TUMORS AND CANCERS HEZEKIAH

PHOSPHATIDYL CRYSTAL STAR MALIGNANT TUMORS CHOLINE {M} HERBAL

NUTRITION

NATREN LIFE START CRYSTAL STAR MALIGNANT TUMORS {M} HERBAL

NUTRITION

CRYSTAL STAR CRYSTAL STAR LEUKEMIA; BONE MARROW CANCER ANEMIGIZE CAPS HERBAL {H} NUTRITION

DETOX CRYSTAL STAR LEUKEMIA; BONE MARROW CANCER CAPSULES&ANTI-BIO HERBAL CAPS/EXTRACT {H} NUTRITION

30


SOLARA Y TURMERIC CRYSTAL STAR SKIN CANCER CAPS W/BURDOCK HERBAL TEA {H} NUTRITION

EVENING PRIMROSE CRYSTAL STAR MALIGNANT TUMORS OIL CAPS {AA} HERBAL

NUTRITION

CRYSTAL STAR CRYSTAL STAR MALIGNANT TUMORS ANTI-BIO CAPS {H} HERBAL

NUTRITION

SIBERIAN GINSENG CRYSTAL STAR MALIGNANT TUMORS EXTRACT {H} HERBAL

NUTRITION

MARINE CAROTENE CRYSTAL STAR MALIGNANT TUMORS {AA} HERBAL

NUTRITION

GERMANIUM WITH CRYSTAL STAR MALIGNANT TUMORS SUMA {M} HERBAL

NUTRITION

CRYSTAL STAR CRYSTAL STAR MALIGNANT TUMORS IODINE THERAPY HERBAL CAPS/EXT {H} NUTRITION

YS OR PREMIER 1 CRYSTAL STAR SKIN CANCER ROY AL JELLY {H} HERBAL

NUTRITION

BARLEY GREEN CRYSTAL STAR MALIGNANT TUMORS MAGMA (H} HERBAL

NUTRITION

CRYSTAL STAR CRYSTAL STAR SKIN CANCER TERADERM HERBAL CAPS/TEA {H} NUTRITION

HYDROGEN PEROXY CRYSTAL STAR SKIN CANCER GEL {M} HERBAL

NUTRITION

OMEGA 3 FLAX OIL CRYSTAL STAR SKIN CANCER {AA} HERBAL

NUTRITION

BROMELAIN {M} CRYSTAL STAR SKIN CANCER HERBAL NUTRITION

31


SUN CHLORELLA CRYSTAL STAR LEUKEMIA; BONE MARROW CANCER {M} HERBAL

NUTRITION

EVENING PRIMROSE CRYSTAL STAR CANCER/MELANOMA OIL {AA} HERBAL

NUTRITION

FORMULA #11 {H} GOLDEN CANCER FIGHTING COMPOUND PRIDE/RA WLEIGH

THIM-J {COMBO-H} THE HERB NOOK FIGHT EPSTEIN-BARR, TUMORS

FORMULA#l0 GOLDEN LOW INCIDENCE OF CANCER {COMBO-V+M} PRIDE/RA WLEIGH

CALCIUM LIFE EXTENSION CANCER ASCORBATE FOUNDATION POWDER {V}

FORTIFIED FLAX OMEGA-LIFE CANCER, ARTHRITIS, DIABETES, HEART {AA} PRODUCTS DISEASE, HIGH CHOLESTEROL, MS, IMMUNE

SYSTEM

HERBAL PUMPKIN THE HERB NOOK TUMORS {H-COMBO}

RED CLOVER {H} THE HERB NOOK HISTORICALLY USED FOR CANCER, TUMORS

CHLOROPLEX LIFE EXTENSION ANTI-CANCER AGENT {COMBO-H,M, V} FOUNDATION

SUPER SELENIUM LIFE EXTENSION PREVENT CANCER AND CATARACTS COMPLEX FOUNDATION {COMBO-M,AA}

KYOLIC GARLIC LIFE EXTENSION PREVENT CERTAIN KINDS OF CANCER BY CAPSULES {H} FOUNDATION ENHANCING THE IMMUNE SYSTEM

CHAPARRAL{H} THE HERB NOOK TUMORS,CANCER,ARTHRITIS

PAU D'ARCO {H} THE HERB NOOK HISTORICALLY USED FOR CANCER, LEUKEMIA, TUMORS

PHYTO PLANKTON BIOTEC/BIOMED CANCER, CARDIOVASCULAR DISEASE, PACIFIC SEA LOWERING CHOLESTEROL PLASMA {AA}

FORTIFIED FLAX OMEGA LIFE, INC. ABILITY TO PREVENT CANCER, TREATMENT {H} OF DIABETES, ARTHRITIS,

CANCER,CHOLESTEROL, MULTIPLE SCLEROSIS

32


PHYTO-PLANKTON BIOTEC/BIOMED REDUCES RISK OF CANCER OF LUNG, AND BETA INTERNATIONAL THROAT, STOMACH, BREAST, LOWERS CAROTENE {COMBO} CENTER CHOLESTEROL, PARKINSONIAN TREMORS

SHARK CARTILAGE INDIANA BOTANIC ERADICATE CANCEROUS TUMORS, {G} GARDENS ARTHRITIS, CAN BE USED IN' CANCER

THERAPY, HELPFUL W/HEART ATTACK, STROKES

RNA COMPLEX PLUS GERO VITA LOWER BLOOD PRESSURE, LOWER {COMBO-H} INTERNATIONAL CHOLESTEROL, ANTIVIRAL, CANCER

PREVENTION, LOWER STROKE RISK

BIOTEC EXTRA CRYSTAL STAR CANCER/MELANOMA ENERGY SOD {M} HERBAL

NUTRITION

SELENIUM {M} CRYSTAL STAR ANTI-CANCER, IMMUNE STIMULANT FACTOR, HERBAL CHOLESTEROL NUTRITION

CARTILADE {G} SURE CANCER, DIABETES ENTERPRISES

INOSITOL {V} CRYSTAL STAR HYPERTENSION AND ARTERIOSCLEROSIS; HERBAL REDUCE BREAST AND OVARIAN CANCER RISK NUTRITION

PACIFIC SEA BIOTEC FOOD REDUCES RISK OF CANCER; HELPS PREVENT PLASMA {AA} CORPORATION CARDIOVASCULAR DISEASE; REDUCES THE

EFFECTS OF AGING

TYROSINE {AA} CRYSTAL STAR TUMOR AND CANCEROUS MELANOMA HERBAL GROWTH; HYPERTENSION NUTRITION

FOLIC ACID {V} CRYSTAL STAR CONTROL LEUKEMIA HERBAL NUTRITION

VITAMIN C {V} CRYSTAL STAR PROTECTION AGAINST CANCER, VIRAL AND HERBAL BACTERIAL INFECTIONS; ARTHRITIC & NUTRITION RHEUMATIC SYMPTOMS; CLOTS

CYSTEINE {AA} CRYSTAL STAR HELPS PREVENT CANCER HERBAL NUTRITION

PHENALALANINE CRYSTAL STAR SLOW GROWTH OF CANCEROUS MELANOMAS {AA} HERBAL

NUTRITION

33


VITAMIN E {V} CRYSTAL STAR CANCER;ANTICOAGULANTAND HERBAL VASODILATOR AGAINST BLOOD CLOTS AND NUTRITION HEART DISEASE

BLUE FLAG {H} HEALTH CENTER CANCER, SKIN DISEASES, IMPURITY OF FOR BETTER BLOOD LIVING

DORPHYNOL {G} NOT LISTED, SUPPRESS CANCER GENES; TREATMENT OF (KOREAN ADDRESS: 1984 CANCER TRANSLATION) HOMESTEAD RD.

BIOTEC CRYSTAL STAR CANCER/MELANOMA GLUTATHIONE {AA} HERBAL

NUTRITION

PROSTATA LIFE FORCE, INC. CANCER

BIOSEL {V} NUTRAMAX REDUCES THE RISK OF CANCER; STIMULATE LABORATORIES THE IMMUNE SYSTEM

ASTRAGALUS {H} INDIANA BOTANIC RESTORES IMMUNE FUNCTION IN CANCER GARDENS PATIENTS WITH IMPAIRED IMMUNE

FUNCTIONS

RENEW AL FORMULA NUTRITIONAL STIMULATE PHAGOCYTIC WHITE CELLS TO {COMBO-HERB} LIFE SUPPORT FIGHT: BACTERIA, VIRUSES, CANCER

SYSTEMS

VITA POTENCIA {H} GERO VITA PREVENTING CANCER INTERNATIONAL

COLON-ENHANCER THE VITAMIN DIABETES, COLON CANCER {COMBO-HERB} SHOPPE

GARLIC TIME ARIZONA HELPS PREVENT CANCER NATURAL PRODUCTS INC.

ROYAL JELLY Y.S. ROYAL JELLY PREVENT CANCER &HONEY FARM

RNA COMPLEX PLUS GERO VITA INHmmoN OF COLON TUMORS; LOWERING {COMBO-M,AA} INTERNATIONAL COLON CANCER RISK

NOURISH FORMULA NUTRITIONAL ANTICANCER, STIMULATES T-CELLS AND {COMBO-H} LIFE SUPPORT INTERFERON PRODUCTION

SYSTEMS

HYPERBALANCE GERO VITA CLEAN ARTERIES, ANTI-CANCER, LOWER {COMBO-AA} INTERNATIONAL BLOOD PRESSURE, STOP PLAQUE

34


BARLEY LIFE J.P. WYNNE COLON CANCER, AND CERTAIN TYPES OF COMPANY DIABETES

ST. JOHNS WORT {H} HEALTH CENTER VERY GOOD IN CASES OF TUMORS, CHRONIC FOR BETTER UTERINE PROBLEMS LMNG

35

I UNSUBSTANTIATED CLAIMS - OTHER I PRODUCT FIRM CLAIM

CRYSTAL ENERGY CRYSTAL STAR GOUT GREEN DRINK {H} HERBAL

NUTRITION

OCTACOSANOL{H} L&H VITAMINS REGENERATE NERVES; TREAT NEUROLOGICAL/MUSCULAR DISORDERS; BENEFIT IN BRAIN DAMAGE; CEREBRAL PALSY; MS

COUNTRY LIFE COUNTRY LIFE FOR HERPES VIRUSES AMINO ACIDS (L-LYSINE) {AA}

CRYSTAL STAR RTH CRYSTAL STAR GOUT EASE CAPSULES {H} HERBAL

NUTRITION

GLYCEMICOL L&H VITAMINS NATURAL RELIEF FROM HYPOGLYCEMIA {COMBO-H+M}

ACID-A-CAL CRYSTAL STAR GOUT CAPSULES {COMBO HERBAL AA-V} NUTRITION

EYEBRIGHT BIORGANIC HELPS COMBAT GLAUCOMA, CATARACTS {COMBO-ff} BRANDS, INC.

BLUE VIOLET {H} HEALTH CENTER FOR INTERNAL ULCERS FORBETIER LIVING

VITAL HEALTH CRYSTAL STAR GOUT FORMULA 1 ORAL HERBAL CHELATION NUTRITION

BORAGE {H} HEALTH CENTER LUNG PROBLEMS FORBETIER LIVING

BUCKTHORN BARK HEALTH CENTER FOR APPENDICITIS {H} FORBETIER

LIVING

ECHINACEA {H} HEALTH CENTER TREAT STREP THROAT FORBETIER LIVING

BEECH {H} HEALTH CENTER INTERNAL ULCERS FORBETIER LMNG

36


BURDOCK {H} BIORGANIC GOUT BRANDS, INC.

BIOTECH EXTRA CRYSTAL STAR GOUT ENERGY ENZYMES HERBAL SOD {AA} NUTRITION

TWIN LAB LIQUID K CRYSTAL STAR GOUT HERBAL NUTRITION

FOLIC ACID {V} NATURE'S PLUS, GASTROINTESTINAL DISORDERS THE ENERGY SUPPLEMENTS

LH-C {H} THE HERB NOOK LUNG HEALER, EMPHYSEMA

DAMIANA {H} THE HERB NOOK PARKINSON'S DISEASE

FENUGREEK {H} HEALTH CENTER EMPHYSEMA, INTESTINAL INFLAMMATION, FORBETIER ULCERS LMNG

BLACK WALNUT THE HERB NOOK HERPES, RINGWORM, IMPETIGO EXTRACT {H}

BURDOCK {H} THE HERB NOOK GOUT

GUTO KOLA {H} THE HERB NOOK SENILITY

LOBELIA {H} THE HERB NOOK PNEUMONIA, PLEURISY

BLACK WALNUT {H} THE HERB NOOK LUPUS

FOLIC ACID LIFE EXTENSION HELPS PROTECT AGAINST INTESTINAL POWDER, 10% {V} FOUNDATION PARASITES

L-GLUT AMINE LIFE EXTENSION ALCOHOLISM, HYPOGLYCEMIA, POWDER {AA} FOUNDATION

DMAE-GINKGO LIFE EXTENSION ARTERIAL/TISSUE DAMAGE,TREATING SENILE CAPSULES FOUNDATION DEMENTIA {COMBO-H,V, PRE-AA}

DMAELIQUID LIFE EXTENSION HELPFUL FOR CHILDREN WHO ARE {AA-PRECURSOR} FOUNDATION HYPERACTIVE OR HAVE ATTENTION DEFICIT

FOLIC ACID LIFE EXTENSION HELPS PROTECT AGAINST INTESTINAL CAPSULES {V} FOUNDATION PARASITES

PASSION FLOWER THE HERB NOOK EYE INFECTIONS {H}

37

I UNSUBSTANTIATED CLAIMS - OTHER I PRODUCT FIRM CLAll\f

ROSE HIPS {H} THE HERB NOOK INFECTIONS

MARSHMELLOW & THE HERB NOOK EMPHYSEMA FENUGREEK {H-COMBO}

PS II {COMBO-H} THE HERB NOOK URINARY TRACT INFECTION

SOLARAY CRYSTAL STAR GOUT ALFAJUICE TABS {H} HERBAL

NUTRITION

AL-C {H} THE HERB NOOK BRONCHms, EMPHYSEMA

IN-X {H-COMBO} THE HERB NOOK INFECTION

HIG II {H-COMBO} THE HERB NOOK FOR HYPOGLYCEMICS

SCULLCAP {H} THE HERB NOOK EPILEPSY, CONVULSIONS

YARROW {H} THE HERB NOOK CHICKEN POX

EW {H-COMBO} THE HERB NOOK EYE INFECTION, CATARACTS

KB-C {H} THE HERB NOOK SPINE DISORDERS

THYME {H} HEALTH CENTER FIGHTS INFECTION FOR BETTER LIVING

SARSAPARILLA {H} HEALTH CENTER GOUT FOR BETTER LIVING

VITAMIN C {V} COUNTRY LIFE IMPROVES RESISTANCE TO BACTERIAL INFECTIONS

ROSEHIPS {H} HEALTH CENTER IS AN INFECTION FIGHTER FOR BETTER LIVING

PLANTAIN {H} HEALTH CENTER USEFUL FOR INFECTIONS OF ALL KINDS FOR BETTER LIVING

PENNYROYAL {H} HEALTH CENTER GOUT FOR BETTER LIVING

SKUNK CABBAGE HEALTH CENTER BRONCHIAL AND LUNG INFECTIONS {H} FOR BETTER

LIVING

38


OCU-MAX {M} GERO VITA PREVENT CATARACTS INTERNATIONAL

PROSTATA GERO VITA PROST A TE DISEASE {COMBO-AA, V ,H} INTERNATIONAL

SHARK CARTILAGE GERO VITA TUMOR PREVENTION EXTRACT {G} INTERNATIONAL

WILD ALUM ROOT HEALTH CENTER VERY USEFUL IN CHOLERA AND DYSENTERY {H} FOR BETTER

LIVING

ORIGANUM {H} HEALTH CENTER WILL HELP RID POISONS FROM THE BODY FOR BETTER LMNG

MULLEIN {H} HEALTH CENTER HELPS PULMONARY AILMENTS FOR BETTER LMNG

MUGWORT {H} HEALTH CENTER GOUT FOR BETTER LIVING

WILD OREGON HEALTH CENTER GOOD FOR UTERINE DISEASES AND CHRONIC GRAPE{H} FOR BETTER SKIN DISEASES

LIVING

BETTERLMNG HEALTH CENTER HERBS THAT CAN MAKE A DIFFERENCE FOR FORM.NO.28 GOUT FOR BETTER THOSE AFFLICTED WITH GOUT {COMBO-ff} LMNG

L-LYSINE {AA} COUNTRY LIFE HERPES VIRUS

EYEBRIGHT {H} INDIANA BOTANIC CYSTS AND CONJUNCTIVITIS GARDENS

CATA VITE {H} INDIANA BOTANIC COUNTERACTS THE DEFICIENCIES GARDENS ASSOCIATED WITH AGE-RELATED

CATARACTS

L-LYSINE {AA} SUNDOWN REDUCTION OF THE INCIDENCE OF VITAMINS HERPES-SIMPLEX INFECTION

PARSLEY {H} HEALTH CENTER PARSLEY IS EXCELLENT FOR REMOVAL OF FOR BETTER KIDNEY AND GALLSTONES IF THEY'RE NOT LIVING TOO LARGE

PREVENTION PLUS RAINBOW LIGHT ANTI-VIRAL AND DEFENSE STRENGTHENING {COMBO-V,H} NUTRmONAL PROPERTIES

SYSTEMS

39


KELP {H} HEALTH CENTER IODINE IS NEEDED BECAUSE IT HELPS FIGHT FOR BETTER INFECTION LIVING

GOLDENSEAL {H} HERBS FOR KIDS AMERICAN ANTIBACTERIAL HERB

WILLOW/GARLIC OIL HERBS FOR KIDS ANTIBACTERIAL {COMBO-H}

ALFALFA LEAF {H} INDIANA BOTANIC ULCEROUS CONDITIONS GARDENS

LIFE EXTENSION LIFE EXTENSION PREVENTING CANCER BOOSTER {AA,V FOUNDATION COMBO}

BURNET{H} HEALTH CENTER BLADDER STONES FOR BETTER LIVING

BITTERROOT{H} HEALTH CENTER FOR GALLSTONES, LIVER AND KIDNEYS FOR BETTER LMNG

BUCHU {H} HEALTH CENTER CHRONIC BLADDER AND KIDNEY DISORDERS FOR BEITER LIVING

LIVA-TOX CAPSULES CRYSTAL STAR HEPATITIS; JAUNDICE; LIVER MALFUNCTION {H} HERBAL

NUTRITION

BETA CAROTENE & CRYSTAL STAR HEPATmS; JAUNDICE; LIVER MALFUNCTION ENER B INTERNASAL HERBAL B12{V} NUTRITION

SIBERIAN GINSENG CRYSTAL STAR HEPATITIS; JAUNDICE; LIVER MALFUNCTION {H} HERBAL

NUTRITION

LIV FLUSH TEA {H} CRYSTAL STAR HEPATITIS; JAUNDICE; LIVER MALFUNCTION HERBAL NUTRITION

ALTA HEALTH CRYSTAL STAR HEPATITIS; JAUNDICE; LIVER MALFUNCTION CANGEST {M} HERBAL

NUTRmON

JUNIPER BERRIES HEALTH CENTER PREVENTIVE FOR ALL DISEASE, KIDNEY {H} FOR BETTER AILMENTS

LMNG

40

Dietary Supplements: Examples of Recent Regulatory Actions

(Seizures and Warning Letters)

41

EXAMPLES OF RECENT REGULATORY ACTIONS

CARDIOVASCULAR SYSTEM CLAIMS

PRODUCT NAME MANUFACTURER MEDICAL CLAIMS

Biowell Cholesterol Dr. Knoll Products lowers cholesterol Control Formula Canfield, OH Tablets

Cardio Formula Shaperite Concepts reduce the risk of cardiovascular Capsules Salt Lake City, UT disease

Evening Primrose Trung Viet Co., Inc. arterial sclerosis, coronary heart Oil Capsules Chicago, IL disease, diabetes mellitus, obesity

• Albacar 2000 American Health reduce the risk of heart attacks, Wafer Products coronary artery disease and stroke

Dallas, TX

Calcium Night The Vi~ Shoppe, high blood pressure Formula Tablets Inc.

North Bergen, NJ

*TAURINE with B-6 Rugby/Darby Group for better blood pressure control, Tablets Co. help lower blood pressure and aid

Rockville Centre, NY the brain

CapTri Liquid Parrillo Performance decrease the absorption of Cincinnati, OH cholesterol, reduce cholesterol level

Heart Food Capsules The Heart Foods Co., lower blood pressure, reverse and · Inc. prevent arteriosclerosis, angina Minneapolis, MN pectoris, strengthens the heart after

surgery or attack, lowers cholesterol, prevents blood clots, stops heart attacks

Arko-Lesterol 2000 Arkopharma, Inc. heart disease, cholesterol Capsules Fairfield, NJ

Arko-Fiber Capsules Arkopharma, Inc. lower blood cholesterol Fairfield, NJ

Arko-BP2000 Arkopharma, Inc. heart ailments, circulatory disorders, Capsules Fairfield, NJ angina attacks, lower blood pressure,

sedative

• An asterisk denotes a seizure of products; all other listings involve warning letters.

42



Hawthorn Berry Gaia Herbs improves circulation; slows down Solid Extract Harvard, MA aging, revitalizes cardi~vascular

function

Gingko Leaf Extract Gaia Herbs improves circulation, slows down Harvard, MA aging, influences abnormalities of

cerebral circulation

Formula 82, Heart Van Luden' s Herbal heart, shortness of breath Liquid Center

Atlanta, GA

Formula 58, IIlBLP Van Luden's Herbal decreases high blood pressure Liquid Center

Atlanta, GA

43


MULTIPLE DISEASE CLAIMS


Evening Primrose Cheryl's Herbs reduce blood cholesterol, lower Oil Capsules Maryland Hts., MO blood pressure, reduce· weight,

relieve PMS, improves eczema, rheumatism and arthritis, acne, hyperactivity in children, relieve hangovers, balance tear and saliva production, slow progression of multiple sclerosis, reduce the risk of thrombosis and the progression of breast cancer

Aloe Pearl Capsules Dandy Day reverse high blood pressure, blood Corporation clots, diabetes, multiple sclerosis, Bloomfield, CO rheumatoid arthritis, lowers

cholesterol, ulcerated colitis, stomach ulcers, arthritis, intestinal and colon problems, and blood disorders

Aloe Rich Dandy Day AIDS, immune system, cleanse Concentrated Aloe Corporation urinary tract, stomach, liver, Vera Liquid Bloomfield, CO bladder, kidney and blood,

stimulating new tissue, disc problems, degeneration of retina

Bee Caps Nature Cure Company ulcers, infection, arteriosclerosis, Conkin, NY depression, fatigue, skin problems,

digestive disorders, liver ailments, acne, anemia, back pain, arthritis

Ganodenna Lucidum Ten Ren Tea & prevent aging, strengthen the Oolong Tea Ginseng Co. of immune system, alleviate the spread

Chicago, Ltd. of cancerous cells, reduce blood fat Chicago, IL and hypertension

Vascular Health News Boutique healing of wounds, heal infections, Maintenance & Brooklyn, NY diuretic, sedative, inflammation, Prevention F onnula I edema, control cholesterol levels, Caps control blood pressure by regulation

of cardiac output, forms antibodies

44



Cartilade Capsules Indiana Botanic cancer, arthritis, forms new lymph Gardens and blood vessels Hobart, IN

Vascular Health News healing of wounds, heal infections, Maintenance & Boutique, Inc. diuretic, sedative, inflammation, Prevention Formula Brooklyn, NY edema, control cholesterol levels, II Tabs control blood pressure by regulation


Vascular Health News healing of wounds, heal infections, Maintenance & Boutique, Inc. diuretic, sedative, inflammation, Prevention Formula Brooklyn, NY edema, control cholesterol levels, III Tablets control blood pressure by regulation


Coenzyme Q 10 Indiana Botanic anti-aging, energizes cells, weight Tablets Gardens reduction, normalizes blood

Hobart, IN pressure, controls gum-related problems, heart-related problems

Vascular Health News healing of wounds, heal infections, Maintenance & Boutique, Inc. diuretic, sedative, inflammation, Prevention Formula Brooklyn, NY edema, control cholesterol levels, IV control blood pressure by regulation


Essentialoids + Oral G.M. International arthritis pain, rheumatism, joint Liquid Billings, MO surgery, sports injuries, menopause

or premenstrual syndrome, osteoarthritis, inflammation in the body; controls many functions in the cardiovascular system and immune systems

Hyssop In Oil Liquid Health News regulate blood pressure, lower Boutique, Inc. cholesterol, improve circulation, Brooklyn, NY gallstones and kidney stones, gout,

dropsy, edema

KH-6 Tablets Lalut Marketing Corp. improves circulation, strengthens Bloomingdale, NJ immune system, enhances memory,

and detoxifies your body

45



Formula #1 Golden cancer, heart disease, stroke, Liquid/f ab EDT A Pride/Rawleigh, Inc. senility, cholesterol, arthritis,

West Palm arteriosclerosis, atherosclerosis, lead Beach, FL poisoning, hormones, chelation

therapy

Ginkgo Biloba Indiana Botanic anti-aging, improve blood Tablets Gardens circulation, reduce clotting of blood,

Hobart, IN improve oxygen flow to brain, relieve dizziness, eliminate ringing in ears, inhibit cellular damage, help relieve depression, makes hardened blood vessels elastic

Herbal Melange C. T.R. International reduce cholesterol, parasites, Drink Inc. diabetes, herpes, tuberculosis, palsy,

New York, NY colitis, liver disorders, diverticulitis

Herp-Elim Liquid Wish Garden Herbs heal herpes sores both types I and Boulder, CO II, immune stimulating, antiviral,

healing, anti-inflammatory, blood purifier, acne

Immune Awake Wish Garden Herbs immune stimulant, internal or Liquid Boulder, CO external infection, hypertension

Infect-Elim Liquid Wish Garden Herbs immune system, antiviral, cold, flu, Boulder, CO fevers, arthritic joints, bites and

swellings

Haelan 851 Liquid Haelan Products Parkinson's cancer, shingles, AIDS, Metairie, LA immunity

Mag-OX 400 and Blaine Co. Inc. calcium oxalate nepbrolithiasis, URO-Mag Capsules Erlanger, KY cardiac death, heart failure,

hypertension, cardiac arrhythmias, fetal and maternal morbidity, tocolysis

46



Osta B3 Liquid Hemcare, Inc. moderate-to-severe vasomotor Beaverton, OR symptoms associated with

menopause (hot flashes), female castration, primary ovarian failure, and atrophic conditions caused by deficient endogenous estrogen production, such as atrophic vaginitis (vaginal dryness) and kraurosis wlvae; effective treatment for the prevention and reversal of osteoporosis; depression, irritability, tiredness, headaches, bloatedness, breast tenderness, tension, anxiety, panics, food cravings, skin lesions, epilepsy, dizziness, alcoholic urges, asthma, sinusitis, postnatal depression, and urinary symptoms

YUXIAOSAN 8805 U.S. Chang's Health diabetes, improved blood circulation Capsules Care Enterprise, Inc. and immunity, delaying the process

San Francisco, CA of aging

Progon B Liquid Hemcare, Inc. moderate-to-severe vasomotor Beaverton, OR symptoms associated with

menopause (hot flashes), female castration, primary ovarian failure, and atrophic conditions caused by deficient endogenous estrogen production, such as atrophic vaginitis ( vaginal dryness) and kraurosis vulvae; effective treatment for the prevention and reversal of osteoporosis; depression, irritability, tiredness, headaches, bloatedness, breast tenderness, tension, anxiety, panics, food cravings, skin lesions, epilepsy, dizziness, alcoholic urges, asthma, sinusitis, postnatal depression, and urinary symptoms

47



Rio Vitalis Lapacho Cheryl's Herbs anti-inflammatory, anti-bacterial, Extract of Tree-Bark Maryland Hts., MO anti-viral, anti-tumor, immune-Capsul~s deficiency

•salubrin Tablets: Research Health Care immune stimulating, AIDS, ulcers, Shiitake extract New Troy, MI gallstones, diabetes, anemia, colds,

high blood pressure, tumors

Terra Maxa Cheryl's Herbs strengthens entire gland system, Maryland Hts., MO strengthens brain & nerves, purifies

blood & lymph system, metabolism, lungs, tumors, growths, lengthens life, anemia, sexual potency, hemorrhages, fever, diabetes, heart, rheumatism, memory, protects from irradiation, all VD, anxiety, nervous breakdown, asthma, infections, antibiotic, neutralizes venom, bruises, muscles, bone, arthritis, worms, gout, inflammations, MS, poison antidote, major for respira-tion, pain, ulcers, epilepsy, TB, antiseptic, depression, anorexia; externally for skin eruptions, ringworm, ulcers, warts growths, scars, and wounds

Mille Thistle Extract Nature's Best, Inc. to relieve symptoms of poor liver Capsules Springfield, MO functions including chronic fatigue,

weakness, myalgia, nausea, joint pain, diarrhea/constipation, allergies, psoriasis, and forgetfulness

Ginkgo Biloba Nature's Best, Inc. eliminating or reversing allergies, Capsules and Tablets Springfield, MO hearing loss, impotency, circulatory

disorders, memory loss, chronic pain, hemorrhoids, headaches, poor eyesight, depression, tinnitus, and dizziness

48



Garlic Tablets Nature's Best, Inc. to strengthen the cardiovascular Springfield, MO system, improve the immune

system, help prevent viral infections and colds, and prevent certain' types of cancer

Echinacea Extract Nature's Best, Inc. preventing or treating colds, flu, Capsules Springfield, MO bronchitis, tonsillitis, tuberculosis,

allergies, meningitis, wounds, yeast infections, abscesses, psoriasis, whooping cough, ear infections, and boosts the immune system

Bilberry Extract Nature's Best, Inc. to relieve eye strain, improve night Capsules Springfield, MO vision, prevent or reverse glaucoma,

cataracts, macular degeneration and myopia, prevent and relieve circulatory disorders (atherosclerosis) and blood clots, relieves varicose veins, helps strengthen connective tissue, counteracts the effects of arthritis and other inflammatory diseases

Panax Ginseng Nature's Best, Inc. anti-fatigue, anti-stress, improves Capsules and Tablets Springfield, MO sugar control, normalizes blood

pressure, protects from effect of radiation, reduces LDL raises HDL, prevents and reduces coronary heart disease, increases blood flow to the brain, increases intellect and ability to perform mental activity for prolonged periods of time

Beijing Tsu Hsueh Trung Viet Co., Inc. febrile delirium, vexation and (Anti-Pestilence and Chicago, IL restlessness, fever and chills, stiff Fever Powder) neck, dizziness, distension of head,

sore throat and thirst, constipation, and darkish yellow urine and measles

49



*Formula 6 Sun Albi Imports Ltd. strengthens the heart muscles; Yuen Li Capsules Lynwood, WA rebuilds the valvular structure;

regulates the heart beat; widens the coronary blood vessels; stimulates flow of blood to heart; beneficial to mitral stenosis and heart diseases; alleviates angina pectoris; allays hypertension, irritability, and epileptic seizures; for coronary insufficiency

PCM-4 in liquid Omega Pharma- AIDS, cancer, viral illness, immune form ceutical, Inc. system

Birmingham, AL

GFE-3 (drops) Breakthrough AIDS, cancer, immune system, high Technologies cholesterol, tuberculosis, arthritis Birmingham, AL

Formula 1 Herbal Albi Imports Ltd. remedy for gallstones; increases bile Laxatives I Capsules Lynnwood, WA secretion; treatment of intestinal

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Formula 3 Super Albi Imports Ltd. to relieve and prevent prostate Compound Capsules Lynnwood, WA problems; a glandular stimulant

(thyroid, hypothalamus, adrenal, pineal, pituitary, lymph, liver, gall bladder, pancreas, spleen); for bronchitis, asthma, tuberculosis; disease of kidney and spleen; diabetes; arthritis, gout, rheumatism; high blood pressure; ulcers; leprosy; smallpox and infected sores.

50



•Formula 14 Albi Imports Ltd. for strengthening the immune Astragulas Capsules Lynnwood, WA system, specifically for resisting

AIDS and cancer; promotes adrenal cortex function; ameliorates bone marrow depression and gastrointestinal toxicity caused by chemotherapy and radiation therapy; preventive for colds and flu

•Formula 8 Capsules Albi Imports Ltd. for kidney disorders and infections; K&B Lynnwood, WA for removal of toxic matter from the

kidneys and expelling bladder stones; eliminates urinary tract infections; as a bladder cleanser for women; helps heal kidney and urinary inflammation; as an antiseptic in killing infections

•Retinol Beautiful E. Burnham Co., Inc. slows the skin's aging process, loss Skin Nutritional Lincolnwood, IL of elasticity, flaking, wrinkling, Supplement tablets drying out; helps prevent spider

veins, inhibits "age spots", eczema, psoriasis; aids digestion of proteins, carbohydrates and fats

TNT Total Miller's Distributors high blood pressure, diabetes, Nutritional Therapy Milwaukee, MI circulation, migraine, heart Tea problems

TNT Total Miller's Distributors gallstones, kidney stones, gout, Nutritional Therapy Milwaukee, MI dropsy, edema, pleurisy, asthma, Hyssop Herbal Food blood pressure, lower cholesterol, Extract stomach worms

Herbal Energy Plus Vitality Products Co. increase energy, mental alertness, Capsules Olympia, WA stress and weight loss

Evening Primrose Vitality Products Co. hardening of the arteries, heart Oil Capsules Olympia, WA disease, premenstrual syndrome,

multiple sclerosis, and high blood pressure

51



Biotin Forte Tablets Vitaline Formulas uremic neurologic disorders, Ashland, OR ischemic heart disease,

hypertension, myoclonus syndromes

Biotin Forte Products Vitaline Formulas uremic neurologic disorders, lower Ashland, OR blood glucose levels, heart disease,

hypertension, myoclonus syndromes, depression

•Regina Royal 100 Bee-Alive Epstein Barr virus/chronic fatigue Jelly Valley Cottage, NY syndrome, chronic bronchitis,

strengthen the immune system

•Regina Royal Bee-Alive Epstein Barr virus/chronic fatigue Concorde liquid Valley Cottage, NY syndrome, chronic bronchitis,


•Regina Royal Jelly Bee-Alive Epstein Barr virus/chronic fatigue Capsules Valley Cottage, NY syndrome, chronic bronchitis,


"Cartilade" Shark Cartilage effective complimentary treatment Cartilage Capsules Technologies, Inc. for reducing the symptoms of

Port Chester, NY psoriasis, arthritis and joint related discomfort; ability to inhibit new blood vessel development; dramatically reduce the lameness and pain associated with arthritis and other inflammatory conditions of the joints; cartilage and anti-inflammatory properties; its cartilaginous skeleton enhances the shark's immune system; reintroduce the cartilage building blocks which can help protect our joints against further loss; angiogenesis inhibitor can block or impede the progression of many abnormal conditions

52



Sun Chlorella The Vitamin Shoppe, strengthens the immune system, Tablets Inc. eliminates toxic heavy metals such

North Bergen, NJ as cadmium from the body, reduces cholesterol levels, reduces high blood pressure, stimulates growth, tissue repair and healing

•uv Flush Tablets Modem Coupon helps liver flush poisons from the Systems dba Dr. body, combat cholesterol Leonard's Health Fest Brooklyn, NY

• eatechin Capsules Thome Research, Inc. hepatitis, allergies and herpes Sandpoint, ID simplex virus

•Hepasil Capsules Thome Research, Inc. jaundice, biliary problems, Sandpoint, ID protecting the liver from toxins,

treating alcohol and cirrhosis problems, allergies, psoriasis, reducing cholesterol and triglyceride levels, and for use as an anti-inflammatory, anti thrombotic, and antirheumatic agent

•Metox Capsules Thome Research, Inc. bronchitis, cystic fibrosis, asthma, Sandpoint, ID pneumonia, serious otitis media, ·

chronic sinusitis, common colds, poisonings, stimulating T-cell colony-forming cells in AIDS and ARC patients, and inhibiting replication of the mv virus

53



Barley Green Ruby Trading Corp. eliminating some diabetic Powder New York, NY medications; retarding aging and the

development of cancerous changes in the cells; suppressing stomach and duodenal inflammation and pancreatitis; alleviating the inflammation associated with arthritis and tendinitis; stimulating DNA repair; lowering blood pressure; calming hyperactive children; alleviating depression; healing injuries; operations and infections; alleviating nasal allergies, asthma and emphysema; improving digestion, alleviating gum disease, alleviating varicose veins, lessening menopausal symptoms and premenstrual syndrome, improving breath and body odors; increasing tolerance to alcohol and decreasing the toxic symptoms of chemotherapy

Natrol ACE Natrol, Inc. strengthen the immune system, Capsules Chatsworth, CA normalize blood cholesterol, prevent

hypercholesterolemia, hepatitis, cancer, polio, heart disease, Epstein-Barr/chronic fatigue syndrome

Natrol High Natrol, Inc. strengthen the immune system, Capsules Chatsworth, CA normalize blood cholesterol, prevent

hypercholesterol-emia, hepatitis, cancer, polio, heart disease, Epstein-Barr/chronic fatigue syndrome

Natrol Ester C with Natrol, Inc. strengthen the immune system, Bioflavonoid Chatsworth, CA normalize blood cholesterol, prevent

hypercholesterol-emia, hepatitis, cancer, polio, heart disease, Epstein-Barr/chronic fatigue syndrome

54



Natrol Ester C Natrol, Inc. strengthen the immune system, Capsules Chatsworth, CA normalize blood cholesterol, prevent

hypercholesterol-emia, · hepatitis, cancer, polio, heart disease, Epstein-Barr/chronic fatigue syndrome

•L-Carnitine Edom Laboratories, hypoglycemia, heart angina, Capsules Inc. dba Consumer diabetes, liver disease, kidney

Vitamin Values disease Deer Park, NY

•L-Arginine/L- Edom Laboratories, immune system stimulator, stroke Ornithine Tablets Inc. dba Consumer prevention

Vitamin Values Deer Park, NYl

Nutri-Tonic QIO Armco Food Products less arthritis pain, lower blood Manufacturing pressure, boosts the immune system, Escondido, CA relieves angina, protects against

heart attacks, extends life itself, helps cure periodontal disease

Redoxol Tablet Lithox Corp. cancer, hypertension, senile Austin,TX dementia, immune deficiency

•Herbal No. 7 Multiway Associates depression, alert mind, sharp Tablets Batesville, AR memory aphrodisiac, Parkinson's

disease

Micro-Mins Capsules Universal Formulas rheumatism, cancer, allergies and Kalamazoo, MI cardiovascular disease

Metal-B-Gone Universal Formulas rheumatism, cancer, allergies and Capsules Kalamazoo, MI cardiovascular disease

lmmunase One Universal Formulas rheumatism, cancer, allergies and Capsules Kalamazoo, MI cardiovascular disease

Flora-Zymes Universal Formulas rheumatism, cancer, allergies and Capsules Kalamazoo, MI cardiovascular disease

Co-Enzyme Universal Formulas rheumatism, cancer, allergies and Multiplex Tablets Kalamazoo, MI cardiovascular disease

55



Chem-Tox Capsules Universal Formulas rheumatism, cancer, allergies and Kalamazoo, MI cardiovascular disease

Black Radish & Universal Formulas rheumatism, cancer, allergies and Parsley Capsules Kalamazoo, MI cardiovascular disease

Bifidiphilus Universal Formulas rheumatism, cancer, allergies and Concentrated Flora Kalamazoo, MI cardiovascular disease Capsules

Reishi Mushroom Organo-Tech, Inc. bronchitis, cardiovascular, hepatitis, Powder Tablets San Antonio, TX high blood cholesterol, immune

system, and cancer

Power Caps The Heart Foods Co., lower blood pressure, reverse and Inc. prevent arteriosclerosis, angina Minneapolis, MN pectoris, strengthens the heart after

surgery or attack, lowers cholesterol, prevents blood clots, stops heart attacks

Arko-Bone Capsules Arkopharma, Inc. diuretic, stop bleeding, wounds, Fairfield, NJ ulcers, rheumatoid arthritis, cure for

bone fractures and connective tissue disorders

Arko-Aging Arkopharma, Inc. anti-aging, protect vascular walls, Fairfield, NJ increase blood flow in occluded

cerebral blood vessels, increase tissue oxygen consumption, hearing disorders, vertigo, tinnitus, senescence, Raynaud' s disease, varicose veins, acrocyanosis, hemorrhoids, and memory loss

Exsativa Packets Ecomer, Inc. increase muscle strength, endurance, Perkasie, PA performance, anti-stress, lowers

cholesterol, prevent illness of the digestive tract, and aphrodisiac

56



Gamma-Oryzanol The Natural Choice cholesterol excretion, direct effect with Ferulic Acid Vitamin Co. on the hypothalamus, pituitary, and Capsules Peoria, IL liver, causes the pituitary to produce

more HGH

Coenzyme Q-10 The Natural Choice increases the strength of the heart; Capsules Vitamin Co. relieves angina; protects against

Peoria, IL heart attacks; lowers high blood pressure; reduces weight naturally and extends life; and periodontal disease

Bumbles Royal Scandinavian Health treating or preventing myocardial Gellee Capsules Factory infarction, congestive heart failure,

Stamford, CT anginal pain, shortness of breath, high triglyceride levels, precancerous lesions of the face and carcinoma of the mouth and face, leukemia, tumor cell, bronchial asthma, liver disease, pancreatitis, stomach ulcers, kidney disease, bone fractures, immune system deficiencies, mental illness, arthritis, alcoholism, warts, and scalp disorders

Ultimate Health Wolfco anti-aging, lowers cholesterol, Longliv Extend New York, NY strengthens immune system, reduces "120" Tablets incidence of tumors, protects against

heart attacks, anti-cancer agent, and aids in repair of lung tissue from damage due to smoking

Rejuvecleanse Drops Gaia Herbs alters the blood and lymph, removes Harvard, MA metabolic wastes

57



Sparkling Energy Life Enthusiast Co-op congestive heart failure, failing Powder Federal Way, WA immune system, failing eyesight,

lethargy, loss of memory, preventing cardiac arrhythmias, lowering blood pressure, reducing ischemic or hypoxic injury, preventing toxicity from drugs, angina pectoris, cancer, heart and circulatory diseases, builds immune resistance, tendinitis, prevents accumulation of cholesterol or plaque formation in the arteries, dissolves calcified deposits from the joints and arteries, cell membrane defense against viruses

Soyessence Powder Life Enthusiast Co-op tendinitis, prevents accumulation Federal Way, WA cholesterol or plaque formation in

the arteries, dissolves calcified deposits from the joints and arteries, cell membrane defense against viruses

Green Gold Powder Life Enthusiast Co-op detoxifies cells, multiple sclerosis, Federal Way, WA rheumatoid arthritis, lowers risk of

cancer, treatment of arthritis, asthma, diabetes, fatigue, gastrointestinal disorders, skin problems, heartburn, blood clots, migraine headaches, cancer, lymphoma, constipation, ulcers, and blood sugar problems

58



Excela Powder Life Enthusiast Co-op tendinitis, prevent accumulation of Federal Way, WA cholesterol or plaque formation in

the arteries, dissolves ·calcified deposits from the joints and arteries, cell membrane defense against viruses, detoxifies cells, multiple sclerosis, rheumatoid arthritis; lowers risk of cancer, treatment of arthritis, asthma, diabetes, gastrointestinal disorders, skin problems, heartburn, blood clots, migraine headaches, cancer, lymphoma, constipation, ulcers, and blood and sugar problems, congestive heart failure, failing immune system, gum disease and tooth loss, failing eyesight, lethargy, preventing cardiac arrhythmias, lowering blood pressure, reducing ischemic or hypoxic injury, preventing toxicity from drugs, angina pectoris, cancer, heart and circulatory diseases, build immune resistance

Cell Guard Caplets Life Enthusiast Co-op detoxifies cells, multiple sclerosis, Federal Way, WA rheumatoid arthritis, post flight

fatigue, and increases energy levels

Fiber 7 Powder ND Labs lowers cholesterol, diabetes, weight Brooklyn, NY loss, decrease risk of colon cancer,

correct gastrointestinal disorders, stabilize blood sugar level

Klean and Klear Triputic, Inc. AIDS, diabetes, high blood ( concentrated aloe Northglenn, CO pressure, multiple sclerosis, vera) Kaposi's sarcoma, skin cancer,

malignancies, many other diseases

Garolic Capsule Triputic, Inc. AIDS, diabetes, high blood Northglenn, CO pressure, multiple sclerosis,

Kaposi's sarcoma, skin cancer, malignancies, many other diseases

59



Aloe Pearl Capsules Triputic, Inc. AIDS, diabetes, high blood Northglenn, CO pressure, multiple sclerosis,

Kaposi's sarcoma, skin cancer, malignancies, many other diseases

Aloe Rich Triputic, Inc. AIDS, diabetes, high blood Concentrated Aloe Northglenn, CO pressure, multiple sclerosis, Vera Liquid Kaposi's sarcoma, skin cancer,

malignancies, many other diseases

Ten Chi Liquid The Environmental regulates blood sugar level, Network strengthens immune system Irving, TX

Enviro-Cleanse The Environmental prevention or repair of digestive Formula #3 Capsules Network system, prevention or repair of

Irving, TX elimination system, hemorrhoids, varicose veins, headaches





Hot Stuff Anabolic National Health increase testosterone levels, release Activator Powder Products growth hormone, anabolic steroid

Orlando, FL alternative, energy enhancement, increase strength

herbs/herb The Herb Shop heart problems, cancer, hepatitis, combinations ( 44 Rome, GA immune system problems, strokes, single and 50 herb Parkinson's disease, and many combinations) others

60


IMMUNE SYSTEM CLAIMS


Astragalus Capsules Indiana Botanic immune system Gardens, Hobart, IN

Basic Immune Wish Garden Herbs immune stimulating, swollen glands, Formula Liquid Boulder, CO tonsillitis, sinus and ear infections,

arthritic joints, fevers, flu

Royal Jelly- I 000 Beehive Botanicals, increases strength of immune Capsules Inc. system, stops the growth of bacteria

Hayward, WI

Immune Formula Shaperite Concepts enhance immune system and Capsules Salt Lake City, UT resistance to infection

Immune Awake for Wish Garden Herbs immune stimulant, anti-microbial, Children Liquor Boulder, CO internal or external infections,

fevers, arthritic joints, bites and swelling

Pau D' Arco Herbs Indiana Botanic immune system for Tea Gardens

Hobart, IN

Echinacea Capsules Vitality Products Co. blood pwifier, builds WBC, Olympia, WA resistance and recovery from

infections, viral, fungal and bacterial

Bee Pollen Capsules Vitality Products Co. immune system Olympia, WA

Thymus 200 Tabs Vitaline Formulas enhance immune system Ashland, OR

•Formula No. 376 L- Vitamin Specialties activates the release of growth Omithine Tablets Co. hormone, vitality needed by the

Wyncote, PA body's immune system to function properly

•Formula No. 326 L- Vitamin Specialties stimulates the release of growth Arginine Tablets Co. hormone, necessary for the proper

Wyncote, PA functioning of the immune system

Biomega 2000 First Fitness immune system Liquid International, Inc.

Richardson, TX

61



Arko-Flu Capsules Arkopharma, Inc. immune system, improve white Fairfield, NJ blood cells and antibodies,

production interferon, wound healing, immunostimulant effects and stimulating phagocytosis

Ecomer Ecomer, Inc. immune system and production of Alkylglycerols Perkasie, PA white blood cells (Shark Liver Oil) Capsules

Echinacea Supreme Gaia Herbs immune modulator, antiviral and and Harvard, MA antibacterial Echinacea/Goldensea 1 Supreme

62


OTHER CLAIMS


Eyebright Herb for Indiana Botanic aids (eye) weakness, cysts and Tea Gardens conjunctivitis

Hobart, IN

See Tablets Quantum, Inc. cataracts, macular degeneration Eugene, OR

Cata Vite Capsules Indiana Botanic cataract prevention Gardens Hobart, IN

Zinc Sulfate Tablets Nationwide Purveyors, macular degeneration Inc. Pittsburgh, PA

Biowell Glycomed Dr. Knoll Products hypoglycemia Tablet Canfield, OH

Ocuguard Caps Twin Labs macular disease Ronkonkoma, NY

Annedda Tablets Reseau International protect non-renewable brain, nerve, Cincinnati, OH muscle (heart) cells from aging and

dying; protect cells from damage

Propolis Tincture Beehive Botanicals, antibiotic, antiviral, antifungal, Inc. burns and cuts Hayward, WI

Propolis Capsules Beehive Botanicals, antibiotic, antiviral, antifungal, Inc. ability to strengthen our thymus Hayward, WI gland (immune center) against

infection

Propolis Granules Beehive Botanicals, antibiotic, antiviral, antifungal, can Inc. stimulate the thymus gland Hayward, WI

Detoxification Tea Health News Boutique cleanse large intestine of toxic Brooklyn, NY poisons, lose body fat and weight

Detox Capsules Health News Boutique cleanse large intestine of toxic Brooklyn, NY poisons, lose body fat and weight

63



Superior Tabellae Trung Viet Co., Inc. bacterial dysentery, gastric and Berberini Chicago, IL intestinal catarrh, indi~estion Hydrochloride Tablets

Fritillaria Compound Trung Viet Co., Inc. acute and chronic bronchitis, cough, Extract Tablets Chicago, IL and asthma due to colds,

bronchiectasis

•Formula 18 "L" Albi Imports Ltd. for treatment of chronic liver Capsules Lynnwood, WA conditions; inducing bile flow in the

liver; lowers blood bilirubins; cleans and fortifies the blood; for cirrhosis of the liver

Formula No. 51 Health Center For infected and enlarged prostate, Prostate Problem Better Living stimulates urine flow Capsules Naples, FL

Formula No. 34 Health Center for lowers blood pressure, gives High Blood Pressure Better Living strength to blood vessels Capsules Naples, FL

Formula No. 22 Health Center for arrests infection in the pancreas, Diabetes Capsules Better Living activates and stimulates the

Naples, FL pancreas, regulates sugar in the bloodstream, and corrects diabetes

Pregnancy Tea: Cheryl's Herbs relieves nausea and prevents raspberry leaf Maryland Hts., MO miscarriages

•L-ornithine Nat-Rul Health immune system, stimulate muscle Products growth, heals wounds, burn excess New York, NY fat

Paratox 22 Capsules The Vitamin Shoppe, anti-protozoa!, irritation, Inc. inflammation North Bergen, NJ

•Mycocidin Perles Thome Research, Inc. Candida albicans Sandpoint, ID

·campycidin Thome Research, Inc. Campylobacter pyloric, gastritis, Capsules Sandpoint, ID duodenitis, duodenal ulcers, gastric

ulcers, and peptic ulcers

64



Pro-Woman Tablets Biokin Co., Inc. depression, mild to severe mood Arlington, TX swings, hypoglycemia

Nature's Diet Life Natural Oriental Herb Makes you lose weight by Water Corp. extracting unnecessary fats and

New York, NY cholesterol from your body

•Formula No. 364 Vitamin Specialties protects against bacteria, viruses, Cysteine Tablets Co. chemicals and radiation, capable of

Wyncote, PA blocking the action of insulin, has been used in cases of hypoglycemia, can extend the mean lifespan of animals by 25%, can increase the survival time of animals with transplanted malignant tumors

•Formula No. 375 L- Vitamin Specialties suggested as an aid in depression, Phenylalanine Co. providing improved memory and Tablets Wyncote, PA increased mental alertness

•L-Lysine Tablets Edom Laboratories, herpes simplex Inc. dba Consumer Vitamin Values Deer Park, NY

•L-Glycine Tablets Edom Laboratories, stress and anxiety, release of growth Inc. dba Consumer hormone Vitamin Values Deer Park, NY

•L-Phenylalanine Nat-Rul Health mental alertness, memory, an anti-Tablets Products depressant

New York, NY

•L-Glutamine Tablets Nat-Rul Health increase concentration, essential for Products cerebral function New York, NY

•slim N' Clenz Palko Distributing Co. eliminate parasites, reduce sugar Capsules Volparaiso, IN absorption

Arko-Vision Arkopharma, Inc. night vision, night blindness, visual Capsules Fairfield, NJ fatigue, severe nearsightedness, and

various vascular disturbances of the retina

65



Arko-Skin Capsules Arkopharma, Inc. scaly skin, eczema Fairfield, NJ

Arko-Rheuma 2000 Arkopharma, Inc. alleviates aches and pains and Capsules Fairfield, NJ stiffness of arthritis, rheumatism and

gout

Arko-Menopause Arkopharma, Inc. anemia, weak glands, female Capsules Fairfield, NJ problems, vaginal spasms, hot

flashes, sweating and perspiration

Arko-H 2000 Arkopharma, Inc. phlebitis, inflammation of the veins, Capsules Fairfield, NK varicosity, and hemorrhoids

Strix Tablets Ecomer, Inc. strengthens the walls of capillaries Perkasie, PA and improved night vision

Inuit 3 Scandinavian Scandinavian Health treating or preventing inflammatory Fish Oil Concentrate Factory, Inc. disease such as joint problems and

Stamford, CT psoriasis

FINNTABS Scandinavian Health treating or preventing arthritis, Factory, Inc. lumbago, bone abnormalities, and Stamford, CT joint pain

Tropamine + Helix Technologies, treatment/recovery of cocaine, Capsules Inc. amphetamine, and other stimulant•

Eliz.aville, NY abusers

SAA VE + Capsules Helix Technologies, treatment for alcoholism and drug Inc. abuse Eliz.aville, NY

Vitex Syrup Gaia Herbs estrogen imbalance, absence of Harvard, MA menses and menopausal problems

Saw Palmetto Gaia Herbs support the prostate and Supreme Drops Harvard, MA reproductive organs, infection and

inflammation

Red Clover Supreme Gaia Herbs alters the blood and lymph, removes Drops Harvard, MA metabolic wastes

Calcium Supreme Gaia Herbs trauma and injury Liquid Harvard, MA

66



Amaloxy Syrup Gaia Herbs rejuvenation, longevity, immunity, Harvard, MA relax nerves and tension

Fiber Supreme ND Labs controls blood sugar levels in Powder Brooklyn, NY diabetics

Enviro-Guard Tablet The Environmental atherosclerosis, cancer Network Irving, TX

Fibercin Approved weight loss, reduction of cholesterol Pharmaceutical Syracuse, NY

Formula 96, CAN Van Luden' s Herbal cancer Liquid Center

Atlanta, GA

Formula 71, Tumors Van Luden's Herbal tumor dissolver, fibroid Liquid Center

Atlanta, GA

Formula 101, Pros Van Luden's Herbal prostate troubles Liquid Center

Atlanta, GA

Formula 91, Van Luden' s Herbal high blood sugar (lowers), diabetes Diabetes Liquid Center

Atlanta, GA

Formula 68, Lupis Van Luden' s Herbal lupus Liquid Center

Atlanta, GA

Cata-Rx Tablets Vision Research cataracts Technologies, Inc. Roslyn, NY

67

Dietary Supplements: Examples of Current Oral Claims

Made by Health Food Store Employees for Specific Illnesses

69

-..J 0

PRODUCTS RECOMMENDED

Synergy Plus Natural Hi-Potency Coenzyme Q-10

Solgar Lecithin Solgar Multi-vitamin

mineral

Kyolic Aged Garlic Extract

Chelated Calcium-Magnesium Complex

Garlic Tablets

Garlicin

DIETARY SUPPLEMENT SURVEY "WHAT DO YOU SELL TO HELP HIGH BLOOD PRESSURE?"

CITY/STATE ORAL CLAIMS

Lansdowne, PA The employee said there were a few dietary supplements that could be most helpful and pointed them out on pag~ 204 from Prescription for Nutritional Healing. He stated the most effective were garlic capsules, coenzyme QI 0, lecithin, and multivitamins with minerals.

Massapequa, NY The employee recommended combining garlic with Calcium-magnesium tablets (four Garlic tablets during the day and two tablets of Calcium-magnesium just before bedtime). The employee said that because the FDA is now very active in this area all of the companies have stopped making this type of information available.

Hicksville, NY The employee handed me a book titled: Earl Mindell's Herb Bible and referred me to pages 97-100. Page 98 lists under possible benefits "Helps prevent heart disease by reducing blood pressure and blood lipids".

Jerome, IL The employee said he knew of several people who had successfully treated their high blood pressure with garlic suppl~ments. The employee stated that her father was able to stop his high blood pressure medication after taldng daily doses of garlic supplements.

....J -

Calcium and Magnesium

Selenium L-Camitine

Formula No. 94 Calcium-Magnesium & Zinc

Formula No. 30 Mega-Plus High Potency Vitamins with Minerals

Formula No. 477 Deoderized Garlic

K yo lie Aged Garlic Extract Powder

Kyolic Enzyme Complex

Garlic Co-Enzyme QlO


Metairie, LA The employee ref erred to the book Prescription for Nutritional Healing, specifically four pages on blood pressure. The employee assisted me in selecting the three supplements and we determined how much of each I should take daily.

Havertown, PA The employee stated that they had a number of dietary supplements that would help hypertension. The employee also stated that all of the supplements were available at the store and they were all good; however, lecithin would be a good choice to help with high blood pressure.

New Orleans, LA The employee stated that garlic extract is good for treating high blood pressure.

Lakewood, CO The employee indicated either garlic or Co-Enzyme QlO to help high blood pressure and provided pamphlets for each. The employee also stated that there were no brochures for individual products per se because of FDA rules.


Circu-Flow (herb Boulder, CO The employee highly recommended product called Circu-Flow, but product with said it wasn't legal to put anything in writing to promote that type of hawthorn berries) in therapy. Employee did provide written testimonials from previous combination with customers which claimed decrease in heart size, no more pain in legs Aloe Vera Gel when exercising, and product negating need for bypass surgery after

only six weeks. A second employee recommended using Circu-Flow with Aloe Vera Gel to treat high blood pressure.

Garlic Oil Hato Rey, PR No contact made with employee. Pamphlet on display at product rack stated that medical authorities know garlic oil's efficacy to reduce blood pressure and clean glucose from the blood. Product labeling also notes anecdotal information linking garlic to investigations into its ability to lower blood pressure.

Pressur-Lo San Juan, PR The employee stated that Pressur-Lo tablets were good for treating (mineral/herb/ high blood pressure. Clerk also stated garlic tablets are good for vitamin complex) treating high blood pressure.

Odorless Garlic Waukegan,IL The employee recommended cod liver oil/fish oil for high blood Cod Liver Oil pressure. An employee ref erred to a book entitled Prescription for Fish Oil Nutritional Health. Book recommended garlic for treating high blood

pressure and also indicated garlic would lower cholesterol.

Garlicin Des Moines, IA The employee stated product worked for his mother, who was suffering from hypertension.


Heart Food Caps Edina, MN The employee looked in several reference books (behind the counter) Hawthorn to detelTiline which herbs or supplements worked best for Cayenne Pepper hypertension. She said garlic, cayenne pepper, and hawthorn were Garlic herbs that helped heart problems and controlled blood pressure. She Coenzyme QI0 said she knows people who do not take BP medication other than the

herbs and they're healthy. She also recommended coenzyme Q 10, which was rated as "Very Important" by one of the reference books.

Coenzyme Q-10 Minneapolis, MN The employee recommended Coenzyme Q 10, garlic, cayenne &

Garlic hawthorn for high blood pressure. Cayenne was listed in several Cayenne different "hot" strengths. When asked if the cayenne bothered Hawthorn (tablets, stomachs she said no. However, if it did she had a product of

fresh herbs & tea) cayenne combined with another herb to soothe the stomach. She stressed that fresh herbs were also sold in the store and an herbalist would consult with me ($30/hour) and mix various herbs for various health problems. A hot tea should be made and consumed to absorb beneficial qualities from the herbs.

Coenzyme Q-10 Houston, TX The store owner stated that the product CoQ 10 (Coenzyme Q-10) would reduce blood pressure. Additionally, she verbally stated the product would aid my immune system and help the heart.

Kyo-chrome Sacramento, CA The employee stated that garlic in combination with niacin and Bioconverted garlic chromium would be the proper product to use for high blood pressure

and that B vitamins would help for stress.

No Claim Citrus Heights, CA The employee stated she could not make claims.


Garlicin garlic East Orange, NJ The employee stated that garlic is best for high blood pressure relief. supplement He suggested a product called "Garlicin garlic supplement" and

B/P Herbal Food provided a brochure. He was unable to locate the product and Formula recommended B/P Herbal Food Formula.

Pressure Relief Tea East Orange, NJ The employee stated that they sell two products: Pressure Relief Tea SP-9 Garlic Valerian and SP-9 Garlic Valerian Blend. The other employee stated that the

Blend Capsules Garlic Valerian Blend is best to start with, and that the capsules are for relief and the tea helps you relax. The first employee stated that the indicated use for SP-9 is for relief of high blood pressure. The second employee asked if I was on medication from a physician, and I said I stopped taking it and she told me to " ... take these capsules for two weeks, then check your pressure. You'll see the difference." I asked her if I should continue to take the pills my doctor said to take and she said" ... you won't need them; you'll see. It [SP-9] really works!" The man interrupted and stated that the reason high blood pressure is not indicated on the bottle is because the product (SP-9) is indicated for many uses. It appeared that he was reading · from a handwritten document. The second employee interrupted him and said, " ... yeah, diabetes, cholesterol, etc."

L-Carnitine Brea, CA The employee informed me that my father would need L-Camitine, Calcium calcium and magnesium diet supplement and that he strongly Magnesium recommends L-Camitine. This was for the healing of hypertension.

The .reference material stated that the amino acid (L-Carnitine) will aid in preventing heart disease.


Kyolic Anaheim, CA The nutritionist provided me with literature on Kyolic, stating why Dutin this is effective as a dietary supplement. The store nutritionist

recommended three (3) tablets per day of Kyolic and one 0) tablet of Dutin.

UltraCoQlO Falls Church, VA The manager stated that "FDA does not allow literature stating cures (coenzyme) for any illnesses." He highly recommended the purchase of the

Gennanium reference book Pr~~riptiQn {Q[ NytritiQnal Healing, stating that he uses it and recommends it like the bible, that he has a customer who purchases CoQ IO for her son who has some coordination disorder and this supplement helps this disorder. He went on to discuss how this book has removed warts from his fingers and how his brother was a doctor who also uses this ref ere nee book.

Ultra Calcium Vienna, VA Both the employee and manager use the book Prescription for Magnesium NutritiQnal Healin& for supplement recommendation for all Maxi L-Carnitine and · illnesses-Le., cancer, hypertension, AIDS, etc.

Selenium

Garlic Charleston, SC The #1 employee said that garlic and cayenne were good for high Cayenne blood pressure. A #2 employee came later and showed me a bottle of

pills labeled HBP with what he said had the same synergistic ingredients as those listed in the book he showed me (The Art of

Self-Healin1:).


L-Carnitine capsules Tampa, FL The employee said that L-Carnitine was good for hypertension and with Calcium and should be taken with the calcium magnesium supplement. The Magnesium employee also recommended going on a Candida control diet to

stabilize the natural intestinal flora.

Garlic/Cayenne Mt. Pleasant, SC The employee said that a Garlic/Cayenne combination was what she combination recommends. She picked up a book and turned to a page that

discussed high blood pressure.

Calcium/Magnesium Tampa, FL The employee referred to the book Prescription for Nutritional Supplement taken Healing. page 204, and showed me the chart. She suggested that the with Garlic Extract above two products taken together would lower blood pressure.

Odorless Garlic Waukegan,IL The employee referred me to cod liver oil, fish oil, and garlic. The Cod Liver Oil employee referred to fres,dplion f oc Nutritional Healing, under Fish Oil "High Blood Pressure," which listed garlic for prescribed use. They

also said garlic would lower cholesterol.

Coenzyme QlO and Creve Coeur, MO The employee pointed out various herbal diuretic products. She various herbal picked out a book, fres,aptioo (Qr Nutdtiooal Healing, discussing diuretic products herbal medications which contained references to the use of various

herbs in treating high blood pressure. The employee pointed out the use of Coenzyme Q 10 in treating the disease. Sh~ said that her store stocked Coenzyme Q 10 and was even having a current sale on the product. She remarked that the book was very good and useful. She stressed that it was written by a pb~si,ian.


Michael's HBP Houston, TX The employee stated that the Michael's Food Supplement tablets Vitamin & Mineral would reduce high blood pressure. Also said that the letters "HBP" Food Supplement stood for high blood pressure. The primary nutrients, including

Garlic, Hawthorn Berries, Calcium, Cayenne, Vitamin B6, Valerian Root, and L-Taurine, in combination, would lower high blood pressure, and then she showed me that the Michael's HBP tablets contained that exact combination of nutrients.

Golden Seal Buffalo, NY The employee recommended the use of Golden Seal as a "natural" Garlic way to lower high blood pressure without added alcohol, sodium, or Cayenne chemicals. She stated it was her "best" product, and assured me that Passion Flower customers who have used it found it acted beneficially, not only for

high blood pressure problems, but diabetes, stress and cholesterol concerns as well. She further documented this by ref erring to several books that she had on hand. After stating I was pregnant, I showed her the warning on the label that stated not to use Golden Seal during pregnancy. She then directed me toward the processed garlic area-which was her "best" alternative.

Kyolic Aged Extract Warwick, RI The employee responded: "Some of my customers have had good Powder Capsules results with Kyolic." She said she had some literature associated

with it. She responded that some herbs might be ~elpful and offered a book on herbal health.

Niacin Sustained- Knoxville, TN The pharmacist indicated that some doctors recommend that their Release Tablets patients purchase and use niacin, primarily for cholesterol.


No specific product Knoxville, TN The owner began to ask the normal ranges of my systolic and recommended, diastolic, how long had I had the condition, an~ what I was talcing for referenced reading it. At first he did a hard sell on a juice-making machine that he material apparently sold. I told him that I was interested in a supplement that

might help me. He stated that many of his customers tell him that certain supplements have helped them but, since he did not know what caused my high blood pressure, he could not recommend anything specific. He informed me that there were two physicians that I could see who treat patients using nutrition. He indicated that he would be glad to sell me whatever they recommended for use in treating my condition.

No specific product Warwick, RI The employee referenced a book: Prescription for Nutritional recommended, Healin,:. Jie looked up and pointed out the products listed therein for referenced reading high blood pressure. These were generally minerals, amino acids, material and related items. Specifically listed were calcium and magnesium

supplements,. L-Camitine, Co-enzyme Q 10, garlic, and others. All were for use as dietary supplements.

Processed Garlic Buffalo, NY The employee was very vague. She mentioned that a better diet, including cutting out the fat, would be a good alternative. She recommended the use of garlic, but said adding it to your meals everyday is a less expensive way to do it. We referred to some of the alternative remedy books she had and most of them mentioned the use of diuretics, lowering sodium iniake, and exercising.


Carnitine Cincinnati, OH The employee suggested three products and referred to a pamphlet Selenium for suggested products. Garlic

CoQlO Cincinnati, OH The employee gave very brief explanations and just suggested buying Camitine all products. Gave me literature to evaluate. Selenium Garlic

B/P Herbal Food Bismark, ND The owner directed me to Nature's Way B/P Herbal Food Formula. Formula He said the ingredients in this product help the immune system, it's

Garlic Tablets good for the heart, and it reduces blood pressure. He also mentioned that garlic capsules were good, but this product (B/P) was better.

Garlic & cayenne Bismark, ND I asked why garlic works, and the employee responded by saying it Coenzyme Q 10 was good for the heart and that it helps lower blood pressure and it Calcium, magnesium improves the immune system, which helps fights colds; you get

fewer colds. She also said garlic is nature's antibiotic. I asked how long would my father have to take this product, holding a bottle of the Coenzyme Q 10 in my hand, and her response was, "forever".

Coenzyme Ql0 Tukwila, WA The employee stated that they carried approximately four brands of CoQ 10. He said the only difference was the num~er of milligrams and price. He suggested the brand I purchased because "l 0-30 mg was enough". He also brought out a book and stated, "if you're going to use this product all the information on it is in the book".

00 0

Pressur-LO

CoQl0 (Coenzyme QlO)

Magnesium/Calcium tablets

Garlicin (Odor Free Garlic Supplement)


Benton, WA The employee stated that they had heard of good results with the use of garlic and cayenne pepper. Also with the use of Hawthorn Berry. She recommended Pressur-LO because it had all three, plus vitamins and minerals.

Houston, TX The owner of the store stated the product would reduce blood pressure. Since the label did not specifically state that it would reduce blood pressure I asked how she knew this. At that point she brought me four pieces of literature. Additionally, she verbally stated the product would aid my immune system and help the heart.

Indianapolis, IN The owner showed me a book entitled Prescription for Nutritional Healing. She pointed out a list of nutrients that I should talce. She further instructed me to read an article on calcium and one on magnesium. She stated that she had a calcium/magnesium combination product. She went to the shelf and obtained the product for me. She explained that she teaches customers the uses of the various supplements for many illnesses and diseases. She stated I should come in on a routine basis and bring a notebook so she could teach me how to use the supplements that would help my high blood pressure.

Indianapolis, IN The employee gave me a package of garlic tablets-. She stated this was the only product she had for high blood pressure. She provided a leaflet entitled "Garlicin Brand Garlic Supplement".

00 -

DIETARY SUPPLEMENT SURVEY "I AM FEELING KIND OF WEAK, DO YOU HA VE

ANYTHING TO HELP FIGHT INFECTION OR HELP MY IMMUNE SYSTEM?"

PRODUCTS CITY/STATE ORAL CLAIMS RECOMMENDED

Immunaid Ocean Springs, The employee stated product was an herbal complex that would boost the MS immune system. Store worker also stated she was trained in the use of

herbs and macrobiotics and gave verbal assurance that this herbal complex would boost the immune system.

Echinacea Root Kansas City, MO The employee stated Chinese Red Ginseng would strengthen the immune Chinese Red Ginseng system and that 155 Shou Wu Chi from China would both strengthen 155 Shoo Wu Chi immune system and fight infection. He stated he was recently bitten by a

brown recluse spider, which caused him great pain, but he took the Echinacea Root product and believed it enhanced his healing process.

Products containing: Prairie Village, KS The employee recommended CFI Herbal Remedy, stating that Echinacea Root, ingredients Echinacea Root and Golden Seal together really help to Golden Seal, strengthen the immune system. The employee also recommended book Licorice, & Prescription for Nutritional Healing and stated that licorice would Burdock Root strengthen the adrenal glands and help strengthen the immune system.

Immuno-Comp Grand Rapids, MI The employee indicated all of the products would increase immune Immuno-plex system response during periods of stress. Written infoanational literature Ginseng on these products included product catalogues touting Echinacea Myrrh Vitamin A Blend as "providing nutrients that may be needed by people suffering Astragalus from fever or infection". Echinacea herb Garlic

00 N



Echinacea DeWitt, NY The "doctor" at the store recommended Echinacea, providing separate written directions on how to take (different from those labeled on product), and stated product would strengthen immune system.

Health Guard with North Syracuse, NY The employee recommended first product over the others stating it had Echinacea additional ingredients that would help the immune system. Clerk

Aces (Vitamins A, C, E & provided copy of page from Herbs to Know book, which discusses the Selenium) effect of Echinacea on blood and lymph systems.

Echinacea with Astragalus & Reishi

L-Cysteine Columbia, MD The employee stated no literature accompanies the products, but made L-Methionine reference for information on how products are used for illness to book Garlic entitled Prescription for Nutritional Healing (available for sale at the

store). This book notes that L-Cysteine & L-methionine "destroys free radicals and viruses. Protects the glands, especially the liver".

Echinacea Parkville, MD The employee referred to books Prescription for Nutritional Healin,: and Golden Seal Root The Vitamin Herb Guide (both available at store). The Vitamin Herb Natural Lecithin Guide, under heading "Immune Deficiency", contains the herbal Lyophilized Liver combination "EchinaGuard" and notes the physiologic actions: stimulates

the immune response systems. Especially helpful in rebuilding the body during convalescence and as a preventative.

Immune Action South Plain- The employee identified this and other products as "immune boosters" field, NJ and recommended this product as best, stating it was used by cancer

patients.



Cell Protector Carolina, PR Employee emphatically recommended "Cell Protector" product but no Health Guard (contains literature available.

Echinacea)

Immune Force Bayamon, PR No contact with employee. Handwritten labels for all dietary Echinacea tabs/tonic supplements on display listing medical uses for each one. Most blatant Lactoferon label for immune system products was for Lactoferon colostrum tablets,

which states "Rich in Immune Agents".

Echinacea N. Olmsted, OH The employee recommended Echinacea and Gold Seal for building up Gold Seal immune system. The employee also discussed Thymuplex, stating it was Thymuplex for use over a long period of time and was good for keeping the immune

system strong and to prevent allergies.

Resistance Cambridge, MA The employee recommended Resistance Formula as an immune booster, Formula/Pioneer indicating it was good for this use because it was herbal based. The

Vitamin C employee also provided copies of pages from book Prescription for Nutritional H~alin& discussing benefits of herbs for immune system.

Multivitamin with Davenport, IA The employee recommended these two products, stating that the Echinacea Echinacea/Golden Seal product would be better. She said she used to get

Echinacea/Golden Seal sick but now uses this product and no longer gets sick. .

DIBTARY SUPPLEMENT SURVEY "I AM FEELING KIND OF WEAK, DO YOU HA VE


PCM-U Ft. Lauderdale, FL The employee stated that Thymu-Plex has raw thymus, which releases Siberian Ginseng additional cells in the thymus to help fight infection more effectively. ThymuPlex Employee also said product contains Echinacea and Golden Seal root

extracts, which are known to kill bacteria and help fight off infections. One PCM-U employee stated this is a new product being studied and looks promising for treatment of AIDS.

L-Lysine Milwaukee, WI The employee described L-Lysine as a good immune system booster.

Antioxidant tablets Greenburg, NY The employee stated antioxidants are best product to improve immune system because they bind up free radicals in the body.

Hypoglycemia Baltimore, MD No contact with employee. Indications for use on bottle label include: sudden drain of energy, weakness, nervous exhaustion, spaciness, fatigue, and poor concentration.

ImmunAid Little Rock, AR The employee recommended ImmunAid and LymphAid but made no LymphAid verbal claims. However, literature next to products stated ImmunAid had

herbs traditionally used to build the body's natural resistance and LymphAid had herbs that were used to promote the flow of lymph, eliminate toxins, and relieve swollen glands.

Cell Guard Hot Springs, AR Store owner recommended several vitamins to help immune system (A, Milk thistle C, E) and Echinacea. She said milk thistle and kelp would help in Kelp digestion so that the body could eliminate all waste products more

efficiently. Cell Guard was recommended as an antioxidant needed in all ..

illness.

00 VI



Echinacea Myrrh Blend Mundelein, IL The employee stated Echinacea is good for fighting infection and helping to boost the immune system and provided pamphlet entitled "The Biochemic Way to Health and Fitness."

Anti-Oxidants Lawndale, CA Store owner stated antioxidants are need to decrease free radicals in the body and build the immune system.

CoQlO Lomita, CA Store owner stated that CoQ 10 in this concentration (30 mg) is good for the immune system; it works at the cellular level to fight infection and is good for T cells.

-Cell Defense Ft. Lauderdale, FL Store "nutritionist" highly recommended Formula X 11, stating it had all CoQl0 the antioxidants needed to fight infections and also contains n-acetyl-Formula XII cysteine, which has been found to stop the spread of AIDS cells in the

body, plus Chinese herbs found to be effective against colds and bronchitis. Nutritionist said Cell Defense product fights infection at the cellular level and CoQ 10 has antioxidants needed for the immune system.

Multi-Nutrients N. Olmsted, OH The employee stated, "We really can't recommend anything. The FDA Multi-Anti-Oxidant doesn't allow us to." She proceeded to pull a book out from under the

Vitamin Preparation counter and told me to read several sections -one on fatigue and one on the weakened immune system. The book was Prescription for Nutritional H~alin,:. She also recommended a multi-antioxidant vitamin preparation.

Centrum brand Davenport, IO The employee suggested a good multivitamin; he also pointed out zinc. multivitamins

00

°'



Echinacea San Francisco, CA The employee said that herbs were better than vitamins for building Siberian Ginseng immunity, and suggested that Siberian Ginseng and Echinacea herbs

were thought to be good, but also stated that he was not allowed to recommend any specific product

I asked the employee what the store had available for immune-compromised individuals, and he recommended I contact a Chinese doctor. He said that he refers many customers with HIV concerns to a Chinese herbalist, and he provided the name and telephone number of the herbalist.

Hydrogen peroxide Berkeley, CA The employee stated she has videotapes on AIDS therapies. The Magnesium peroxide salesperson showed me a bottle of Earth's Bounty brand Oxy-Cleanse Echinacea herb magnesium peroxide, containing 90- to 600-mg capsules of magnesium Superoxy Plus peroxide. She said it was new product that some people use.

The employee said the Superoxy Plus was commonly used for AIDS patients, also that hydrogen peroxide could be purchased from a drugstore and used in a bath to "remove toxins". Salesperson told me ozone and hydrogen peroxide therapy is commonly being used to treat HIV positive people.

T-Hypo Midvale, UT The employee asked if I was tired all the time and stated it sounded like an adrenal problem, although it might be diabetes. She recommended T-Hypo, stating it would provide continuous energy throughout the day.

00 --.J



Ginsa-Max (ginseng Salt Lake City, UT The employee stated ginseng is proven to give energy and build up the extract) immune system, and helps prevent colds and flu. She stated that no

matter what the cause, ginseng will restore energy levels and you will be a healthier person. The employee also ref erred to a book entitled Prescrintion for Nutritional Healing.

Coenzyme QlO Chicago, IL The store manager recommended taking garlic for the immune system, Garlic stating that it works well and helps naturally to fight infection, working

like penicillin. The manager also recommended/ref erred to the book Prescrintion for Nutritional Healing and pages in book on garlic and the immune system.

Coenzyme QlO Cambridge, MA The employee recommended Coenzyme Q 10. Stated if something Echinacea cheaper was wanted he'd recommend a product with echinacea herb or Vitamin C vitamin C. He stated QlO is the best supplement for the immune system.

Imu-Comp Decatur, GA The employee recommended all products as good for boosting immune Wellness Formula system, but highly recommended the Immuno-Quest product, stating it · Imu-Stimu even works best with the Imu-Stimu product. Immuno-Quest Nutrient

Formula

Echinacea Decatur, GA The employee provided a brochure, highlighting these products as good Golden Seal Root for the immune system, but made no specific verbal claims. Immune Maintenance Imm-C

00 00



Immune-Action Grandville, MI The employee recommended these products to increase immune system's Echinaf orce efficiency by increasing the body's immune response during periods of Ginseng high stress. Garlic Echinacea herb Astragalus Vitamin A

Priority 1-Biotic Eugene, OR The employee pointed out three shelves of products to boost the immune Priority 1-Immune system, recommending these three particular products. Worker stated Vita-Biotic Vita-Biotic works especially well to help heal the immune system if

you're sick.

Advanced Antioxidant Portland, OR The employee recommended antioxidants for boosting the immune Formula with S.O.D. system as well as milk thistle. The employee looked up CoQ 10 in the Inducers and book Prescription for Nutritional Healin1: and also recommended it for Proanthocyanidin boosting the immune system. Complex

Milk Thistle CoQlO

EchinaGuard Nashville, TN The employee identified this product as the best choice·for a boost to the immune system. She said the product was actually a mild antibiotic, although it contained a high amount of alcohol. The employee also referenced several books relating to herbs which made direct claims for specific herbs to cure diseases.

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Michael's I.M. Immuno Nashville, TN The employee recommended the Michael's I.M. for boosting the immune Protector system and provided a book entitled The Art of Self Healing which

references AIDS, arthritis, cancer, and pellagra in the "Immune System" section as being affected by specific immune system herbs. A handwritten notation of "I.M." was beside the section title which the clerk identified as ref erring to the subject product.

Coenzyme QlO Cambridge, MA The employee directed me to the QI 0. He said if he was to talce any one Echinacea supplement, it would be QIO. He also suggested QIO was expensive so Vitamin C if I wanted something cheaper, to go with a product with echinacea herb.

He stated QlO is the best supplement for the immune system.

The Immunizer Pale Kenner, LA The store owner stated this product would help boost the immune system to keep persons from getting sick and would provide lots of energy.

\0 0

PRODUCTS RECOMMENDED

Colonic Rinse Blood Cleanser

Antioxidants

Gennanium

DIETARY SUPPLEMENT SURVEY "DO YOU HA VE ANYTHING THAT WORKS ON CANCER?~'

CITY/STATE ORAL CLAIMS

Pearl City, HI The employee stated that the product would cleanse the vital organs: the liver, kidneys and colon. The product prevents and cures cancer. According to him, the feces would initially sink for the first couple of weeks and then start to float. When about 70 percent floated, it meant that the organs had been cleaned and that I was healthy.

Albuquerque, NM The employee stated you won't see anything on the labeling but the antioxidants work well. She also told me to read a chapter in the book Prescription for Nutritional Healin1: called "Cancer," and try the products it recommends. (NOTE: Doctor testimonial on label mentions cancer.)

Springfield, IL The employee had a copy of a book entitled Germanium-The Health and Life Enhancer, which he directed me to read. The book discussed the product's usefulness in the treatment of lung cancer, Hodgkin's disease, and ovarian cancer. During the discussion, the employee stated that he had personally heard of cancer patients who received beneficial results from the drug. Neither he nor the book gave a recommended dosage; he stated that the proper dosage would have to be determined on a person-by-person basis.

DIETARY SUPPLEMENT SURVEY "DO YOU HA VE ANYTHING THAT WORKS ON CANCER?"

Shark cartilage Raleigh, NC The store owner highly recommended the shark cartilage capsules, stating Venus fly trap that the product cures cancer by not allowing the cancerous cells to receive PCM-4 any blood. Also stated one man saw benefits from relief of his arthritis. Siberian ginseng Shark cartilage is also suggested for the cure of rheumatoid arthritis, other natural herbs psoriasis, enteritis, glaucoma, and blindness. Store owner also stated that

"Siberian ginseng" will cure cancer, and stated, "Red clover will cure cancer, but I'm not supposed to tell you that." The store owner also advocated the use of carnivora, a variety of venus fly trap, and said, "FDA will no longer allow this to be marketed," and offered to phone Germany and place an order for me.

Ecomer Alkyglycerols Kansas City, KS The employee recommended Shark Cartilage Tablets, stating he had videos Shark cartilage (all out on loan) explaining product's effect. He next recommended the

alkyglycerols, providing literature on the product.

Hathaway's Diet Plan Merriam, KS The employee stated biggest problem with cancer is weight loss and so recommended Hathaway's Diet Plan, identifying product as a food supplement that helped build her father (suffering from cancer) back up.

Cartilade New Orleans, LA Store owner stated cartilade is being used for cancer and that studies are currently being done on its benefits. Stated product constricts the new blood vessels forming around the tumor, thereby "starving" the tumor.

Shark Cartilage Raleigh, NC Product located on shelf with handwritten sign stating that sharks don't get cancer. Employee referred to various articles on shark cartilage/cancer under sales counter.


Bee Propolis Albuquerque, NM The employee recommended antioxidants and bee propolis for cancer, stating she heard both were able to help cancer patients. A booklet displayed near the products entitled Propolis; Nature's Energizer contains a testimonial for controlling cancer with propolis.

Shark cartilage with Oklahoma City, OK The employee gave testimonial about a recent customer with prostate cancer Reishi Mushroom who took the recommended products. Customer returned to the store about

Pau D'Arcoffaheebo Tea 60 days later and told employee doctors could no longer find any trace of Red Clover cancer. Clerk also recommended drinking lots of "purified water". LBS II Vegitabs P-X&SUMA

Combination

Jason Winters Herbal Tea Libertyville, IL The employee was asked what works on cancer and ref erred to these two Jason Winters Herbal products, noting that it all helps. He further added that Pau D'Arco was an

Tablets extra alternative for cancer. When asked for literature, clerk referred to bookt The Jason Winters Stmy by J. Winters, which contains a reference to red clover in tea as a remedy for cancer.

Anamu-Llanten caps or Rio Piedras, PR Employee recommended these products for cancer treatment, especially extract Anamu-Llanton. Employee stated that Co Q removes malignant and sick

Co Q Enzyme caps cells. Pau D'Arco (Lapacho)

caps/extract

Pau D'Arco (Lapacho Tea)

Lion Teeth

Radical Fighter Capsules Cartilade Shark Cartilage

Capsules

Antioxidants

Antioxidants


San Juan, PR Employee stated that although there are no products available to "cure" cancer, some are available that could help patients and recommended Pau D'Arco and Lion Tee~. In regard to literature, book entitled Prescription for Natural Healing was recommended which cites Pau D'Arco as good as an alternative treatment for cancer.

Oklahoma City, OK Employee recommended Radical Fighters to help strengthen the immune system. He provided a copy of a one-page leaflet titled "Protect Yourself' and a magazine titled Better Nutrition. He then recommended Cartilade and said the product was achieving results in the protection of cartilage. He provided a one-page leaflet titled "Some Basic Facts About Cartilade. 11

Creve Coeur, MO

Creve Coeur, MO

Employee said literature was unavailable because of FDA, but said the antioxidant products are good for cancer prevention. She responded that for breast cancer prevention she recommended the Super C, E, and Carotene combination product.

The employee stated he wasn't sure. Label stated that " ... Studies indicate that exposure of our bodies to certain conditions ... can cause the generation of free radicals (oxidants) that may be responsible for cellular damage. . . . Vitamin E is a protector and helps prevent damage to the cells in our bodies .... " The labeling also discusses the effectiveness of vitamins C, E, and Beta Carotene as antioxidant nutrients that can ·provide protection. In response to questions, the employee said he wasn't sure if the product was effective in preventing cancer.


Aloe Vera Juice Studio City, CA Employee said Aloe Vera Juice and Carinova worked on cancer. She said Carinova some people take Power Mushrooms for cancer, but mostly for AIDS. Power Mushrooms

BLD Blood Cleanser Dearborn, Ml Employee said BLD cured two cysts in her breasts. She recommended Shark Cartilage shark cartilage to prevent cancer. A display said it was a "New Weapon

Against Cancer". She also recommended Prescription for Nutritional Healing, a book by James Balch, M.D.

Honey Suckle Crystals Shennan Oaks, CA Employee said honeysuckle tea would cure cancer, and showed the label with the claim. In response to a request for tablets, she produced a bottle with no English writing. The insert claims were different from the tea, but she insisted that the product was the same. The two proprietors, male and fem ale, offered to treat the patient for cancer. When the customer returned to buy the tea, the female said it was illegal to say that the product would definitely cure cancer.

Kal·Multi Harper Woods, MI Employee said he would not tell what _specific products would work on ( 4 multivitamin) cancer, and showed the customer the book Prescription for Nutritional

Co-EnzymeQlO (Co-QlO) Healing. He referred to the section in the book titled "Cancer," and showed Shark Cartilage the customer where the store had the products listed in the section. He said

CoQlO was one of the better products. He said the vitamin product contained most of the vitamins recommended in this section of the book. He recommended the shark product and said he was surprised it was not in the book, and said the book Shru:ks Don't Get Cancer was temporarily out of stock. He recommended talking to a doctor about taking the multivitamins.


Shark Cartilage Louisville, KY The owner's husband said that shark cartilage is the only product on the market that would prevent cancer. He was unsure if it would cure it. He recommended one tablet three times daily.

Beta Carotene Louisville, KY Employee said Beta Carotene will prevent, but not cure, cancer. She said it Co-EnzymeQlO (Co-Q 10) would destroy "Free Radicals," atoms that have either too many protons or Beta Carotene Juice electrons. She relied on the book Prescription for Nutritional Healing by Garlic James Balch, pages 120-121.

Co-EnzymeQlO (Co-Ql0) Casselberry, FL Employee recommended Co-Ql0, beta carotene, and barley green for cancer Beta Carotene prevention. She said she could not explain how they worked because that Barley Green would constitute illegal prescribing, and instead recommended books sold in

the storefront. She said Co-Q 10 was too strong for cancer prevention, but was for people who actually had cancer.

Advanced Shark Cartilage Raleigh, NC A handwritten sign by the shark product said "Sharks don't get cancer". After a request for literature, the employee allowed the customer to choose from pamphlets available under the counter, and reviewed the book with the customer.

The Atkins Center Anti- Scotia,NY Employee recommended a book with a cancer section that recommended Oxidants antioxidants. When the customer asked where to find such products, the

employee pointed out The Atkins Center Anti-Oxidant product. A brochure on the product was also available.


Advanced Shark Cartilage Roanoke, VA Employee made no verbal claims but the store sold a book called Sharks Don't Get Cancer. The employee told the customer that the store did carry the shark cartilage product, and recommended a copy of the store's July magazine, which lists products and their indications related to cancer prevention and treatment.

Essaic Tonic Virginia Beach, VA Employee recommended these products and provided literature from the Shark Cartilage back of the store to accompany it. The literature for the Essaic Tonic

included claims to cure cancer, AIDS, thyroid conditions, diabetes, ulcers, and common colds. He also recommended the book Sharks Don't Get Cancer for cancer tumors, and The Cancer Answer and The Cayce Encyclopedia. The employee said the essaic mixture could be made at home from ingredients sold in the store, but the tonic was stronger. He recommended 4 tablespoons two times daily.

Biochem Formula XI Rocky Hill, CT The employee was not sure so he called his son who works at another health PROSTA-MAX food store. He recommended using Saw Palmetto berries in combination

with vitamins. He showed me the Biochem Formula XI Prosta-Max product.

MAXI-PROS PLUS Bloomfield, CT The employee claimed that this was the "hottest" thing out in the market for prostate problems. He claimed that the "Saw Palmetto berries" were the key ingredient.

No specific product Pittsburgh, PA Employees declined to provide advice except to recommend book. recommended, referenced reading material.


No specific product Greensburg, PA The employee ref erred me to Nutrition magazine with article specifically recommended, about "surviving cancer." referenced reading material.

No Claim Greensburg, PA Employee said she could not recommend specific products for cancer.

No specific product Aiea, HI Employee said he was not a doctor and recommended that the customer recommended, browse through the book section for advice. referenced reading material.

No Claim Orlando, FL Drugstore employee said some products make all kinds of claims, but she ref used to make verbal claims.

Jason Winters Her}?al Tea Libertyville, IL Employee referred me to Jason Winters Tea and herbal tablets. I asked if Jason Winters Herbal those products would cure or treat cancer. Employee said, "it all works."

Tablets

Co-EnzymeQI0 Tempe,AZ Employee referred me to the book Prescription for Nutritional Healin&. Superoxide dismutase Employee also said I should get either coenzyme QIO, SOD or germanium.

(SOD) Gennanium

No specific product Tempe,AZ Employee said they could not prescribe anything-however, handed me the recommended, book Prescription for Nutritional Healing. referenced reading material.

\0 00

Oxy-Quenchers

Advanced Shark Cartilage Extract

Mega-Zyme

Preventive Beta Carotene Shark Cartilage


Metairie, LA The owner stated that the product she recommended was all of the antioxidants combined in one caplet. These antioxidants combat free radicals that cause cancer. Owner opened bottle because it was the last one on the shelf and she wanted to smell it to make sure it was not old.

Schenectady, NY Employee stated they had a new product, shark cartilage, and provided literature.

Schenectady, NY Employee gave me two brochures to read re: "cancer": Prescription for Nutritional Healint: and The Vitamin Herb Guide. I was asked what type of cancer I was referring to and I replied "pancreas". With that, the product recommended was "Mega-Zyme", which he stated contained a "pancreatic enzyme".

Seattle, WA Employee recommended Beta Carotene. Employee also recommended shark cartilage, and said she had heard of cases where it had caused cancer to go into remission. She pointed out that it was proven that sharks do not get cancer.

\0 \0

Flora Herbal Tea Blend


Kent, WA The employee stated that there were other products; however, she would recommend the tea over anything else. She explained that it was proven to work and referred to "testimonials" inside the Well Being Journal referring to people who had been cured of cancer using the tea. I told her that I had throat cancer and she recommended that I gargle the tea before swallowing it. She warned of side effects-for example, she broke out with acne because the tea was getting rid of toxin~ in her body. She continued to explain that the tea was underground for some time, but it had just started to come out again; but it would probably go underground again soon. When asked how long I should take it, she replied until it clears up and then another two or three months; in fact she would probably never stop taking it.

•

Illn~es and Injuries Associated With the Use of Selected Dietary Supplements

Products marketed as "dietary supplements" include a diverse range of products, from traditional nutrients, such as vitamins or minerals, to such substances as high-potency free amino acids, botanicals, enzymes, animal extracts, and bioflavanoids that often have no scientifically recognized role in nutrition.

There is cwrently no systematic evaluation of the safety of products marketed as dietary supplements. Dietary supplements routinely enter the marketplace without undergoing a safety review by FDA. Published studies on the safety of these products are extremely sparse. There is no systematic oollection and review of adverse reaction reports for dietary supplements, as there is for drugs, and physicians rarely seek information about their patients' use of dietary supplements. Despite the lack of any system for gaining information about the risks of dietary supplements, an inaeased number of reports of adverse reactions to dietary supplement products has recently been recognized. Because of concern about these products, FDA has, in the last year, initiated an effort to collect and evaluate existing studies and case reports on safety problems associated with dietary supplements. As a result of that effort, FDA has begun to identify dietary supplements for which serious adverse reactions have been documented. A list of selected dietary supplements associated with serious safety problems follows. This list is not intended to include all hazardous ingredients in dietary supplements.

LHerbals Herbal and other botanical ingredients of dietary

supplements include processed or tmprocessed plant parts (bark, leaves, flowers, fruits, and stems), as well as extracts and essential oils. They are available in a variety of

forms, including water infusions (teas), powders, tablets, capsules, and elixirs, and may be marketed as single substances or in oombination with other materials, such a~ vitamins, minerals, amino acids, and non-nutrient ingredients. Although data on the availability, consumer use, and health effects of herbals are very limited, some herbal ingredients have been associated with serious adverse health effects.

A. Chapan-al (Larrea tridentata) Chaparral, commonly called the creosote bush, is a

desert shrub with a long history of use as a traditional medicine by Native Americans. Chaparral is marketed a~ a tea, as well as in tablet, capsule, and concentrated extract form, and has been promoted as a natural antioxidant "blood pwifier," cancer cure, and acne treatment At lea'it six cases (five in the United States and one in Canada) of acute non-viral hepatitis (rapidly developing liver damage) have been associated with the consumption of chaparral as a dietary supplement Additional cases have been reported and are tmder investigation. In the majority of the ca~ reported thus far, the injury to the liver resolves over time, after discontinuation of the product In at leac;t two patients, however, there is evidence that chaparral consumption caused irreversible liver damage. One patient suffered terminal liver failure requiring liver tram,'J)lant

Most of these cases are associated with the consumption of single ingredient chaparral capsules or tablets; however, a few of the more recent cases appear to be a~ociated with oonsumption of multi-ingredient producLc; (capsules, tablets or teas) that oontain chaparral as one ingredient Chemical analyses have identified no contaminanL" in the products associated with the cases of hepatitis. Prod-

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ucts from at least four different distributors and from at least two different sources have been implicated thus far.

After FDA' s health warning, many distributors of chaparral products voluntarily removed the products from the market in December of 1992. Some chaparral products remain on the madcet, however, and other distributors who removed their products from the market are seeking to clarify the stab.ls of these products.

B. Comfrey (Symphytum o.fficinale (common comfrey), S. asperum (prickly comfrey), or S. X uplandicum (Russian comfrey))

Preparations of comfrey, a fast-growing leafy plant, are widely sold in the United States as teas, tablets, capsules, tinctures, medicinal poultices, and lotions. Since 1985, at least seven cases of hepatic veno-occlusive disease-obstruction of blood flow from the liver with potential scarring (cirrbosis)-including one death, have been associated with the use of commercially available oral comfrey products.

Comfrey, like a number of other plants (e.g., Senecio species), contains pyrrolizidine alkaloids. The toxicity of pyrrolizidine aJkaloids to humans is well-docmnented. Hepatic veno-occlusive disease, following ingestion of pyrrolizidine alkaloid-containing products, has been documented repeatedly throughout the world. Hepatic venoocclusive disease is usually acute and may result in fatal liver failure. In less severe cases, liver disease may progress to a subacute form. Even after apparent recovery, chronic liver disease, including cilThosis, has been noted. Individuals who ingest small amounts of pynolizidine alkaloids for a prolonged period may also be at risk for development of hepatic cirrhosis. The diagnosis of pynolizidine alkaloid-induced hepatic veno-occlusive ~ is complex, and the condition is probably llllderdiagnosed.

The degree of injury caused by pyrrolizidine alkaloidcontaining plants, like comfrey, is probably influenced by such factors as the age of the user, body mass, gender, and hepatic function, as well the total cumulative dose ingested and the type of exposure (i.e., whether exposure was to leaves or roots, infusions or capsules). Infants in general appear to be particularly susceptible to adverse effects of exposure to pyrrolizidine alkaloids; there are reports of infants developing hepatic veno-occlusive ~ following aaite exposure of less than one week. Transplacental pynolizidine poisoning bas been suggested by the occurrence of hepatic disease in the newborn infant of a woman who consumed herbal tea during pregnancy.

Although liver damage is the major documented fonn of injury to hwnans from pyrrolizidine alkaloid-containing herbals, animal studies suggest that their toxicity is much broader. Animals exposed to pynolizidine alkaloids have developed a wide range of pulmonary, kidney and gastrointestinal pathologies. Pyrrolizidine alkaloid-containing plants, including comfrey, have also been shown to cause cancer in laboratory animals.

Four countries (the United Kingdom, Australia, Canada, and Germany) have recently restricted the availability of products containing comfrey, and other countries permit use of comfrey only under a physician's prescription.

C. Yohimbe (Pausinystalia yohimbe) Yohimbe is a tree bark containing a variety of phanna

cologically active chemicals. It is marketed in a nwnber of products for body building and "enhanced male performance." Serious adverse effects, including renal failure, seizures and death, have been reported to FDA with products containing yohimbe and are currently under investigation.

The major identified alkaloid in yohimbe is yohimbine, a chemical that causes vasoclilation, thereby lowering blood pressure. Yohimbine is also a presaiption drug in the United States. Side effects are well recognized and may include central nervous system stimulation that causes anxiety attacks. At high doses, yohimbine is a monoamine oxidase (MAO) inhibitor. MAO inhibitors can cause serious adverse effects when taken concomitantly with tyramine-containing foods (e.g., liver, cheeses, red wine) or with over-the-counter (OTC) products containing phenylpropanolamine, such as nasal decongestants and diet aids. Individuals talcing yohimbe should be warned to rigorously avoid these foods and OTC products because of the increased likelihood of adverse effects.

Yohimbe should also be avoided by individuals with hypotension (low blood pressure), diabetes, and heart, liver or kidney disease. Symptoms of ovenlosage include weakness and nervous stimulation followed by paralysis, fatigue, stomach disonlers, and ultimately death.

D. Lobelia (Lobelia injlata) Lobelia, also lmown as Indian tobacco, contains

pyridine-derived alkaloids. primarily lobeline. These alkaloids have pharmacological actions similar to, although less potent than, nicotine. There have been several reported cases of adverse reactions associated with con-

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sumption of dietary supplements containing lobelia. Depending on the dose, lobeline can cause either auto

nomic nervous system stimulation or depression. At low doses, it produces bronchial dilation and inaeased respiratory rate. Higher doses result in respiratory depression, as well as sweating, rapid heart rate, hypotension, and even coma and death. As little as 50 milligrams of dried belb or a single milliliter of lobelia tincture has caused these reactions.

Because of its similarity to nicotine, lobelia may be dangerous to susceptible populations, including children, pregnant women, and individuals with cardiac disease. Lobelia is nevertheless folllld in dietary supplement products that are marketed for use by children and infants, pregnant women, and smokers.

E. Germander (Teucrium genus) Germander is the common name for a group of plants

that are contained in medicinal teas, elixirs and capsules or tablets, either singly or in combination with other herbs, and marketed for the treatment of obesity and to facilitate weight loss.

Since 1986, at least 27 C$e8 of acute nonviral hepatitis (liver disease), including one death, have been associated with the use of commercially available germander products in France. These cases show a clear temporal relationship between ingestion of germander and onset of hepatitis, as well as the resolution of symptoms when the use of germander was stopped. In 12 cases, re-administration of germander was followed by prompt recwrence of hepatitis. Recovery occurred gradually in most cases, approximately two to six months after withdrawal of germander. Analyses of these cases does not indicate a strong relationship between the dosage or duration of ingestion and the occmrence of hepatitis.

Although the constituent in germander responsible for its hepatic toxicity bas not been identified, germander contaim several chemicals, including polyphenols, tannins, diterpenoids, and tlavonoids.

On the basis of the 27 French hepatitis cases, the French Ministry of Health bas forbidden the use of germander in drugs. Its use bas been restricted in other COlllltries.

F. Willow Bark (Salix species) Willow bark bas long been used for its analgesic (pain

killing), antirheumatic, and antipyretic (fever-reducing) properties. Willow bade is widely promoted as an "aspirin-

free" analgesic, including in dietary supplement products for children. Because it shares the same chemical properties and the same adverse effects as aspirin, this claim is highly misleading. The "aspirin-free" claim is particularly dangerous on products marketed, without warning labels, for use by children and other aspirin-sensitive individuals.

The pharmacologically active component in willow bark is "salicin," a compound that is converted to salicylic acid by the body after ingestion. Both willow bark and aspirin are salicylates, a c~ of compounds that work by virtue of their salicylic acid content. Aspirin (acetylsalicylic acid) is also converted to salicylic acid after ingestion.

All salicylates share substantially the same side effects. The major adverse effects include irritation of the gastric mucosa (a particular bai.ard to individuals with ulcer disease), adverse effects when used during pregnancy (including stillbirth, bleeding, prolonged gestation and labor, and low-birth-weight infants), stroke, and adverse effects in children with fever and dehydration. Children with influema or chickenpox should avoid salicylates because their use, even in small doses, is associated with development of Reye syndrome, which is characterized by severe, sometimes fatal, liver injury. Salicylate intoxication (headache, dizziness, ringing in ears, difficulty hearing, dimn~s of vision, confusion, lassitude, drow~iiness, sweating, hyperventilation, nausea, vomiting, and central nervous system disturbances in severe cases) may occur as the result of over-medication, or kidney or liver insufficiency. Hypersensitivity, manifested by itching, bronchospa.w and localized swelling ( which may be life-threatening), can occur with very small doses of salicylates, and may occur even in those without a prior history of sensitivity to salicylates. Approximately 5 percent of the population is hypersensitive to salicylates.

G. Jin Bu Ruan Jin Bu Huan is a Chinese herbal product whose label

claims that it is good for "insomnia due to pain," ulcer, "stomachic [sic] neuralgia, pain in shrunken womb after childbirth, nervous insomnia, spasmodic cough, and etc." Jin Bu Huan bas been recently reponed to be responsible for the poisoning of at least three young children (ages 13 months to 2 1'2 years), who accidentally ingested this product. The children were hospitalized with rapid-onse~ lifethreatening bradycardia (very low heart rate), and central nervous system and respiratory depression. One child required intubation (assisted breathing). All three ultimately

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recovered, following intensive medical care. Aldiougb the product label identified die plant source

for Jin Bu Huan as Polygala chinensis, this appears to be incorrect since preliminary analyses indicate die presence of tettabydropaJroatine (TI-IP), a chemical not found in Polygala. TIIP is found, however, in high ooncentrations in plants of cenain Stephania species. In animals, exposure to TIIP results in sedation, analgesia, and neuromuscular blockade (paralysis). The symptoms of the three children are consistent with these effects.

An additional case of TIIP toxicity, reported in the Netherlands, appears to be associated with the same product, and is being investigated.

H. Herbal products containing Stephania and Magnolia species

A Chinese herbal preparation containing Stephania and Magnolia species that was sold as a weight-loss treatment in Belgium has been implicated recently as a cause of severe kidney injury in at least 48 women. These cases were only discovered by diligent investigations by physicians treating two young women who presented with similar cases of rapidly progressing kidney disease that required renal dialysis. Once it was determined that both these women had used the herbal diet treatment, further investigation of kidney dialysis centers in Belgium found a total of 48 individuals with kidney injury who had used the herbal product.

At the time that a report of these adverse effects was published in February 1993, 18 of the 48 women had terminal kidney failure that will require either kidney transplantation or life-long renal dialysis.

I. Mahuang Ma huang is one of several names for herbal products

containing members of the genus Ephedra. There are many common names for these evergreen plants, including squaw tea and Mormon tea Serious adverse effects, including hypertension (elevated blood pressure), palpitations (rapid bean rate), neuropathy (nerve damage), myopathy (muscle injury), psychosis, stroke, and memory loss, have been reported to FDA with products containing Ma huang as ingredients and are cwrently under investigation.

The Ephedras have been shown to contain various chemical stimulants, including the alkaloids ephedrine, pseudoephedrine and norpseudoephedrine, as well as various tannins and related chemicals. The concentrations of these alkaloids depends upon the particular species of

Ephedra used. Ephedrine and pseudoephedrine are amphetamine-like chemicals used in OTC and prescription drugs. Many of these stimulants have known serious side effects.

Ma huang is sold in products for weight control, as well as in products that boost energy levels. These products often contain other stimulants, such as caffeine, which may have synergistic effects and increase the potential for adverse effects.

II. Amino Acids Amino acids are the individual constituent pans of

proteins. Consumption of foods containing intact proteins ordinarily provides sufficient amounts of the nine amino acids needed for growth and development in children and for maintenance of health of adults. The safety of amino acids in this form is generally not a concern. When marketed as dietary supplements, amino acids are sold as single compounds, in combinations of two or more amino acids, as components of protein powders, as chelated single compounds, or in chelated mixtures. Amino acids are promoted for a variety of uses, including body-building. Some are promoted for claimed phannacologic effects.

The Federation of American Societies for Experimental Biology (FASEB) recently conducted an exhaustive search of available data on amino acids and concluded that there was insufficient information to establish a &'lfe intake level for any amino acids in dietary supplements, and that their safety should not be a'iSumed. FASEB warned that consuming amino acids in dietary supplement form posed potential risks for several subgroups of the general population, including women of childbearing age (especially if pregnant or nursing), infants, children, adolescents, the elderly, individuals with inherited disorders of amino acid metabolism, and individuals with certain disea~es.

At least two of the amino acids consumed in dielary supplements have also been associated with serious injuries in healthy adults.

A. L-tryptophan L-ttyptophan is associated with the most serious re

cent outbreak of illness and death known to be due to consumption of dietary supplements. In 1989, public health officials reali7.ed that an epidemic of eosinophilia-myalgia syndrome (EMS) was a~ociated with the ingestion of Lttyptophan in a dietary supplement. EMS is a systemic connective tissue disease characterized by severe muscle

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pain, an inaease in white blood cells, and cenain skin and neuromuscular manifestations.

More than 1,500 cases of L-ttyptophan-related FMS have been reported to the national Centers for Disease Conttol and Prevention. At least 38 patients are known to have died. The true incidence of L-tryptophan-related EMS is thought to be much higher. Some of the individuals suffering from L-tryptophan-related EMS have recovered, while other individuals' illnesses have persisted or worsened over time.

Although initial epidemiologic studies suggested that the illnesses might be due to impurities in an L-ttyptophan product from a single Japanese manufacturer, this hypothesis has not been verified, and additional evidence suggests that L-tryptophan itself may cause or contribute to development of EMS. Cases of EMS and related disorders have been found to be associated with ingestion of L-ttyptophan from other batches or sources of L-ttyptophan. These illnesses have also been associated with the use of L-5-hydroxytryptophan, a compound that is closely related to L-tryptophan, but is not produced using the manufacturing process that created the impurities in the particular Japanese product

B. Phenylalanine A number of illnesses, including those similar to the

eosinophilia myalgia syndrome (EMS) associated with L-tryptophan consumption, have been reported to FDA in individuals using dietruy supplements containing phenylalanine. There are also published reports of scleroderma/ scleroderma-like illnesses, which have symptoms similar to EMS, occwring in children with poorly controlled blood phenylalanine levels, as well as in those with phenylketonuria (PKU), a genetic disorder characterized by the inability to metabolize phenylalanine.

Ill. Vitamim and Minerals Vitamin and mineral dietruy supplements have a long

history of use at levels consistent with the Recommended Dietary Allowances (RDA's) or at low multiples of the RDA's, and are generally considered safe at these levels for the general population. Intakes above the RDA, however, vary widely in their potential for adverse effects. Cenain vitamins and minerals that are safe when conswned at low levels are toxic at higher doses. The difference between a safe low dose and a toxic higher dose is quite large for some vitamins and minerals and quite small for others.

A. VitaminA Vitamin A is found in several fonns in dietary supple

ments. Preformed vitamin A (vitamin A acetate and vitamin A palmitate) has well-recognized toxicity when conswned at levels of 25,000 International Units (IU) per day, or higher. (Beta-carotene does not have the potential for adverse effects that the other forms of vitamin A do, because high intakes of beta-carotene are converted to vitamin A in the body at much lower levels.) The RDA for vitamin A is 1,000 retinol equivalents (RE) for men, which is equivalent to 3,300 IU of preformed vitamin A, and 80 percent of these amounts for women.

The adverse effects associated with consumption of vitamin A at 25,000+ IU include severe liver injury (including cirrhosis), bone and cartilage pathologies, elevated intracranial pressure, and birth defects in infants whose mothers consumed vitamin A during pregnancy. Groups especially vulnerable to vitamin A toxicity are children, pregnant women, and those with liver disease caused by a variety of factors, including alcohol, viral hepatitis, and severe protein-energy malnutrition.

There are some studies that suggest vitamin A toxicity has occmTed at levels of ingestion below 25,000 IU. In addition, the severity of the injuries that occur at 25,000 IU suggests that substantial, but less severe and less readily recognized, injuries probably occur at somewhat lower intakes. Most experts recommend that vitamin A intake not exceed 10,000 IU for most adults or 8,000 IU for pregnant and nursing women.

B. VitaminB, Neurologic toxicity, including ataxia (alteration in bal

ance) and sensory neuropathy (changes in sensations due to nerve injury), is associated with intake of vitamin B6

(pyridoxine) supplements at levels above 100 milligrams per day. As little as 50 milligrams per day has caused reswnption of symptoms in an individual previously injured by higher intakes. The RDA for vitamin B6 is 2 milligrams. Vitamin B6 is marketed in capsules containing dosages in the 100-, 200-and 500-milligrams range.

C. Niacin (nicotinic acid and nicotinamide) Niacin taken in high doses is known to cause a wide

range of adverse effects. The RDA for niacin is 20 milligrams. Niacin is marketed in dietary supplements at potencies of 250 mg, 400 mg, and 500 mg, in both immediate and slow-release fonnulations. Daily doses of 500 mg from slow-release fonnulations, and 750 mg of immediate-

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release niacin, have been associated with severe adverse reactions, including gastrointestinal dis~ (burning pain, nausea, vomiting, bloating, aamping, and dianbea) and mild to severe liver damage. Less common, but more serious (in some ~ life-threatening), reactions include liver injury, myopathy (muscle disease), maculopathy of the eyes (injury to the eyes resulting in decreased vision), coagulopathy (increased bleeding problems), cytopenia (decreases in cell types in the blood), hypotensive myocardial ischemia (heart injury caused by too low blood ~me), and metabolic acidosis (increases in the acidity of the blood and urine).

Niacin (nicotinic acid) is approved as a prescription drug to lower cholesterol. Many of the observed adverse reactions have occurred when patients have switched to OTC f01D1ulations of niacin, and particularly when they have switched from immediate-release f01D1ulations to dietary supplements containing slow-release niacin fommlations without the knowledge of their physicians.

D. Selenium Selenium is a mineral found in dietary supplement

products. At high doses (approximately 800 to 1,000 micrograms per day), selenium can cause tissue damage, especially in tissues or organs that concentrate the element The toxicity of selenium depends upon the chemical form of selenium in the ingested supplement and upon the selenium levels in the foods consumed. Human injuries have occurred following ingestion of high doses over a few weeks.

IV. Other Products Marketed as Dietary Supplements

A. Gennaniwn Germanium is a nonessential element Recently, ger

manium has been marketed in the form of inorganic germanium salts and novel organogennanium compounds, as a "dietary supplement." These products are promoted for their claimed immunomodulatory effects~ or as "healthpromoting" elixirs. Germanium supplements, when used chronically, have caused nephrotoxicity (kidney injury) and death. Since 1982, there have been 20 reported cases of acute renal failure, including two deaths, attributed to oral intakes of germanium elixirs. In surviving patients, kidney function has improved after discontinuation of germanium, but none of the patients have recovered nonnal kidney function.

One particular organogennanium compound, an azaspiran organogennanium, bas been studied for its potential use as an anticancer drug. Forty percent of the patients in this study experienced ·transient neurotoxicity (nerve damage), and two patients developed puhnonruy toxicity. Because of these side effects, medically supervised administration of this drug with monitoring for toxicity has been recommended for those using gennanium chronically.

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llnsubstantiat0d~fai1ii's ,~ and · dietary supplements: a review of current promotional...

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