GAO

United States General Accounting Office

Report to Chairman, Special Committee 

on Aging, U.S. Senate

September 2001 HEALTH PRODUCTS 

FOR SENIORS

“Anti-Aging” Products 

Pose Potential for 

Physical and 

Economic Harm

GAO-01-1129

Page i GAO-01-1129 "Anti-Aging" Health Products

Contents

Letter 1

Results in Brief 3

Background 4

Some Dietary Supplements Have Been Associated With Potentially 

Serious Health Consequences for Senior Citizens 7

Senior Citizens May Spend Millions of Dollars on Unproven or 

Poorly Manufactured Products 13

Federal and State Education, Research, and Enforcement Activities 

Aim to Protect Senior Citizens 15

Conclusions 23

Agency Comments 23

Appendixes

Appendix I: Scope and Methodology 26

Appendix II: Known Claims, Adverse Effects, Contraindications, and 

Interactions of Herbal and Specialty Supplements 28

Appendix III: NCCAM Studies on Alternative Therapies Relevant to Senior 

Citizens 34

Appendix IV: Recent FDA Actions 36

Appendix V: Recent FTC Actions 39

Appendix VI: Examples of Questionable Health Care Products Used by 

Senior Citizens, as Reported by State Officials 42

Appendix VII: GAO Contact and Staff Acknowledgments 43

Tables Table 1: Organizations Consulted 27

Table 2: Principal Claims and Principal Known Adverse Effects, 

Contraindications, and Interactions of Leading Dietary 

Supplements Used by Seniors to Address Issues of 

Aging 28

Table 3: Studies Identified in NCCAM’s Fiscal Year 2001-2005 

Strategic Plan Relevant to Senior Citizens 34

Table 4: Recent FDA Actions for Health Products Determined to Be 

Making Illegal Claims 36

Table 5: FTC Cases of Illegal Advertising for Products Targeted to 

Senior Citizens 39
Contents

Page ii GAO-01-1129 "Anti-Aging" Health Products

Abbreviations

AG Attorney General

CDC Centers for Disease Control and Prevention

DHEA dehydroepiandrosterone

DSHEA Dietary Supplement Health and Education Act

FDA Food and Drug Administration

FTC Federal Trade Commission

GMP good manufacturing practice

HHS Department of Health and Human Services

NCCAM National Center for Complementary and Alternative Medicine

NIH National Institutes of Health
Page 1 GAO-01-1129 "Anti-Aging" Health Products

United States General Accounting Office

Washington, D.C. 20548

A

September 7, 2001 Letr

The Honorable John Breaux

Chairman, Special Committee on Aging

United States Senate

Dear Mr. Chairman:

The risk to consumers from potentially harmful health products is a 

perennial concern for consumer protection groups, health authorities, 

federal and state regulators, and law enforcement officials. Many 

alternative medicine products, including dietary supplements,1

 have 

widespread popular appeal among consumers, and some have yielded 

promising results in studies that focus on chronic health conditions that 

affect many older adults, such as depression, dementia, and arthritis. For 

example, some studies have suggested that St. John’s wort may counteract 

feelings of mild to moderate depression and that ginkgo biloba may 

improve cognitive performance in dementia. At the same time, regulators 

and medical experts are concerned that some products have health risks or 

are marketed with misleading and unsubstantiated claims. 

Some companies promote their products to senior citizens by using “antiaging” or “cure-all” claims for which there is little or no supporting 

scientific evidence of either safety or efficacy.2

 In addition, there are 

concerns that some of these products may cause physical or economic 

harm. Seniors are thought to be at particular risk of physical harm because 

they often take multiple prescription pharmaceuticals, increasing their risk 

of possibly dangerous supplement-drug interactions. Seniors can also be 

harmed indirectly if they decide to follow an unsubstantiated alternative 

regimen and forgo needed conventional medical treatment. There is also 

concern that seniors may be wasting money on products that have little or 

no therapeutic value.

1

Alternative medicine products are those remedies, supplements, and devices that are not 

currently considered an integral part of conventional medicine. These include dietary 

supplements such as vitamins, minerals, herbal and botanical supplements, and specialty 

supplements.

2

Efficacy is the ability of a medication to produce the intended or desired effect under ideal 

conditions of use.
Page 2 GAO-01-1129 "Anti-Aging" Health Products

Since 1994, when the Dietary Supplement Health and Education Act 

(DSHEA) was enacted, sales of dietary supplements have soared. A 

significant number of these products are herbal supplements, and others 

are nonherbal specialty supplements.3

 DSHEA permits dietary supplements 

to feature so-called structure/function label claims, which are statements 

that an ingredient in the product will benefit a body’s structure (such as 

“builds strong bones”) or function (such as “promotes restful sleep”). As 

we reported last year, consumers may incorrectly view such statements as 

claims to reduce the risk of or to treat a disease.4

In light of these concerns, you asked us to examine (1) whether there is 

evidence that anti-aging and alternative medicine products, particularly 

dietary supplements aimed at conditions of aging, cause physical harm to 

senior citizens; (2) whether there is evidence that questionable anti-aging 

and alternative medicine products cause economic harm to senior citizens; 

and (3) federal and state oversight efforts to protect consumers from 

questionable anti-aging and alternative medicine products. 

To address these questions, we obtained documents from and interviewed 

officials with the Food and Drug Administration (FDA), the Federal Trade 

Commission (FTC), the National Institutes of Health (NIH), state Attorneys 

General (AG) offices, and state health departments, as well as 

representatives of the dietary supplement industry and other interested 

organizations and experts. We also reviewed the scientific literature on 

dietary supplements and other products marketed as anti-aging therapies. 

Our work focused primarily on those products that purport to have antiaging properties or which claim to address chronic diseases and conditions 

common among senior citizens, such as cancer, memory loss, and arthritis. 

We conducted our review from April through August 2001 in accordance 

with generally accepted government auditing standards. (See app. I for 

further information on our scope and methodology, including a list of the 

organizations we contacted.)

3

Specialty supplements are generally those that are not herbs, botanicals, vitamins, or 

minerals, and may include amino acids, animal products, concentrates, metabolites, 

constituents, or proteins. 

4

Food Safety: Improvements Needed in Overseeing the Safety of Dietary Supplements and 

“Functional Foods” (GAO/RCED-00-156, July 11, 2000).
Page 3 GAO-01-1129 "Anti-Aging" Health Products

Results in Brief Dietary supplements marketed as anti-aging therapies may pose a potential 

for physical harm to senior citizens. Evidence from the medical literature 

shows that a variety of frequently used dietary supplements can have 

serious health consequences for seniors. Particularly risky are products 

that may be used by seniors who have underlying diseases or health 

conditions that make the use of the product medically inadvisable or 

supplements that interact with medications that are being taken 

concurrently. Further, studies have found that products sometimes contain 

harmful contaminants or much more of an active ingredient than is 

indicated on the label. FDA and the Centers for Disease Control and 

Prevention (CDC) have received reports of adverse events for persons 

taking dietary supplements in recent years, including some for senior 

citizens. FDA has issued warnings to consumers and industry about the 

health risks of several dietary supplement products. The dietary 

supplement trade associations and medical experts we talked with 

generally agreed that some products may pose a potential for harm to 

seniors under certain conditions.

Unproven anti-aging and alternative medicine products also pose a risk of 

economic harm to seniors. Although we were unable to find any recent, 

reliable estimates of the overall economic harm to seniors from these 

products, we did uncover several examples that illustrate the risk of 

economic harm. FDA and FTC have identified a number of products that 

make advertising or labeling claims with insufficient substantiation, some 

costing consumers hundreds or thousands of dollars apiece. A recent 

review of cases prepared for us by FTC estimated that, for 20 companies 

marketing products to seniors that have been the subject of law 

enforcement activities, the average economic harm to consumers as a 

whole was about $1.8 million per company. In addition, tests of selected 

dietary supplements have found that some contain little or none of the 

active ingredient claimed on the label, rendering these products virtually 

worthless. 

The potential for harm to senior citizens from health products making 

questionable claims has been a concern for public health and law 

enforcement officials, and federal and state agencies have activities under 

way to protect consumers of these products. FDA and FTC sponsor 

programs and provide educational materials for senior citizens to help 

them avoid health fraud on the Internet and in other media. NIH has an 

evolving and expanding research agenda to evaluate popular alternative 

therapies. FDA has taken various enforcement actions against firms that 
Page 4 GAO-01-1129 "Anti-Aging" Health Products

have violated laws regarding the marketing and sales of anti-aging and 

alternative products, including products that were being marketed as 

dietary supplements but which are drugs. However, FDA has not 

prohibited the marketing of any specific substances using its administrative 

rulemaking authority. FDA’s voluntary adverse event reporting system for 

dietary supplements has shortcomings, and proposed regulations to 

establish standards for good manufacturing practices, which could provide 

FDA with additional authority to regulate facilities that manufacture, 

distribute, and store dietary supplement products, have not yet been 

issued. Recently, FTC and FDA have combined efforts to combat health 

fraud against seniors and other vulnerable consumer populations in an 

ongoing Internet-based initiative known as “Operation Cure.All,” which 

targets companies that make unsubstantiated advertising and labeling 

claims for dietary supplements and other health products. At the state 

level, agencies are working to protect consumers of health products by 

enforcing state consumer protection and public health laws, although antiaging and alternative products are receiving limited attention. 

Background Dietary supplements and other alternative medicine products are widely 

used by seniors. For example, as many as 4 out of 10 senior citizens have 

reported using herbal dietary supplements. In 2000, total U.S. sales for the 

herbal and specialty supplement industry reached $5.8 billion.5

 Research 

suggests that some of these products show promise for mitigating 

symptoms associated with certain health conditions. FDA, FTC, and state 

agencies all have oversight responsibility for alternative medicine 

products. 

5

Estimates of 1997 out-of-pocket expenditures by Americans of all ages for alternative 

therapies--including herbal products, high-dose vitamins, therapy-specific books and 

classes, diet products, and professional services--range from $27 billion to $34.4 billion 

nationally.
Page 5 GAO-01-1129 "Anti-Aging" Health Products

Use of Alternative Medicine 

Products by Older 

Americans

A number of surveys have been conducted to determine the proportion of 

the population that uses alternative medicine products. One national 

survey of more than 2,000 adults conducted in 1997 found that 42 percent 

of Americans of all ages used at least one type of alternative therapy in the 

prior year for conditions such as back problems, fatigue, arthritis, high 

blood pressure, insomnia, depression, and anxiety.6

 The survey found that 

12 percent used herbal remedies. Other studies have found that 16 to 18 

percent of Americans used dietary supplements, including amino acids and 

over-the-counter hormones.7

When considering only senior citizens, surveys have generally found that as 

many as 40 percent of seniors used herbal and specialty supplements at 

some time in the previous year, with a smaller percentage reporting regular 

use. For example, a survey conducted in 1999 for Prevention Magazine

found that 43 percent of seniors used herbal supplements and 23 percent 

used specialty supplements in the previous year. This study also found that 

one-quarter of older Americans often use herbal and specialty supplements 

in combination with prescription medications. A recent unpublished 

Harris Poll survey conducted for the Dietary Supplement Education 

Alliance (June and July 2001) found that 12 percent of those aged 65 or 

older used herbal supplements and 9 percent used specialty supplements 

on a regular basis. Surveys have found that many older Americans use 

these supplements to maintain overall health, increase energy, improve 

memory, and prevent and treat serious illness, as well as to slow the aging 

process, among other purposes. Products frequently used by seniors to 

address aging concerns include herbal supplements such as evening 

primrose, ginkgo biloba, ginseng, kava kava, saw palmetto, St. John’s wort, 

and valerian, and specialty supplements such as chondroitin, coenzyme 

Q10, dehydroepiandrosterone (DHEA), glucosamine, melatonin, omega-3 

fatty acids (fish oil), shark cartilage, and soy proteins (see app. II for details 

regarding these substances).

6

D.M. Eisenberg and others, “Trends in Alternative Medicine Use in the United States, 1990-

1997,” Journal of the American Medical Association, Vol. 280, No. 18 (1998), pp. 1569-74.

7

R.J. Blendon and others, “Americans’ Views on the Use and Regulation of Dietary 

Supplements,” Archives of Internal Medicine, Vol. 161(2000), pp. 805-10.
Page 6 GAO-01-1129 "Anti-Aging" Health Products

Research on Alternative 

Medicine Products 

NIH’s National Center for Complementary and Alternative Medicine 

(NCCAM) has noted that preliminary evidence-based reviews suggest that 

some alternative therapies may have beneficial effects. These include St. 

John’s wort for depression, ginkgo biloba for dementia, and glucosamine 

and chondroitin sulfate for osteoarthritis. For example, one source stated 

that increased memory performance and learning capacity have been 

established experimentally for ginkgo biloba.8

 One controlled study has 

shown positive results for ginkgo biloba in tests of cognitive performance 

in dementia.9

 Similarly, some reviews have suggested that studies of 

glucosamine in the treatment of osteoarthritis found positive results,10 as 

did studies of St. John’s wort for depression.11 A systematic review of 

studies of St. John’s wort for depression found evidence of effectiveness in 

the treatment of mild to moderately severe depression,12 although it has 

also been associated with potentially dangerous interactions with 

prescription drugs.

Government Oversight of 

Anti-Aging Products and 

Dietary Supplements

FDA, FTC, and state government agencies all have oversight responsibility 

for products marketed as anti-aging therapies. In general, the law permits 

FDA to remove from the market products under its regulatory authority 

that are deemed dangerous or illegally marketed. FDA’s regulation of 

dietary supplements is governed by the Federal Food, Drug, and Cosmetic 

Act as amended by DSHEA in 1994. DSHEA does not require manufacturers 

of dietary supplements to demonstrate either safety or efficacy to FDA 

prior to marketing them. However, if FDA subsequently determines that a 

dietary supplement is unsafe, the agency can ask a court to halt its sale. For 

dietary supplements, the Health and Human Services Secretary may 

declare the existence of an imminent hazard from a dietary supplement, 

8

M. Blumental (ed.), The Complete German Commission E Monographs: Therapeutic 

Guide to Herbal Medicines (Boston, Mass.: American Botanical Council, 1998).

9

P.L. Le Bars and others, “A Placebo-Controlled, Double-Blind, Randomized Trial of an 

Extract of Ginkgo Biloba for Dementia,” Journal of the American Medical Association, Vol. 

278, No. 16 (1997), pp. 1327-32.

10T.E. Towheed and others, “Glucosamine Therapy for Treating Osteoarthritis,” The 

Cochrane Library, No. 3 (2001).

11L.K. Mulrow, “St. John’s Wort for Depression,” The Cochrane Library, No. 2 (2001).

12K. Linde and others, “St. John’s Wort for Depression—an Overview and Meta-Analysis of 

Randomised Clinical Trials,” British Medical Journal, Vol. 313 (1996), pp. 253-58.
Page 7 GAO-01-1129 "Anti-Aging" Health Products

after which the Secretary must initiate an administrative hearing to 

determine the matter, which may then be reviewed in court. DSHEA does 

not require dietary supplement manufacturers to register with FDA, or to 

identify to FDA the products they manufacture, and dietary supplement 

manufacturers are not required to provide the adverse event reports they 

receive to FDA. However, FDA does regulate nutritional and health claims 

made in conjunction with dietary supplements. 

FTC has responsibility for ensuring that advertising for anti-aging health 

products and dietary supplements is truthful and can be substantiated. 

FTC can ask companies to remove misleading or unsubstantiated claims 

from their advertising and it can seek monetary redress for conduct 

injurious to consumers in appropriate cases. FTC published an advertising 

guide for the dietary supplements industry in November 1998 that 

reminded the industry that advertising must be truthful and that objective 

product claims must be substantiated. State agencies can take action 

against firms that fraudulently market anti-aging and other health products. 

Some Dietary 

Supplements Have 

Been Associated With 

Potentially Serious 

Health Consequences 

for Senior Citizens

Some dietary supplements can have potentially serious health 

consequences for seniors. Although precise estimates of the physical harm 

caused to senior citizens by questionable anti-aging and alternative 

products are not available, there is evidence in the medical literature that 

seniors are at risk for adverse effects, that dietary supplements are 

contraindicated for individuals with some underlying health problems, and 

that a variety of frequently used dietary supplements can have dangerous 

interactions with drugs that are being taken concurrently. Although 

documented adverse effects from most herbal and specialty supplements 

are generally mild, potential complications from supplements that might be 

contraindicated under certain circumstances and from interactions with 

certain prescription medications may be serious. In addition, there is 

evidence that 1 in 10 herbal products may be contaminated with pesticides 

and heavy metals, which can have serious health consequences. Adverse 

event reports received by FDA and others give an indication of some 

possible risks. FDA has issued warnings to consumers and industry about 

the health risks of several dietary supplement products. Recognizing these 

health risks, the American Medical Association has recommended that 

dietary supplements and herbal remedies include specific warnings on 

their labels, and several trade associations representing manufacturers, 

suppliers, and distributors of dietary supplements have instituted voluntary 

programs to reduce the risk of potentially harmful products.
Page 8 GAO-01-1129 "Anti-Aging" Health Products

Scientific Evidence Shows 

Potential Adverse Effects, 

Contraindications, and Drug 

Interactions for Some 

Popular Supplements

Our review of the medical literature identified several areas where 

individuals, particularly seniors, may be at risk of physical harm due to 

adverse effects--especially if dietary supplements are used when they are 

contraindicated--or interactions between these dietary supplement 

products and prescription or over-the-counter drugs.13

The literature suggests that among healthy adults, most supplements when 

taken alone have been associated with only rare and minor adverse effects. 

These include stomach distress, headache, breast tenderness, restlessness, 

skin reactions, and hypersensitivity to sunlight. However, others are 

associated with more serious adverse effects. For example, the literature 

suggests that DHEA may increase the risk of breast, prostate, and 

endometrial cancer, and shark cartilage has been associated with thyroid 

hormone toxicity. 

Contraindications have been identified in the literature for several 

supplements. Ginseng is not recommended for persons with hypoglycemia. 

Kava kava may worsen symptoms of Parkinson’s disease. Saw palmetto is 

contraindicated for patients with breast cancer, and valerian should not be 

used by those with liver or kidney disease without first consulting a 

physician. A recent study also suggested that echinacea (promoted to help 

fight colds and flu), ephedra (promoted as an energy booster and diet aid), 

garlic, ginkgo biloba, ginseng, kava kava, St. John’s wort, and valerian may 

pose particular risks to people during surgery, with complications including 

bleeding, cardiovascular instability, and hypoglycemia. Other potential 

complications cited were an increase in the sedative effect of anesthetics 

and increased metabolism of many drugs.14

The literature also identifies a number of possible interactions with 

prescription medications. Since seniors take more prescription medicines 

on average than do younger adults, the risk of interactions among seniors 

may be higher. For example, evening primrose oil, garlic, ginkgo biloba, 

ginseng, glucosamine, and St. John’s wort magnify the effect of bloodthinning drugs such as warfarin or coumadin. We also identified reports 

13A summary of some of the principal known adverse effects, contraindications, and 

interactions for leading supplement products is provided in appendix II. 

14M.K. Ang-Lee and others, “Herbal medicines and preoperative care,” Journal of the 

American Medical Association, Vol. 286, No. 2 (2001), pp. 208-16.
Page 9 GAO-01-1129 "Anti-Aging" Health Products

suggesting that ginkgo biloba may reduce the effects of seizure medications 

and glucosamine may have a harmful effect on insulin resistance.

An additional concern is that individuals with potentially serious health 

conditions may seek alternative therapies, some of which are unproven, in 

lieu of conventional medical therapies, and may do so without consulting 

their physician. For example, the Prevention Magazine survey we 

described earlier found that 39 percent of the respondents aged 65 or older 

who used a herbal supplement to prevent or treat a disease used the herbal 

remedy instead of an over-the-counter medication and 34 percent had tried 

a herbal remedy instead of a prescription medication. Surveys have also 

found that individuals who use alternative therapies (either in conjunction 

with or instead of traditional therapies) often do not discuss this fact with 

their physicians. For example, one survey found that only 39 percent of 

adults who used an alternative therapy said they informed their doctor,15

and a Harris poll survey found that 49 percent of respondents who used a 

dietary supplement informed their doctor. In addition, many respondents 

in that survey were found to have misperceptions about the responsible use 

of supplements. For example, one-third said they did not think it was 

necessary to follow recommended dosage guidelines. Nearly 40 percent 

thought they would benefit from having more information about avoiding 

potential adverse reactions. 

Some Dietary Supplements 

Contain Harmful 

Contaminants or Too Much 

Active Ingredient 

Commercial and scientific studies of selected dietary supplements have 

repeatedly found that contaminants may be present and that the amount of 

active ingredient present does not always match that indicated on the 

product label. 

15D.M. Eisenberg and others, “Trends in Alternative Medicine Use in the United States, 1990-

1997,” Journal of the American Medical Association, Vol. 280, No. 18 (1998), pp. 1569-74.
Page 10 GAO-01-1129 "Anti-Aging" Health Products

Contaminants can pose significant health risks to consumers. Some 

pesticides and heavy metals, for example, are probable carcinogens and 

can be toxic to the liver and kidney or impair oxygen transport in the blood. 

One commercial laboratory found contamination in samples from 

echinacea, ginseng, and St. John’s wort products. As much as 20 times the 

level of pesticides allowable by the U.S. Pharmacopeia was found in two 

samples of ginseng. Overall, 11 percent of the herbal products tested were 

contaminated in some way. Three percent of the specialty supplement 

products showed signs of contamination. 

Some scientific studies have found that there may be significantly more 

active ingredient in some herbal and specialty supplement products than is 

indicated on the label. Amounts of active ingredients that exceed what is 

indicated on a product label may increase the risk of overdose for some 

patients. For pharmaceuticals, the tolerable range of product content is 

between 90 and 110 percent of the amount of active ingredient stated on 

the label. For example, one study of DHEA found that only 44 percent of 

the products sampled were within this range and one brand contained 150 

percent of the amount indicated on the label.16 In a study of ephedra, one 

product was shown to have as much as 154 percent of the active ingredient 

indicated on the label.17 A study of feverfew (promoted as a migraine 

prophylaxis) found that 22 percent of the products tested contained more 

than 110 percent of what the authors considered to be the therapeutic dose 

of its active ingredient, in two cases doubling that amount.18 Studies of 

ginseng have found that product concentrations varied nearly fivefold 

across different products19 and that 38 percent of the products tested had 

more than 110 percent of the amount of active ingredient on the label, four 

of them containing more than twice as much.20 Studies of SAM-e (promoted 

as an antidepressant and in the treatment of the joint pain, stiffness, and 

inflammation associated with osteoarthritis) and St. John’s wort also found 

16J. Parasrampuria and others, “Quality Control of Dehydroepiandrosterone Dietary 

Supplement Products,” Journal of the American Medical Association, Vol. 280, No. 18 

(1998), p. 1565.

17B.J. Gurley and others, “Content Versus Label Claims in Ephedra-Containing Dietary 

Supplements,” American Journal of Health-System Pharmacists, Vol. 57 (2000), pp. 963-69.

18S. Hepinstall and others, “Parthenolide Content and Bioactivity of Feverfew (Tanacetum 

parthenium (L.) Schultz-Bip.). Estimation of Commercial and Authenticated Feverfew 

Products,” The Journal of Pharmacy and Pharmacology, Vol. 44, No. 5 (1992), pp. 391-95.

19J. Cui and others, “What Do Commercial Ginseng Preparations Contain?” Lancet, Vol. 344 

(1994), p. 134.
Page 11 GAO-01-1129 "Anti-Aging" Health Products

that products frequently contained more of the active ingredient than 

indicated on the label. This was true for 42 percent and 20 percent of the 

products tested, respectively. 

Reports of Adverse Events 

Associated With the Use of 

Dietary Supplements Signal 

Possible Risks 

Although FDA does not determine causality in the adverse event reports it 

receives, it does use these reports to signal possible risks to consumers 

from dietary supplements. The agency also consults other sources, such as 

reports in the medical literature, to identify dietary supplements that may 

be hazardous to consumers. 

In 1993, FDA published a list of dietary supplements for which evidence of 

harm existed.21 In 1998, the agency also published a guide to dietary 

supplements, which included a list of supplements associated with 

illnesses and injuries.22 FDA has also issued warnings and alerts for dietary 

supplements and posted those to its Web site.23 The most recent alert 

reiterated the agency’s concern, first noted in 1993, that the herbal product 

comfrey represents a serious safety risk to consumers from liver toxicity. 

In addition, the agency has issued warnings for products including, among 

others, chapparal, which is promoted as an antioxidant and cancer cure 

and is associated with nonviral hepatitis; aristolochic acid, which is sold as 

“traditional medicine” and has been associated with permanent kidney 

damage and some cancers; and L-tryptophan, which is promoted for 

insomnia and depression but has been associated with an autoimmune 

disorder and deaths. CDC has also identified reports of adverse events 

associated with dietary supplements and reported them in Morbidity and 

Mortality Weekly Report. CDC’s report about L-tryptophan also noted that 

the substance has led to at least 27 deaths. 

20M.R. Harkey and others, “Variability in Commercial Ginseng Products: An Analysis of 25 

Preparations,” American Journal of Clinical Nutrition, Vol. 73 (2001), pp. 1101-06.

21http://www.cfsan.fda.gov/~dms/ds-ill.html.

22P. Kurtzweil, “An FDA Guide to Dietary Supplements,” FDA Consumer (Sept.-Oct. 1998, 

FDA 99-2323).

23http://www.cfsan.fda.gov/~dms/ds-warn.html and http://www.cfsan.fda.gov/~dms/dsosupp.html. 
Page 12 GAO-01-1129 "Anti-Aging" Health Products

Medical Organizations and 

Trade Associations Have 

Taken Steps to Address 

Health Risks 

Medical organizations and trade associations that represent manufacturers, 

suppliers, and distributors of dietary supplements recognize that some 

health risks are associated with these products and have made 

recommendations and adopted voluntary programs to address some of the 

concerns. For example, the American Medical Association has issued a 

policy statement recommending that dietary supplements and herbal 

remedies include the following information on the product label: “This 

product may have significant adverse side effects and/or interactions with 

medications and other dietary supplements; therefore it is important that 

you inform your doctor that you are using this product.” The policy 

statement also recommends that manufacturers be required to label 

products with data on adverse effects, contraindications, and possible drug 

interactions.

Trade associations that represent various manufacturers, suppliers, and 

distributors of dietary supplements have adopted voluntary programs to 

reduce the risks of potentially harmful products. Thus, the Consumer 

Healthcare Products Association has established eight voluntary programs 

focusing on either product manufacturing or labeling of specific products. 

For example, the association urges manufacturers to put quality control 

procedures in place to ensure that ginseng is free of quintozene (a 

potentially carcinogenic pesticide) and related compounds. For kava kava 

products, member companies are asked to include specific dosage limits 

and cautionary statements, and for comfrey and St. John’s wort products, 

members are asked to include general label warnings about the advisability 

of consulting a physician. The American Herbal Products Association has 

incorporated labeling and warning recommendations in its code of ethics 

for members. These include, among others, labeling recommendations for 

ephedra (with both warnings and serving limits), warnings for chaparral 

and pyrrolizidine alkaloids (which are found in comfrey and can cause fatal 

liver failure), and dosage limits and warnings for kava kava. The 

association has also suggested warning labels for both saw palmetto and 

St. John’s wort. 

The National Nutritional Foods Association requires all members who 

manufacture dietary supplements and herbs under their own label to 

participate in a quality assurance program. The program was established, in 

part, to increase confidence that products are accurately labeled. Products 

are registered, with random testing for content every 2 to 3 years. 

Association officials reported that approximately 25,000 product labels are 

currently registered under this program, estimating that this accounts for 

more than half of the dietary supplements on the market. The association 
Page 13 GAO-01-1129 "Anti-Aging" Health Products

also sponsors its own good manufacturing practices program, and 23 

manufacturers are currently certified.

Senior Citizens May 

Spend Millions of 

Dollars on Unproven or 

Poorly Manufactured

Products 

Senior citizens who buy anti-aging and alternative medicine products may 

spend millions of dollars on products that either make unsubstantiated 

claims or contain less of the active ingredient than is indicated on the label. 

There are no overall estimates of economic harm attributable to 

questionable anti-aging products; however, federal officials have identified 

a number of expensive products making unsubstantiated claims. In an 

analysis of 20 of its cases for products targeted to senior citizens, FTC 

estimated that consumers as a whole spent an average of nearly $1.8 

million annually per company. In addition, because some dietary 

supplement products contain little or none of the active ingredient listed on 

the product label, consumers may be spending millions of dollars per year 

on products that are virtually worthless. 

Expensive Products With 

Unsubstantiated Claims 

Cost Consumers Millions of 

Dollars

FTC and FDA have identified a number of anti-aging and alternative 

medicine companies making unsubstantiated advertising or labeling 

claims for their products. FTC does not have an estimate of economic 

harm attributable to these products, but some of these unproven products 

can cost hundreds or thousands of dollars apiece. For example, rife 

machines,24 which are frequently advertised on the Internet, can cost up to 

$5,000, and some herbal product packages for cancer cures can cost nearly 

$1,000. PC-SPES, an herbal supplement being studied for prostate cancer, 

costs more than $400 per month. 

FTC provided us with a partial estimate of economic harm based on 20 

cases involving companies that fraudulently marketed unproven health 

care products commonly used by seniors and for which national sales data 

were available. FTC estimated the average annual sales at $1,759,000 per 

company. 

24Rife machines are designed to emit light-only or electrical frequencies that manufacturers 

claim kill viruses and parasites and mitigate a wide variety of diseases and health 

conditions. 
Page 14 GAO-01-1129 "Anti-Aging" Health Products

Consumers May Waste 

Money on Products 

Containing Less Active 

Ingredient Than Indicated 

on Product Labels 

Consumers may purchase anti-aging and alternative medicine products that 

contain much less active ingredient than is indicated on the product label, 

thereby wasting their money on worthless products. Results of 

commercial laboratory tests and scientific studies that analyzed product 

contents for active ingredient levels have shown that some dietary 

supplement products contain far less of that active ingredient than labeled. 

For some products, analyses have found no active ingredient. 

A series of commercial laboratory analyses of herbal products showed that 

22 percent of herbal supplements, and 19 percent of specialty supplements, 

contained substantially less active ingredient than the amount indicated on 

the label.25 Tests on echinacea products found that two had no detectable 

levels, and for valerian, four products were found to have none of the active 

ingredient. Six SAM-e products tested had less than half of the labeled 

amount of active ingredient. 

Studies published in the medical literature have shown similar results. In 

an analysis of DHEA products, nearly one-fifth contained only trace 

amounts or no active ingredient.26 In analyses of garlic products, most 

were found to release less than 20 percent of their active ingredient.27 One 

study of ginseng found that 35 percent of the products tested contained no 

detectable levels of an active ingredient,28 and another found no detectable 

levels in 12 percent of the tested products.29 Studies of SAM-e and St. John’s 

wort products also found that tested samples often contained less active 

ingredient than indicated on the label. 

25More detailed test results for all products tested can be found at www.consumerslab.com.

26J. Parasrampuria, “Quality Control of Dehydroepiandrosterone Dietary Supplement 

Products.”

27L.D. Lawson and others, “Identification and HPLC Quantification of the Sulfides and 

Dialk(en)yl Thiosulfinates in Commercial Garlic Products,” Planta Medica, Vol. 57 (1991), 

pp. 363-70.

28L.E. Liberti and A.D. Marderosian, “Evaluation of Commercial Ginseng Products,” Journal 

of Pharmaceutical Sciences, Vol. 67, No. 10 (1978), pp. 1487-89.

29J. Cui, “What Do Commercial Ginseng Preparations Contain?”
Page 15 GAO-01-1129 "Anti-Aging" Health Products

Federal and State 

Education, Research, 

and Enforcement 

Activities Aim to 

Protect Senior Citizens

The potential for harm to senior citizens from health products making 

questionable claims has long been a concern for public health and law 

enforcement officials, and federal and state agencies have activities under 

way to protect consumers from these products. FDA and FTC sponsor 

programs and provide educational materials for senior citizens to help 

them avoid health fraud on the Internet and in other media. NIH is funding 

research and research centers to evaluate popular anti-aging and 

alternative therapies. FDA has taken various enforcement actions against 

firms that have violated legal requirements regarding the marketing and 

sales of anti-aging and alternative products, including dietary supplements, 

but it has not prohibited the marketing of any specific substances using its 

administrative rulemaking authority. FDA’s voluntary adverse event 

reporting system for dietary supplements has shortcomings, and proposed 

regulations to establish good manufacturing practices for dietary 

supplements are still under review by the Office of Management and 

Budget. Through “Operation Cure.All,” FTC is trying to stop companies 

from making unqualified health claims that are not supported by credible 

scientific evidence, and it has been joined in these efforts by FDA and other 

agencies. At the state level, agencies are working to protect consumers of 

health products by enforcing state consumer protection and public health 

laws, although anti-aging and alternative products have received limited 

attention. 

Some Federal Consumer 

Education Activities Target 

Health Fraud Against Senior 

Citizens

Both FDA and FTC sponsor education activities that focus on health fraud 

and seniors. For example, public affairs specialists in several FDA district 

offices had exhibits at senior health fairs and health conferences where 

they distributed educational materials on how to avoid health fraud, as well 

as cautionary guidance on purchasing medicines and medical products 

online. In addition, officials in some districts made drug safety 

presentations that highlighted ongoing FDA programs, including the 

MedWatch adverse event reporting system that consumers are encouraged 

to use and which encompasses drugs, biological products such as vaccines, 

medical devices, dietary supplements, and food products.

To help consumers discriminate between legitimate and fraudulent claims, 

FTC publishes consumer education materials on certain frequently 

promoted products and services, including hearing aids and varicose vein 

treatments. The agency also publishes guidelines on how to spot false 

claims and how to differentiate television shows from “infomercials.”
Page 16 GAO-01-1129 "Anti-Aging" Health Products

NIH Supports Research on 

Alternative Therapies

Federal support of research on alternative therapies is provided by NIH’s 

NCCAM, which has developed research programs to fund clinical trials to 

evaluate the safety and efficacy of some popular products and therapies. 

The trials are studying alternative products and therapies for conditions 

such as arthritis, cardiovascular disease, and neurological disorders. There 

are also studies, either ongoing or planned, to examine the effects of 

glucosamine/chondroitin, St. John’s wort, ginkgo biloba, and others. (A list 

of NCCAM studies on alternative therapies relevant to seniors is provided 

in app. III.) In addition, the agency funds specialized, multidisciplinary 

research centers on alternative medicine in such areas as cardiovascular 

disease, neurological disorders, aging, and arthritis.

FDA Has Taken 

Enforcement Actions 

FDA has taken enforcement actions against firms selling anti-aging 

products alleged to be dangerous or illegally marketed. It has taken actions 

to remove from the market anti-aging products that the agency found were 

actually unapproved new drugs or medical devices and actions against 

firms that promoted their dietary supplements for the treatment or cure of 

a disease. Although DSHEA allows FDA to remove from the market dietary 

supplements that the agency can prove are dangerous, the agency has not 

prohibited the marketing of any specific substances using its administrative 

rulemaking authority. However, the agency has taken steps to identify for 

consumers and industry ingredients it deems to be unsafe and unlawful. 

The agency has then pursued cases against specific manufacturers and 

products when the ingredients continued to be marketed in dietary 

supplements despite the agency’s warnings. FDA’s efforts in this regard 

have been unsuccessful, and many of these products remain on the market 

and are still available to consumers. A description of some of FDA’s recent 

enforcement activities is provided in appendix IV.

FDA enforcement actions taken against products that it judged to be 

unapproved drugs or medical devices include court cases filed to halt 

distribution of laetrile products that claimed to cure cancer and to halt the 

sale of “Cholestin,” a red yeast rice product with lovastatin that was 

marketed with cholesterol-lowering claims. FDA also took action to halt 

the marketing of the “Stimulator,” a device that the manufacturer claimed 

would relieve pain from sciatica, swollen joints, carpal tunnel syndrome, 

and other chronic conditions. The devices have been purchased by many 

senior citizens, according to FDA officials. An estimated 800,000 of these 

devices were sold between 1994 and 1997.
Page 17 GAO-01-1129 "Anti-Aging" Health Products

FDA has notified some dietary supplement manufacturers that their 

promotional materials have illegally claimed that their products cure 

disease, but some of these products are still available. For example, some 

manufacturers of colloidal silver products have claimed efficacy in treating 

HIV and other diseases and conditions. Even though FDA banned colloidal 

silver products as a U.S. over-the-counter drug in September 1999, after 

concluding that it was not aware of any substantial scientific evidence that 

supported the disease claims used in marketing the products, colloidal 

silver products may still be marketed as dietary supplements as long as 

they are not promoted with claims that they treat or cure disease. FDA sent 

several dozen “cyber-letters” by electronic mail to Internet-based 

companies making such claims stating that their therapeutic claims may be 

illegal. Despite these oversight activities, colloidal silver products claiming 

“natural antibiotic” properties to address numerous health conditions 

remain available.

FDA has not initiated any administrative rulemaking activities to remove 

from the market certain substances that its analysis suggests pose health 

risks, but has sought voluntary restrictions and attempted to warn 

consumers. For example, aristolochic acid, a known potent carcinogen 

and nephrotoxin, is believed to be present, in certain traditional herbal 

remedies as well as a number of dietary supplement products. Following 

reports of aristolochic-acid-associated renal failure cases in Europe, FDA 

has recently taken several steps. In May 2000, FDA issued a “letter to 

industry” urging leading dietary supplement trade associations to alert 

member companies that aristolochic acid had been reported to cause 

“severe nephropathy in consumers consuming dietary supplements 

containing aristolochic acid.” This letter also advised the industry that 

FDA had concluded that any dietary supplement that contained 

aristolochic acids was adulterated under the law and that it was unlawful to 

market such a product. At the same time, the agency issued an import 

bulletin (later converted to an import alert) that prohibited the importation 

of bulk and finished products that may contain aristolochic acids until the 

importer could provide direct analytical evidence that the product was free 

of these substances. In April 2001, the agency issued a new industry letter 

and consumer warning after its analysis of marketed products found that 

many contained aristolochic acids. This letter reiterated the agency’s 

conclusion that the marketing of such products was unlawful and that 

manufacturers needed to take steps to ensure that aristolochic-acidcontaining products do not find their way into the marketplace. 
Page 18 GAO-01-1129 "Anti-Aging" Health Products

FDA pointed to another safety risk for consumers using herbal medicines 

in July 2001, when the agency announced that herbal comfrey products 

containing pyrrolizidine alkaloids may cause liver damage. The agency’s 

letter to eight leading dietary supplement trade associations urged them to 

advise their members to stop distributing comfrey products containing 

pyrrolizidine alkaloids. However, even though FDA has told firms that 

market dietary supplements that products that contain comfrey are 

adulterated and unlawful, some firms continue to market them, and the 

agency is left to identify and take action to remove them on a case-by-case 

basis as it becomes aware of them.

FDA’s Voluntary Adverse 

Event Reporting System Has 

Shortcomings

As we reported in 1999,30 FDA’s adverse event reporting system for dietary 

supplements receives reports for only a small proportion of all adverse 

events, and the reports it receives are often incomplete. FDA’s adverse 

event reporting system for dietary supplements is a voluntary 

postmarketing surveillance system. There is no statutory requirement that 

dietary supplement manufacturers provide adverse event reports they 

receive to FDA. For example, we found that documents disclosed in a 

recent court case showed that a manufacturer of a product containing 

ephedra had received more than 1,200 complaints of adverse events related 

to its product; FDA told us that it was aware of few, if any, of these reports 

before the lawsuit was filed. Similarly, a 2001 report by the HHS Office of 

Inspector General noted that FDA’s reporting system fails to capture 

sufficient data on medical information, product information, and 

manufacturer information.31 For example, FDA told us that 12 percent of 

the dietary supplement adverse event reports that included consumer age 

that it has received since 1994 were for senior citizens, but that many of the 

reports did not contain information about the age of the consumer.

30Dietary Supplements: Uncertainties in Analyses Underlying FDA’s Proposed Rule on 

Ephedrine Alkaloids (GAO/HEHS/GGD-99-90, July 2, 1999).

31Department of Health and Human Services (HHS), Office of Inspector General, Adverse 

Event Reporting for Dietary Supplements, OEI-01-00-00180 (Washington, D.C.: HHS, April 

2001).
Page 19 GAO-01-1129 "Anti-Aging" Health Products

FDA Currently Inspects 

Relatively Few Dietary 

Supplement Manufacturers 

and Related Facilities

FDA inspects relatively few dietary supplement manufacturers and related 

facilities. 32 FDA told us that the agency inspected 61 manufacturers and 

repackers of dietary supplements in 1999, and 53 in 2000. In 2001, 80 

inspections are planned. The agency does not know precisely how many 

facilities are operating, because there is no registration requirement. 

However, FDA estimates that there are more than 1,500 facilities, 

suggesting that FDA inspects less than 5 percent of facilities annually. FDA 

officials told us that its inspectors look at sanitation, buildings and 

facilities, equipment, production, and process controls. 

Regulations to Establish 

Good Manufacturing 

Practices for Dietary 

Supplements Have Not Yet 

Been Issued 

In 1997, FDA published an advance notice of proposed rulemaking 

regarding good manufacturing practice (GMP) in manufacturing, packing, 

and holding of dietary supplements. In publishing the draft for comment, 

FDA noted that much of the dietary supplement industry believes GMP 

regulations are important in establishing standards to ensure that dietary 

supplements are “safe and properly labeled.” FDA officials have stated that 

a proposed GMP rule has now been developed and is still under review by 

the Office of Management and Budget. Publication of final GMP 

regulations will improve FDA’s enforcement capabilities, since DSHEA 

provides that dietary supplements not manufactured under conditions that 

meet GMPs would be considered adulterated and unlawful.

Recent FTC and JointAgency Enforcement 

Efforts Focus on the 

Internet 

As part of its consumer protection activities, FTC enforces federal statutes 

that prohibit misleading and unsubstantiated advertising. In recent years, 

FTC has joined with other organizations to focus attention on the 

fraudulent marketing of some anti-aging and other alternative medicine 

products. 

32Inspections are authorized under 21 U.S.C. 374. 
Page 20 GAO-01-1129 "Anti-Aging" Health Products

In 1997, FTC launched an effort to find companies making questionable 

claims for health products on the Internet, as well as in other media. This 

initiative, which later became known as “Operation Cure.All,” primarily 

involved conducting Internet-based searches to identify Internet sites 

making unsubstantiated claims that use of their products would prevent, 

treat, or cure serious diseases and conditions. The searches were 

conducted with the participation of FDA, CDC, and some state attorneys 

general and other organizations.33

Evaluations of “Operation Cure.All” have found that some companies have 

made changes in their Internet advertising as a result of receiving e-mail 

alerts from FTC about potentially unsupported advertising claims. In 1997, 

an estimated 13 percent of notified companies withdrew their claims or 

Web site, while 10 percent made some changes. In 1998, an estimated

28 percent of notified companies withdrew their claims or Web site, while 

10 percent made some changes. By comparison, the percentage of 

companies that made no changes in both years exceeded 60 percent. In 

addition, FTC identified for us 15 “Operation Cure.All” cases brought by the 

FTC against companies and individuals making claims for products or 

services that were not backed by “competent and reliable” scientific 

evidence. In total, FTC has brought over 30 dietary supplement cases since 

the agency released guidelines on its approach to substantiation of 

advertised claims in 1998. A list of relevant cases from FTC enforcement 

efforts is provided in appendix V.

A majority of “Operation Cure.All” cases have been settled administratively, 

with the companies agreeing to stop making unsupported disease 

treatment claims in advertising materials, with some calling for consumer 

redress. For example, FTC sued Lane Labs-USA for representing that its 

shark cartilage products could cure cancer. The company agreed in June 

2000 to stop making these claims and to pay a $550,000 fine to FTC and 

$450,000 to be used for purchasing shark cartilage and placebo products to 

be tested in a clinical trial sponsored by NIH. In an ongoing “Operation 

Cure.All” case involving a company that markets various herbal packages 

as well as a device known as the “Zapper Electrical Unit,” FTC’s complaint 

33On the basis of a long-standing memorandum of understanding coordinating the agencies’

jurisdictional policies over product claims, FDA and FTC are working together within 

“Operation Cure.All” to curb the number of health products on the Internet making 

questionable advertising and labeling claims. 
Page 21 GAO-01-1129 "Anti-Aging" Health Products

seeks consumer redress and a permanent injunction against false and 

misleading claims.

State Agencies Have Limited 

Focus on Anti-Aging and 

Alternative Medicine

Products 

The fourteen states we contacted varied in their efforts to protect 

consumers from fraudulent or harmful health products, but in general 

focused little attention on anti-aging and alternative medicine products. 

State agencies reported that they receive relatively few complaints 

regarding these products. However, many officials said that consumers are 

being harmed in ways that are unlikely to be reported to state agencies and 

that misleading advertising and questionable health products are serious 

problems. States have identified a number of questionable health care 

products, services, and advertising claims that may affect older consumers, 

and these are listed in appendix VI.

States protect consumers from fraudulent or harmful health products 

through two approaches. The first is enforcement of state consumer 

protection laws against false or misleading advertising. The second is 

through their public health authority to ensure food, drug, and medical 

device safety. With some exceptions, the states we contacted take action 

only if there is a pattern of complaints or an acute health problem 

associated with a particular substance or device. Seven of the fourteen 

states we contacted were involved to some degree in monitoring or 

enforcement activity, and three have ongoing efforts to review advertising, 

labels, or products to enforce their health and consumer protection laws.

Enforcement of Consumer 

Protection Laws

In the states we contacted, oversight of anti-aging product advertising has 

not been a priority for state consumer protection agencies. Although many 

representatives of state consumer protection agencies we contacted said 

that misleading advertising of health products targeted to seniors is a 

serious issue, their agencies have devoted greater resources to larger scale 

types of fraud such as identity theft and sweepstakes fraud. 

State laws protecting consumers from false or misleading advertising may 

be applied to anti-aging and alternative remedies for which complaints 

have been filed. There is often a multi-tiered approach to resolving 

consumer complaints. Individual complaints may be filed with an office, 

usually within the Attorney General’s or Governor’s Office, that facilitates 

informal resolution between the consumer and the company. Consumers 

wishing to pursue legal remedies beyond this point are generally referred to 

a private attorney. In cases in which there are patterns or egregious cases 
Page 22 GAO-01-1129 "Anti-Aging" Health Products

of deceptive advertising, the Attorney General’s consumer complaint 

division may pursue administrative or legal remedies against the company. 

Although many state consumer protection agencies are monitoring cases to 

see if patterns of deceptive advertising are developing that could warrant 

full investigation in the future, such patterns may be difficult to determine 

for a number of reasons. None of the consumer protection officials we 

contacted receives a high volume of complaints about health-related 

products. State consumer protection Web sites often refer consumers to a 

variety of resources, including the FTC, FDA, and Better Business Bureaus, 

and thus the agencies are not likely to have a comprehensive picture of all 

consumer complaints. Most of the consumer protection agencies we 

contacted could not search their complaint databases to obtain counts of 

complaints about health-related products, and none of the agencies we 

contacted was able to provide us with counts of complaints.

Some states consider the content of advertisements for health products to 

be a matter for federal authorities, whereas other states specifically 

regulate such advertising. For example, Ohio’s consumer sales practices 

act covers an advertisement’s claims about the sales transaction—such as 

price or quantity—not the content of statements about a product’s 

effectiveness. In contrast, Iowa has a special provision in its consumer 

protection law for additional penalties when false advertising is targeted at 

seniors. 

Public Health Authority In all but one of the states we contacted, public health officials were either 

unable to obtain data on adverse health events resulting from anti-aging or 

alternative health products or have received few, if any, reports of relevant 

cases in the recent past. Some noted that the health department may learn 

of an acute event linked to a dietary supplement but that the more subtle 

forms of harm typically go unreported. With regard to seniors, officials are 

particularly concerned about supplements that make unsubstantiated 

claims to cure disease. Officials believe that when a product such as a 

dietary supplement does not achieve the promised effect, many people 

simply stop using it or return it to the retailer rather than notify state 

authorities.

Public health laws allow state and local authorities to take action against 

adulterated, misbranded, or dangerous products. Some states have 

provisions in their food and drug safety laws that incorporate federal 

standards. 
Page 23 GAO-01-1129 "Anti-Aging" Health Products

Health authorities in the states we contacted are active to varying degrees 

in regulating questionable health products. In three of the states we 

contacted, consumer protection, law enforcement, or public health 

officials routinely review labels and advertising in a variety of media to 

determine if they are false or misleading. In several other states, 

authorities have ongoing investigations stemming from consumer 

complaints. Investigators may contact the company, review 

documentation that it submits in support of its claims, conduct inspections, 

and obtain expert analysis of products. Remedies can include restitution 

for consumers, fines, court orders to change or remove false claims or to 

prohibit the sale of misbranded products in the state, and seizure of 

harmful products. 

Conclusions The risk of harm to seniors from anti-aging and alternative health products 

has not been specifically identified as a top public health priority or a 

leading enforcement target for federal and state regulators. However, 

evidence demonstrates that many senior citizens use anti-aging products 

and that consumers who suffer from aging-related health conditions may 

be at risk of physical and economic harm from some anti-aging and 

alternative health products, including dietary supplements, that make 

misleading advertising and labeling claims. The medical literature has 

identified products that are safe under most conditions but contraindicated 

for consumers with certain health conditions. Other products, such as St. 

John’s wort, hold promise as potential treatments for some conditions but 

are also associated with adverse interactions with some prescription 

medications. Senior citizens may have a higher risk of physical harm from 

the use of anti-aging alternative medicine products because they have a 

high prevalence of chronic health conditions and consume a 

disproportionate share of prescription medications compared to younger 

adults. 

Agency Comments FDA, FTC, and NIH gave us technical comments on the portions of a draft 

of this report that addressed their respective activities. We have 

incorporated their suggestions where appropriate.

As agreed with your office, unless you publicly announce its contents 

earlier, we plan no further distribution of this report until 30 days from the 

date of this letter. At that time, we will send copies to the Secretary of 
Page 24 GAO-01-1129 "Anti-Aging" Health Products

Health and Human Services and others who are interested. We will also 

provide copies to others upon request. If you or your staff have any 

questions, please contact me at (202) 512-7119. Another contact and major 

contributors to this report are listed in appendix VII. 

Sincerely yours, 

Janet Heinrich

Director, Health Care—Public Health Issues
Page 25 GAO-01-1129 "Anti-Aging" Health Products
Page 26 GAO-01-1129 "Anti-Aging" Health Products

Appendix I

Scope and Methodology ApApenednxidexiIs

We began our work by attempting to identify alternative medicine products 

marketed as anti-aging therapies that present health and economic risks to 

seniors. We asked experts in this area which products pose the greatest 

risk to seniors. Most of the responses we received concerned potential 

problems with dietary supplements (both herbal and specialty 

supplements), and occasionally some potentially harmful devices. We did 

not hear widespread concerns regarding alternative medical services. 

Therefore, our work focused principally on those herbal and specialty 

supplements and devices that address health conditions related to aging, 

such as heart disease, memory loss, fatigue, joint health, and cancer. We 

reviewed scientific literature and talked with medical and scientific 

experts, trade association representatives, consumer group 

representatives, individual practitioners, and researchers. Our 

investigation of adverse effects, contraindications, and interactions 

focused primarily on those supplements that were most commonly used by 

seniors to address issues of aging as identified in a recent survey by 

Prevention Magazine.

1

 We conducted analyses of the data from this survey 

to focus on the use of dietary supplements by people aged 65 years or older. 

We also interviewed officials and reviewed documents from the Food and 

Drug Administration (FDA), Federal Trade Commission (FTC), and 

National Institutes of Health (NIH). From FDA, we obtained all adverse 

event reports from 1994 through 2001 reported by people over 65 years old, 

as well as all reports for most of the dietary supplements mentioned in our 

report. We examined other FDA and FTC documents to identify warnings 

that the agencies have issued against certain products because of concerns 

about safety, labeling, or advertising. We obtained case information from 

FTC and FDA to determine estimates of economic harm, as well as to 

review the agencies’ enforcement efforts. We also interviewed state 

attorneys general and public health officials in 14 states to examine 

enforcement efforts at the state level. These states were selected because 

they were identified by experts as being the most active in their efforts to 

curb the marketing and sale of health products making questionable 

claims. (Table 1 lists the organizations we consulted.)

1

The herbal supplements we focused on were evening primrose oil, garlic, ginkgo biloba, 

ginseng, kava kava, saw palmetto, St. John’s wort, and valerian. The specialty supplements 

we focused on were chondroitin sulfate, coenzyme Q10, dehydroepiandrosterone (DHEA), 

glucosamine, melatonin, omega-3 fatty acids, soy proteins, and shark cartilage.
Appendix I

Scope and Methodology

Page 27 GAO-01-1129 "Anti-Aging" Health Products

Table 1: Organizations Consulted

Type of 

organization Name of organizations

Federal 

agencies and 

organizations

National Institutes of Health (National Center for Complementary and

 Alternative Medicine, National Institute on Aging, Office of Dietary

 Supplements)

Federal Trade Commission

Food and Drug Administration (Center for Food Safety and Applied

 Nutrition, Center for Drug Evaluation and Research, Center for Devices

 and Radiological Health, Office of Regulatory Affairs, fraud and

 enforcement officers)

Centers for Disease Control and Prevention

White House Commission on Complementary and Alternative Medicine

 Policy

Consumer 

groups

Center for Science in the Public Interest

National Poison Control Center

Public Citizen Health Research Group

American Council on Science and Health

National Consumers League

Quackwatch.com

American Cancer Society

AARP

Professional 

and trade 

associations

Consumer Healthcare Products Association

American Academy of Anti-Aging Medicine

Council for Responsible Nutrition

National Nutritional Foods Association

American Herbal Products Association

Utah Natural Products Alliance

American Medical Association representatives

American Pharmaceutical Association

Federation of State Medical Boards of the United States

Other U.S. Pharmacopeia 

Institute of Medicine

States 

(attorneys 

general, public 

health officials, 

and/or 

consumer affairs 

officers)

Arizona

California

Florida

Georgia

Illinois

Iowa

Louisiana

Massachusetts

Michigan

Montana

Nebraska

New York

Ohio

Texas
Page 28 GAO-01-1129 "Anti-Aging" Health Products

Appendix II

Known Claims, Adverse Effects, 

Contraindications, and Interactions of Herbal 

and Specialty Supplements ApendxiI

We focused our review on those herbal and specialty supplements that a 

recent survey by Prevention Magazine found were most frequently used by 

senior citizens for conditions associated with aging. For each of those 

supplements, we have listed in table 2 the health claims frequently 

associated with the products, although we have not attempted to validate 

the merits of any of the claims. We also list adverse effects that have been 

associated with the supplements, conditions for which the supplements 

might be contraindicated, and prescription medications with which the 

supplements might have dangerous interactions. 

Table 2: Principal Claims and Principal Known Adverse Effects, Contraindications, and Interactions of Leading Dietary 

Supplements Used by Seniors to Address Issues of Aging

Product Principal claimsa

Principal known adverse 

effects

Principal known 

contraindicationsb

Principal known 

interactions

Chondroitin 

sulfate

Alleviates joint pain 

associated with osteoarthritis 

and reduces inflammation.

Mild gastrointestinal 

complaints such as 

heartburn and nausea.

Coenzyme Q10 Slows aging; increases 

energy; enhances endurance 

and aerobic performance;

strengthens heart; lowers 

blood pressure; improves 

immune function; promotes 

weight loss;

treats cancer, stroke, and gum 

diseases.

Rare, but include heartburn, 

nausea, stomachache, 

diarrhea, headache, fatigue, 

and skin reactions.

May interact with blood 

thinners.
Appendix II

Known Claims, Adverse Effects, 

Contraindications, and Interactions of 

Herbal and Specialty Supplements

Page 29 GAO-01-1129 "Anti-Aging" Health Products

Dehydroepiandrosterone 

(DHEA)

Slows aging; improves 

memory; stimulates libido and 

increases sex drive; eases 

symptoms of depression; 

boosts energy; promotes 

weight loss; builds muscle 

mass and increases strength;

prevents growth and 

recurrence of some cancers; 

protects against heart 

disease; reduces the risk of 

osteoporosis; prevents 

diseases such as diabetes, 

Parkinson's, and Alzheimer's.

Increased facial hair; acne; 

scalp hair loss; oily skin; 

mood swings; 

aggressiveness; altered 

hormone profiles; liver 

abnormalities; menstrual 

cycle irregularities; 

increased risk of heart 

disease, diabetes, stroke, 

prostate cancer in men, and 

breast and endometrial 

cancer in women; insomnia; 

fatigue; low energy; 

headache; nervousness; 

deepening of the voice; 

irritiability; decreased levels 

of high-density lipoprotein 

(HDL) cholesterol; heart 

rhythm disturbances; 

hepatitis.

People with a hormonerelated cancer (prostate, 

ovarian, endometrial, 

breast) should consult 

physician. Should be 

avoided by men with 

enlarged prostate.

Evening 

primrose oil

Beneficial for victims of 

coronary artery disease; 

improves rheumatoid arthritis 

and other inflammatory 

conditions; alleviates hot 

flashes, pre-menstral 

syndrome, and breast pain 

associated with the menstrual 

cycle; improves eczema and 

dermatitis; aids in weight loss; 

prevents diabetic neuropathy; 

eases symptoms of 

schizophrenia and attention 

deficit/hyperactivity disorder; 

benefits chronic viral 

infections such as chronic 

fatigue syndrome; reduces 

effects of multiple sclerosis; 

aids high cholesterol, 

asthmatic cough, and upset 

stomach; has anticancer 

properties.

Gastrointestinal upset, 

nausea, loose stools, 

headache, seizure. 

May increase the 

anticoagulant effect of 

drugs such as warfarin. 

Should not be used with 

anticonvulsant 

medication.

(Continued From Previous Page)

Product Principal claimsa

Principal known adverse 

effects

Principal known 

contraindicationsb

Principal known 

interactions
Appendix II

Known Claims, Adverse Effects, 

Contraindications, and Interactions of 

Herbal and Specialty Supplements

Page 30 GAO-01-1129 "Anti-Aging" Health Products

Garlic Reduces serum cholesterol; 

thins blood; lowers blood 

pressure; may prevent heart 

disease, atherosclerosis, 

stroke, and hypertension; acts 

as antimicrobial for mild 

respiratory and digestive tract 

infections; relieves nausea. 

Rare, but include mild 

gastrointestinal symptoms 

such as heartburn and 

nausea, body and breath 

odor, headache, and vertigo.

May decrease blood 

glucose. 

May potentiate the bloodthinning effects of antiinflammatory medications 

such as aspirin and 

supplements such as 

vitamin E and fish oil; may 

interact with the bloodthinning drug warfarin 

(Coumadin); may 

potentiate 

antihypertensives.

Ginkgo biloba Improves memory and mental 

sharpness; alleviates 

symptoms of Alzheimer's 

disease; eases symptoms of 

depression; improves 

circulation; thins blood; 

improves cardiovascular 

health; acts as antioxidant;

improves vertigo, headache, 

and tinnitus; relieves 

intermittent lower leg cramps, 

diabetic retinopathy, 

wheezing, dizziness, motion 

sickness, and Raynaud's.

Very rarely associated with 

gastrointestinal upset, 

allergic skin reaction, and 

headache.

Not for people with seizure 

disorders because it may 

reduce the effects of seizure 

medication. Not to be taken 

by people hypersensitive to 

poison ivy, cashews, or 

mangoes.

Could pose a concern to 

people with blood clotting 

problems or those taking 

anticoagulant 

medications. Not 

recommended for people 

using aspirin, or 

nonsteroidal 

antiinflammatory drugs.

Ginseng Relieves stress, eases 

symtoms of anxiety, delays or 

reduces the effects of aging 

used as a tonic for well-being, 

enhances immune function, 

reduces blood sugar, 

improves cognitive function,

relieves menopausal 

symptoms, acts as an 

antioxidant, 

hypocholesterolemia, 

enhances athletic 

performance, boosts energy, 

increases sexual stamina, 

helps with impotence and 

infertility, prevents and fights 

diseases such as cancer, 

increases energy, protects the 

heart, strengthens stomach 

functions, prevents 

arteriosclerosis, stabilizes 

blood pressure and insulin 

levels. 

Generally considered quite 

safe although it is 

recommended that a course 

of treatment not exceed 3 

months; may cause breast 

tenderness, swollen breasts, 

vaginal bleeding in women, 

nervousness, excitation, 

hypertension, headaches, 

insomnia, restlessness, 

vomiting, and may cause 

breast cancer to reoccur in 

women who have had the 

disease previously.

Caution recommended for 

individuals with 

hypertension and those 

prone to hypoglycemia. 

High doses may inhibit 

immune function in early 

stages of infection.

People with cancer should 

consult their physician. 

People with cardiovascular 

disease or diabetes 

exercise caution.

May interfere with digoxin 

activity or monitoring.

If used with warfarin or 

other anticoagulant, can 

alter bleeding times. If 

used with phenelzine 

sulfate (an 

antidepressant) or a 

monoamine ozidase 

inhibitor (MAOI), can 

cause headaches, 

tremors, and manic 

episodes. Caution with 

insulin.

(Continued From Previous Page)

Product Principal claimsa

Principal known adverse 

effects

Principal known 

contraindicationsb

Principal known 

interactions
Appendix II

Known Claims, Adverse Effects, 

Contraindications, and Interactions of 

Herbal and Specialty Supplements

Page 31 GAO-01-1129 "Anti-Aging" Health Products

Glucosamine Reverses osteoarthritis, 

protects joints and tendons 

from injury, decreases 

inflammation. 

Occasional symptoms of 

gastrointestinal discomfort; 

reduced insulin secretion 

noted in animal studies.

Concern about 

interactions for people on 

blood-thinning 

medications and about 

harmful effects on insulin 

resistance.

Kava kava Eases symtoms of anxiety, 

restlessness and nervous 

tension; promotes relaxation; 

aids sleep; balances mood; 

restores vigor; eases 

symptoms of depression and 

menopause (hot flashes); acts 

as an analgesic, headache 

remedy, and mild sedative; 

eases uterine inflammation, 

colds, rheumatism; promotes 

urination; soothes upset 

stomachs; eases symptoms 

of asthma and tuberculosis; 

cures fungal infections; 

inhibits gonorrhea; soothes 

stings and skin inflammations. 

Can result in temporary skin 

and liver problems, allergic 

reactions, gastrointestinal 

discomfort, absence of 

urination, numbness of the 

mouth, painful twisting 

movements of the trunk, 

disturbances of the 

oculomotor equilibrium, and 

can disturb motor reflexes 

and judgment when driving.

Not appropriate for 

individuals with major 

anxiety conditions. Should 

not be used while driving. 

May worsen symptoms of 

Parkinson's. Use in 

endogenous depression 

should be avoided. Should 

not be used for more than 3 

months. Should not be used 

if gall bladder or liver 

problems, including 

cirrhosis and hepatitis. 

Should not be taken with 

alcohol or antianxiety 

drugs such as valium.

May have additive effects 

with other muscle 

relaxants, sedatives, 

antianxiety agents, and 

antidepressants.

Should not be taken with 

antidepressants or 

antipsychotics. 

Melatonin Promotes sleep, reduces 

symptoms of jet-lag, slows 

aging process, increases sex 

hormone secretion, acts as 

antioxidant, relieves tinnitus, 

may inhibit growth of breast 

cancer cells.

May cause infertility, 

hypothermia, and retinal 

damage; reduces sex drive 

in males; leads to high blood 

pressure, diabetes, and 

cancer.

Can induce or deepen 

depression in susceptible 

individuals. May be 

dangerous for people with 

cardiovascular risk factors. 

Should not be taken by 

people with immune-system 

disorders (including severe 

allergies), autoimmune 

diseases (such as 

rheumatoid arthritis), 

immune-system cancers 

(e.g., lymphoma), severe 

mental illness, or those 

taking steroids.

May interfere with 

hormone replacement 

therapy. May enhance the 

effectiveness of certain 

chemotherapy drugs.

(Continued From Previous Page)

Product Principal claimsa

Principal known adverse 

effects

Principal known 

contraindicationsb

Principal known 

interactions
Appendix II

Known Claims, Adverse Effects, 

Contraindications, and Interactions of 

Herbal and Specialty Supplements

Page 32 GAO-01-1129 "Anti-Aging" Health Products

Omega-3 fatty 

acids (fish oil)

Provides heart protection; 

dilates blood vessels; reduces 

blood pressure; reduces 

blood clotting; suppresses 

inflammation; relieves pain of 

rheumatoid arthritis; eases 

symptoms of depression and 

attention deficit/hyperactivity 

disorder; increases growth 

hormone levels; relieves 

symptoms of allergies, 

asthma, and skin disorders; 

can help prevent breast, 

prostate, and colon cancers; 

inhibits growth of pancreatic 

cancer, protects against 

kidney failure.

Encourages bleeding and 

hemorrhage, causes fishy 

breath odor, belching, 

abdominal bloating, 

increases total blood 

cholesterol.

Saw palmetto Aids in the treatment of 

benign prostate hyperplasia 

(BPH), increases libido, 

increases sperm production, 

increases breast size of 

women, useful as a urinary 

antiseptic and diuretic, 

prevents hair loss (men only), 

treats low thyroid function and 

irritable bladder.

Rare but include headaches, 

gastrointestinal 

disturbances, diarrhea, 

vomiting, upset stomach, 

constipation, nausea, 

dizziness, erectile 

dysfunction, difficulty 

sleeping, fatigue, and heart 

pain.

People with enlarged 

prostate should consult 

physician on a regular 

basis. Use should be 

avoided in patients with 

breast cancer.

Shark cartilage Cures or prevents cancer, 

promotes wound healing, 

relieves arthritis pain and 

stiffness.

Could lead to thyroid 

hormone toxicity, may cause 

nausea, indigestion, fatigue, 

fever, and dizziness.

May slow down the healing 

process for people 

recovering from surgery. 

Shark cartilage enemas 

should be avoided by 

people with a low white 

blood cell count. Relying on 

this type of treatment alone 

and avoiding conventional 

medical care may have 

serious health 

consequences.

Soy proteins and 

isoflavones

Reduces cholesterol and 

triglyceride levels, reduces 

risk of heart disease, 

suppresses menopausal 

symptoms (hot flashes), 

reduces bone breakdown 

(osteoporosis), prevents 

cancer.

Mild gastrointestinal 

complaints such as bloating 

and flatulence. 

May interfere with the 

absorption of 

supplemental thyroid 

hormones. May interact 

with ipriflavone, a 

synthetic isoflavone.

(Continued From Previous Page)

Product Principal claimsa

Principal known adverse 

effects

Principal known 

contraindicationsb

Principal known 

interactions
Appendix II

Known Claims, Adverse Effects, 

Contraindications, and Interactions of 

Herbal and Specialty Supplements

Page 33 GAO-01-1129 "Anti-Aging" Health Products

a

Principal claims are manufacturing claims and uses that have been reported. However, we have not 

substantiated any of these claims.

b

We do not include any contraindications for children or pregnant or nursing women.

Sources: 

Physicians' Desk Reference for Herbal Medicines, 2nd ed. (Montvale, N.J.: Medical Economics, 2000); 

Blumental, M. (ed.) The Complete German Commission E monographs: Therapeutic Guide to Herbal 

Medicines, (Boston, Mass.: American Botanical Council, 1998); J. H. McDermott, "Herbal Chart for 

Health Care Professionals" (chart) (Washington, DC: American Pharmaceutical Association. 1999); 

Bruss, Katherine (ed.), American Cancer Society's Guide to Complementary and Alternative Cancer 

Methods (Atlanta, Ga.: American Cancer Society, 2000); M. McGuffin and others (eds.), American 

Herbal Products Association's Botanical Safety Handbook, (Boca Raton, Fla.: CRC Press, 1997); 

Center for Science in the Public Interest, "Supplements: Latest research on vitamins, minerals and 

herbs" (reprinted selections from Nutrition Action Healthletter) (Washington, D.C.: Center for Science 

in the Public Interest, 1999); www.supplementwatch.com; and www.supplementinfo.org.

St. John's wort Eases symptoms of mild to 

moderate depression; 

stabilizes mood; improves 

tolerance to stress; improves 

sleep patterns in older people; 

eases symptoms of anxiety; 

increases energy levels; 

controls appetite and 

promotes weight loss; eases

bronchial inflammation, 

stomach problems, 

hemorrhoids, hypothyroidism, 

migraines, kidney disorders; 

aides insect bites and stings, 

skin diseases, scabies, skin 

inflammation, burns and 

wounds, and blunt injuries 

bedwetting; aids in wound 

healing and in resistance to 

viral infection when applied 

topically.

Mild gastrointestinal upset, 

skin rashes, tiredness, 

insomnia, restlessness, 

dizziness, confusion, 

photosensitivity, (especially 

in fair-skinned individuals)

serotonin syndrome,

dry mouth, fast or irregular 

breathing.

Can be toxic to sperm; not 

for the treatment of severe 

depression. 

No longer believed that it 

magnifies effect of MAOI, 

but users should consult 

physician. May decrease 

effectiveness of HIV 

drugs, 

immunosuppressants, 

digoxin, blood thinners, 

chemotherapy drugs, and 

asthma medications. 

Abrupt withdrawal can 

increase blood levels of 

various medications. 

Should not be used with 

alcohol, narcotics, 

amphetamines, 

anticoagulants, 

antibiotics, or cold and flu 

medicines such as 

pseudo-ephedrine. 

Should not be used with 

other antidepressants or 

with certain cheeses. 

May interfere with action 

of certain oral 

contraceptives.

Valerian Promotes relaxation, induces 

sleep, ease symptoms of 

anxiety, calms nerves, helps 

people quit smoking, eases 

congestion, and relieves 

muscle spasms.

Headaches, mild nausea, 

upset stomach, heart 

palpitations, restlessness, 

excitability, hypersensitivity 

reactions, insomnia, blurred 

vision, and very high doses 

may weaken the heartbeat 

and cause paralysis.

People taking sedatives or 

antidepressants should 

consult physician. Should 

not be consumed for more 

than 2 weeks. People with 

liver or kidney disease 

should consult physician.

Should not be taken with 

alcohol, certain 

antihistimines, muscle 

relaxants, psychotropic 

drugs, sedatives, 

barbiturates, or narcotics.

Should not be taken with 

alcohol or other 

tranquilizers.

(Continued From Previous Page)

Product Principal claimsa

Principal known adverse 

effects

Principal known 

contraindicationsb

Principal known 

interactions
Page 34 GAO-01-1129 "Anti-Aging" Health Products

Appendix III

NCCAM Studies on Alternative Therapies 

Relevant to Senior Citizens ApendxiI

The National Center for Complementary and Alternative Medicine 

(NCCAM) supports research to test the safety and efficacy of a variety of 

complementary and alternative medicine modalities. Some of this research 

focuses on health issues that are relevant to senior citizens, such as 

arthritis and cancer (see table 3). In fiscal year 2000, appropriations for 

NCCAM totaled $68.3 million. Additional expenditures by other NIH 

Institutes and Centers brought the agency’s commitment to complementary 

and alternative medicine to $161 million for fiscal year 2000. In fiscal year 

2001, NCCAM’s appropriations increased 29 percent to approximately 

$89 million. 

Table 3: Studies Identified in NCCAM’s Fiscal Year 2001-2005 Strategic Plan 

Relevant to Senior Citizens

In addition, NCCAM funds a variety of specialized research centers that 

serve as focal points for initiating and maintaining state-of-the-art 

multidisciplinary research on complementary and alternative medicine. 

Some of these focus on issues specifically relevant to older Americans: 

• The center for cardiovascular diseases at the University of Michigan is 

examining the effect of hawthorn (an herbal supplement) in the 

Condition Studies

Arthritis • Acupuncture safety/efficacy in knee osteoarthritis

• Study of the efficacy of glucosamine and glucosamine/chondroitin 

sulfate in knee osteoarthritis

Cancer • Control trial of ancillary nutritional support and detoxification 

procedures for inoperable pancreatic cancer

• Self-transcendence in breast cancer support groups

• Shark cartilage trial (in the treatment of patients with breast or 

colorectal cancer)

• Shark cartilage trial (in the treatment of non-small-cell lung cancer)

Cardiovascular 

diseases

• Acupuncture and hypertension: efficacy and mechanisms

• Effect of high-dose vitamin E on carotid atherosclerosis

• Effects of medication on mechanisms of coronary heart disease

Mental health 

disorders

• Effects of a standardized extract of Hypericum perforatum (St. John’s 

wort) in major depressive disorder

• Acupuncture in the treatment of depression

• Omega-3 fatty acids in bipolar disorder prophylaxis

Neurological 

disorders

• Ginkgo biloba depression-prevention trial in older individuals

• Melatonin for sleep disorders in Parkinson’s disease

Urological 

disorders

• Saw palmetto extract in benign prostatic hyperplasia 
Appendix III

NCCAM Studies on Alternative Therapies 

Relevant to Senior Citizens

Page 35 GAO-01-1129 "Anti-Aging" Health Products

treatment of heart failure; the effect of Reiki (a natural energy therapy) 

on diabetes and cardiovascular autonomic function; and the effect of Qi 

gong (a Chinese practice that combines movement, meditation, and 

regulation to enhance the flow of energy) and spirituality and 

psychosocial factors on wound closure, pain, medication usage, and 

hospital stay in postoperative cardiac patients. 

• The center for neurological disorders at Oregon Health Sciences 

University is examining the effectiveness of three antioxidant regimens 

in decreasing multiple sclerosis disease activity, ginkgo biloba in the 

prevention or delay of cognitive decline in elderly patients, hatha yoga 

on cognitive and behavioral changes associated with aging and 

neurological disorders in multiple sclerosis, and vitamin E and ginkgo 

biloba in reducing oxidative end-products. 

• The center on arthritis at the University of Maryland is investigating the 

effectiveness of acupuncture for the treatment of osteoarthritis of the 

knee, the effectiveness of mind-body therapies for fibromyalgia, the 

effects of electroacupuncture on persistent pain and inflammation, and 

the mechanism of an herbal combination with immunomodulatory 

properties.

• The center on aging at Columbia University is investigating the influence 

of a macrobiotic diet on endocrine, biochemical, and cardiovascular 

parameters; whether phytoestrogens influence bone metabolism in 

postmenopausal women; whether black cohosh (an herbal supplement) 

reduces the frequency and intensity of menopausal hot flashes and other 

menopausal symptoms; and the biological activities and mechanisms of 

a Chinese herbal formula on breast cancer cells.

• The center for the study of minority aging and cardiovascular disease at 

the Maharishi University of Management focuses on a form of Ayurvedic 

Indian medicine that incorporates herbal formulations and medication 

in older blacks. Specific studies focus on the basic mechanisms of 

meditation and cardiovascular disease in older blacks, the effect of 

transcendental meditation on reducing hypertension, and the effects of 

herbal antioxidants on cardiovascular disease in older blacks.
Page 36 GAO-01-1129 "Anti-Aging" Health Products

Appendix IV

Recent FDA Actions ApendxiIV

FDA identified actions it has taken in response to products making illegal 

claims that were targeted at least in part toward senior citizens. These are 

listed in table 4.

Table 4: Recent FDA Actions for Health Products Determined to Be Making Illegal Claims

Company 

Products or 

servicesa Claimb FDA actions Outcome

Christian Brothers 

Contracting Corp. 

(New York)

Laetrile products: 

“Vitamin B-17 

Tablets,” “Apricot 

Seeds,” and 

“Amigdalina” ampuls

FDA alleged that video touted 

efficacy of products in curing 

cancer. Several Web sites 

featured similar claims; company 

sent out unsolicited e-mail 

notices to potential customers.

Issued warning letter to 

company that products being 

promoted were unapproved 

new drugs and were 

misbranded and that laetrile 

remains the subject of an 

import alert and had been 

declared to be an 

unapproved new drug in 

other matters. FDA 

subsequently filed a 

complaint for permanent 

injunction, based in part on 

an undercover investigation 

during which FDA agents 

purchased laetrile products 

after company allegedly said 

distribution had stopped. 

Consent decree in 

November 2000 granted 

permanent injunction. 

Laetrile products ordered 

destroyed at company’s 

expense. FDA given 

authority to make continuing 

unannounced inspections to 

check compliance.

Health Resources 

(Alabama)

“b-Calm’d,”

“Earthwise,”

“AloeGold,” “Para 

90,” “Maxi-Chel,”

“Enhance Plus,”

“Super BP,” “Triomin,”

and “Perform,”

among other 

supplement 

products

Among primary claims were that 

products could treat high blood 

pressure, strokes, alcoholism, 

flu, fevers, herpes, hepatitis, 

Epstein-Barr, pneumonia, and 

other diseases and conditions. 

Issued warning letter in May 

2000.

Company removed Web 

site and agreed to modify 

promotional literature and 

advertising to remove 

claims.

Hillestad Pharmaceuticals, USA 

(Wisconsin)

Various herbal 

products, including 

garlic, gingko biloba, 

and St. John’s wort

Primary claims were that 

products could cure and treat 

various diseases and conditions, 

including anxiety, depression, 

coughs, asthma, and allergies.

Filed complaint arguing that 

products were misbranded 

and that labeling showed that 

intended use was in cure, 

treatment, mitigation, and 

prevention of disease, 

making products unapproved 

new drugs. Seized products. 

Court order, July 2000, 

required products and 

catalogs featuring disease 

treatment claims to be 

destroyed or revised to 

remove disease treatment 

claims, and Web site 

modified to remove disease 

treatment claims. FDA given 

authority to make 

unannounced inspections.
Appendix IV

Recent FDA Actions

Page 37 GAO-01-1129 "Anti-Aging" Health Products

Jewell Hall 

(Arkansas)

“Black Pills for 

Arthritis” and “Joint 

Factors”

Primary claims were that “Black 

Pills” could relieve pain due to 

rheumatism, paralysis, bone 

pain, and acute and chronic 

neuralgia. “Joint Factors”

claimed to address pain, 

rheumatoid arthritis. FDA 

analysis also revealed “Black 

Pills” contained four prescription 

drugs not on the label.

Filed seizure complaint, 

arguing that “Black Pills”

were misbranded, labeling 

was inadequate, and 

products were unapproved 

new drugs. Destroyed drugs 

and labeling after court 

condemnation.

Following no reply to 

complaint, products ordered 

destroyed in court order 

issued November 2000.

Lane Labs-USA, 

Inc. (New Jersey)

“BeneFin” (produced 

from shark 

cartilage), 

“SkinAnswer” (a 

glycoalkaloid skin 

cream), and “MGN3” (rice bran extract)

FDA alleges that the products 

are intended for use in the 

treatment of cancer, skin cancer, 

and HIV/AIDS, among other 

diseases. 

Issued warning letter in 

September 1997 notifying 

the company that “BeneFin”

and “SkinAnswer” were 

misbranded and unapproved 

new drugs. Through an 

undercover investigation in 

1998-99, FDA determined 

that the company was 

continuing to distribute 

unapproved and misbranded 

drugs. A complaint for 

permanent injunction was 

filed in December 1999. 

In December 1999, FDA 

filed a complaint for 

permanent injunction 

alleging violations in 

warning letter.

NutriSOY International (Indiana)Soy protein 

products, including 

“California Joe 

Drink”; other 

products included 

“Essential 

ProPLUS,” and 

“Essential Protein”

Primary claims were for lowering 

cholesterol; treatment of 

numerous diseases, including 

cancer, diabetes, and heart 

disease; to “help the liver 

recover from the effects of 

alcohol, viruses, and other toxic 

agents;” and to treat kidney 

stones, stroke, and other serious 

illnesses and conditions.

Issued warning letter in 

March 2000 that products 

were making disease 

treatment claims and were 

unapproved new drugs.

Company agreed to 

redesign Web site and other 

promotional materials to 

remove disease treatment 

claims.

Pharmanex 

(California,Delawa

re, and Utah)

“Cholestin,” a red 

yeast rice product 

containing lovastatin

Primary claims were that 

“Cholestin” lowers serum total 

cholesterol, lowers serum 

triglycerides, lowers LDL 

cholesterol, and raises HDL 

cholesterol.

Issued an administrative 

ruling that “Cholestin” was 

not a dietary supplement but 

an unapproved new drug.

Court upheld FDA decision.

(Continued From Previous Page)

Company 

Products or 

servicesa Claimb FDA actions Outcome
Appendix IV

Recent FDA Actions

Page 38 GAO-01-1129 "Anti-Aging" Health Products

a

Specific product names are listed in quotation marks.

b

List does not necessarily include all claims for products.

Scientific Health 

Products doing 

business as 

Natural Wonders

(Utah)

“Prevent,”

“AloeWonder,”

“Inflammation-B,” “Herb-ADerm,” “S-E-T Free,”

“Kleen-Sweep-I,”

“Me Again,” and 

“Depression,” among 

other products.

Primary claims were various 

disease treatment claims, 

including “prevents degenerative 

disease and age-related health 

problems,” most commonly, 

heart disease and cancer.

Issued warning letter in 

August 1999, with follow-up 

inspection in July 2000.

Company modified claims 

for some, but not all, 

products, and destroyed 

some catalogs. In May 

2001, company agreed to 

cease operation.

Universal 

Management Services, 

and Natural 

Choice Products 

(Ohio)

“Stimulator” device 

(similar to gas grill 

igniters outfitted with 

finger grips)

Primary claims were for relief of 

many kinds of pain, including 

migraine headaches, sciatica, 

swollen joints, and carpal tunnel 

syndrome.

At FDA’s request, U.S. 

Marshals seized about 

16,000 “Stimulators” from 

company’s offices. Company 

continued to distribute the 

unapproved devices. 

Court order required 

companies to pay refunds 

of about $82 each on 

request; refund program 

administered externally. 

Worldtech 

Research Group; 

World Without 

Cancer, Corp.; 

Health Genesis 

Corp.; The Health 

World International

(Florida)

“Vitamin B17”

(commonly known 

as laetrile or 

amygdalin). 

Primary claim was that laetrile 

products cured cancer and 

inhibited tumor growth. 

Issued warning letter to 

Worldtech Research Group 

that laetrile is an unapproved 

new drug, and that claims for 

other products were disease 

treatment claims.

Permanent injunction 

granted against sale and 

distribution of laetrile 

products or any other “new 

drugs.” FDA given authority 

to make continuing 

unannounced inspections to 

check compliance. Decree 

required defendants to 

modify Web sites so as to 

cease using the Web sites 

to promote for sale laetrile 

products or any other drug 

product that is a new drug.

(Continued From Previous Page)

Company 

Products or 

servicesa Claimb FDA actions Outcome
Page 39 GAO-01-1129 "Anti-Aging" Health Products

Appendix V

Recent FTC Actions ApendxiV

FTC identified examples of actions it has taken in response to products 

with illegal advertisements and that were targeted at least in part to senior 

citizens. These are listed in table 5.

Table 5: FTC Cases of Illegal Advertising for Products Targeted to Senior Citizens

Company Products or servicesa Claims challenged Outcome

Aaron Company 

(Florida)

Colloidal silver, chitosan 

with vitamin C, and 

“Ultimate Energizer”

Colloidal silver product can cure or treat 

more than 650 diseases (including 

HIV/AIDS, multiple sclerosis, and 

cancer); chitosan product made weight 

loss claims; and “Ultimate Energizer” is 

safe and has no side effects.

July 2001, company ordered not to make 

unsubstantiated disease treatment claims 

and ordered that products containing 

ephedra or ephedrine carry a label warning 

that such products can have dangerous 

effects on the central nervous system and 

should not be taken with MAO inhibitors or 

allergy medications.

No consumer redress ordered.

Arthritis Pain Care 

Center (Texas)

“CMO” (cetylmyristoleate)“CMO” treats most forms of arthritis and 

is beneficial in treating numerous other 

diseases. 

September 1999, company ordered not to 

make future unsubstantiated disease 

treatment claims and to monitor distributors’

advertising and promotional activities, and to 

notify distributors about the order. 

No consumer redress ordered.

Christopher 

Enterprises (Utah)

Various comfrey products Comfrey products for internal 

consumption are effective in treating 

and/or curing asthma, colds, coughs, 

lung congestion, sore throats, 

emphysema, bronchitis, tuberculosis, 

broken bones, polio, multiple sclerosis, 

spinal curvature, and spinal cancer. 

Suppository products are effective for 

prolapsed bowel and uterus, yeast 

infections, and herpes simplex. 

Comfrey antiseptic is effective for 

thrush, infection, pyorrhea, sore throat, 

and toothaches.

July 2001, company agreed to preliminary 

injunction to stop marketing comfrey products 

for internal uses or use on open wounds, to 

include a warning on products, and to cease 

making safety and health benefit claims in 

the absence of supporting scientific 

evidence.

CMO Distribution 

Centers of America 

(Michigan and 

Florida)

“CMO” (cetylmyristoleate)“CMO” “normalizes” immune system; 

cures arthritis; and treats asthma, 

emphysema, and certain cancers.

May 2000, company ordered not to make 

future unsubstantiated disease treatment 

claims and required to monitor product 

advertising by distributors, and to notify 

distributors about order. 

Full refund (about $100 per bottle) ordered 

for individuals requesting one within 120 days 

of order.
Appendix V

Recent FTC Actions

Page 40 GAO-01-1129 "Anti-Aging" Health Products

EHP Products 

(Kentucky)

“CMO” product, “Myristin”

capsules 

“CMO”/Myristin relieves arthritis and 

prevents rheumatoid arthritis and 

osteoarthritis.

May 2000, company ordered not to make 

unsubstantiated treatment claims, and 

required to notify distributors of order and to 

monitor product advertising by distributors.

Ordered full consumer refund (about $100 

per bottle), plus shipping fee of $3.50, for 

consumers requesting one within 120 days.

ForMor (Arkansas) “St. John’s Kava Kava,”

colloidal silver, and 

“Ultimate II Shark 

Cartilage Concen-trate”

“St. John’s Kava Kava” is effective in 

treatment of HIV/AIDS, colds, syphilis, 

tuberculosis, dysentery, and other 

conditions; colloidal silver was effective 

for more than 650 infectious diseases; 

and shark cartilage product was 

effective in treatment of arthritis and 

brain cancer.

August 2001, company ordered not to make 

unsubstantiated disease treatment claims 

and to include warning label on “St. John’s 

Kava Kava” product alerting consumers to 

potential risks of interactions with 

prescription drugs, including anticoagulants, 

oral contraceptives, antiseizure medications, 

HIV drugs; and not to make unsubstantiated

disease treatment claims for colloidal silver 

and shark cartilage.

Ordered full consumer refunds for customers 

requesting refund within 90 days for colloidal 

silver and shark cartilage products 

purchased between January 1999 and 

August 2001.

Jaguar Enterprises 

(Florida, North 

Carolina, Texas)

Electronic devices, 

including the “Black Box,”

the “Magnetic Pulser,” the 

“Magnetic Multi-Pulser,”

the “Beck-Rife Unit,” and 

the “Portable Rife 

Frequency Generator”; 

also, a “Miracle Herbs”

product. 

Electronic devices cure and prevent 

serious diseases such as cancer, AIDS, 

arthritis, Gulf War syndrome, and 

chronic fatigue syndrome, and 

“Miracle Herbs” treats cancer of all 

types, AIDS, and various bacterial and 

viral infections.

August 2001, company ordered not to make 

unsubstantiated disease treatment claims.

Ordered full consumer refund, including 

shipping and handling fees, for individuals 

requesting refund within 90 days of required 

notice.

Lane Labs-USA, Inc. 

and Cartilage 

Consultants (New 

Jersey)

“BeneFin” and “SkinAnswer”“BeneFin” and “SkinAnswer” effectively 

treat cancer. 

June 2000, company ordered not to make 

unsubstantiated therapeutic claims.

Judgment of $1 million required, including 

$450,000 to be used for purchase of shark 

cartilage and placebo products to be tested 

in NIH clinical trial.

Maxcell Bioscience, 

Inc., and Oasis 

Wellness Network 

(Colorado)

“Longevity Signal 

Formula with DHEA 

(LSF),” and “Anabolic/ 

Catabolic Index Test” (an 

at-home urine test).

“LSF” reverses the aging process and 

prevents, treats, or cures numerous 

age-related diseases and conditions, 

including atherosclerosis, arthritis, high 

blood pressure, elevated cholesterol 

levels, weight gain, and poor liver 

function. “Anabolic/Catabolic Index”

measures youthfulness and 

healthiness.

August 2001, company ordered not to make 

unsubstantiated disease treatment and “antiaging” claims for LSF or claims that device 

test results provide a clinical gauge of overall 

healthiness and youthfulness; and company 

required to notify distributors of order and to 

monitor product advertising and promotion by 

distributors.

Ordered $150,000 in consumer redress.

(Continued From Previous Page)

Company Products or servicesa Claims challenged Outcome
Appendix V

Recent FTC Actions

Page 41 GAO-01-1129 "Anti-Aging" Health Products

a

Specific product names are listed in quotation marks.

Natural Heritage 

Enterprises 

(Colorado)

Essiac tea Essiac tea treats cancer, diabetes, 

HIV/AIDS, and

feline leukemia.

May 2000, company ordered not to make 

unsubstantiated disease treatment claims 

and required company to notify consumers 

that there is no scientific evidence that Essiac 

tea cures cancer or other diseases.

Ordered payment of $17,500 for consumer 

redress.

Pain Stops Here! 

(New York)

Magnets and magnetic 

products, including 

magnetic sleep pads and 

magnetized water

Magnets and magnetic products can 

treat cancer, cure liver disease, reduce 

cholesterol, prevent and reverse heart 

disease, and relieve pain associated 

with arthritis, bursitis, and sciatica.

September 1999, company ordered not to 

make unsubstantiated disease treatment 

claims and to notify distributors of order and 

to monitor product advertising by distributors. 

No consumer redress ordered.

Panda Herbal 

International, Inc. 

(Pennsylvania)

“Herbal Outlook” and 

“Herb Veil 8”

“Herbal Outlook” is an effective 

treatment for HIV/AIDS, tuberculosis, 

influenza, and hepatitis B; “Herb Veil 8”

is an effective treatment for carcinomas, 

and melanoma.

August 2001, company ordered not to make 

unsubstantiated disease treatment claims; 

required warning label for “Herbal Outlook”

alerting consumers to potential risks of 

interactions with prescription drugs, including 

anticoagulants, oral contraceptives, 

antiseizure medications, HIV/AIDS drugs; 

and required company to monitor advertising 

and promotional materials distributed by 

purchasers who are resellers. 

Ordered to pay full refunds within 90 days to 

consumers who purchased “Herb Veil 8” and 

requested a refund. 

Rose Creek Health 

Products and Staff of 

Life (Washington)

“Vitamin O” “Vitamin O” allows oxygen molecules to 

be absorbed through the 

gastrointestinal system and prevents or 

treats life-threatening diseases. 

April 2000, companies ordered not to make 

unsubstantiated therapeutic claims and to 

notify distributors of order.

Payment of $375,000 ordered for consumer 

redress and consumer education.

SmartScience 

Laboratories

(Florida)

“JointFlex” “JointFlex,” a topical skin cream, 

eliminates pain due to disabling joint 

conditions, crushed vertebrae, 

herniated disks, and other conditions. 

November 2000, company ordered not to 

make unsubstantiated disease treatment 

claims for its products.

No consumer redress ordered.

Western Dietary 

Products Co. 

(Washington)

Various herbal formulas, 

“cure” packages, and 

“Zapper Electrical Unit”

device

Herb formulas and cure packages can 

treat and cure cancer, diabetes, and 

arthritis. “Zapper Electrical Unit” can 

treat and cure Alzheimer’s and 

HIV/AIDS.

Company agreed to preliminary injunction in 

June 2001, involving its products and 

activities. 

FTC has requested consumer refund.

Outcome is pending.

(Continued From Previous Page)

Company Products or servicesa Claims challenged Outcome
Page 42 GAO-01-1129 "Anti-Aging" Health Products

Appendix VI

Examples of Questionable Health Care 

Products Used by Senior Citizens, as 

Reported by State Officials ApendxiVI

State officials we talked with described a number of products used by 

seniors that were questionable or had questionable advertising and where 

state action was taken, including the following: 

• Companies marketing therapeutic magnets with unsubstantiated claims 

that they can cure a variety of diseases, including diabetes and 

osteoporosis. One state health department official noted that some 

magnet companies are aware that they can only be sold for general wellbeing, but in other states they continue to be marketed with health 

claims. 

• A national mail-order company selling a variety of health products with 

unsubstantiated promises to cure prostate disease, bladder problems, 

hair loss, skin discoloration, sexual impotence, and cancer. Authorities 

in one state have obtained restitution for consumers, civil fines, and 

court orders to keep this and similar companies from selling 

fraudulently advertised products, including anti-aging formulas, to its 

residents. However, the authorities have no means to prevent the 

company from publishing misleading material and selling questionable 

products in the rest of the country. 

• A Web-based company advertising a breast-enhancement product to 

women who have had mastectomies with the claim that it can 

regenerate lost breast tissue. The company removed its claim after 

being contacted by a state attorney general’s office. 

• Herbal remedies contaminated with toxic substances such as heavy 

metals. Authorities in one state have analyzed products and found cases 

of adulteration in imported ingredients used in traditional Chinese 

medicine. 

• Herbal supplements “spiked” with prescription drugs or synthetic 

ingredients. In one case a diabetic had to seek medical treatment after 

taking an herbal product that contained a prescription diabetes drug. 

Another product marketed as an “all-herbal” weight-loss formula using 

ephedra was found to contain ephedrine, a synthetic substance not 

listed on the label. Concerns about the potential health hazards 

associated with ephedra have prompted several states to issue 

regulations restricting its dosage or sale. 

• Testing blood and hair samples to diagnose nutritional deficiencies or 

illnesses to induce people to buy a particular dietary supplement as 

treatment. In one state, there is an ownership link between the out-ofstate laboratories doing the analyses and the manufacturer of the 

dietary supplements.
Page 43 GAO-01-1129 "Anti-Aging" Health Products

Appendix VII

GAO Contact and Staff Acknowledgments ApendxiVI

GAO Contact Martin T. Gahart, (202) 512-3596

Staff 

Acknowledgments

Carolyn Feis Korman, Anne Montgomery, Mark Patterson, Roseanne Price, 

and Suzanne Rubins also made major contributions to this report. 

(290051) Letr
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