Testimony

Before the Special Committee on Aging, U.S. Senate

United States General Accounting Office

GAO

For Release on Delivery

Expected at 10:00 a.m.

Monday, September 10, 2001 HEALTH PRODUCTS FOR

SENIORS

Potential Harm From

“Anti-Aging” Products

Statement of Janet Heinrich

Director, Health Care—Public Health Issues

GAO-01-1139T
Page 1 GAO-01-1139T

Mr. Chairman and Members of the Committee:

I am pleased to have the opportunity to testify as the Committee considers

“anti-aging” and alternative medicine products marketed to America’s

senior citizens. Today we are releasing a report that summarizes the risks

associated with such products and reviews federal and state oversight

activities in this area.1

Anti-aging and alternative medicine products are popular among

consumers. Surveys have found that as many as 40 percent of senior

citizens have used dietary supplements in the past year and that

approximately 10 percent of seniors use them regularly. These

supplements include herbal or botanical dietary supplements, such as

ginkgo biloba, ginseng, and St. John’s wort, as well as specialty

supplements, such as glucosamine, fish oil, and melatonin. Some of these

products show potential health benefits. For example, some studies have

suggested that St. John’s wort may counteract feelings of mild to moderate

depression and that gingko biloba may improve cognitive performance in

dementia. However, regulators and medical experts are concerned that

some products have health risks and some are marketed to seniors with

anti-aging and “cure-all” claims for which there is little scientific evidence

of either safety or effectiveness. There is also concern that seniors may be

wasting money on products that have little or no therapeutic value.

Because of these concerns, you asked us to look at dietary supplements

and devices that are marketed for health conditions that affect older

adults. I will summarize the key findings of our report, in which we (1)

describe the potential physical harm associated with some anti-aging and

alternative medicine products, (2) describe the economic harm associated

with questionable anti-aging and alternative medicine products, and (3)

examine federal and state oversight efforts designed to protect consumers

from questionable anti-aging and alternative medicine products.

In summary, 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

 1

Health Products for Seniors: “Anti-Aging” Products Pose Potential for Physical and

Economic Harm (GAO-01-1129, Sept. 7, 2001).
Page 2 GAO-01-1139T

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. The Food and Drug

Administration (FDA) and the Centers for Disease Control and Prevention

(CDC) have received reports of adverse events experienced by seniors

taking dietary supplements in recent years. FDA has issued warnings to

consumers and industry about the health risks of several dietary

supplement products.

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 the Federal Trade Commission (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. The National Institutes of Health (NIH) has an

expanding research agenda to evaluate popular alternative therapies. FDA

has taken various enforcement actions against firms that 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 rulemaking authority.

Further, 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,
Page 3 GAO-01-1139T

FTC and FDA have combined efforts 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 anti-aging and

alternative products are receiving limited attention.

Since 1994, when the Dietary Supplement Health and Education Act

(DSHEA) was enacted, sales of dietary supplements have soared. In 2000,

total U.S. sales for herbal and specialty supplements reached $5.8 billion.

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 the appendix for

details regarding these substances.)

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 Secretary of the Department

of Health and Human Services may declare the existence of an imminent

hazard from a dietary supplement, 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.

Background
Page 4 GAO-01-1139T

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, which

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.

Health risks associated with dietary supplements come in a number of

forms. First, some dietary supplements have been associated with adverse

effects, some of which can be serious. Second, individuals with certain

underlying medical conditions should avoid some dietary supplements.

Third, some frequently used dietary supplements can have dangerous

interactions with prescription or over-the-counter drugs that are being

taken concurrently. Fourth, dietary supplements may contain harmful

contaminants. Finally, dietary supplements may contain more active

ingredient than indicated on the product label.

Research suggests that among healthy adults, most dietary supplements,

when taken alone, have been associated with only rare and minor adverse

effects. Other supplements are associated with more serious adverse

effects. For example, research suggests that DHEA may increase the risk

of breast, prostate, and endometrial cancer, and shark cartilage has been

associated with thyroid hormone toxicity. Adverse event reports can also

signal possible risks from dietary supplements. FDA publishes lists of

dietary supplements for which evidence of harm exists.2

 In 1998, the

agency published a guide to dietary supplements, which included a list of

supplements associated with illnesses and injuries.3

 FDA has also issued

warnings and alerts for dietary supplements and posted them to its Web

site.4

 For example, the most recent alert reiterated the agency’s concern,

 2

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

3

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

FDA 99-2323).

4

http://www.cfsan.fda.gov/~dms/ds-warn.html and http://www.cfsan.fda.gov/~dms/dsosupp.html.

Some Dietary

Supplements May Be

Risky for Senior

Citizens
Page 5 GAO-01-1139T

first noted in 1993, that the herbal product comfrey represents a serious

safety risk to consumers from liver toxicity.

Consumption of some substances has been shown to be inadvisable, or

contraindicated, for persons with some preexisting medical conditions.

For example, 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.5

According to a recent survey,6 about half of seniors who use a dietary

supplement do not inform their doctor. Another survey found that seniors

often used dietary supplements with a prescription medication. Since

seniors take more prescription medicines on average than do younger

adults, the risk of drug-supplement interactions may be higher. For

example, evening primrose, ginkgo biloba, ginseng, glucosamine, and St.

John’s wort magnify the effect of blood-thinning drugs such as warfarin or

coumadin. We also identified reports suggesting that ginkgo biloba may

reduce the effects of seizure medications and glucosamine may have a

harmful effect on insulin resistance.

Contaminanted products can also pose significant health risks to

consumers. For example, supplements have been found to be

contaminated with pesticides or heavy metals, some of which are probable

carcinogens and may 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 and 3 percent of the specialty supplements tested were

contaminated in some way.

 5

M.K. Ang-Lee and others, “Herbal Medicines and Preoperative Care,” Journal of the

American Medical Association, Vol. 286, No. 2 (2001), pp. 208-16.

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.
Page 6 GAO-01-1139T

Amounts of active ingredients that exceed what is indicated on a product

label may increase the risk of overdose for some patients. 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. Studies of DHEA, ephedra, feverfew (promoted as a migraine

prophylaxis), ginseng, SAM-e (promoted as an antidepressant and in the

treatment of symptoms associated with osteoarthritis), and St. John’s wort

have found that a number of products have substantially more active

ingredient than indicated on the label. One study of DHEA found one

brand contained 150 percent of the amount of active ingredient indicated

on the label.7

 In a study of ephedra, one product was shown to have as

much as 154 percent of the active ingredient indicated on the label.8

Studies of ginseng have found some products contained more than twice

as much active ingredient as indicated on the product label.

Recognizing that there are some safety risks, trade associations that

represent manufacturers, suppliers, and distributors of dietary

supplements have created and adopted voluntary programs to reduce the

risks of potentially harmful products by standardizing manufacturing

practices.

Some unproven anti-aging products can cost hundreds or thousands of

dollars apiece. For example, rife machines, which emit light or electrical

frequencies and claim to kill viruses and parasites, are frequently

advertised on the Internet and can cost up to $5,000. Some herbal product

packages for cancer cures can cost nearly $1,000. 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 for those products at nearly $1.8 million per

company.

Consumers may be purchasing products that contain much less active

ingredient than indicated on the label. Results of commercial laboratory

 7

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

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

(1998), p. 1565.

8

B.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.

Seniors May Spend

Millions of Dollars on

Unproven or Poorly

Manufactured

Products
Page 7 GAO-01-1139T

tests and scientific studies that analyzed product contents for active

ingredient levels have shown that some dietary supplement products

contain far less active ingredient than labeled. For some products,

analyses have found no active ingredient. Academic studies have shown

similar results. In an analysis of DHEA products, nearly one-fifth contained

only trace amounts or no active ingredient.9 In analyses of garlic products,

most were found to release less than 20 percent of their active ingredient.10

One study of ginseng found that 35 percent of the products tested

contained no detectable levels of an active ingredient,11 and another found

no detectable levels in 12 percent of the tested products.12 Studies of SAMe and St. John’s wort products also found that tested samples often

contained less active ingredient than indicated on the label.

Federal efforts to protect seniors from health fraud include providing

educational materials on avoiding health fraud, funding research to

evaluate popular anti-aging therapies, and carrying out enforcement

activities against companies that have violated regulations. 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 have received limited attention.

Both FDA and FTC sponsor educational 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. To help seniors discriminate between legitimate and

fraudulent claims, FTC publishes a range of consumer education materials

on certain frequently promoted products and services, including hearing

aids and varicose vein treatments. The agency also publishes guidelines on

 9

J. Parasrampuria, “Quality Control of Dehydroepiandrosterone Dietary Supplement

Products.”

10L.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.

11L.E. Liberti and A.D. Marderosian, “Evaluation of Commercial Ginseng Products,” Journal

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

12J. Cui, “What Do Commercial Ginseng Preparations Contain?” Lancet, Vol. 344 (1994), p.

134.

Federal and State

Activities Aim to

Protect Seniors
Page 8 GAO-01-1139T

how to spot false claims and how to differentiate television shows from

“infomercials.”

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

National Center for Complementary and Alternative Medicine (NCCAM). It

has developed research programs to fund clinical trials to evaluate the

safety and efficacy of some popular products and therapies for conditions

such as arthritis, cardiovascular diseases, and neurological disorders.

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

glucosamine/chondroitin, melatonin, St. John’s wort, ginkgo biloba, and

others. In addition, the agency funds specialized, multidisciplinary

research centers on alternative medicine in such areas as cardiovascular

disease, neurological disorders, aging, and arthritis.

FDA enforcement actions taken against products that it judged to be

unapproved drugs or medical devices include court cases filed to halt the

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. According to FDA officials, an estimated

800,000 of these devices were sold between 1994 and 1997, with many

purchased by senior citizens.

FDA has notified some dietary supplement manufacturers that their

promotional materials illegally claimed that their products cure disease.

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 advertised disease

claims, 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 notified several dozen Internet-based companies

making such claims 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
Page 9 GAO-01-1139T

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.” In this letter, FDA concluded that any

dietary supplement that contained aristolochic acids was adulterated

under the law and that it was unlawful to market such a product. FDA has

also 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 containing 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 can also monitor dietary supplements by conducting inspections of

manufacturing facilities,13 during which its inspectors look at sanitation,

buildings and facilities, equipment, production, and process controls.

However, the agency inspects less than 5 percent of facilities annually.

Publication of good manufacturing practice (GMP) regulations would

improve FDA’s enforcement capabilities, since DSHEA provides that

dietary supplements not manufactured under conditions that meet GMPs

would be considered adulterated and unlawful. A proposed GMP rule has

been developed and is under review by the Office of Management and

Budget.

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, “Operation Cure.All,” primarily involved conducting Web-based

searches on specified dates to identify Web sites making unsubstantiated

claims that use of their products would prevent, treat, or cure serious

diseases and conditions. The searches were conducted with the

 13Inspections are authorized under 21 U.S.C. 374.
Page 10 GAO-01-1139T

participation of FDA, CDC, and some state attorneys general and other

organizations.

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

made changes in their Web 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 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. FTC has brought

over 30 dietary supplement cases, including those from “Operation

Cure.All,” against companies making unsupported claims since the agency

released guidelines on its approach to substantiation of advertised claims

in 1998.

The 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.

States can 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.

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

Conclusions
Page 11 GAO-01-1139T

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 can be

harmful for consumers with certain health conditions. Other products,

such as St. John’s wort, are promising 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.

This concludes my prepared statement, Mr. Chairman. I will be happy to

respond to any questions that you or Members of the Committee may

have.

For more information regarding this testimony, please call me at (202) 512-

7119. Key contributors include Martin T. Gahart, Carolyn Feis Korman,

Anne Montgomery, Mark Patterson, Roseanne Price, and Suzanne Rubins.

GAO Contact and

Acknowledgments
Page 12 GAO-01-1139T

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 supplement,

we have listed in table 1 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 1: 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.

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 highdensity 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.

Appendix: Known Claims, Adverse Effects,

Contraindications, and Interactions of Herbal

and Specialty Supplements
Page 13 GAO-01-1139T

Product Principal claimsa

Principal known adverse

effects

Principal known

contraindicationsb

Principal known

interactions

Evening

primrose oil

Beneficial for victims of

coronary artery disease;

improves rheumatoid

arthritis and other

inflammatory conditions;

alleviates hot flashes, premenstral 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.

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

blood- thinning effects of

anti- inflammatory

medications such as

aspirin and supplements

such as vitamin E and

fish oil; may interact with

the blood- thinning 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.
Page 14 GAO-01-1139T

Product Principal claimsa

Principal known adverse

effects

Principal known

contraindicationsb

Principal known

interactions

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.

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.
Page 15 GAO-01-1139T

Product Principal claimsa

Principal known adverse

effects

Principal known

contraindicationsb

Principal known

interactions

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 immunesystem 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.

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.
Page 16 GAO-01-1139T

Product Principal claimsa

Principal known adverse

effects

Principal known

contraindicationsb

Principal known

interactions

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.

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.
Page 17 GAO-01-1139T

Product Principal claimsa

Principal known adverse

effects

Principal known

contraindicationsb

Principal known

interactions

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.

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.

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