Health Products for Seniors: Potential Harm From 'Anti-Aging'
Products (10-SEP-01, GAO-01-1139T).
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.
Studies have also found that these products sometimes contain
harmful contaminants or much more of an active ingredient than is
indicated on the label. Although GAO was unable to find any
recent, reliable estimates of the overall economic harm to
seniors from these products, it did uncover several examples that
illustrate the risk of economic harm. The Food and Drug
Administration (FDA) and the Federal Trade Commission (FTC) have
identified several products that make advertising or labeling
claims with insufficient substantiation, some costing consumers
hundreds or thousands of dollars apiece. The potential for harm
to senior citizens from health products making questionable
claims has been a concern for public health and law enforcement
officials. FDA and FTC sponsor programs and provide educational
materials for senior citizens to help them avoid health fraud. 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. This testimony summarized a
September report (GAO-01-1129).
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-01-1139T
ACCNO: A01763
TITLE: Health Products for Seniors: Potential Harm From
'Anti-Aging' Products
DATE: 09/10/2001
SUBJECT: Health hazards
Health statistics
Consumer protection
Product safety
Drugs
Economic analysis
Elderly persons
FDA/FTC Operation Cure.All
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GAO-01-1139T
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, 19901997,? 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.? 10 L. 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.
11 L. E. Liberti and A. D. Marderosian, ?Evaluation of Commercial Ginseng
Products,? Journal of Pharmaceutical Sciences, Vol. 67, No. 10 (1978), pp.
1487- 89. 12 J. 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
13 Inspections 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 claims a Principal known adverse effects Principal known
contraindications b 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 claims a Principal known adverse effects Principal known
contraindications b 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 claims a Principal known adverse effects Principal known
contraindications b 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 claims a Principal known adverse effects Principal known
contraindications b 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 claims a Principal known adverse effects Principal known
contraindications b 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 claims a Principal known adverse effects Principal known
contraindications b 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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