Health Products for Seniors: "Anti-Aging" Products Pose Potential
for Physical and Economic Harm (07-SEP-01, GAO-01-1129).	 
								 
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. Unproven anti-aging and alternative	 
medicine products also pose a risk of economic harm to seniors.  
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 a number of 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, 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. 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. GAO	 
summarized this report in testimony before Congress; see: Health 
Products for Seniors: Potential Harm From "Anti-Aging" Products, 
by Janet Heinrich, Director for Public Health Issues, before the 
Senate Special Committee on Aging. GAO-01-1139T, Sept. 10 (17	 
pages). 							 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-01-1129					        
    ACCNO:   A01760						        
    TITLE:   Health Products for Seniors: "Anti-Aging" Products Pose  
             Potential for Physical and Economic Harm                         
     DATE:   09/07/2001 
  SUBJECT:   Health hazards					 
	     Consumer protection				 
	     Product safety					 
	     Drugs						 
	     Economic analysis					 
	     Elderly persons					 
	     FDA/FTC Operation Cure.All 			 

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GAO-01-1129
     
A

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

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

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

Lett er

September 7, 2001 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.

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).

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

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.

Use of Alternative Medicine A number of surveys have been conducted to
determine the proportion of Products by Older the population that uses
alternative medicine products. One national Americans

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, 19901997,?

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.

Research on Alternative NIH?s National Center for Complementary and
Alternative Medicine

Medicine Products (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

FDA, FTC, and state government agencies all have oversight responsibility
Anti- Aging Products and for products marketed as anti- aging therapies. In
general, the law permits

Dietary Supplements 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.

10 T. E. Towheed and others, ?Glucosamine Therapy for Treating
Osteoarthritis,? The Cochrane Library, No. 3 (2001). 11 L. K. Mulrow, ?St.
John?s Wort for Depression,? The Cochrane Library, No. 2 (2001). 12 K. 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.

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

Some dietary supplements can have potentially serious health Supplements
Have

consequences for seniors. Although precise estimates of the physical harm
caused to senior citizens by questionable anti- aging and alternative Been
Associated With products are not available, there is evidence in the medical
literature that Potentially Serious

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

contraindicated for individuals with some underlying health problems, and
that a variety of frequently used dietary supplements can have dangerous

for Senior Citizens 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.

Scientific Evidence Shows Our review of the medical literature identified
several areas where

Potential Adverse Effects, individuals, particularly seniors, may be at risk
of physical harm due to Contraindications, and Drug adverse effects--
especially if dietary supplements are used when they are contraindicated--
or interactions between these dietary supplement Interactions for Some
products and prescription or over- the- counter drugs. 13 Popular
Supplements

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

interactions for leading supplement products is provided in appendix II. 14
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.

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

Commercial and scientific studies of selected dietary supplements have
Contain Harmful

repeatedly found that contaminants may be present and that the amount of
Contaminants or Too Much active ingredient present does not always match
that indicated on the Active Ingredient product label. 15 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.

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 products 19 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

16 J. Parasrampuria and others, ?Quality Control of Dehydroepiandrosterone
Dietary Supplement Products,? Journal of the American Medical Association,
Vol. 280, No. 18 (1998), p. 1565.

17 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. 18 S. 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.

19 J. Cui and others, ?What Do Commercial Ginseng Preparations Contain??
Lancet, Vol. 344 (1994), p. 134.

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

Although FDA does not determine causality in the adverse event reports it
Associated With the Use of receives, it does use these reports to signal
possible risks to consumers Dietary Supplements Signal from dietary
supplements. The agency also consults other sources, such as

Possible Risks 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.

20 M. 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. 21 http:// www. cfsan. fda. gov/~ dms/ ds- ill.
html. 22 P. Kurtzweil, ?An FDA Guide to Dietary Supplements,? FDA Consumer
(Sept.- Oct. 1998, FDA 99- 2323). 23 http:// www. cfsan. fda. gov/~ dms/ ds-
warn. html and http:// www. cfsan. fda. gov/~ dms/ dsosupp. html.

Medical Organizations and Medical organizations and trade associations that
represent manufacturers, Trade Associations Have suppliers, and distributors
of dietary supplements recognize that some

Taken Steps to Address health risks are associated with these products and
have made

Health Risks 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

also sponsors its own good manufacturing practices program, and 23
manufacturers are currently certified. Senior Citizens May

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

spend millions of dollars on products that either make unsubstantiated
claims or contain less of the active ingredient than is indicated on the
label. Dollars on Unproven or

There are no overall estimates of economic harm attributable to Poorly
Manufactured questionable anti- aging products; however, federal officials
have identified Products

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

FTC and FDA have identified a number of anti- aging and alternative
Unsubstantiated Claims medicine companies making unsubstantiated advertising
or labeling Cost Consumers Millions of claims for their products. FTC does
not have an estimate of economic Dollars 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. 24 Rife
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.

Consumers May Waste Consumers may purchase anti- aging and alternative
medicine products that Money on Products contain much less active ingredient
than is indicated on the product label,

Containing Less Active thereby wasting their money on worthless products.
Results of Ingredient Than Indicated

commercial laboratory tests and scientific studies that analyzed product
contents for active ingredient levels have shown that some dietary on
Product Labels 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. 25 More detailed test results for
all products tested can be found at www. consumerslab. com. 26 J.
Parasrampuria, ?Quality Control of Dehydroepiandrosterone Dietary Supplement
Products.? 27 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.

28 L. E. Liberti and A. D. Marderosian, ?Evaluation of Commercial Ginseng
Products,? Journal of Pharmaceutical Sciences, Vol. 67, No. 10 (1978), pp.
1487- 89. 29 J. Cui, ?What Do Commercial Ginseng Preparations Contain??

Federal and State The potential for harm to senior citizens from health
products making

Education, Research, questionable claims has long been a concern for public
health and law enforcement officials, and federal and state agencies have
activities under and Enforcement way to protect consumers from these
products. FDA and FTC sponsor Activities Aim to programs and provide
educational materials for senior citizens to help

Protect Senior Citizens 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 Both FDA and FTC sponsor education activities that
focus on health fraud Education Activities Target and seniors. For example,
public affairs specialists in several FDA district Health Fraud Against
Senior offices had exhibits at senior health fairs and health conferences
where

Citizens 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.?

NIH Supports Research on Federal support of research on alternative
therapies is provided by NIH?s Alternative Therapies

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 FDA has taken enforcement actions against firms selling anti-
aging Enforcement Actions

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.

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.

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 As we reported in 1999, 30 FDA?s adverse event
reporting system for dietary Event Reporting System Has supplements receives
reports for only a small proportion of all adverse Shortcomings 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.

30 Dietary Supplements: Uncertainties in Analyses Underlying FDA?s Proposed
Rule on Ephedrine Alkaloids (GAO/ HEHS/ GGD- 99- 90, July 2, 1999). 31
Department 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).

FDA Currently Inspects FDA inspects relatively few dietary supplement
manufacturers and related

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

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

and Related Facilities 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 In 1997, FDA published an advance notice of
proposed rulemaking

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

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

Supplements Have Not Yet FDA noted that much of the dietary supplement
industry believes GMP

regulations are important in establishing standards to ensure that dietary
Been Issued 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 As part of its consumer protection activities,
FTC enforces federal statutes Enforcement

that prohibit misleading and unsubstantiated advertising. In recent years,
Efforts Focus on the

FTC has joined with other organizations to focus attention on the Internet

fraudulent marketing of some anti- aging and other alternative medicine
products. 32 Inspections are authorized under 21 U. S. C. 374.

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 33
On 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.

seeks consumer redress and a permanent injunction against false and
misleading claims.

State Agencies Have Limited The fourteen states we contacted varied in their
efforts to protect

Focus on Anti- Aging and consumers from fraudulent or harmful health
products, but in general

Alternative Medicine focused little attention on anti- aging and alternative
medicine products. 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 In the states we contacted, oversight of anti- aging
product advertising has Protection Laws

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

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.

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

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

Appendi Appendi xes x I

Scope and Methodology 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.

Table 1: Organizations Consulted Type of organization Name of organizations

Federal National Institutes of Health (National Center for Complementary and

agencies and Alternative Medicine, National Institute on Aging, Office of
Dietary organizations

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 Center for Science in the Public Interest groups 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 Consumer Healthcare Products Association

and trade American Academy of Anti- Aging Medicine

associations 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 Arizona (attorneys California general, public Florida health
officials, Georgia and/ or Illinois consumeraffairs Iowa officers)

Louisiana Massachusetts Michigan Montana Nebraska New York Ohio Texas

Known Claims, Adverse Effects, Contraindications, and Interactions of Herbal

Appendi x II

and Specialty Supplements 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 Principal known adverse

Principal known Principal known Product Principal claims a effects
contraindications b interactions

Chondroitin Alleviates joint pain

Mild gastrointestinal sulfate associated with osteoarthritis

complaints such as and reduces inflammation. heartburn and nausea.

Coenzyme Q10 Slows aging; increases Rare, but include heartburn,

May interact with blood energy; enhances endurance

nausea, stomachache, thinners.

and aerobic performance; diarrhea, headache, fatigue,

strengthens heart; lowers and skin reactions. blood pressure; improves
immune function; promotes weight loss;

treats cancer, stroke, and gum diseases.

(Continued From Previous Page)

Principal known adverse Principal known

Principal known Product Principal claims a effects contraindications b
interactions

Dehydroepiandrosterone Slows aging; improves Increased facial hair; acne;
People with a hormonerelated

memory; stimulates libido and scalp hair loss; oily skin;

cancer (prostate, (DHEA) increases sex drive; eases

mood swings; ovarian, endometrial,

symptoms of depression; aggressiveness; altered breast) should consult

boosts energy; promotes hormone profiles; liver physician. Should be weight
loss; builds muscle

abnormalities; menstrual avoided by men with mass and increases strength;
cycle irregularities; enlarged prostate. prevents growth and

increased risk of heart recurrence of some cancers; disease, diabetes,
stroke, protects against heart prostate cancer in men, and disease; reduces
the risk of

breast and endometrial osteoporosis; prevents cancer in women; insomnia;
diseases such as diabetes, fatigue; low energy; Parkinson's, and
Alzheimer's.

headache; nervousness; deepening of the voice; irritiability; decreased
levels of high- density lipoprotein

(HDL) cholesterol; heart rhythm disturbances; hepatitis.

Evening Beneficial for victims of Gastrointestinal upset,

May increase the primrose oil coronary artery disease; nausea, loose stools,

anticoagulant effect of improves rheumatoid arthritis headache, seizure.
drugs such as warfarin. and other inflammatory Should not be used with

conditions; alleviates hot anticonvulsant flashes, pre- menstral medication.

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.

(Continued From Previous Page)

Principal known adverse Principal known

Principal known Product Principal claims a effects contraindications b
interactions

Garlic Reduces serum cholesterol; Rare, but include mild May decrease blood
May potentiate the bloodthinning

thins blood; lowers blood gastrointestinal symptoms glucose. effects of
antiinflammatory pressure; may prevent heart such as heartburn and
medications disease, atherosclerosis, nausea, body and breath such as
aspirin and

stroke, and hypertension; acts odor, headache, and vertigo. supplements such
as as antimicrobial for mild vitamin E and fish oil; may

respiratory and digestive tract interact with the bloodthinning

infections; relieves nausea. drug warfarin (Coumadin); may

potentiate antihypertensives. Ginkgo biloba Improves memory and mental Very
rarely associated with Not for people with seizure

Could pose a concern to sharpness; alleviates gastrointestinal upset,
disorders because it may

people with blood clotting symptoms of Alzheimer's allergic skin reaction,
and reduce the effects of seizure

problems or those taking disease; eases symptoms of headache.

medication. Not to be taken anticoagulant

depression; improves by people hypersensitive to medications. Not
circulation; thins blood;

poison ivy, cashews, or recommended for people improves cardiovascular

mangoes. using aspirin, or health; acts as antioxidant;

nonsteroidal improves vertigo, headache, antiinflammatory drugs. and
tinnitus; relieves intermittent lower leg cramps, diabetic retinopathy,
wheezing, dizziness, motion sickness, and Raynaud's.

Ginseng Relieves stress, eases Generally considered quite Caution
recommended for

May interfere with digoxin symtoms of anxiety, delays or

safe although it is individuals with activity or monitoring. reduces the
effects of aging recommended that a course hypertension and those

If used with warfarin or used as a tonic for well- being,

of treatment not exceed 3 prone to hypoglycemia. other anticoagulant, can

enhances immune function, months; may cause breast

High doses may inhibit alter bleeding times. If reduces blood sugar,
tenderness, swollen breasts, immune function in early used with phenelzine
improves cognitive function,

vaginal bleeding in women, stages of infection. sulfate (an

relieves menopausal nervousness, excitation,

People with cancer should antidepressant) or a

symptoms, acts as an hypertension, headaches, consult their physician.
monoamine ozidase

antioxidant, insomnia, restlessness, People with cardiovascular inhibitor
(MAOI), can

hypocholesterolemia, vomiting, and may cause disease or diabetes cause
headaches,

enhances athletic breast cancer to reoccur in exercise caution. tremors, and
manic performance, boosts energy,

women who have had the episodes. Caution with

increases sexual stamina, disease previously. insulin.

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.

(Continued From Previous Page)

Principal known adverse Principal known

Principal known Product Principal claims a effects contraindications b
interactions

Glucosamine Reverses osteoarthritis, Occasional symptoms of Concern about

protects joints and tendons gastrointestinal discomfort; interactions for
people on from injury, decreases reduced insulin secretion blood- thinning
inflammation. noted in animal studies.

medications and about harmful effects on insulin resistance.

Kava kava Eases symtoms of anxiety, Can result in temporary skin Not
appropriate for Should not be taken with restlessness and nervous and liver
problems, allergic individuals with major alcohol or antianxiety tension;
promotes relaxation;

reactions, gastrointestinal anxiety conditions. Should drugs such as valium.
aids sleep; balances mood; discomfort, absence of not be used while driving.
May have additive effects restores vigor; eases urination, numbness of the

May worsen symptoms of with other muscle symptoms of depression and mouth,
painful twisting Parkinson's. Use in relaxants, sedatives, menopause (hot
flashes); acts movements of the trunk, endogenous depression

antianxiety agents, and as an analgesic, headache disturbances of the

should be avoided. Should antidepressants.

remedy, and mild sedative; oculomotor equilibrium, and

not be used for more than 3 Should not be taken with eases uterine
inflammation,

can disturb motor reflexes months. Should not be used antidepressants or

colds, rheumatism; promotes and judgment when driving. if gall bladder or
liver

antipsychotics. urination; soothes upset problems, including stomachs; eases
symptoms cirrhosis and hepatitis. of asthma and tuberculosis;

cures fungal infections; inhibits gonorrhea; soothes stings and skin
inflammations. Melatonin Promotes sleep, reduces May cause infertility, Can
induce or deepen May interfere with symptoms of jet- lag, slows hypothermia,
and retinal

depression in susceptible hormone replacement aging process, increases sex
damage; reduces sex drive

individuals. May be therapy. May enhance the hormone secretion, acts as in
males; leads to high blood dangerous for people with effectiveness of
certain antioxidant, relieves tinnitus, pressure, diabetes, and
cardiovascular risk factors. chemotherapy drugs. may inhibit growth of
breast

cancer. Should not be taken by cancer cells.

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.

(Continued From Previous Page)

Principal known adverse Principal known

Principal known Product Principal claims a effects contraindications b
interactions

Omega- 3 fatty Provides heart protection; Encourages bleeding and

acids (fish oil) dilates blood vessels; reduces hemorrhage, causes fishy
blood pressure; reduces

breath odor, belching, blood clotting; suppresses abdominal bloating,
inflammation; relieves pain of

increases total blood rheumatoid arthritis; eases cholesterol. 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. Saw palmetto Aids in the treatment of Rare but include
headaches,

People with enlarged benign prostate hyperplasia gastrointestinal prostate
should consult (BPH), increases libido, disturbances, diarrhea, physician on
a regular increases sperm production,

vomiting, upset stomach, basis. Use should be increases breast size of
constipation, nausea,

avoided in patients with women, useful as a urinary dizziness, erectile
breast cancer. antiseptic and diuretic,

dysfunction, difficulty prevents hair loss (men only),

sleeping, fatigue, and heart treats low thyroid function and

pain. irritable bladder.

Shark cartilage Cures or prevents cancer, Could lead to thyroid May slow
down the healing

promotes wound healing, hormone toxicity, may cause

process for people relieves arthritis pain and nausea, indigestion, fatigue,
recovering from surgery. stiffness. fever, and dizziness.

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 Reduces cholesterol and Mild gastrointestinal

May interfere with the isoflavones triglyceride levels, reduces complaints
such as bloating absorption of

risk of heart disease, and flatulence. supplemental thyroid

suppresses menopausal hormones. May interact symptoms (hot flashes),

with ipriflavone, a reduces bone breakdown

synthetic isoflavone. (osteoporosis), prevents cancer.

(Continued From Previous Page)

Principal known adverse Principal known

Principal known Product Principal claims a effects contraindications b
interactions

St. John's wort Eases symptoms of mild to Mild gastrointestinal upset, Can
be toxic to sperm; not No longer believed that it

moderate depression; skin rashes, tiredness,

for the treatment of severe magnifies effect of MAOI, stabilizes mood;
improves insomnia, restlessness, depression.

but users should consult tolerance to stress; improves

dizziness, confusion, physician. May decrease sleep patterns in older
people; photosensitivity, (especially

effectiveness of HIV eases symptoms of anxiety; in fair- skinned
individuals)

drugs, increases energy levels; serotonin syndrome, immunosuppressants,
controls appetite and dry mouth, fast or irregular

digoxin, blood thinners, promotes weight loss; eases breathing.

chemotherapy drugs, and bronchial inflammation,

asthma medications. stomach problems, Abrupt withdrawal can hemorrhoids,
hypothyroidism,

increase blood levels of migraines, kidney disorders; various medications.
aides insect bites and stings, Should not be used with skin diseases,
scabies, skin

alcohol, narcotics, inflammation, burns and

amphetamines, wounds, and blunt injuries anticoagulants, bedwetting; aids in
wound antibiotics, or cold and flu

healing and in resistance to medicines such as viral infection when applied

pseudo- ephedrine. topically.

Should not be used with other antidepressants or with certain cheeses. May
interfere with action

of certain oral contraceptives. Valerian Promotes relaxation, induces

Headaches, mild nausea, People taking sedatives or Should not be taken with
sleep, ease symptoms of

upset stomach, heart antidepressants should alcohol, certain

anxiety, calms nerves, helps palpitations, restlessness, consult physician.
Should antihistimines, muscle people quit smoking, eases excitability,
hypersensitivity

not be consumed for more relaxants, psychotropic congestion, and relieves
reactions, insomnia, blurred than 2 weeks. People with

drugs, sedatives, muscle spasms. vision, and very high doses

liver or kidney disease barbiturates, or narcotics. may weaken the heartbeat

should consult physician. Should not be taken with and cause paralysis.

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.

NCCAM Studies on Alternative Therapies

Appendi x II I Relevant to Senior Citizens 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

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  Acupuncture and hypertension: efficacy and mechanisms
diseases  Effect of high- dose vitamin E on carotid atherosclerosis

 Effects of medication on mechanisms of coronary heart disease Mental
health  Effects of a standardized extract of Hypericum perforatum (St.
John?s disorders wort) in major depressive disorder

 Acupuncture in the treatment of depression  Omega- 3 fatty acids in
bipolar disorder prophylaxis

Neurological  Ginkgo biloba depression- prevention trial in older
individuals

disorders  Melatonin for sleep disorders in Parkinson?s disease Urological

 Saw palmetto extract in benign prostatic hyperplasia disorders 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

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.

Appendi x V I Recent FDA Actions 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 Products or Company services a Claim b FDA actions Outcome

Christian Brothers Laetrile products: FDA alleged that video touted Issued
warning letter to Consent decree in Contracting Corp.

?Vitamin B- 17 efficacy of products in curing company that products being

November 2000 granted (New York)

Tablets,? ?Apricot

cancer. Several Web sites promoted were unapproved permanent injunction.

Seeds,? and featured similar claims; company new drugs and were Laetrile
products ordered

?Amigdalina? ampuls sent out unsolicited e- mail misbranded and that
laetrile destroyed at company?s

notices to potential customers. remains the subject of an expense. FDA given
import alert and had been

authority to make continuing declared to be an unannounced inspections to
unapproved new drug in

check compliance. 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.

Health Resources

?b- Calm?d,? Among primary claims were that Issued warning letter in May
Company removed Web

(Alabama) ?Earthwise,? products could treat high blood 2000. site and agreed
to modify ?AloeGold,? ?Para pressure, strokes, alcoholism, promotional
literature and 90,? ?Maxi- Chel,? flu, fevers, herpes, hepatitis,

advertising to remove ?Enhance Plus,? Epstein- Barr, pneumonia, and claims.

?Super BP,? ?Triomin,? other diseases and conditions. and ?Perform,? among
other supplement products Hillestad Pharmaceuticals, Various herbal

Primary claims were that Filed complaint arguing that Court order, July
2000,

USA products, including products could cure and treat

products were misbranded required products and

(Wisconsin) garlic, gingko biloba,

various diseases and conditions, and that labeling showed that catalogs
featuring disease and St. John?s wort

including anxiety, depression, intended use was in cure,

treatment claims to be coughs, asthma, and allergies.

treatment, mitigation, and destroyed or revised to

prevention of disease, remove disease treatment making products unapproved

claims, and Web site new drugs. Seized products. modified to remove disease

treatment claims. FDA given authority to make unannounced inspections.

(Continued From Previous Page)

Products or Company services a Claim b FDA actions Outcome

Jewell Hall ?Black Pills for Primary claims were that ?Black Filed seizure
complaint, Following no reply to (Arkansas) Arthritis? and ?Joint Pills?
could relieve pain due to arguing that ?Black Pills? complaint, products
ordered

Factors? rheumatism, paralysis, bone were misbranded, labeling destroyed in
court order pain, and acute and chronic

was inadequate, and issued November 2000.

neuralgia. ?Joint Factors? products were unapproved claimed to address pain,
new drugs. Destroyed drugs rheumatoid arthritis. FDA

and labeling after court analysis also revealed ?Black condemnation. Pills?
contained four prescription drugs not on the label. Lane Labs- USA,

?BeneFin? (produced FDA alleges that the products Issued warning letter in
In December 1999, FDA Inc. (New Jersey) from shark are intended for use in
the

September 1997 notifying filed a complaint for

cartilage), treatment of cancer, skin cancer, the company that ?BeneFin?
permanent injunction ?SkinAnswer? (a

and HIV/ AIDS, among other and ?SkinAnswer? were alleging violations in
glycoalkaloid skin diseases.

misbranded and unapproved warning letter. cream), and ?MGN3?

new drugs. Through an (rice bran extract) 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.

NutriSOY International Soy protein Primary claims were for lowering Issued
warning letter in Company agreed to

(Indiana) products, including cholesterol; treatment of March 2000 that
products redesign Web site and other

?California Joe numerous diseases, including were making disease promotional
materials to Drink?; other cancer, diabetes, and heart treatment claims and
were remove disease treatment products included

disease; to ?help the liver unapproved new drugs.

claims.

?Essential

recover from the effects of ProPLUS,? and alcohol, viruses, and other toxic

?Essential Protein? agents;? and to treat kidney stones, stroke, and other
serious

illnesses and conditions. Pharmanex ?Cholestin,? a red

Primary claims were that Issued an administrative Court upheld FDA decision.
(California, Delawa

yeast rice product

?Cholestin? lowers serum total ruling that ?Cholestin? was re, and Utah)
containing lovastatin

cholesterol, lowers serum not a dietary supplement but triglycerides, lowers
LDL an unapproved new drug. cholesterol, and raises HDL cholesterol.

(Continued From Previous Page)

Products or Company services a Claim b FDA actions Outcome

Scientific Health

?Prevent,? Primary claims were various Issued warning letter in Company
modified claims Products doing ?AloeWonder,? disease treatment claims,
August 1999, with follow- up

for some, but not all, business as ?Inflammation-

including ?prevents degenerative inspection in July 2000. products, and
destroyed

Natural Wonders B,? ?Herb- ADerm,?

disease and age- related health some catalogs. In May (Utah)

?S- E- T Free,? problems,? most commonly, 2001, company agreed to ?Kleen-
Sweep- I,? heart disease and cancer.

cease operation.

?Me Again,? and ?Depression,? among other products. Universal

?Stimulator? device Primary claims were for relief of At FDA?s request, U.
S. Court order required Management

(similar to gas grill many kinds of pain, including

Marshals seized about companies to pay refunds

Services, igniters outfitted with migraine headaches, sciatica,

16, 000 ?Stimulators? from of about $82 each on and Natural finger grips)

swollen joints, and carpal tunnel company?s offices. Company request; refund
program Choice Products syndrome. continued to distribute the administered
externally. (Ohio)

unapproved devices. Worldtech

?Vitamin B17? Primary claim was that laetrile Issued warning letter to
Permanent injunction

Research Group; (commonly known products cured cancer and Worldtech Research
Group

granted against sale and World Without as laetrile or

inhibited tumor growth. that laetrile is an unapproved distribution of
laetrile Cancer, Corp.;

amygdalin). new drug, and that claims for

products or any other ?new Health Genesis other products were disease

drugs.? FDA given authority Corp.; The Health treatment claims. to make
continuing World International unannounced inspections to check compliance.
Decree (Florida)

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. a Specific product names are listed in quotation marks. b List
does not necessarily include all claims for products.

Appendi x V

Recent FTC Actions 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 services a Claims challenged Outcome

Aaron Company Colloidal silver, chitosan Colloidal silver product can cure
or treat

July 2001, company ordered not to make (Florida) with vitamin C, and more
than 650 diseases (including unsubstantiated disease treatment claims
?Ultimate Energizer? HIV/ AIDS, multiple sclerosis, and and ordered that
products containing cancer); chitosan product made weight ephedra or
ephedrine carry a label warning

loss claims; and ?Ultimate Energizer? is that such products can have
dangerous safe and has no side effects. effects on the central nervous
system and should not be taken with MAO inhibitors or allergy medications.

No consumer redress ordered. Arthritis Pain Care

?CMO? (cetylmyristoleate)

?CMO? treats most forms of arthritis and September 1999, company ordered not
to

Center (Texas) is beneficial in treating numerous other make future
unsubstantiated disease

diseases. treatment claims and to monitor distributors? advertising and
promotional activities, and to

notify distributors about the order. No consumer redress ordered.
Christopher

Various comfrey products Comfrey products for internal July 2001, company
agreed to preliminary

Enterprises (Utah) consumption are effective in treating injunction to stop
marketing comfrey products and/ or curing asthma, colds, coughs, for
internal uses or use on open wounds, to lung congestion, sore throats,
include a warning on products, and to cease emphysema, bronchitis,
tuberculosis,

making safety and health benefit claims in broken bones, polio, multiple
sclerosis,

the absence of supporting scientific spinal curvature, and spinal cancer.
evidence. 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.

CMO Distribution ?CMO? (cetylmyr

?CMO? ?normalizes? immune system; May 2000, company ordered not to make
Centers of America

istoleate) cures arthritis; and treats asthma, future unsubstantiated
disease treatment

(Michigan and emphysema, and certain cancers.

claims and required to monitor product Florida)

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.

(Continued From Previous Page)

Company Products or services a Claims challenged Outcome

EHP Products ?CMO? product, ?Myristin? ?CMO?/ Myristin relieves arthritis
and May 2000, company ordered not to make (Kentucky) capsules prevents
rheumatoid arthritis and unsubstantiated treatment claims, and

osteoarthritis. 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,? ?St. John?s Kava Kava? is
effective in August 2001, company ordered not to make colloidal silver, and

treatment of HIV/ AIDS, colds, syphilis, unsubstantiated disease treatment
claims ?Ultimate II Shark tuberculosis, dysentery, and other and to include
warning label on ?St. John?s Cartilage Concen- trate?

conditions; colloidal silver was effective Kava Kava? product alerting
consumers to for more than 650 infectious diseases; potential risks of
interactions with and shark cartilage product was prescription drugs,
including anticoagulants, effective in treatment of arthritis and oral
contraceptives, antiseizure medications, brain cancer.

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

Electronic devices, Electronic devices cure and prevent August 2001, company
ordered not to make (Florida, North including the ?Black Box,? serious
diseases such as cancer, AIDS,

unsubstantiated disease treatment claims. Carolina, Texas)

the ?Magnetic Pulser,? the arthritis, Gulf War syndrome, and ?Magnetic
Multi- Pulser,? chronic fatigue syndrome, and Ordered full consumer refund,
including the ?Beck- Rife Unit,? and ?Miracle Herbs? treats cancer of all

shipping and handling fees, for individuals the ?Portable Rife types, AIDS,
and various bacterial and requesting refund within 90 days of required
Frequency Generator?; viral infections.

notice. also, a ?Miracle Herbs? product.

Lane Labs- USA, Inc. ?BeneFin? and ?Skin- ?BeneFin? and ?SkinAnswer?
effectively June 2000, company ordered not to make and Cartilage Answer?
treat cancer. unsubstantiated therapeutic claims.

Consultants (New Jersey) 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,

?Longevity Signal

?LSF? reverses the aging process and August 2001, company ordered not to
make Inc., and Oasis Formula with DHEA

prevents, treats, or cures numerous unsubstantiated disease treatment and
?anti

Wellness Network (LSF),? and ?Anabolic/

age- related diseases and conditions, aging? claims for LSF or claims that
device (Colorado) Catabolic Index Test? (an

including atherosclerosis, arthritis, high test results provide a clinical
gauge of overall at- home urine test).

blood pressure, elevated cholesterol healthiness and youthfulness; and
company levels, weight gain, and poor liver required to notify distributors
of order and to function. ?Anabolic/ Catabolic Index? monitor product
advertising and promotion by measures youthfulness and distributors.

healthiness. Ordered $150,000 in consumer redress.

(Continued From Previous Page)

Company Products or services a Claims challenged Outcome

Natural Heritage Essiac tea Essiac tea treats cancer, diabetes, May 2000,
company ordered not to make Enterprises

HIV/ AIDS, and unsubstantiated disease treatment claims (Colorado)

feline leukemia. 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!

Magnets and magnetic Magnets and magnetic products can

September 1999, company ordered not to (New York) products, including

treat cancer, cure liver disease, reduce make unsubstantiated disease
treatment magnetic sleep pads and

cholesterol, prevent and reverse heart claims and to notify distributors of
order and magnetized water

disease, and relieve pain associated to monitor product advertising by
distributors. with arthritis, bursitis, and sciatica. No consumer redress
ordered. Panda Herbal

?Herbal Outlook? and

?Herbal Outlook? is an effective August 2001, company ordered not to make
International, Inc. ?Herb Veil 8? treatment for HIV/ AIDS, tuberculosis,

unsubstantiated disease treatment claims; (Pennsylvania)

influenza, and hepatitis B; ?Herb Veil 8? required warning label for ?Herbal
Outlook? is an effective treatment for carcinomas, alerting consumers to
potential risks of and melanoma. 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 ?Vitamin
O?? Vitamin O? allows oxygen molecules to

April 2000, companies ordered not to make Products and Staff of be absorbed
through the unsubstantiated therapeutic claims and to Life (Washington)

gastrointestinal system and prevents or notify distributors of order.

treats life- threatening diseases. Payment of $375, 000 ordered for consumer
redress and consumer education.

SmartScience ?JointFlex?? JointFlex,? a topical skin cream, November 2000,
company ordered not to

Laboratories eliminates pain due to disabling joint make unsubstantiated
disease treatment

(Florida) conditions, crushed vertebrae, claims for its products.

herniated disks, and other conditions. No consumer redress ordered. Western
Dietary Various herbal formulas,

Herb formulas and cure packages can Company agreed to preliminary injunction
in Products Co. ?cure? packages, and treat and cure cancer, diabetes, and

June 2001, involving its products and (Washington)

?Zapper Electrical Unit? arthritis. ?Zapper Electrical Unit? can activities.

device treat and cure Alzheimer?s and

HIV/ AIDS. FTC has requested consumer refund.

Outcome is pending. a Specific product names are listed in quotation marks.

Examples of Questionable Health Care Products Used by Senior Citizens, as

Appendi x VI

Reported by State Officials 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.

Appendi x VII

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

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

and Suzanne Rubins also made major contributions to this report. (290051)
Lett er

GAO United States General Accounting Office

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

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Appendix I

Appendix I Scope and Methodology

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Appendix II

Appendix II Known Claims, Adverse Effects, Contraindications, and
Interactions of Herbal and Specialty Supplements

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Appendix II Known Claims, Adverse Effects, Contraindications, and
Interactions of Herbal and Specialty Supplements

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Appendix II Known Claims, Adverse Effects, Contraindications, and
Interactions of Herbal and Specialty Supplements

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Appendix II Known Claims, Adverse Effects, Contraindications, and
Interactions of Herbal and Specialty Supplements

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Appendix II Known Claims, Adverse Effects, Contraindications, and
Interactions of Herbal and Specialty Supplements

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Appendix III

Appendix III NCCAM Studies on Alternative Therapies Relevant to Senior
Citizens

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Appendix IV

Appendix IV Recent FDA Actions

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Appendix IV Recent FDA Actions

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Appendix V

Appendix V Recent FTC Actions

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Appendix V Recent FTC Actions

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Appendix VI

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Appendix VII

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