• Money Matters

 • Reverse Mortgage

 • Retirement

United States General Accounting Office
Report to Chairman, Special Committee
on Aging, U.S. Senate

September 2001

September 7, 2001 

The Honorable John Breaux
Chairman, Special Committee on Aging
United States Senate

Dear Mr. Chairman:

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.)
 

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

Use of Alternative Medicine Products by Older Americans

Research on Alternative Medicine Products

Government Oversight of Anti-Aging Products and Dietary Supplements

FDA, FTC, and state government agencies all have oversight responsibility for products marketed as anti-aging therapies. In general, the law permits FDA to remove from the market products under its regulatory authority that are deemed dangerous or illegally marketed. FDA's regulation of dietary supplements is governed by the Federal Food, Drug, and Cosmetic Act as amended by DSHEA in 1994. DSHEA does not require manufacturers of dietary supplements to demonstrate either safety or efficacy to FDA prior to marketing them. However, if FDA subsequently determines that a dietary supplement is unsafe, the agency can ask a court to halt its sale. For dietary supplements, the Health and Human Services Secretary may declare the existence of an imminent hazard from a dietary supplement, after which the Secretary must initiate an administrative hearing to determine the matter, which may then be reviewed in court. DSHEA does not require dietary supplement manufacturers to register with FDA, or to identify to FDA the products they manufacture, and dietary supplement manufacturers are not required to provide the adverse event reports they receive to FDA. However, FDA does regulate nutritional and health claims made in conjunction with dietary supplements. FTC has responsibility for ensuring that advertising for anti-aging health products and dietary supplements is truthful and can be substantiated. FTC can ask companies to remove misleading or unsubstantiated claims from their advertising and it can seek monetary redress for conduct injurious to consumers in appropriate cases. FTC published an advertising guide for the dietary supplements industry in November 1998 that reminded the industry that advertising must be truthful and that objective product claims must be substantiated. State agencies can take action against firms that fraudulently market anti-aging and other health products.
 

Some Dietary Supplements Have Been Associated With Potentially Serious Health Consequences for Senior Citizens

Some dietary supplements can have potentially serious health consequences for seniors. Although precise estimates of the physical harm caused to senior citizens by questionable anti-aging and alternative products are not available, there is evidence in the medical literature that seniors are at risk for adverse effects, that dietary supplements are contraindicated for individuals with some underlying health problems, and that a variety of frequently used dietary supplements can have dangerous interactions with drugs that are being taken concurrently. Although documented adverse effects from most herbal and specialty supplements are generally mild, potential complications from supplements that might be contraindicated under certain circumstances and from interactions with certain prescription medications may be serious. In addition, there is evidence that 1 in 10 herbal products may be contaminated with pesticides and heavy metals, which can have serious health consequences. Adverse event reports received by FDA and others give an indication of some possible risks. FDA has issued warnings to consumers and industry about the health risks of several dietary supplement products. Recognizing these health risks, the American Medical Association has recommended that

dietary supplements and herbal remedies include specific warnings on their labels, and several trade associations representing manufacturers, suppliers, and distributors of dietary supplements have instituted voluntary programs to reduce the risk of potentially harmful products.

Scientific Evidence Shows Potential Adverse Effects, Contraindications, and Drug Interactions for Some Popular Supplements

Some Dietary Supplements Contain Harmful Contaminants or Too Much Active Ingredient

Reports of Adverse Events Associated With the Use of Dietary Supplements Signal Possible Risks

Medical Organizations and Trade Associations Have Taken Steps to Address Health Risks

Medical organizations and trade associations that represent manufacturers, suppliers, and distributors of dietary supplements recognize that some health risks are associated with these products and have made recommendations and adopted voluntary programs to address some of the concerns. For example, the American Medical Association has issued a policy statement recommending that dietary supplements and herbal remedies include the following information on the product label: "This product may have significant adverse side effects and/or interactions with medications and other dietary supplements; therefore it is important that you inform your doctor that you are using this product." The policy statement also recommends that manufacturers be required to label products with data on adverse effects, contraindications, and possible drug interactions.

Trade associations that represent various manufacturers, suppliers, and distributors of dietary supplements have adopted voluntary programs to reduce the risks of potentially harmful products. Thus, the Consumer Healthcare Products Association has established eight voluntary programs focusing on either product manufacturing or labeling of specific products. For example, the association urges manufacturers to put quality control procedures in place to ensure that ginseng is free of quintozene (a potentially carcinogenic pesticide) and related compounds. For kava kava products, member companies are asked to include specific dosage limits and cautionary statements, and for comfrey and St. John's wort products, members are asked to include general label warnings about the advisability of consulting a physician. The American Herbal Products Association has incorporated labeling and warning recommendations in its code of ethics for members. These include, among others, labeling recommendations for ephedra (with both warnings and serving limits), warnings for chaparral and pyrrolizidine alkaloids (which are found in comfrey and can cause fatal liver failure), and dosage limits and warnings for kava kava. The association has also suggested warning labels for both saw palmetto and St. John's wort.

The National Nutritional Foods Association requires all members who manufacture dietary supplements and herbs under their own label to participate in a quality assurance program. The program was established, in part, to increase confidence that products are accurately labeled. Products are registered, with random testing for content every 2 to 3 years. Association officials reported that approximately 25,000 product labels are currently registered under this program, estimating that this accounts for more than half of the dietary supplements on the market. The association also sponsors its own good manufacturing practices program, and 23 manufacturers are currently certified.

Senior Citizens May Spend Millions of Dollars on Unproven or Poorly Manufactured Products

Senior citizens who buy anti-aging and alternative medicine products may spend millions of dollars on products that either make unsubstantiated claims or contain less of the active ingredient than is indicated on the label. There are no overall estimates of economic harm attributable to questionable anti-aging products; however, federal officials have identified a number of expensive products making unsubstantiated claims. In an analysis of 20 of its cases for products targeted to senior citizens, FTC estimated that consumers as a whole spent an average of nearly $1.8 million annually per company. In addition, because some dietary supplement products contain little or none of the active ingredient listed on the product label, consumers may be spending millions of dollars per year on products that are virtually worthless.

Expensive Products With Unsubstantiated Claims Cost Consumers Millions of Dollars

Consumers May Waste Money on Products Containing Less Active Ingredient Than Indicated on Product Labels

Federal and State Education, Research, and Enforcement Activities Aim to Protect Senior Citizens

The potential for harm to senior citizens from health products making questionable claims has long been a concern for public health and law enforcement officials, and federal and state agencies have activities under way to protect consumers from these products. FDA and FTC sponsor programs and provide educational materials for senior citizens to help them avoid health fraud on the Internet and in other media. NIH is funding research and research centers to evaluate popular anti-aging and alternative therapies. FDA has taken various enforcement actions against firms that have violated legal requirements regarding the marketing and sales of anti-aging and alternative products, including dietary supplements, but it has not prohibited the marketing of any specific substances using its administrative rulemaking authority. FDA's voluntary adverse event reporting system for dietary supplements has shortcomings, and proposed regulations to establish good manufacturing practices for dietary supplements are still under review by the Office of Management and Budget. Through "Operation Cure.All," FTC is trying to stop companies

from making unqualified health claims that are not supported by credible scientific evidence, and it has been joined in these efforts by FDA and other agencies. At the state level, agencies are working to protect consumers of health products by enforcing state consumer protection and public health laws, although anti-aging and alternative products have received limited attention.

Some Federal Consumer Education Activities Target Health Fraud Against Senior Citizens

Both FDA and FTC sponsor education activities that focus on health fraud and seniors. For example, public affairs specialists in several FDA district offices had exhibits at senior health fairs and health conferences where they distributed educational materials on how to avoid health fraud, as well as cautionary guidance on purchasing medicines and medical products online. In addition, officials in some districts made drug safety presentations that highlighted ongoing FDA programs, including the MedWatch adverse event reporting system that consumers are encouraged to use and which encompasses drugs, biological products such as vaccines, medical devices, dietary supplements, and food products. To help consumers discriminate between legitimate and fraudulent claims, FTC publishes consumer education materials on certain frequently promoted products and services, including hearing aids and varicose vein treatments. The agency also publishes guidelines on how to spot false claims and how to differentiate television shows from "infomercials."

NIH Supports Research on Alternative Therapies

Federal support of research on alternative therapies is provided by NIH's NCCAM, which has developed research programs to fund clinical trials to evaluate the safety and efficacy of some popular products and therapies. The trials are studying alternative products and therapies for conditions such as arthritis, cardiovascular disease, and neurological disorders. There are also studies, either ongoing or planned, to examine the effects of glucosamine/chondroitin, St. John's wort, ginkgo biloba, and others. (A list of NCCAM studies on alternative therapies relevant to seniors is provided in app. III.) In addition, the agency funds specialized, multidisciplinary research centers on alternative medicine in such areas as cardiovascular disease, neurological disorders, aging, and arthritis.

FDA Has Taken Enforcement Actions

FDA has taken enforcement actions against firms selling anti-aging products alleged to be dangerous or illegally marketed. It has taken actions to remove from the market anti-aging products that the agency found were actually unapproved new drugs or medical devices and actions against firms that promoted their dietary supplements for the treatment or cure of a disease. Although DSHEA allows FDA to remove from the market dietary supplements that the agency can prove are dangerous, the agency has not prohibited the marketing of any specific substances using its administrative rulemaking authority. However, the agency has taken steps to identify for consumers and industry ingredients it deems to be unsafe and unlawful. The agency has then pursued cases against specific manufacturers and products when the ingredients continued to be marketed in dietary supplements despite the agency's warnings. FDA's efforts in this regard have been unsuccessful, and many of these products remain on the market and are still available to consumers. A description of some of FDA's recent enforcement activities is provided in appendix IV.

FDA enforcement actions taken against products that it judged to be unapproved drugs or medical devices include court cases filed to halt distribution of laetrile products that claimed to cure cancer and to halt the sale of "Cholestin," a red yeast rice product with lovastatin that was marketed with cholesterol-lowering claims. FDA also took action to halt the marketing of the "Stimulator," a device that the manufacturer claimed would relieve pain from sciatica, swollen joints, carpal tunnel syndrome, and other chronic conditions. The devices have been purchased by many senior citizens, according to FDA officials. An estimated 800,000 of these devices were sold between 1994 and 1997.

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 Event Reporting System Has Shortcomings

FDA Currently Inspects Relatively Few Dietary Supplement Manufacturers and Related Facilities

Regulations to Establish Good Manufacturing Practices for Dietary Supplements Have Not Yet Been Issued

In 1997, FDA published an advance notice of proposed rulemaking regarding good manufacturing practice (GMP) in manufacturing, packing, and holding of dietary supplements. In publishing the draft for comment, FDA noted that much of the dietary supplement industry believes GMP regulations are important in establishing standards to ensure that dietary supplements are "safe and properly labeled." FDA officials have stated that a proposed GMP rule has now been developed and is still under review by the Office of Management and Budget. Publication of final GMP regulations will improve FDA's enforcement capabilities, since DSHEA provides that dietary supplements not manufactured under conditions that meet GMPs would be considered adulterated and unlawful.

Recent FTC and Joint-Agency Enforcement Efforts Focus on the Internet

State Agencies Have Limited Focus on Anti-Aging and Alternative Medicine Products

The fourteen states we contacted varied in their efforts to protect consumers from fraudulent or harmful health products, but in general focused little attention on anti-aging and alternative medicine products. State agencies reported that they receive relatively few complaints regarding these products. However, many officials said that consumers are being harmed in ways that are unlikely to be reported to state agencies and that misleading advertising and questionable health products are serious problems. States have identified a number of questionable health care products, services, and advertising claims that may affect older consumers, and these are listed in appendix VI.

States protect consumers from fraudulent or harmful health products through two approaches. The first is enforcement of state consumer protection laws against false or misleading advertising. The second is through their public health authority to ensure food, drug, and medical device safety. With some exceptions, the states we contacted take action only if there is a pattern of complaints or an acute health problem associated with a particular substance or device. Seven of the fourteen states we contacted were involved to some degree in monitoring or enforcement activity, and three have ongoing efforts to review advertising, labels, or products to enforce their health and consumer protection laws.

Enforcement of Consumer Protection Laws

In the states we contacted, oversight of anti-aging product advertising has not been a priority for state consumer protection agencies. Although many representatives of state consumer protection agencies we contacted said that misleading advertising of health products targeted to seniors is a serious issue, their agencies have devoted greater resources to larger scale types of fraud such as identity theft and sweepstakes fraud.

State laws protecting consumers from false or misleading advertising may be applied to anti-aging and alternative remedies for which complaints have been filed. There is often a multi-tiered approach to resolving consumer complaints. Individual complaints may be filed with an office, usually within the Attorney General's or Governor's Office, that facilitates informal resolution between the consumer and the company. Consumers wishing to pursue legal remedies beyond this point are generally referred to a private attorney. In cases in which there are patterns or egregious cases 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

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.
3Specialty supplements are generally those that are not herbs, botanicals, vitamins, or minerals, and may include amino acids, animal products, concentrates, metabolites, constituents, or proteins.
4Food Safety: Improvements Needed in Overseeing the Safety of Dietary Supplements and "Functional Foods" (GAO/RCED-00-156, July 11, 2000).
5Estimates 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.
6D.M. Eisenberg and others, "Trends in Alternative Medicine Use in the United States, 1990-1997," Journal of the American Medical Association, Vol. 280, No. 18 (1998), pp. 1569-74.
7R.J. Blendon and others, "Americans' Views on the Use and Regulation of Dietary Supplements," Archives of Internal Medicine, Vol. 161(2000), pp. 805-10.
8M. Blumental (ed.), The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines (Boston, Mass.: American Botanical Council, 1998).
9P.L. Le Bars and others, "A Placebo-Controlled, Double-Blind, Randomized Trial of an Extract of Ginkgo Biloba for Dementia," Journal of the American Medical Association, Vol. 278, No. 16 (1997), pp. 1327-32.
10T.E. Towheed and others, "Glucosamine Therapy for Treating Osteoarthritis," The Cochrane Library, No. 3 (2001).
11L.K. Mulrow , "St. John's Wort for Depression," The Cochrane Library, No. 2 (2001).
12K. Linde and others, "St. John's Wort for Depression--an Overview and Meta-Analysis of Randomised Clinical Trials," British Medical Journal, Vol. 313 (1996), pp. 253-58.
13A summary of some of the principal known adverse effects, contraindications, and interactions for leading supplement products is provided in appendix II.
14M.K. Ang-Lee and others, "Herbal medicines and preoperative care," Journal of the American Medical Association, Vol. 286, No. 2 (2001), pp. 208-16.
1 5D. M. Eisenberg and others, "Trends in Alternative Medicine Use in the United States, 1990-1997," Journal of the American Medical Association, Vol. 280, No. 18 (1998), pp. 1569-74.
16J. 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.
19J. Cui and others, "What Do Commercial Ginseng Preparations Contain?" Lancet, Vol. 344 (1994), p. 134.
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
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.
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?"
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).
32 Inspections are authorized under 21 U.S.C. 374.
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.
 

Appendix 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.)

1The herbal supplements we focused on were evening primrose oil, garlic, ginkgo biloba, ginseng, kava kava, saw palmetto, St. John's wort, and valerian. The specialty supplements we focused on were chondroitin sulfate, coenzyme Q10, dehydroepiandrosterone (DHEA), glucosamine, melatonin, omega-3 fatty acids, soy proteins, and shark cartilage.

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

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.

• The center for cardiovascular diseases at the University of Michigan is examining the effect of hawthorn (an herbal supplement) in the Condition Studies Arthritis 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.

Appendix IV: Recent FDA Actions Appendix IV

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.

Appendix 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.

Appendix VI: Examples of Questionable Health Care Products Used by Senior Citizens, as Reported by State Officials

Appendix VII: GAO Contact and Staff Acknowledgments

GAO Contact

Martin T. Gahart, (202) 512-3596

Staff Acknowledgments

Carolyn Feis Korman, Anne Montgomery, Mark Patterson, Roseanne Price, and Suzanne Rubins also made major contributions to this report.

GAO's Mission

The General Accounting Office, the investigative arm of Congress, exists to support Congress in meeting its constitutional responsibilities and to help improve the performance and accountability of the federal government for the American people. GAO examines the use of public funds; evaluates federal programs and policies; and provides analyses, recommendations, and other assistance to help Congress make informed oversight, policy, and funding decisions. GAO's commitment to good government is reflected in its core values of accountability, integrity, and reliability.

Obtaining Copies of GAO Reports and Testimony

The fastest and easiest way to obtain copies of GAO documents is through the Internet. GAO's Web site (www.gao.gov) contains abstracts and full-text files of current reports and testimony and an expanding archive of older products. The Web site features a search engine to help you locate documents using key words and phrases. You can print these documents in their entirety, including charts and other graphics.

Each day, GAO issues a list of newly released reports, testimony, and correspondence. GAO posts this list, known as "Today's Reports," on its Web site daily. The list contains links to the full-text document files. To have GAO E-mail this list to you every afternoon, go to our home page and complete the easy-to-use electronic order form found under "To Order GAO Products."

Order by Mail or Phone

The first copy of each printed report is free. Additional copies are $2 each. A check or money order should be made out to the Superintendent of Documents. GAO also accepts VISA and Mastercard. Orders for 100 or more copies mailed to a single address are discounted 25 percent. Orders should be sent to:

U.S. General Accounting Office
P.O. Box 37050
Washington, D.C. 20013

To order by Phone: Voice: (202) 512-6000
TDD: (301) 413-0006
Fax: (202) 258-4066

Visit GAO's Document Distribution Center

GAO Building
Room 1100, 700 4th Street, NW (corner of 4th and G Streets, NW)
Washington, D.C. 20013

To Report Fraud, Waste, and Abuse in Federal Programs

Public Affairs