Health Products for Seniors: Potential Harm From 'Anti-Aging' Products
Released: 2001-09-10T00:00:00

Letter

Background

Since 1994, when the Dietary Supplement Health and Education Act (DSHEA) was enacted, sales of dietary supplements have soared. In 2000, total U.S. sales for herbal and specialty supplements reached $5.8 billion. Surveys have found that many older Americans use these supplements to maintain overall health, increase energy, improve memory, and prevent and treat serious illness, as well as to slow the aging process, among other purposes. Products frequently used by seniors to address aging concerns include herbal supplements such as evening primrose, ginkgo biloba, ginseng, kava kava, saw palmetto, St. John’s wort, and valerian, and specialty supplements such as chondroitin, coenzyme Q10, dehydroepiandrosterone (DHEA), glucosamine, melatonin, omega-3 fatty acids (fish oil), shark cartilage, and soy proteins. (See the appendix for details regarding these substances.)

FDA, FTC, and state government agencies all have oversight responsibility for products marketed as anti-aging therapies. In general, the law permits FDA to remove from the market products under its regulatory authority that are deemed dangerous or illegally marketed. FDA’s regulation of dietary supplements is governed by the Federal Food, Drug, and Cosmetic Act as amended by DSHEA in 1994. DSHEA does not require manufacturers of dietary supplements to demonstrate either safety or efficacy to FDA prior to marketing them. However, if FDA subsequently determines that a dietary supplement is unsafe, the agency can ask a court to halt its sale. For dietary supplements, the Secretary of the Department of Health and Human Services may declare the existence of an imminent hazard from a dietary supplement, after which the Secretary must initiate an administrative hearing to determine the matter, which may then be reviewed in court. DSHEA does not require dietary supplement manufacturers to register with FDA, or to identify to FDA the products they manufacture, and dietary supplement manufacturers are not required to provide the adverse event reports they receive to FDA. However, FDA does regulate nutritional and health claims made in conjunction with dietary supplements.

FTC has responsibility for ensuring that advertising for anti-aging health products and dietary supplements is truthful and can be substantiated. FTC can ask companies to remove misleading or unsubstantiated claims from their advertising, and it can seek monetary redress for conduct injurious to consumers in appropriate cases. FTC published an advertising guide for the dietary supplements industry in November 1998, which reminded the industry that advertising must be truthful and that objective product claims must be substantiated. State agencies can take action against firms that fraudulently market anti-aging and other health products.

Some Dietary Supplements May Be Risky for Senior Citizens

Health risks associated with dietary supplements come in a number of forms. First, some dietary supplements have been associated with adverse effects, some of which can be serious. Second, individuals with certain underlying medical conditions should avoid some dietary supplements. Third, some frequently used dietary supplements can have dangerous interactions with prescription or over-the-counter drugs that are being taken concurrently. Fourth, dietary supplements may contain harmful contaminants. Finally, dietary supplements may contain more active ingredient than indicated on the product label.

Research suggests that among healthy adults, most dietary supplements, when taken alone, have been associated with only rare and minor adverse effects. Other supplements are associated with more serious adverse effects. For example, research suggests that DHEA may increase the risk of breast, prostate, and endometrial cancer, and shark cartilage has been associated with thyroid hormone toxicity. Adverse event reports can also signal possible risks from dietary supplements. FDA publishes lists of dietary supplements for which evidence of harm exists. In 1998, the agency published a guide to dietary supplements, which included a list of supplements associated with illnesses and injuries. FDA has also issued warnings and alerts for dietary supplements and posted them to its Web site. For example, 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.

Consumption of some substances has been shown to be inadvisable, or contraindicated, for persons with some preexisting medical conditions. For example, ginseng is not recommended for persons with hypoglycemia. Kava kava may worsen symptoms of Parkinson’s disease. Saw palmetto is contraindicated for patients with breast cancer, and valerian should not be used by those with liver or kidney disease without first consulting a physician. A recent study also suggested that echinacea (promoted to help fight colds and flu), ephedra (promoted as an energy booster and diet aid), garlic, ginkgo biloba, ginseng, kava kava, St. John’s wort, and valerian may pose particular risks to people during surgery, with complications including bleeding, cardiovascular instability, and hypoglycemia.

According to a recent survey, about half of seniors who use a dietary supplement do not inform their doctor. Another survey found that seniors often used dietary supplements with a prescription medication. Since seniors take more prescription medicines on average than do younger adults, the risk of drug-supplement interactions may be higher. For example, evening primrose, ginkgo biloba, ginseng, glucosamine, and St. John’s wort magnify the effect of blood-thinning drugs such as warfarin or coumadin. We also identified reports suggesting that ginkgo biloba may reduce the effects of seizure medications and glucosamine may have a harmful effect on insulin resistance.

Contaminanted products can also pose significant health risks to consumers. For example, supplements have been found to be contaminated with pesticides or heavy metals, some of which are probable carcinogens and may be toxic to the liver and kidney or impair oxygen transport in the blood. One commercial laboratory found contamination in samples from echinacea, ginseng, and St. John’s wort products. As much as 20 times the level of pesticides allowable by the U.S. Pharmacopeia was found in two samples of ginseng. Overall, 11 percent of the herbal products and 3 percent of the specialty supplements tested were contaminated in some way.

Amounts of active ingredients that exceed what is indicated on a product label may increase the risk of overdose for some patients. Some scientific studies have found that there may be significantly more active ingredient in some herbal and specialty supplement products than is indicated on the label. Studies of DHEA, ephedra, feverfew (promoted as a migraine prophylaxis), ginseng, SAM-e (promoted as an antidepressant and in the treatment of symptoms associated with osteoarthritis), and St. John’s wort have found that a number of products have substantially more active ingredient than indicated on the label. One study of DHEA found one brand contained 150 percent of the amount of active ingredient indicated on the label. In a study of ephedra, one product was shown to have as much as 154 percent of the active ingredient indicated on the label.Studies of ginseng have found some products contained more than twice as much active ingredient as indicated on the product label.

Recognizing that there are some safety risks, trade associations that represent manufacturers, suppliers, and distributors of dietary supplements have created and adopted voluntary programs to reduce the risks of potentially harmful products by standardizing manufacturing practices.

Seniors May Spend Millions of Dollars on Unproven or Poorly Manufactured Products

Some unproven anti-aging products can cost hundreds or thousands of dollars apiece. For example, rife machines, which emit light or electrical frequencies and claim to kill viruses and parasites, are frequently advertised on the Internet and can cost up to $5,000. Some herbal product packages for cancer cures can cost nearly $1,000. FTC provided us with a partial estimate of economic harm based on 20 cases involving companies that fraudulently marketed unproven health care products commonly used by seniors and for which national sales data were available. FTC estimated the average annual sales for those products at nearly $1.8 million per company.

Consumers may be purchasing products that contain much less active ingredient than indicated on the label. Results of commercial laboratory tests and scientific studies that analyzed product contents for active ingredient levels have shown that some dietary supplement products contain far less active ingredient than labeled. For some products, analyses have found no active ingredient. Academic studies have shown similar results. In an analysis of DHEA products, nearly one-fifth contained only trace amounts or no active ingredient. In analyses of garlic products, most were found to release less than 20 percent of their active ingredient.One study of ginseng found that 35 percent of the products tested contained no detectable levels of an active ingredient, and another found no detectable levels in 12 percent of the tested products. 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.

Federal and State Activities Aim to Protect Seniors

Federal efforts to protect seniors from health fraud include providing educational materials on avoiding health fraud, funding research to evaluate popular anti-aging therapies, and carrying out enforcement activities against companies that have violated regulations. At the state level, agencies are working to protect consumers of health products by enforcing state consumer protection and public health laws, although anti- aging and alternative products have received limited attention.

Both FDA and FTC sponsor educational activities that focus on health fraud and seniors. For example, public affairs specialists in several FDA district offices had exhibits at senior health fairs and health conferences where they distributed educational materials on how to avoid health fraud, as well as cautionary guidance on purchasing medicines and medical products online. To help seniors discriminate between legitimate and fraudulent claims, FTC publishes a range of consumer education materials on certain frequently promoted products and services, including hearing aids and varicose vein treatments. The agency also publishes guidelines on how to spot false claims and how to differentiate television shows from “infomercials.”

Federal support of research on alternative therapies is provided by NIH’s National Center for Complementary and Alternative Medicine (NCCAM). It has developed research programs to fund clinical trials to evaluate the safety and efficacy of some popular products and therapies for conditions such as arthritis, cardiovascular diseases, and neurological disorders. There are studies, either ongoing or planned, to examine the effects of glucosamine/chondroitin, melatonin, St. John’s wort, ginkgo biloba, and others. In addition, the agency funds specialized, multidisciplinary research centers on alternative medicine in such areas as cardiovascular disease, neurological disorders, aging, and arthritis.

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

FDA has notified some dietary supplement manufacturers that their promotional materials illegally claimed that their products cure disease. For example, some manufacturers of colloidal silver products have claimed efficacy in treating HIV and other diseases and conditions. Even though FDA banned colloidal silver products as a U.S. over-the-counter drug in September 1999, after concluding that it was not aware of any substantial scientific evidence that supported the advertised disease claims, colloidal silver products may still be marketed as dietary supplements as long as they are not promoted with claims that they treat or cure disease. FDA notified several dozen Internet-based companies making such claims that their therapeutic claims may be illegal. Despite these oversight activities, colloidal silver products claiming “natural antibiotic” properties to address numerous health conditions remain available.

FDA has not initiated any administrative rulemaking activities to remove from the market certain substances that its analysis suggests pose health risks, but has sought voluntary restrictions and attempted to warn consumers. For example, aristolochic acid, a known potent carcinogen and nephrotoxin, is believed to be present in certain traditional herbal remedies as well as a number of dietary supplement products. Following reports of aristolochic-acid-associated renal failure cases in Europe, FDA has recently taken several steps. In May 2000, FDA issued a “letter to industry” urging leading dietary supplement trade associations to alert member companies that aristolochic acid had been reported to cause “severe nephropathy in consumers consuming dietary supplements containing aristolochic acid.” In this letter, FDA concluded that any dietary supplement that contained aristolochic acids was adulterated under the law and that it was unlawful to market such a product. FDA has also announced that herbal comfrey products containing pyrrolizidine alkaloids may cause liver damage. The agency’s letter to eight leading dietary supplement trade associations urged them to advise their members to stop distributing comfrey products containing pyrrolizidine alkaloids. However, even though FDA has told firms that market dietary supplements that products containing comfrey are adulterated and unlawful, some firms continue to market them, and the agency is left to identify and take action to remove them on a case-by-case basis as it becomes aware of them.

FDA can also monitor dietary supplements by conducting inspections of manufacturing facilities, during which its inspectors look at sanitation, buildings and facilities, equipment, production, and process controls. However, the agency inspects less than 5 percent of facilities annually. Publication of good manufacturing practice (GMP) regulations would improve FDA’s enforcement capabilities, since DSHEA provides that dietary supplements not manufactured under conditions that meet GMPs would be considered adulterated and unlawful. A proposed GMP rule has been developed and is under review by the Office of Management and Budget.

In 1997, FTC launched an effort to find companies making questionable claims for health products on the Internet, as well as in other media. This initiative, “Operation Cure.All,” primarily involved conducting Web-based searches on specified dates to identify Web sites making unsubstantiated claims that use of their products would prevent, treat, or cure serious diseases and conditions. The searches were conducted with the participation of FDA, CDC, and some state attorneys general and other organizations.

Evaluations of “Operation Cure.All” have found that some companies have made changes in their Web advertising as a result of receiving e-mail alerts from FTC about potentially unsupported advertising claims. In 1997, an estimated 13 percent of notified companies withdrew their claims or Web site, while 10 percent made some changes. In 1998, an estimated 28 percent of companies withdrew their claims or Web site, while 10 percent made some changes. By comparison, the percentage of companies that made no changes in both years exceeded 60 percent. FTC has brought over 30 dietary supplement cases, including those from “Operation Cure.All,” against companies making unsupported claims since the agency released guidelines on its approach to substantiation of advertised claims in 1998.

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

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

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 can be harmful for consumers with certain health conditions. Other products, such as St. John’s wort, are promising for some conditions, but are also associated with adverse interactions with some prescription medications. Senior citizens may have a higher risk of physical harm from the use of anti-aging alternative medicine products because they have a high prevalence of chronic health conditions and consume a disproportionate share of prescription medications compared to younger adults.

This concludes my prepared statement, Mr. Chairman. I will be happy to respond to any questions that you or Members of the Committee may have.

GAO Contact and Acknowledgments

For more information regarding this testimony, please call me at (202) 512- 7119. Key contributors include Martin T. Gahart, Carolyn Feis Korman, Anne Montgomery, Mark Patterson, Roseanne Price, and Suzanne Rubins.

Appendix: 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 supplement, we have listed in table 1 the health claims frequently associated with the products, although we have not attempted to validate the merits of any of the claims. We also list adverse effects that have been associated with the supplements, conditions for which the supplements might be contraindicated, and prescription medications with which the supplements might have dangerous interactions.