The Federal Trade Commission (FTC) regulates advertising for dietary  supplements and other products sold to consumers. The most egregious practices included suspect marketing claims  that a dietary supplement prevented or cured extremely serious diseases,  such as cancer and cardiovascular disease. In addition, while conducting in-person and  telephone conversations with dietary supplements sellers, our  investigators, posing as elderly consumers, were given potentially harmful  medical advice by sales staff, including that they could take supplements  in lieu of prescription medication. A link to selected audio clips from these calls  is available at: http://www.gao.gov/products/GAO-10-662T. All cases of deceptive or questionable marketing and  inappropriate medical advice have been referred to FDA and FTC for  appropriate action. These  claims are unproven—no studies confirm that ginseng can prevent or cure  any disease. The  sales representative recommended a garlic supplement and stated that the  product could be taken in lieu of prescribed blood pressure medication. The consumer told the representative that he takes aspirin  everyday and asked if it was safe to take aspirin and ginkgo biloba  together. In addition, FDA and NIH both noted that by definition, no dietary  supplement can treat, prevent, or cure any disease. Trace Contaminants Found in Selected Herbal Dietary Supplements, but None Pose an Acute Toxicity Hazard to Humans

We found trace amounts of at least one potentially hazardous contaminant  in 37 of the 40 herbal dietary supplement products we tested, though none  of the contaminants were found in amounts considered to pose an acute  toxicity hazard to humans. Specifically, all 37 supplements tested  positive for trace amounts of lead. Thirty-two also contained mercury, 28  contained cadmium, 21 contained arsenic, and 18 contained residues from  at least one pesticide. The levels of contaminants found do not exceed any FDA or EPA  regulations governing dietary supplements or their raw ingredients, and  FDA and EPA officials did not express concern regarding any immediate  negative health consequences from consuming these 40 supplements. While the manufacturers we spoke with were  concerned about finding any contaminants in their supplements, they  noted that the levels identified were too low to raise any issues during  their own internal product testing processes. Appendix I: Scope and Methodology

To determine whether sellers of herbal dietary supplements are using  deceptive or questionable marketing practices to encourage the use of  these products, we investigated a nonrepresentative selection of 22  storefront and mail-order retailers selling herbal dietary supplements. Posing as elderly customers, we asked sales staff at each company a series  of questions regarding the potential health benefits of herbal dietary  supplements as well as potential interactions with other common over-the- counter and prescription drugs. We also reviewed written marketing language used on approximately  30 retail Web sites. We evaluated the accuracy of product marketing  claims against health benefit evaluations published through the National  Institutes of Health and Food and Drug Administration (FDA). To determine whether selected herbal dietary supplements were  contaminated with harmful substances, we purchased 40 unique single- ingredient herbal supplement products from 40 different manufacturers  and submitted them to an accredited laboratory for analysis. All 40 products were submitted to an accredited  laboratory where they were screened for the presence of lead, arsenic,  mercury, cadmium, and residues from organichlorine and  organophosphorous pesticides.
Why GAO Did This Study

Recent studies have shown that use of herbal dietary supplements--chamomile, echinacea, garlic, ginkgo biloba, and ginseng--by the elderly within the United States has increased substantially. Sellers, such as retail stores, Web sites, and distributors, often claim these supplements help improve memory, circulation, and other bodily functions. GAO was asked to determine (1) whether sellers of herbal dietary supplements are using deceptive or questionable marketing practices and (2) whether selected herbal dietary supplements are contaminated with harmful substances. To conduct this investigation, GAO investigated a nonrepresentative selection of 22 storefront and mail-order retailers of herbal dietary supplements. Posing as elderly consumers, GAO investigators asked sales staff (by phone and in person) at each retailer a series of questions regarding herbal dietary supplements. GAO also reviewed written marketing language used on approximately 30 retail Web sites. Claims were evaluated against recognized scientific research published by the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). GAO also had an accredited lab test 40 unique popular single-ingredient herbal dietary supplements for the presence of lead, arsenic, mercury, cadmium, organichlorine pesticides, and organophosphorous pesticides.

What GAO Found

Certain dietary supplements commonly used by the elderly were deceptively or questionably marketed. FDA statutes and regulations do not permit sellers to make claims that their products can treat, prevent, or cure specific diseases. However, in several cases, written sales materials for products sold through online retailers claimed that herbal dietary supplements could treat, prevent, or cure conditions such as diabetes, cancer, or cardiovascular disease. When GAO shared these claims with FDA and the Federal Trade Commission (FTC), both agreed that the claims were improper and likely in violation of statutes and regulations. In addition, while posing as elderly customers, GAO investigators were often told by sales staff that a given supplement would prevent or cure conditions such as high cholesterol or Alzheimer's disease. To hear clips of undercover calls, see http://www.gao.gov/products/GAO-10-662T . Perhaps more dangerously, GAO investigators were given potentially harmful medical advice. For example, a seller stated it was not a problem to take ginkgo biloba with aspirin to improve memory; however, FDA warns that combining aspirin and ginkgo biloba can increase a person's risk of bleeding. In another case, a seller stated that an herbal dietary supplement could be taken instead of a medication prescribed by a doctor. GAO referred these sellers to FDA and FTC for appropriate action. GAO also found trace amounts of at least one potentially hazardous contaminant in 37 of the 40 herbal dietary supplement products tested, though none in amounts considered to pose an acute toxicity hazard. All 37 supplements tested positive for trace amounts of lead; of those, 32 also contained mercury, 28 cadmium, 21 arsenic, and 18 residues from at least one pesticide. The levels of heavy metals found do not exceed any FDA or Environmental Protection Agency (EPA) regulations governing dietary supplements or their raw ingredients, and FDA and EPA officials did not express concern regarding any immediate negative health consequences from consuming these 40 supplements. While the manufacturers GAO spoke with were concerned about finding any contaminants in their supplements, they noted that the levels identified were too low to raise any issues internal product testing.