Herbal dietary supplements are traditionally used to alleviate certain medical conditions, such as anxiety, digestive problems, and depression, and to improve general quality of life. However, for many traditional uses, there is not clear scientific evidence to show that they prevent or treat underlying diseases or conditions. Further, some herbal dietary supplements may interact in a potentially harmful manner with some prescription drugs. For example, according to NIH, St. John’s wort can negatively affect the efficacy of antidepressants, HIV treatments, cancer drugs, and anticoagulants, though this is not always noted on product labels. The possibility of adverse drug interactions is one of the reasons that FDA recommends that consumers check with their health practitioners before beginning any supplement regimen. The elderly are particularly at risk from these interactions since recent studies have found that approximately 85 percent of the elderly take at least one prescription drug over the course of a year and 58 percent take three or more. Many herbal supplements have not been exhaustively tested for hazardous interactions with prescription drugs, other supplements, or foods. Under DSHEA, dietary supplements are broadly presumed safe, and FDA does not have the authority to require them to be approved for safety and efficacy before they enter the market, as it does for drugs. However, a dietary supplement manufacturer or distributor of a supplement with a “new dietary ingredient”—an ingredient that was not marketed in the United States before October 15, 1994—may be required to notify FDA at least 75 days before marketing the product, depending on the history of use of the ingredient. Also, all domestic and foreign companies that manufacture, package, label, or hold dietary supplements must follow FDA’s current good manufacturing practice regulations, which outline procedures for ensuring the quality of supplements intended for sale. Under DSHEA, a firm, not FDA, is responsible for determining that any representation or claims made about the dietary supplements it manufactures or distributes are substantiated by adequate evidence to show that they are not false or misleading. Except in the case of a new dietary ingredient, where premarket review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate effectiveness before or after it markets its products. For the most part, FDA relies on postmarket surveillance efforts—such as monitoring adverse event reports it receives from companies, health care practitioners, and individuals; reviewing consumer complaints; and conducting facility inspections—to identify potential safety concerns related to dietary supplements. Once a safety concern is identified, FDA must demonstrate that the dietary supplement presents a significant or unreasonable risk, or is otherwise adulterated, before it can be removed from the market. A product sold as a dietary supplement cannot suggest on its label or in labeling that it treats, prevents, or cures a specific disease or condition without specific approval from FDA. Under FDA regulations, a manufacturer may submit a health claim petition in order to use a claim on its product labeling that characterizes a relationship between the product and risk of a disease, and FDA may authorize it provided the claims meet certain criteria and are authorized by FDA regulations (e.g., diets high in calcium may reduce the risk of osteoporosis). However, manufacturers may make “qualified health claims” when there is emerging evidence for a relationship between a dietary supplement and reduced risk of a disease or condition, subject to FDA’s enforcement discretion. The claim must include specific qualifying language to indicate that the supporting evidence is limited. Dietary supplement labeling may include other claims describing how a dietary ingredient is intended to affect the normal structure or function of the body (e.g. fiber maintains bowel regularity). The manufacturer is responsible for ensuring the accuracy and truthfulness of such claims, but must submit a claim to FDA for review no later than 30 days after marketing it. Because FDA does not confirm the claim—a lack of objection allows the manufacturer to use it—the following disclaimer must be included: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” The manufacturer does not need to provide FDA with documentation, and FDA does not test to determine if the claim is true. In addition, these claims generally may not state that a product is intended to diagnose, mitigate, treat, cure, or prevent a disease or the adverse effects associated with a therapy for a disease, either by naming or describing a specific disease. A claim also cannot suggest an effect on an abnormal condition associated with a natural state or process, such as aging. Context is a consideration; a product’s name and labeling cannot imply such an effect by use of pictures or scientific or lay terminology. Finally, a product cannot claim to be a substitute for a product that is a therapy for a disease, or claim to augment a therapy or drug. To make any of these claims, a manufacturer must submit and receive authorization of a health claim petition. The Federal Trade Commission (FTC) regulates advertising for dietary supplements and other products sold to consumers. FTC receives thousands of consumer complaints each year related to dietary supplements and herbal remedies. FTC has, in the past, taken action against supplement sellers and manufacturers whose advertising was deemed to pose harm to the general public. FDA works with FTC in this area, but FTC’s work is directed by different laws. Consuming high levels of the contaminants for which we tested the 40 products can lead to severe health consequences, such as increased risk of cancer, as noted in table 1. The negative health effects described are, unless otherwise noted, for the acute toxicity in the human body. However, the exact effects of these contaminants on an individual are based on an individual’s specific characteristics. For instance, since lead can build up in the human body, the effect of consuming a potentially dangerous level of lead by a 55-year-old man depends on the amount of lead that man has consumed during his lifetime, among other factors. FDA has not issued any regulations addressing safe or unsafe levels of contaminants in dietary supplements, but both FDA and EPA have set certain advisory levels for contaminants in other foods. The human body’s absorption of many contaminants is governed by intake method, so advisory levels for other foods (e.g., drinking water) cannot be strictly applied to dietary supplements. In addition, EPA sets limits on how much pesticide residue can remain on food and feed products. These pesticide residue limits are known as tolerances and are enforced by FDA. If no residue tolerance has been set for a particular pesticide, any product containing that pesticide residue is considered adulterated and its sale is prohibited by law. See table 2 for a summary of the regulations issued by FDA or EPA regarding some of the contaminants we tested for. Our investigation found examples of deceptive or questionable marketing and sales practices for dietary supplements popular among the elderly (see table 3). The most egregious practices included suspect marketing claims that a dietary supplement prevented or cured extremely serious diseases, such as cancer and cardiovascular disease. Other dietary supplements were claimed to mitigate age-related medical conditions, such as Alzheimer’s disease and diverticular disorder. We also found some claims that followed FDA’s labeling regulations and guidelines, but could still be considered deceptive or questionable and provide consumers with inaccurate information. 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. In making these claims, sellers put the health of consumers at risk. A link to selected audio clips from these calls is available at: http://www.gao.gov/products/GAO-10-662T. Below are details on several cases in which herbal supplement marketing practices were deceptive or questionable and sometimes posed health risks to consumers. All cases of deceptive or questionable marketing and inappropriate medical advice have been referred to FDA and FTC for appropriate action. Case 2: In online materials, this garlic supplement included claims that it would (1) prevent and cure cardiovascular disease, (2) prevent and cure tumors and cancer, (3) prevent obesity, and (4) reduce glycemia to prevent diabetes. According to NIH, all these claims are unproven, and garlic is not recommended for treating these conditions. In fact, for several of these conditions, garlic may interact adversely with common FDA-approved drug treatments. Nowhere in this product’s marketing materials does the seller suggest that consumers should consult their health care providers prior to taking its supplement. While NIH recognizes that garlic may have some anticancer properties, the agency notes that additional clinical trials are needed to conclude whether these properties are strong enough to prevent or treat cancer. Further, studies have shown that garlic may alter the levels of some cancer drugs in the human body, lessening their effectiveness. For diabetes, there are no studies that confirm that garlic lowers blood sugar or increases the release of insulin in humans. In fact, NIH recommends caution when combining garlic with medications that lower blood sugar, and further suggests that patients taking insulin or oral drugs for diabetes be monitored closely by qualified health care professionals. Case 3: According to its labeling, this ginseng supplement—which costs $500 for a 90-day supply—cures diseases, effectively prevents diabetes and cardiovascular disease, and prevents cancer or halts its progression. These claims are unproven—no studies confirm that ginseng can prevent or cure any disease. In fact, NIH recommends that breast and uterine cancer patients avoid ginseng. In addition, ginseng may adversely interact with cancer drugs. The product labeling claims do not differentiate between type 1 and type 2 diabetes. According to NIH, ginseng’s effect on patients with type 1 diabetes is not well studied. While ginseng may lower blood sugar levels in patients with type 2 diabetes, the long-term effects of such a treatment program are unclear, and it is not known what doses are safe or effective. NIH specifically recommends that consumers with type 2 diabetes use proven therapies instead of this supplement. Case 7: While our investigators posed as consumers purchasing dietary supplements, sales staff provided them with an informational booklet regarding an enzyme that claims to “ us against dementia and Alzheimer’s, exhibiting a truly miraculous capacity to optimize mental performance and fight off cognitive decline.” In fact, FDA reviewed the scientific evidence for the active ingredient of this supplement and found that it was not adequate to make such a claim. Because the agency considered such a health claim potentially misleading, FDA provided for the use of a qualified health claim that contains a disclaimer that must accompany the health claim in all labeling in which these claims appear. While the booklet we received does state the FDA disclaimer on the first page, the manufacturer follows it with a rejoinder: “The very cautious language of these claims, which FDA mandates can only be stated word for word, is at best a grudging concession to the extensive clinical research done with . Considering this agency’s legendary toughness against dietary supplements, FDA’s willingness to go this far with the suggests that the FDA must be sure it is safe to take and also that the FDA is unable to deny can improve human brain function.” Case 8: One of our fictitious consumers visited a supplement specialty store looking for a product that would help with high blood pressure. The sales representative recommended a garlic supplement and stated that the product could be taken in lieu of prescribed blood pressure medication. According to NIH, while this herb may lower blood pressure by a small amount, the scientific evidence is unclear. NIH does not recommend this supplement as a treatment for high blood pressure and warns patients to use caution while taking this product with other drugs or supplements that can lower blood pressure. Further, it is not recommended that a consumer start or stop a course of treatment without consulting with his or her health care provider. Even if a sales representative is licensed to dispense medical advice, he or she still does not know the consumer’s patient history, including other drug programs, allergies, and medical conditions, making it potentially dangerous for the sales representative to provide medical advice. Case 9: At a supplement specialty store, one of our investigators posed as an elderly consumer who was having difficulty remembering things. A sales representative recommended one of the store’s ginkgo biloba supplements. The consumer told the representative that he takes aspirin everyday and asked if it was safe to take aspirin and ginkgo biloba together. The sales representative told him that it is completely safe to take the two together. However, according to FDA, if aspirin is taken with the recommended product, it can increase the potential for internal bleeding. We spoke to FDA and FTC regarding these 10 claims, and they agreed that the statements made in product labeling for cases 1 through 6 are largely improper, as the labeling suggests that each product has an effect on a specific disease. For case 7, FDA stated that while the specific claims discussed here are allowable, depending on the context in which they were made, FDA might consider the totality of marketing materials to be improper. FDA also agreed that the claims made to our undercover investigators in cases 8 and 10 were questionable or likely constituted improper disease claims, but that to take action, additional information as to the prevalence and context of the claims would be necessary. For case 9, FDA noted that, since the statement made by sales staff was safe usage information, not a claim about the product’s effects, it would not violate FDA regulations, unless the agency could develop other evidence to show that the claim was false or misleading or constituted an implied disease claim. In addition, FDA and NIH both noted that by definition, no dietary supplement can treat, prevent, or cure any disease. 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. See appendixes III and IV for the complete results of these tests. 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. However, because EPA has not set pesticide tolerance limits for the main ingredients of the herbal dietary supplements we tested, the pesticide contaminants exceed FDA advisory levels. FDA agreed that 16 of the 40 supplements we tested would be considered in violation of U.S. pesticide tolerances if FDA, using prescribed testing procedures, confirmed our results. We note that 4 of the residues detected are from pesticides that currently have no registered use in the United States. According to FDA, scientific research has not been done on the long-term health effects from consumption of such low levels of many of these specific contaminants, as current technology cannot detect these trace contaminants when they are diluted in human bloodstreams. We have referred these products to FDA for its review. After reviewing test results with EPA and FDA officials, we also spoke with several of the manufacturers of supplements that had trace amounts of contaminants. The manufacturers we spoke with stated that they ensure that their products are tested for contamination, and that these tests have shown that their products do not contain contaminants in excess of regulatory standards. Manufacturers also stated that they comply with all FDA regulations and follow good manufacturing practices as defined by the agency. 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. Mr. Chairman, this concludes my statement. I would be pleased to answer any questions that you or other members of the committee may have at this time. For further information about this testimony, please contact Gregory D. Kutz at (202) 512-6722 or kutzg@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this testimony. Individuals who made major contributions to this testimony were Jonathan Meyer and Andrew O’Connell, Assistant Directors; John Ahern; Dennis Fauber; Robert Graves; Cristian Ion; Elizabeth Isom; Leslie Kirsch; Barbara Lewis; Flavio Martinez; James Murphy; Ramon Rodriguez; Tim Walker; and John Wilbur. 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. We identified these retailers by searching online using search terms likely to be used by actual consumers and by observing newspaper advertisements. 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. While our work focused on herbal dietary supplements, we also evaluated claims made regarding nonherbal supplement products during undercover storefront visits and telephone calls. 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. We selected the types of herbs to purchase based on recent surveys about the supplements usage of the elderly, defined for this report as individuals over the age of 65. These surveys identified the most commonly used herbs among the elderly as chamomile, echinacea, garlic, ginkgo biloba, ginseng, peppermint, saw palmetto, and St. John’s wort. We purchased these 40 unique products from a combination of retail chain storefronts and online or mail-order retailers. For each online retailer, we selected products based primarily on relative popularity according to the site’s list of top sellers. At each retail chain storefront, because of limited selection, we selected only items that would be expected to be sold at all chain locations. 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. These contaminants were selected based on prevalence and the likelihood of negative health consequences due to consumption. The recommended daily intake levels of these contaminants and the likely negative health consequences because of consumption were determined based on a review of relevant health standards and discussions with FDA and Environmental Protection Agency experts. For each herbal dietary supplement product, we submitted one unopened, manufacturer-sealed bottle to the laboratory for analysis. To identify levels of arsenic, cadmium, lead, and mercury, products were analyzed using inductively coupled plasma mass spectrometry according to method AOAC 993.14. Detection limits for these contaminants were .075 milligrams/kilogram, .010 milligrams/kilogram, .005 milligrams/kilogram, and .050 nanograms/gram, respectively. To identify levels of pesticide residues, products were analyzed using a variety of residue-specific methods, including those methods published in the FDA Pesticide Analytical Manual. We did not independently validate the results received with another lab or through any other mechanism. See appendix II for a complete list of analytes and their related detection levels. Detection limit (ppm) Detection limit (ppm) Dacthal (DCPA) Diazinon (O Analog) Endosulfan I (alpha-endosulfan) Detection limit (ppm) Detection limit (ppm) Endosulfan II (beta-Endosulfan) Malathion OA (Malaoxon) Detection limit (ppm) Detection limit (ppm) Quintozene (PCNB) S 421 (Octachlordipropylether) Detection limit (ppm) Detection limit (ppm) Parts per million is a measure equivalent to milligrams per kilogram or milligrams per liter. Chlorpyrifos (Dursban) St. John’s wort gamma-HCH (Lindane) Chlorpyrifos (Dursban) Hexachlorobenzene (HCB) Dacthal (DCPA) This is a work of the U.S. government and is not subject to copyright protection in the United States. The published product may be reproduced and distributed in its entirety without further permission from GAO. 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Summary: 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. 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.