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United States In the name of deregulation, the Dietary Supplement Health and Education Act of 1994 restricted the Food and Drug Administration from exerting authority over supplements as long as manufacturers made no claims about preventing or treating disease. As a result, the FDA currently regulates dietary supplements as a category of food, and not pharmaceutical drugs. In contrast with pharmaceutical manufacturers — who must demonstrate their products are effective as well as safe — supplement manufacturers are not required to demonstrate efficacy. Supplement manufacturers must, however, indicate a product is safe prior to introduction. The product cannot be marketed for 75 days following filing of this information with the FDA. Listing the information, however, does not mean the FDA regards the product as necessarily safe.[31] In practice, the FDA has said it has lacked funds to determine whether a given supplement should be considered "hazardous" and, thus, removed from the market. In one situation where this standard was reached (Ephedra), the agency faced significant opposition from the supplement industry and the U.S. Congress, and thus limited itself to making announcements about Ephedra's problematic safety records on the FDA website.[32] In 2007 the FDA implemented a "good manufacturing practices" policy to ensure dietary supplements "are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled." [33] Also in that year, the FDA implemented a rule requiring that supplement manufacturers submit reports of serious adverse events involving their products. Because of the 1994 legislation, the FDA must demonstrate that individual supplements are unsafe using its adverse events reporting system, which may capture only 1 to 10 percent of all adverse events linked to supplements.[34] In 2012 the director of the FDA’s Dietary Supplements Program, called the level of non-compliance with regulations on dietary supplements “astonishing." Based on audits completed by the FDA’s compliance division in 2011 and 2012, the official, Dan Fabricant, said it was estimated that nearly 70% of dietary supplement manufacturers are currently not compliant with rules governing "good manufacturing practices." Fabricant also indicated that FDA had concerns regarding under-reporting of adverse events.[35] A 2001 study, published in Archives of Internal Medicine, found broad public support for greater regulation of dietary supplements.[36] According to Consumer Reports, the 1994 law "has left consumers without the protections surrounding the manufacture and marketing of over-the-counter or prescription medications" and it became the FDA's responsibility to prove that a supplement is not safe. Similarly, Time described the 1994 legislation as "ill-conceived and reprehensible", that "gives the industry virtually free reign [sic] to market products defined as dietary supplements, while severely limiting the FDA's ability to regulate them".[37] Quality Rules (U.S.) FDA rules require that supplements meet specifications for "purity, strength, and composition and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration." [38] FDA inspectors can look at a company's records upon request.[39] However, enforcement is difficult given the number of supplement manufacturers and the 16% decline in FDA investigators from 2003 to 2006.[40] Suppliers provide certificates of analysis stating that they have tested the material.[40] In the U.S., contamination and false labeling are "not uncommon".[41] The United States Pharmacopeia offers a "seal" that may indicate that the product has been tested for integrity and safe manufacturing,[42] and it is the only certification program that conducts random off-the-shelf testing.[41][43] In 2008 ConsumerLab.com criticized the USP for proposing a 10 microgram per daily serving limit on lead in dietary supplements and drugs. It noted that under the FDA's 2006 guidance on lead in candy, only 0.2 micrograms of lead per serving are allowed.[44] Consumerlab randomly tests some dietary supplements and makes the results available to subscribers. It has reported that 25% of the supplements it tests have problems, and half of the multivitamins category had similar problems.[40] NSF International,[45] HFL Sport Science,[46] and the Natural Products Association[47] also have dietary supplement certification programs. Permissible claims (U.S) The FDA says that if a product sold in the U.S. as a dietary supplement is promoted or claimed as a treatment, prevention or cure for disease, it is considered an unapproved — and thus illegal — drug. In addition, all supplements must, in the U.S., include on the label a statement that all claims by the seller "have not been evaluated by the Food and Drug Administration," and that the product "is not intended to diagnose, treat, cure or prevent any disease." Supplement makers are permitted, however, to claim their product supports the structure or function of the body (e.g., "glucosamine helps support healthy joints" or "the hormone melatonin helps establish normal sleep patterns"). The FDA must be notified of these claims, which must be substantiated according to FDA rules. In reality, however, inaccurate claims are very common.[48][49] For example, the compound hydrazine sulfate is promoted as a treatment for cancer, despite no significant evidence that it is either safe or effective.[50][51] In the U.S., a supplement may include vitamins, minerals herbs, amino acids, or any substance historically used as a diet supplement. Products must also be for ingestion as a pill, capsule, tablet, powder or liquid and not represented for use as a conventional food or as the sole item of a meal or diet. Finally, the products must be labeled as a "dietary supplement". Regulation in European Union The European Union's Food Supplements Directive of 2002 requires that supplements be demonstrated to be safe, both in dosages and in purity.[52] Only those supplements that have been proven to be safe may be sold in the bloc without prescription. As a category of food, food supplements cannot be labeled with drug claims but can bear health claims and nutrition claims.[53] The dietary supplements industry in the United Kingdom (UK), one of the 28 countries in the bloc, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and various doctors and scientists, had signed petitions by 2005 against what are viewed by the petitioners as unjustified restrictions of consumer choice.[54] In 2004, along with two British trade associations, the Alliance for Natural Health (ANH) had a legal challenge to the Food Supplements Directive[55] referred to the European Court of Justice by the High Court in London.[56] Although the European Court of Justice's Advocate General subsequently said that the bloc's plan to tighten rules on the sale of vitamins and food supplements should be scrapped,[57] he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health. ANH, however, interpreted the ban as applying only to synthetically produced supplements—and not to vitamins and minerals normally found in or consumed as part of the diet.[58] Nevertheless, the European judges acknowledged the Advocate General's concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add the product to the list must be open to challenge in the courts.[59] |
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