Dietary Supplements Law
The FDA regulates food additives pursuant to the Dietary Supplement Health and Education Act of 1994, but because this obsolete legislation has major gaps, the agency is not effective or efficient at protecting the health of the public. Under the Dietary Supplement Health and Education Act (DSHEA)-the 1994 legislation that established the current regulatory framework for dietary supplements the FDA does not typically perform premarket reviews of dietary supplements, nor are manufacturers required to submit essential information about their products, including names or ingredients, to the agency prior to marketing. This leaves the agency without clear visibility into what is available in the marketplace at any given moment. Quality issues within the supply chain also present a risk for safety. FDA inspections of dietary supplement manufacturing facilities have consistently revealed violations of federal standards for quality and accurate labeling. Unlike drugs or devices, the FDA does not regulate dietary supplements for effectiveness. Under current law, the FDA may act only when it finds that supplement manufacturers make unlawful claims about their products or have broken the rules governing product labeling.
Under the federal Food, Drug, and Cosmetic Act and related legislation, the FDA has authority to monitor the quality of substances sold as foods in the U.S., as well as monitor claims made on food labels regarding both the ingredients and the health benefits. FDAs main emphasis is the enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, particularly Section 361 of the Public Health Service Act, and related regulations. The FDA is charged with protecting and promoting the publics health by controlling and supervising food safety, tobacco products, food additives, prescription and over-the-counter drug products (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emission devices (EREDs), cosmetics, animal feeds, and animal products. In the U.S., dietary supplement safety is regulated by the U.S. Food and Drug Administration (FDA), but legal limitations inhibit the FDAs ability to effectively regulate dietary supplements (e.g., increasing risks to public health, and has generated many calls for reform.
Unlike prescription drugs, supplements do not typically require FDA approval before being introduced for sale. Safety Monitoring The main mechanism to monitor the safety of supplements is through a voluntary reporting system established by FDAs Centers for Food Safety and Applied Nutrition called the Centers for Food Safety and Applied Nutritions (CAERS) Supplement E-Reporting System. For that reason, FDA will continue to strive to complement these measures with industry and consumer education, and continue to help the supplement industry through regulations and guidance documents that address dietary supplement manufacturing, labeling, and sales. For example, the Food and Drug Administrations Statement on Identity, Nutrition, and Labeling of Ingredients in Dietary Supplements small entity compliance guide discusses the implementation of Agency regulations that address labeling provisions in the bill; and it is also using resources, continuing to coordinate with other Federal and State entities involved in addressing health fraud.
CFSAN has also issued consumer alerts regarding unsafe products, such as an alert that Food and Drug Administration issued regarding dietary supplements that contained Kava, a botanical ingredient; continued communication with the dietary supplement industry regarding practices allowed under DSHA. We encourage the Agency to publish definitive new dietary ingredient (NDI) guidelines offering protections to innovation and research; establish and clarify the legal pathway for hemp-derived cannabidiol (CBD) as a dietary supplement; implement mandatory product listings providing transparency for regulators and consumers; and address issues regarding N-acetyl-l-cysteine (NAC) and other ingredients shared between supplements and medications. Taken together, a product listing and a clear authority to issue recalls will significantly enhance FDAs oversight of supplements, providing the agency with key information about products in the dietary supplement marketplace and ensure it can take action swiftly if it becomes known to pose risks to public health. A mandatory product listing requirement is a low-cost, low-burden solution that will ensure that FDA has the information necessary to adequately oversee the supplements market.
Two critical issues to be addressed are the inability for FDA to learn about which supplements are available in the market, and the failure of the agency to order recalls for supplements that contain pharmaceutical ingredients. In cases in which supplements are contaminated with drug ingredients, gaps in the law leave the agencys recall powers murky. In addition, concerns about safety have been raised regarding both regular and higher-dose supplements. At least four people have died from using Tianeptine, and nearly two dozen people reported hospitalizations and other adverse effects, according to analysis of FDA data, scientific case reports, and documents obtained under the Freedom of Information Act.
In some cases, excess amounts of vitamins and minerals can be harmful or produce undesirable side effects; thus, maximal levels are needed to assure safe use of them in dietary supplements. These are applicable only for supplements that contain vitamins and/or minerals in which those products are regulated as foods, and address the supplement ingredients, including safety, purity, and bioavailability. The underlying framework of DSHEA allowed for all products that were sold as food supplements at the time of enactment of the act to remain on the market, except where FDA may have shown a safety issue with the specific product or product line this is what is called a grandfather clause; manufacturers are required to inform the FDA before marketing any new ingredients.
The Federal Nutrition Food Program substantially increased the Federal regulatory power over drugs, mandating a premarket review of all new drugs for safety, as well as prohibiting misrepresentations of medical benefits on medication labels, without requiring FDA to demonstrate fraudulent intent. Advertising and Marketing Advertising is a major enforcement area, because almost two-thirds of people in the U.S. report having been exposed to advertisements for food additives. The Federal Trade Commission regulates supplements advertisements, including print and Internet advertisements, infomercials, catalogs, and other materials from manufacturers, in order to ensure that advertisements are truthful, non-misleading, and justified.
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