The Food and Drug Administration regulates the safety, manufacture and labelling of nutritional supplements, and our partners at the Federal Trade Commission are primarily responsible for regulating the advertising of these products. The Food and Drug Administration regulates nutritional supplement quality, safety, and labeling, while the Federal Trade Commission controls advertising and marketing; however, significant enforcement challenges remain, and optimal state oversight has not yet been achieved. The FDA regulates nutritional supplements under many different rules than “regular” foods and drugs. The Dietary Additives and Food Labeling Act of 1994 weakened the USDA’s ability to regulate dietary supplements, classifying them as foods rather than drugs.
The law placed dietary supplements in a special subcategory under the general food umbrella, but products that meet the definition of drugs are subject to regulation as drugs. The basic structure of the DSHEA allowed all products sold as dietary supplements at the time of the bill’s passage to remain on the market, unless the Food and Drug Administration could raise concerns about the safety of a particular product or product line – this is the so-called ” grandfather’s position. ; manufacturers must notify the FDA before any new ingredient is released to the market. For this reason, the FDA will continue its efforts to integrate these measures with industry and consumer education and will continue to assist the dietary supplement industry by issuing regulations and guidance documents regarding manufacturing , labeling and sale of food additives.
Public Health Regulations
The Meat Inspection Act establishes specific labeling requirements, provides a regulatory framework, and authorizes the FDA to enact Good Manufacturing Practices for dietary supplements. One difference between these over 100 accounts is that, under the Meat Inspection Act, government inspectors must always know that a meat processing plant is in operation and that every element of the product is inspected by a government agency. By law, other food companies (and their products) are only subject to periodic government inspections.
Federal regulation of the industry began in the early 20th century when Congress passed the Pure Food and Drug Act of 1906. With stronger legislation, the agency would have greater powers to regulate the patented drug industry.
The USDA has the authority to regulate the treatment claims that drug manufacturers print on their product labels; however, under the Wheeler-Lee Act of 1938, drug advertising authority rests with the Federal Trade Commission (FTC). Under the Wheeler-Lee Act, the FTC oversees advertising related to other products. Excluding prescription drugs, The U.S. Food and Drug Administration (FDA), the regulatory agency the act spawned, now directly oversees one-fifth to one-quarter of U.S. gross domestic product (GDP) and has considerable control over how and how goods enter the market great power. Their food and drug sales to consumers and the production practices of food and pharmaceutical companies.
The Food Safety Modernization Act completely changed the way food is regulated and restored the FDA’s authority over food farms. The FDA has completed the Food Safety Plan regulation (see 21 CFR 121 Strategies to Protect Food from Deliberate Adulteration) as part of the implementation of the Food Safety Modernization Act. China’s new food safety law (adopted in 2015) includes 13 articles related to the regulation of food for health (27).
The FDA is asking for information about the use of the word “natural” in food labeling after receiving several petitions from citizens on the matter. Mexico (among others) is moving towards a first food label requirement and we anticipate that this will expand to other countries and possibly complement the labels.
The European Food Safety Authority (EFSA) adds: “Supplements can be used to correct nutritional deficiencies or to maintain adequate intake of certain nutrients. In some cases, excessive intake of vitamins and minerals can be harmful or cause side effects. Therefore, maximum levels are necessary to ensure their safe use in dietary supplements.” (31). They apply only to supplements that contain vitamins and/or minerals, where these products are regulated as food and refer to the composition of supplements, including their safety, purity, and bioavailability (36, 114).
In Australia, most dietary supplements fall into the complementary medicine category, which includes vitamins, minerals, herbal, aromatherapy and homeopathic products, although some may be considered specialty products and regulated by the Food Administration (11, 38, 110, 111 ). Food supplements are classified as Health Functional Foods (HFF) in Korea and are regulated by the Ministry of Food and Drug Safety (MFDS) under the HFF Safety Act (94). These regulations are often specific to food (Hutt and Hutt, 1984). This hostility, and the lack of a clear regulatory framework for dietary supplements, was made clear even before the law was passed. The FTC has adopted a higher standard for proving that claims are misleading, arguing that inconclusive scientific evidence or overestimated health benefits are insufficient to justify health benefit claims55,61,62. 55 courts have ruled that the use of disclaimers combined with unsubstantiated health claims is more consistent with commercial free speech rights than outright bans. 61,62 In addition, post-market surveillance remains an issue. Interestingly, Sen. Richard Durbin (D-IL) and Rep. Rosa DeLauro (D-CT) – both Democrats and critics of nutritional supplements -have regularly introduced legislation since 1999 to redefine the FDA “Federal Drug Administration”, and create a new federal agency to oversee all food businesses – now a division between the FDA and USDA.