The FDA regulates both finished dietary supplements and dietary ingredients. The FDA regulates dietary supplements according to a different set of rules than those that regulate conventional foods and drugs. Although the FDA does not approve dietary supplements, the agency has functions to regulate them. The Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (Act FD&C) to create a new regulatory framework for dietary supplements.
According to the DSHEA, the FDA does not have the authority to approve dietary supplements before they are marketed. Generally, a company does not have to provide the FDA with the evidence it relies on to demonstrate safety before or after marketing its products; however, there is an exception for dietary supplements that contain a new dietary ingredient that is not present in the food supply as an item used for food in a way in which the food has not been chemically altered. At least 75 days before introducing such dietary supplement into interstate commerce or delivering it for introduction into interstate commerce, the manufacturer or distributor must submit a notification to the FDA with information on the basis of which the company has concluded that the dietary supplement containing NDI can reasonably be expected to be safe. In addition, FDA regulations require that those who manufacture, package, or store dietary supplements follow current good manufacturing practices that help ensure the identity, purity, quality, concentration, and composition of dietary supplements.
Generally, the FDA does not approve dietary supplement statements or other labels before use. The Food and Drug Administration is a federal agency responsible for regulating products that affect public health, such as food products, drugs, medical devices, cosmetics, and even tobacco products. The FDA plays an important role in ensuring the safety of the products we use every day, but it doesn't give prior approval to every industry it oversees. More on that in a minute.
According to the FDA, drugs are used to treat, prevent, mitigate, diagnose, or cure diseases. Clinical trials in humans must demonstrate that a pharmaceutical drug is safe and effective for its intended use. The drug must then be manufactured under controlled conditions and packaged to meet strict labeling standards before the FDA pre-approves it for consumer use. Unlike drugs, the FDA says supplements are for nutritional purposes only.
Because supplements are not considered drugs, they are not controlled in the same way. While the FDA has regulations for manufacturing and labeling, dietary supplements have different testing, safety, and efficacy guidelines than pharmaceutical drugs. Unlike drugs, supplements do not require prior approval by the FDA before going on sale to the consumer. The Dietary Supplement Health and Education Act of 1994 (DSHEA) defined the role of supplements and described what dietary supplement companies can legally say about their products.
The law dictates that, since supplements are not drugs, supplement companies cannot imply, insinuate, or assert that their product diagnoses, treats, cures, or prevents diseases of any kind. The FDA has also interpreted some normal conditions as precursors or markers of diseases. That's why you might see some vague words about what a supplement does to meet FDA guidelines on approved dietary supplement declarations. The FDA doesn't “approve” dietary supplements because it doesn't approve foods.
The FDA only approves pharmaceutical drugs. The FDA oversees the manufacturing and labeling of supplements, and periodically inspects companies to ensure that they meet all regulations. If a supplement company doesn't comply with FDA regulations, the FDA may prohibit you from selling your product. For example, calcium and vitamin D can help strengthen bones, and fiber can help maintain bowel regularity.
For a list of possible serious reactions to watch out for and to learn how to report an adverse effect, see the FDA website, How to Report a Problem with Dietary Supplements. The Dietary Supplement Health and Education Act (DSHEA) requires the manufacturer or distributor to notify the FDA in advance and submit safety information if it intends to market a dietary supplement in the United States that contains a new dietary ingredient, unless the new dietary ingredient is present in the food supply as an item used for food in a form where the food has not been chemically altered. To ensure public safety, the FDA has defined good manufacturing practices (GMP) that it enforces through inspections, and has the authority to process, seize, and recall dangerous products from the market. In general, the FDA is limited to enforcing the law after they are marketed because, unlike drugs that must demonstrate their safety and efficacy for their intended use before marketing, there are no provisions in the law that allow the FDA to approve the safety of dietary supplements before they reach the consumer.
The FDA's role in regulating dietary supplements includes (among other things) inspecting dietary supplement manufacturing facilities, reviewing notifications of new dietary ingredients (NDIs) and other regulatory requests regarding dietary supplements, investigating complaints, monitoring the dietary supplement market, examining dietary supplements and dietary ingredients offered for import to determine if they meet the requirements of. A coalition comprised of health food stores, supplement users, the supplement industry, lobbyists, and sympathetic members of Congress created a new class of products and, at the same time, declared that this new class would not be subject to the FDA's mission. However, manufacturers and distributors of dietary supplements must record, investigate, and submit to the FDA any reports they receive about serious adverse events related to the use of their products. Therefore, the DSHEA eliminated the premarket review and approval of dietary supplements by the FDA, and it also eliminated the FDA's authority to test dietary supplements.
So what exactly is the FDA's role in the supplement industry, and what do those two little phrases mean? Let's dive in. The FDA is committed to protecting the public by identifying and recalling unsafe and illegal products and ensuring that products marketed as dietary supplements are safe, well-manufactured, and accurately labeled. Health Education and Dietary Supplements Act Health food and supplement store lobbyists worked hard to ensure that the FDA could not maintain any control over vitamins through the NLEA or any other method. Because taking supplements can also involve health risks, the FDA recommends that consumers inform themselves and talk to their doctor, pharmacist, or other health professional before deciding to buy or use a dietary supplement.
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