The FDA does not approve dietary supplements. The FDA is not authorized to approve dietary supplements because of their safety and effectiveness. In fact, many dietary supplements can be marketed without even notifying the FDA. Dietary supplements are regulated by the FDA as foods, not as drugs.
However, many dietary supplements contain ingredients that have strong biological effects that may conflict with a medication you are taking or with a medical condition you may have. Products containing hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at even greater risk. For these reasons, it's important to consult with a healthcare professional before using any dietary supplement. Read these consumer updates for more information.
In particular, the Food and Drug Administration (FDA) does not have the authority to review the safety and effectiveness of dietary supplements before they are marketed. The FDA is committed to protecting the public by identifying and removing unsafe and illegal products from the market and ensuring that products marketed as dietary supplements are safe, well-manufactured, and precisely labeled. The Dietary Supplements Health and Education Act (DSHEA) of 1994, which amended the Federal Food, Drug, and Cosmetic Act, transformed the FDA's authority to regulate dietary supplements. No, a product sold as a dietary supplement and presented explicitly or implicitly for the treatment, prevention, or cure of a specific disease or class of diseases meets the definition of a drug and is subject to regulation as a drug.
If you have any general complaints or concerns about food products, including dietary supplements, you can contact the consumer complaint coordinator at the FDA district office closest to your home. In fact, in many cases, companies can legally introduce dietary supplements to the market without even notifying the FDA. That changed when Congress defined the term dietary supplement in the Health and Education on Dietary Supplements Act (DSHEA) of 1994. Congress defined the term dietary supplement in the Dietary Supplements Health and Education Act (DSHEA) of 1994. In addition to the manufacturer's responsibility to comply with safety regulations and labeling requirements for dietary supplements and to comply with current standards of good manufacturing, there are no laws or regulations that limit the serving size of a dietary supplement or the amount of a dietary ingredient.
What can be in one serving of a dietary supplement. Along with information about the new dietary ingredient and the dietary supplement in which it will be marketed, the notification must include the safety information on which the notifier has based his conclusion that the new dietary ingredient can reasonably be expected to be safe when used under the conditions recommended or suggested on the dietary supplement label. Whatever its form, the DSHEA places dietary supplements (DS) in a special category within the general scope of foods and, therefore, the FDA continues to have a responsibility to help regulate the industry, even if it plays a minor role. In the case of articles authorized for clinical research by virtue of an IND, the exclusion from the definition of dietary supplement applies only if substantial clinical research has been initiated and the existence of such research has been made public.
And with more than 90,000 different supplements on the market, it can be confusing to understand what's safe and what's not. 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, such as an item that is used as food in a way in which the food has not been chemically altered. Consumers can contact the manufacturer of the dietary supplement or a commercial laboratory to analyze the content of a product. In general, the FDA is limited to post-market application because, unlike drugs that must demonstrate their safety and effectiveness for their intended use before marketing, the law does not require the FDA to approve the safety of dietary supplements before they reach the consumer.
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