On Nov. 24, 2021, the Food and Drug Administration (FDA) issued a request for information on the past use of N-acetyl-L-cysteine (NAC) in products marketed as dietary supplements, which includes: the earliest date that NAC was marketed as a dietary supplement or as a food, the safe use of NAC in products marketed as a dietary supplement, and any safety concerns. The FDA is asking interested parties to submit such information by January 25, 2022.
On June 2021, the Council for Responsible Nutrition (CRN) asked the FDA to reverse the agency’s position that NAC-containing products cannot be dietary supplements. In August 2021, the Natural Products Association (NPA) asked the FDA to either determine that NAC is not excluded from the definition of a dietary supplement or, in the alternative, initiate rulemaking to make NAC a lawful dietary supplement under the Federal Food, Drug, and Cosmetic Act.
As a tentative response to both citizen petitions, FDA is requesting additional information from the petitioners and interested parties while noting that the agency needs additional time to carefully and thoroughly review the complex questions posed in these petitions.
What Is Dietary Supplement Product & Ingredient?
The FDA defines dietary supplements as products (other than tobacco) intended to supplement the diet that contain at least one of the following ingredients: vitamin, mineral, amino acid, herb or other botanical; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. They may be found in many forms such as pills, capsules, tablets, or liquids. Whatever their form may be, they can never be the replacement of conventional food or a sole item of a meal or diet. It is required that every supplement is labeled as "dietary supplement”.
Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as “reduces pain” or “treats heart disease.” Claims like these can only legitimately be made for drugs, not dietary supplements.
Regulations on Dietary Supplements
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):
Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. This means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of the FDA and DSHEA.
FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market.
Post time: Mar-15-2022