FDA regulations on vitamins and dietary supplements
In short, yes. There are specific FDA regulations on supplements.
Raw ingredients, vitamins and dietary supplements fall under FDA regulations, under the Dietary Supplement Health and Education Act (DSHEA) 1994. New ingredients (post 1994) to be added into dietary supplements need to go through the New Dietary Ingredient Notification (NDIN) process.
Dietary supplements include products such as vitamins and minerals, herbal products, amino acids and enzyme supplements. Albeit having requirements on labels and product safety, FDA relies more on post-market surveillance for dietary supplements, unless the product contains non GRAS (Generally Recognized as Safe) substances or new ingredients. FDA generally begins regulation after supplement products enter the market.
There are three categories of claims for dietary supplements in the U.S.:
(a) nutrient content claims with terms such as “high”, “free” and “reduced” indicating the level of key nutrients;
(b) structure/function claims describing the effect of a dietary supplement on the structure and function of body. It cannot imply any effects of the dietary ingredient on disease or condition.
(c) health claims, which needs approval from FDA describing a relationship between an ingredient and a disease or health-related condition.
Facing growing regulatory needs from the dietary supplement industry that has more than quadrupled in the last two decades, the FDA announced in December 2015 the creation of the new Office of Dietary Supplement Programs (ODSP), previously a division under Office of Nutrition Labeling and Dietary Supplements.
