
Unlike prescription and over-the-counter drugs, dietary supplements do not require FDA approval before they reach the market. According to the NIH Office of Dietary Supplements, supplement companies are responsible for having evidence that their products are safe and that label claims are truthful, but as long as the product does not make a disease claim, it can be sold without any pre-market clinical review. For anyone evaluating a finished formulation, understanding that regulatory context changes how you read an ingredient list.