FDA and Dietary Supplements
Friday, May 04, 2012
FDA has the authority to remove from the market adulterated or unsafe products.
- If a product contains an ingredient not listed on the label (or if an ingredient on the label is not listed in the product at the claimed amount), the product is adulterated and FDA can impose sanctions on the company, ranging from imposing fines to removing the product from the marketplace to criminal prosecution of the manufacturer.
- By law, dietary supplement manufacturers must adhere to Good Manufacturing Practices (GMPs) specific to dietary supplements which go beyond conventional food GMPs and cover virtually all aspects of supplement manufacturing, labeling, and quality control. Products that are not made according to the GMPs can be deemed adulterated or misbranded by FDA.
- Dietary supplement manufacturers must notify FDA before they introduce a new ingredient to the marketplace and must have evidence of safety in support of the new ingredient.
- Advertising and labeling for dietary supplements must be truthful and not misleading to consumers. FDA, FTC, and state agencies and attorneys general all have enforcement authority and have exercised that power with large civil fines and penalties.
Additionally, dietary supplement manufacturers must notify FDA within 15 days of any serious adverse event reports they receive, a requirement comparable to prescription and some over-the-counter drugs, but not conventional foods.
It is true that dietary supplement products do not have to undergo the same pre-market approval process as that required for drugs; however, pre-market approval does not always provide a guarantee of safety, as we have seen with so many FDA approved prescription drugs.
Ellen Troyer, MT MA
Biosyntrx CEO / Chief Research Officer
Manufacturing Flow Chart