When it comes to food, dietary supplement, and cosmetic labeling, structure-function claims are statements about the effects that a product has on the body’s structure or function. This guide provides an in-depth look into FDA regulations surrounding these claims and how to ensure compliance. The FDA has strict regulations on these claims, and it’s important to understand them to avoid legal issues.
Gain the upper hand in preparing your structure-function claim notification for a successful pre-market notification to the FDA.
According to 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, it is mandatory for any dietary supplement (that is marketed with at least one structure-function claim) to notify FDA within 30 days after the dietary supplement is first marketed in US.
We help you prepare the structure-function claim notification, develop your product labelling, ensure your product labels comply with FDA regulations. Note that only electronic submissions receive confirmation from FDA of receipt.
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