Gain upper hand in preparing structure-function claim notification for a successful pre-market notification to FDA electronically.
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.
The dietary supplement regulations are very technical. Staying compliant with FDA regulations or submitting a 30-day notification with federal law is complex. Consequently, marketers of dietary supplement products look for assistance from a team of experienced and talented FDA consultants.
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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