Structure-Function Claims Pre-Market Notification

Gain upper hand in preparing structure-function claim notification for a successful pre-market notification to FDA electronically.

What is a Structure-Function Claim?

A Structure-Function Claim is a key description made about nutritional supplements and vitamins. It explains how an ingredient or nutrient reacts to the structure or functions of the human body. It appears on dietary supplements of drugs or the labels of foods.
Example: A product is classified as food. But, if its labelling contains disease claims, FDA will classify the product as a drug. Hence, understanding the type of claims used for your particular product is important when marketing an FDA-regulated product. The claims must be accurately worded and fit the structure-function claims.

30-Day Notification to 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.

Why You Need An Experienced FDA Consultant

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.

Structure-Function Claims Pre-Market Notification Offered by 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.

  • We review your product labelling
  • Draft and submit a 30-day notification
  • Include your actual product labels, websites
  • Submit your 30-day notification on your behalf
  • Act as your contact person with the FDA
  • Handle any communications with respect to the 30-day notification 
  • Provide guidance with respect to any changes to your claims
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