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Structure-Function Claims Pre-Market Notification

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

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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. Structure-function claims can appear on the labels for dietary supplements or drugs.
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 examples

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 structure-function claim notification
  • Include a copy of your product labels with the notification
  • Submit the notification on your behalf
  • Act as your contact person with the FDA
  • Handle any communications with respect to the notification 
  • Provide guidance with respect to any changes to your claims
Get Support for Structure-Function Claims Pre-Market Notification

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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