Structure/Function Claims for Conventional Foods and Dietary Supplements

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Jan 29, 2019
60 minutes
Product Description

Unlock the FDA’s 10 Regulatory Criteria for Permissible S/F Labeling

“Certain Types of Statements for Dietary Supplements” was published in 1997, and contains 10 criteria that apply to Structure/Function (S/F) claims. But understanding the wording of permissible S/F claims—and what is not acceptable—can still be a challenge. An S/F claim phrased incorrectly, or one in which S/F claims could represent your products as drugs, can wind up as a citation in U.S. Food and Drug Administration (FDA) warning letters. To stay on the right side of the FDA, you need to understand exactly what to and what not to do when it comes to products with S/F claims.

The key to avoiding unwanted attention from the FDA is to understand what constitute S/F claims and how they should be worded, says international labeling expert Gisela Leon. In this webinar, Leon details labeling that must appear on products that bear S/F claims and how the claims have to be reported to the FDA in a notification where the responsible party signs that the claims are substantiated.

After attending this detailed webinar, you will understand the definition of S/F claims and FDA disclaimers. You will also know the similarities and differences between S/F claims on conventional foods and dietary supplements, and you will understand the permissible phrases for S/F claims according to examples from each of the FDA’s 10 regulatory criteria. Finally, you will go beyond labeling with FDA notifications for S/F claims on the label. Don’t get on the FDA’s wrong side—what you need is this well-structured explanation of the requirements of Structure/Function claims and a full understanding of their regulatory requirements.

Session Highlights

This program will teach you about:

  • FDA disclaimers
  • Similarities and differences between S/F claims on conventional foods and dietary supplements
  • Permissible phrases for S/F claims for each of the FDA’s 10 regulatory criteria
  • FDA notifications for S/F claims on the label and in labeling
  • Substantiation of S/F claims

Who Should Attend

  • Regulatory staff in food and dietary supplement companies
  • Label reviewers
  • Label creators

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Gisela Leon

Gisela Leon has over 30 years of expert knowledge in international labeling. She is well-experienced in U.S. labeling requirements for food, dietary supplements and cosmetics, in European food laws and multi-language labeling. As a regulatory consultant, she focuses on a concise review process, having reviewed hundreds of labels for U.S. compliance and brought international products into compliance with U.S. regulations. Her international labeling background allows...   More Info
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