FDA To Redefine the Healthy Claim Update

Product Id : FDA162
Instructor : Norma Skolnik
Nov 20, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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How the FDA’s Redefinition of “Healthy” Claims Will Impact FDA Enforcement

The FDA has decided to redefine the “healthy” claim used in food labeling. In order to respond to FDA changes regarding the “healthy” claim for food labeling and promotion, it’s critical to understand how FDA defines it now and how it is planning to redefine the “healthy” claim.

Join this session, where expert speaker Norma Skolnik will offer an overview of the current FDA regulations on use of the term “healthy” per FDA’s 1993 final rule and why the agency intends to redefine the term in view of the evolving science related to public health recommendations for dietary intake.

Norma will provide an update on the FDA’s recent public meeting, references to all relevant FDA regulations, guidance documents, and FDA websites for general nutritional claims and “healthy” claims, in addition to the regulatory insights. You will get know-how tips on marketing foods with a “healthy” claim and citations to all relevant FDA regulations and guidance documents.

Session Highlights

  • Overview and background on current FDA regulations for a “healthy” claim per 21 CFR 101.65(d)
  • The role of the 2016 rules updating the "Nutrition Facts" label
  • FDA’s reasons for wanting to redefine the term in view of the evolving science and public health recommendations for dietary intake
  • Beneficial nutrients and FDA’s view on how they relate to the definition of the term “healthy”
  • Definition changes to “healthy” that we are likely to see
  • Update on FDA’s recent public meeting regarding “healthy” claim changes
  • What this change means regarding FDA enforcement discretion

Session Agenda

  • Healthy claim background
    • May 1994 regulation
    • FDA’s criteria for the term "Healthy"
  • 1998 healthy claim regulation
  • Current healthy claim: Definition
  • Why is FDA redefining "Healthy" claim
  • Dietary recommendations included in the “2015-2020 Dietary Guidelines for Americans”
  • Influence of new scientific thinking
  • FDA’s warning letter to Kind LLC for not meeting the FDA's requirements
  • Kind petition: Overview, impact and influence
  • September 2016 Federal Register Notices regarding “healthy” claim
  • Enforcement discretion: Overview
  • What to expect next from FDA
  • Potential implications of Trump administration

Who Should Attend

  • Regulatory affairs managers and associates
  • QA mangers
  • Food marketing managers
  • Anyone interested in learning about how FDA will redefine the “healthy” claim
  • Food company representatives
Speaker Profile:

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that, she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company.

She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare, as Associate Director of Marketed Product Support for Lederle Laboratories and as Associate Director of Regulatory Affairs for Wyeth.

Norma currently works as a regulatory consultant and also enjoys coaching those who are just starting out in the consulting field

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