FDA Announces Initiative to Redefine “Healthy” Claim for Food Labeling

Product Id : FDA53
Instructor : Norma Skolnik
Jul 25, 2019 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

Overview of Current FDA Regulations on Use of the Term “Healthy” on Food Labels and Why it Intends to Redefine the Term

The U.S. Food and Drug Administration (“FDA”) announced in September that it is considering how to redefine the term “healthy” as a nutrient content claim for the labeling of human food products. The FDA issued a guidance for industry entitled “Use of the Term ‘Healthy’ in the Labeling of Human Food Products: Guidance for Industry” stating that FDA does not intend to enforce the regulatory requirements for products that use the term if certain criteria set forth in the guidance are met.

In this session, expert speaker Norma Skolnik will offer an overview of 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.

References to all relevant FDA regulations, Guidance documents, and FDA websites for general nutritional claims and “Healthy” claims will be provided as well as regulatory insights.

Why Should you Attend

Understanding food labels can sometimes feel like you're trying to crack a secret code. Manufacturers slap 'natural,' 'gluten-free' and 'fat-free' on food packages, but products may include ingredients that contradict their claims. You know to never judge a book by its cover, but with food labels it's a must. And separating the good from the bad can be tricky. That's particularly true of the term 'healthy.' Now, the Food and Drug Administration (FDA) is on a mission to clear up the confusion. This webinar will explain criteria for the new FDA 'healthy' claim for Food Labeling and promotion.

Session highlights:

  • Background to the current FDA regulations for a “Healthy claim” per 21 CFR 101.65(d)
  • The role of the new 2016 final 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”
  • FDA enforcement discretion if foods do not meet the specified nutritional requirements

Who Should Attend:

  • Regulatory Affairs managers
  • Directors & associates
  • Labeling managers
  • Marketing managers involved in food labeling
  • Consumer Relations
  • Product Development
  • Product managers
  • Risk Management
  • Quality Assurance
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


Available Options