Medical Foods – When Will the FDA Enforcement “Shoe” Drop?

EAS Complimentary Webinar

Presented by Timothy Morck, Ph.D. and Manfred Ruthsatz, Ph.D., EAS Independent Consultants

The industry’s interest in Medical Foods is growing with many new products as well as the repositioning and relabeling of existing products that places them into the medical foods space. FDA’s oversight and enforcement effort focused on Medical Foods has been limited partly due to the resource drain caused by COVID and other priorities. However, there is a real possibility in 2021, FDA will focus more attention and resources on Medical Food labeling, formulations, advertising statements, ingredients, co-manufacturers and distributors. Some products positioned in the Medical Foods category appear to be a better fit as a dietary supplement.

Although FDA’s definition of a Medical Foods is clear, many in the industry believe that a food with special nutritional ingredients and the ability to deliver improved nutrition to the consumers can be called a “Medical Food”. While many foods do have “special” nutrition ingredients and are scientifically formulated to deliver health benefits, this by itself does not qualify a food to be labeled and marketed as a Medical Food.

What exactly is a Medical Food and why is FDA’s guidance, issued in 2016, still misunderstood? Join EAS independent consultants, Timothy Morck, Ph.D. and Manfred Ruthsatz, Ph.D. for a look at Medical Foods including how they are viewed in the U.S. and how the EU’s version of Foods for Special Medical Purpose (FSMP) differs.

You’ll learn some of the challenges of complying with FDA’s current interpretation of the definition of Medical Foods, a review of related FDA’s enforcement actions to date, and the impact on new Medical Foods product development and innovation.

About the Presenters

Timothy Morck, Ph.D.

Timothy Morck, Ph.D. provides expertise in nutrition-related research, product development, regulatory and public policy and global scientific affairs. His career has included clinical nutrition practice, research, association management and personalized nutrition start-ups working at The Dannon Company, Mead Johnson Nutritionals, Abbott Nutrition, Nestle Health Science and Nestle Corporate Affairs, facilitating the interplay between the legal, scientific, and regulatory framework surrounding medical foods has been a particularly sharp focus for him.

Manfred Ruthsatz, Ph.D.

Manfred Ruthsatz, Ph.D. facilitates FDA compliance in the areas of food and nutrition including HealthCare, Sports, NutriCosmetics, Supplement), and pharma including novel, biotechnology, generics; prescription, OTC and parenteral and more. Focusing on global strategy and relationship building he resolves compliance issues while advocating for nutrition therapy in regulations and policies including the EU, Americas and Asia. Prior to consulting he worked as Global Head, Regulatory Advocacy at Nestlé Health Science, Global Headquarters, Switzerland.

Posted in Foods, On Demand Webinar.