A medical food per FDA is a specific category “formulated to be consumed… under the supervision of a physician and which is intended for the specific dietary management of a disease or condition” which need “distinctive nutritional requirements.”
This means that medical foods are not those simply recommended by a physician as part of an overall diet to manage symptoms or reduce the risk of a disease. Additionally, not all foods fed to patients with a disease, including diseases that require dietary management, are medical foods.
It’s a tricky category and one increasingly under FDA scrutiny. Per section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), medical foods are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state), and intended to be taken enterally by a patient who requires use of this food product as a major component dietary management of a specific disease or condition.
How can you ensure that the foods you are producing under the category of “medical foods” meets FDA’s intent? What other regulatory requirements apply to this unique category – such as labeling, food facility registrations, Good Manufacturing Practices and those of low-acid and acidified foods? Once it is determined that a food does meet FDA’s definition of medical foods, then what?
Join EAS March 9, 2021 at 1pm eastern for a webinar on Medical Foods – When Will the Other Regulatory Shoe Drop for a look at how FDA views this unique category of foods and how to comply with federal requirements. Presented by EAS independent consultants Timothy Morck, Ph.D. and Manfred Ruthsatz, Ph.D., you’ll come away with an understanding of what’s required in creating, marketing and labeling these products.