Insight into Medical Foods and the Scope of FDA Regulation

Photo by Gabrielle Henderson on Unsplash

The FDA has issued warning letters to manufacturers of products marketed as medical foods to treat a range of medical conditions, including fibromyalgia, autoimmune disorders, irritable bowel syndrome, arthritis, asthma, allergies, psoriasis, and cardiovascular disease. The FDA sets a high bar for foods to be classified as medical foods.

The medical foods market is a rapidly growing sector in the consumer healthcare and nutrition industry. The global market valuation for medical foods is roughly $20 billion today and may approach $30 billion by 2026. Companies in this space must pay close attention to the FDA’s regulations and guidance on what constitutes a medical food and how medical foods can be marketed.

Medical foods are not prescription medicines and are not dietary supplements. So, what are they? Federal law and FDA regulation define medical food as, “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation” (§ 5(b) of the 1988 Orphan Drug Act (21 U.S.C. 360ee(b)(3)) and FDA regulation 21 CFR 101.9(j)(8)).

To provide greater clarity on this definition, the FDA in 2016 published, “Frequently Asked Questions About Medical Foods; Second Edition; Guidance for Industry.” This guidance explained that “medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who requires use of the product as a major component of a disease or condition’s specific dietary management.”

So what diseases or medical conditions do medical foods treat? The FDA has recognized “inborn errors of metabolism” (IEMs) as a condition that medical foods may be used to manage (2016 FDA Guidance). IEMs are rare genetic (or inherited) disorders in which the body cannot properly turn food into energy. These conditions can produce a broad range of health complications, including failure to grow, deafness, dental abnormalities, depression, joint pain, cognitive impairment, and death.

On the other hand, the FDA does not recognize more common conditions, such as pregnancy and diabetes mellitus, as medical conditions requiring distinctive nutritional management via medical foods. Nutrient requirements to support pregnancy can be met by diet modification, while diabetes can be managed with diet modification and drug therapy.

As medical foods are not drugs, they are not subject to any regulatory requirements specific to drugs. While a doctor may “prescribe” enteral nutrition for a patient (feeding directly into the gastrointestinal tract), medical foods do not require a doctor’s prescription. Furthermore, medical foods are exempt both from the nutrition labeling requirements of 21 CFR 101.9 and from the labeling requirement for health claims and nutrient content claims under the Nutrition Labeling and Education Act of 1990 (21 U.S.C. 343(r)(5)(A)). That said, as with any food, a medical food that flaunts a false or misleading claim would be in violation of § 403(a)(1) of the Federal Food, Drug, and Cosmetic Act.

Any manufacturer or distributor of medical foods should consider seeking advice from counsel knowledgeable about the regulatory and statutory requirements that define and govern medical foods.

[View source.]