On August 13, 2013, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Frequently Asked Questions about Medical Foods; Second Edition.” The first edition of this guidance was previously issued in May 2007. The draft provides the FDA’s answers to commonly asked questions concerning the definition and regulation of medical foods and updates the responses in the 2007 document. You can read the draft guidance on the FDA’s website, available here.
More specifically, a medical food—defined in section 5(b)(3) of the Orphan Drug Act (ODA)—is 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.” Pursuant to 21 CFR 101.9(j)(8), which clarifies the definition of a medical food under the ODA, a food is a medical food only if it meets certain criteria, particularly if it is: (1) specifically formulated and processed for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube; (2) intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone; (3) intended to be used under medical supervision and (4) intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.
As explained in the draft, medical foods are generally regulated as conventional foods but are exempt from the labeling requirements for health claims and nutrient content claims under the Nutrition Labeling and Education Act (NLEA) of 1990. Aside from applicable exemptions, however, medical foods must comply with all FDA requirements pertaining to conventional foods. This includes the Current Good Manufacturing Practices (cGMPs) published in 21 CFR part 110, the food facility registration requirements in 21 CFR part 1, subpart H, and all food allergen labeling regulations. Industry compliance with these regulations is explained by the FDA’s Compliance Program Guidance Manual.
Significantly, medical foods are not considered to be drugs and are not required to comply with regulations applicable to drugs specifically. For example, the FDA does not require medical foods be made available by written or oral prescription, as this only applies to the dispensing of prescription drug products. Additionally, the agency notes that certain labeling statements intended for drugs can cause a medical food to be misbranded. The labeling on medical foods, for example, must not include National Drug Code (NDC) numbers because NDC numbers are intended to unique identify drugs only. Including an NDC number on the labeling of a medical food will cause the product to be misbranded under 403 (a)(1) the Food, Drug, and Cosmetic Act (FDCA).
In all, the FDA distinguishes between the types of conditions for which medical foods can be labeled and marketed and those for which they cannot. Inborn errors of metabolism (IEMs) are typically considered appropriate for the use of medical foods. Classical nutrient deficiencies, pregnancy, and diabetes are not considered by the FDA to be appropriate; foods intended to address these conditions should not be labeled as medical foods.
When finalized, the draft guidance will represent the agency’s current interpretation of the requirements for medical foods. Comments must be submitted within 60 days of its publication (October 11, 2013). If you have any questions about medical foods, including compliance with FDA requirements, please contact us at: contact@sglawfl.com.
