On August 13th, the Food and Drug Administration (FDA) announced the availability of a revised draft guidance on medical foods entitled, “Draft Guidance for Industry: Frequently Asked Questions About Medical Foods, Second Edition.” FDA issued the draft guidance in response to confusion over the definition, labeling, and availability of medical foods, and to update FDA’s prior guidance in field.
Notably, FDA’s draft guidance greatly restricts the universe of diseases manageable by “medical food” products. For example, FDA clarified that medical foods cannot be used to manage disease or conditions that can theoretically be managed by modifying the normal diet alone. FDA specifically identified diabetes, classical nutrient deficiency diseases (e.g., scurvy and pellagra) that result from essential nutrient deficiencies, and pregnancy as diseases or conditions that medical foods cannot be used to manage. The agency, however, will allow inborn errors of metabolism (IEMs), including inherited biochemical disorders in which a specific enzyme defect interferes with normal metabolism of protein, fat, or carbohydrate, to be managed with medical foods when the medical food is required in addition to dietary modification to maintain sufficient levels of essential nutrients that are reduced by modifying the normal diet.
The problem with FDA’s approach is that it eliminates beneficial products from the marketplace, requiring them to either proceed through the drug approval process or be marketed as dietary supplements with limited structure/function claims, thus depriving consumers of valuable information that can improve their health. Although some diseases and conditions that have special nutritional requirements can be managed through diet modifications alone, not all consumers are willing or able to make drastic diet modifications. If FDA’s new position stands, companies could resort to the DSHEA’s health claims provisions to spread information concerning a nutrient’s relationship with certain disease states.
The agency asked for written comments on the draft guidance by October 15, 2013. Please contact us for information about the commenting process.