FDA has finalized its guidance document relating to medical foods, a special class of products defined under the Orphan Drug Act.

Although most of the content of the final guidance mirrors the draft guidance released in August 2013, the final guidance clarifies the following points:

  • Medical foods are exempt from the labeling requirements for nutrient content claims and for health claims under the Nutrition Labeling and Education Act of 1990. However, if they bear false or misleading claims they will be considered misbranded under section 403(a)(1) of the Food, Drug, and Cosmetic Act.
  • FDA does not maintain a comprehensive list of medical food products. This question and answer was not included in the draft guidance.
  • There are no distinctive nutritional requirements associated with pregnancy. This is a departure from the conclusions in the draft guidance.
  • There are no distinctive nutritional requirements associated with the management of diabetes mellitus. This, too, is a departure from the conclusions in the draft guidance.

Medical foods must be formulated to be consumed or administered enterally under the supervision of a physician and are used for specific dietary management of a disease or condition with distinctive nutritional requirements. 21 U.S.C. 360ee(b)(3).  FDA’s reading of this definition has been criticized as being unduly restrictive.  For instance, FDA’s interpretation excludes products directed towards diseases or conditions that can also be addressed through modification of the diet, a limitation not included in the statutory definition.See 21 CFR 101.9(j)(8).  The final guidance does not broaden FDA’s interpretation of the medical foods category.

Under FDA’s interpretation, medical foods can be used to manage inborn errors of metabolism such as phenylketonuria, which impairs metabolism of the amino acid phenylalanine. However, the guidance advises that pregnancy, diabetes mellitus, and diseases resulting from essential nutrient deficiencies are not diseases or conditions with distinctive nutritional requirements, and thus FDA generally does not see products intended to manage those conditions as medical foods.

Aside from providing guidance on the scope of the medical foods category, the FAQs offer practical advice for manufacturers and retailers of medical foods. For instance, although medical foods should be formulated to be used “under the supervision of a physician,” which means that the patient should generally see the physician on a recurring basis for, among other things, instructions on the use of the medical food.  A product can be labeled accordingly.  However, the guidance makes clear that medical foods should not be labeled as “Rx only,” as that designation would be false and misleading. In addition, the guidance is clear that the labeling of medical foods should not include National Drug Code (NDC) numbers, the unique numbers assigned to each listed drug that identifies the labeler, product, and trade package size.  NDC numbers are often used by retailers to track sales of products, but FDA’s view is that NDC numbers should only be used on drugs.  According to FDA, using NDC numbers on medical foods could convey a false message that FDA has approved the medical food.

Understanding your product’s category under FDA’s regulatory regime – whether conventional food, dietary supplement, medical food, or drug – is essential for complying with FDA requirements for registration, labeling, and promotion of the product. This final guidance reiterates FDA’s position that the medical food category is narrow.  Companies marketing a product as a medical food should carefully consider FDA’s reading of the term “medical food” and ensure that their labeling and promotion of the product is consistent with FDA rules.