On May 12, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) finalized its 2013 draft guidance for industry, “Frequently Asked Questions About Medical Foods; Second Edition.”[1]  Despite significant industry response and disagreement with the 2013 draft guidance, the final guidance largely implements the draft guidance as written, tracking its language regarding the definition of medical foods, allowable medical food uses, and other regulatory requirements.[2]  Accordingly, companies engaged in marketing medical food should carefully review the final guidance and consider whether and how their products fit within the framework of the final guidance.

Frequently Asked Questions About Medical Foods; Second Edition (Final Guidance)
Under the U.S. Federal Food, Drug, and Cosmetic Act (“FDCA”), a “medical food” is “a food which is formulated to be consumed or administered entrally 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.”[3]  Consistent with its historic position on medical foods, FDA states in its final guidance that it “considers the statutory definition of medical foods to narrowly constrain the types of products that fit within this category of food.”[4]  FDA explains:

Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition.  Not all foods fed to patients with a disease, including diseases that require dietary management, are medical foods.  Instead, medical foods are foods that are specially formulated and processed . . . for a patient who requires use of the product as a major component of a disease or condition’s specific dietary management.[5]

The final guidance further sets forth medical food labeling requirements and other FDA requirements that apply to medical food manufacturers, including but not limited to current good manufacturing practices, registration of food facilities, and emergency permit control.[6]

As in its draft guidance, FDA provides that it generally considers inborn errors of metabolism (“IEMs”) to be diseases or conditions that a medical food could be used to manage.[7]  We discussed IEMs in greater detail in our prior Alerts on Medical Foods here and here, but, briefly, IEMs “include inherited biochemical disorders in which a specific enzyme defect interferes with the normal metabolism of protein, fat, or carbohydrate.”[8]  According to the final guidance, where the IEM cannot be managed “solely with diet modification,” then medical foods would be necessary for individuals with IEMs “to meet the daily requirements of essential nutrients and to limit the metabolic disturbances associated with the particular IEM.”[9]

As in the draft guidance, FDA indicates that pregnancy, diabetes mellitus, and diseases resulting from essential nutrient deficiencies are diseases or conditions that generally do not meet the regulatory criteria for requiring a medical food.[10]  However, since its draft guidance, FDA’s rationale underlying the exclusion of pregnancy and diabetes from the scope of medical food uses has changed.  In its draft guidance, FDA acknowledged that nutrient requirements exist for individuals affected by pregnancy or diabetes, but that, because modification of a regular diet alone can meet the needs of these individuals, the Agency generally would not consider a product labeled and marketed for these diseases or conditions to be a medical food.[11]  In its final guidance, FDA now provides that no distinctive nutritional requirements exist for the management of pregnancy or diabetes and individuals affected by pregnancy or diabetes can manage these conditions through modification of diet, thus products labeled and marketed for pregnancy or diabetes cannot be medical foods.[12]  In comparison to the draft guidance, FDA’s current rationale appears to be tied more closely to the statutory definition of medical foods, which requires a medical food to be intended for the “management of a disease or condition for which distinctive nutritional requirements . . . are established . . . .”[13]  Although not expressly explained by the Agency, this shift may be in response to industry reaction that FDA had diverted from the plain language of the FDCA statute when defining medical foods and the scope of medical food uses in the draft guidance.  FDA may apply this same approach to other diseases or conditions in order to conclude that products sold to manage such diseases or conditions cannot be medical foods. 

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Although the draft guidance generated considerable discussion and comments, FDA’s final guidance largely follows the draft guidance without significant response to the comments raised.  We will continue to monitor developments in this area closely, including FDA enforcement activity, to see how FDA implements this guidance.  Companies marketing (or considering marketing) products as medical food would be well advised to review these documents and seek legal counsel since the issuance of the final guidance may portend increased enforcement interest. 

Notes:
[1] FDA Final Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition (FDA May 2016), available here (“Medical Foods Final Guidance”).