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.”

By Riëtte van LaackAs we reported previously, in 2013, Health Science Funding, LLC (HSF) filed what might be the first medical food lawsuit against FDA. Plaintiff markets a medical food for women with lupus, Prastera® DHEA. Medical foods may be marketed without pre-market approval by FDA. In fact, as HSF learned, FDA will not approve or review the label for a medical food or any other food before marketing, even if the company requests that FDA do so.In 2013, seemingly unwilling to live with the uncertainty as to whether FDA would disagree with HSF’s determination that Prastera qualifies as medical food under the Orphan Drug Act Amendments of 1988, 21 U.S.C. §360ee(b)(3), HSF filed a complaint asking that the Court declare that Prastera is a medical food and enjoin FDA from taking action against Prastera in the future. The Court did not seize the “opportunity to create a legacy” provided by HSF’s lawsuit and, in November 2013, after various communications with the parties dismissed the case without prejudice.HSF apparently concluded that the Court closed the case because FDA had agreed to let the company market its medical food and to refrain from any enforcement action in exchange for HSF’s stay of its request for Declaratory Judgment.

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), availablehere (“Medical Foods Final Guidance”).[2] For further information on the legal framework for medical foods, the 2013 draft guidance, and industry response to the 2013 draft guidance, please see our previous alert, “Update: Regulation of Medical Food and Nutritionals in the European Union, China, and the United States” and article in our Global Food, Drug, Medical Device and Cosmetics Newsletter, “Regulation of Medical Foods in the U.S.”[3] 21 U.S.C. § 360ee(b)(3). See also 21 CFR 101.9(j)(8) (regulation defining medical food).[4] Medical Foods Final Guidance at 4.[5]Id.[6]Id.

This Bulletin will describe briefly the definition of a medical food and summarize the guidance.What is Medical Food? The statutory and regulatory references to medical foods can be found at 21 U.S.C. § 360ee(b)(3) and 21 C.F.R. § 101.9(j)(B).

The agency’s treatment of the medical food category, however, reflects no such recognition in the context of foods assisting individuals in managing nutritional needs associated with disease. 1 21 U.S.C. § 360ee(b)(3).2 61 Fed. Reg. 60661 (November 29, 1996); 69 Fed. Reg. 68831 (November 26, 2004).3 21 C.F.R. § 101.9(j)(8)(ii). If you have any questions regarding this Sidley Update, please contact the Sidley lawyer with whom you usually work, orScott BassPartnersbass@sidley.com +1 212 839 5613 Diane C. McEnroePartner dmcenroe@sidley.

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.

Briefly, the statutory hallmarks of a medical food are that it must be formulated for oral or enteral use under physician supervision “for the special dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Orphan Drug Act, 21 U.S.C. § 360ee(b)(3). By FDA’s regulation, a medical food must be “specially formulated” (rather than naturally occurring), and the patient’s distinctive nutritional requirements must be impossible to meet “by the modification of the normal diet alone.”

the goal of securing insurance coverage for certain medical foods. The legislation would secure coverage under federal insurance plans (e.g., Medicaid and Medicare), plans governed by the Employment Retirement Income Security Act (ERISA), and plans on the individual and group markets for the following types of food:medically necessary food and food modified to be low protein that is formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC); pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the ACHDNC and as prescribed by a qualified medical provider.The legislation defines “medically necessary food” in a manner that is generally consistent with the definition of "medical food" in section 5(b) of the Orphan Drug Act (21 U.S.C. § 360ee(b)(3)), and includes both “nutritionally modified counterparts of traditional foods” and “other forms of foods such as formulas, pills, capsules, and bars, so long as consumed or administered enterally.” As matters now stand, coverage of medical foods by insurance plans appears to be fairly widespread.