Update Nov Dec 2013 - (Page 27)

Enforcement food product used to treat a specific medical disorder that has a scientifically-established nutritional component - has existed since the mid-1950s. One of the earliest products to serve a nutritional and a medical function was Lofenalac®, an infant formula approved as a new drug in 1957 for the dietary management of phenylketonuria.10 In 1972, FDA determined that Lofenalac® should not be classified as a drug11 for several reasons, including the desire to stimulate the development of such products for patients. Although FDA made an administrative decision to change the regulatory status of this product, Lofenalac® and other products like it did not lose their "druglike" characteristics. They still need to be safe and efficacious (or, in medical food terms, functional) and used under a physician's supervision. The definition of a medical food in the Federal Food, Drug, and Cosmetic Act (FFDCA) contains several critical elements. Medical food is (1) a food (2) that is formulated for enteral consumption or administration (3) under the supervision of a physician (4) 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.12 Most significantly, if the disease or condition can be treated with modification of the normal diet alone, then the condition is not amenable to treatment with a medical food. There is no statutory basis for this conclusion. FDA makes this point in the food labeling regulations13 and in the Draft Medical Food Guidance.14 FDA later incorporated this statutory definition into its regulations by exempting medical food products from conventional food nutrition labeling.15 This exemption, however, did not clarify how to FDLI establish that a disease or condition has "distinctive nutritional requirements," or what "recognized scientific principles" should be used. In 1996, FDA published a Federal Register notice soliciting public comments about the Agency's approach to regulating medical food. FDA explained that health and disease claims for the products it regulates fall along a continuum, with conventional foods and drugs on either ends of the spectrum and medical foods falling "somewhere between these two points." FDA stated that medical food claims must be supported by a "strong standard of substantiation," which could include some types of data used to support drug claims, including clinical investigations.16 Although medical food claims must be scientifically substantiated, the studies do not have to meet the contemporary criteria for new drug approvals. FDA later withdrew its medical food Federal Register notice for administrative reasons.17 Today, 25 years after medical food was first formally recognized, FDA still has not promulgated medical food regulations. FDA has filled this regulatory vacuum by issuing a medical food compliance program,18 warning letters against illegal medical food products,19 and the Draft Medical Food Guidance. FDA's most recent August 2013 revisions to the Draft Medical Food Guidance therefore represent a significant step in FDA's education of both industry and the public about medical food. 2013 Revisions to the Medical Food Guidance The 2013 revisions to the Draft Medical Food Guidance both update and clarify the previous guidance document, and provide answers to new questions that have arisen since its last publication. In particular, FDA discusses for the first time the propriety of medical foods to treat three specific disease states: (1) inborn errors of metabolism, (2) pregnancy, and (3) Types 1 and 2 Diabetes Mellitus. Key points from the revisions include the following: * A medical food is not a drug, and does not undergo premarket review or approval. It is not a product that a physician simply recommends as part of overall diet to manage a disease or condition. It is not a naturally-occurring food; rather, it is specially formulated and processed. * A medical food must meet all food labeling requirements, except for the requirements from which it is exempt. In general, a medical food must comply with 21 C.F.R. Part 101. * A medical food must comply with current good manufacturing practices; registration of food facilities; and the Food Allergen Labeling and Consumer Protection Act of 2004.20 * No use of "Rx only" - Because a medical food is not a drug, it must not be labeled with "Rx only." Although a medical food is used under a physician's supervision, FDA does not interpret the FFDCA or the regulations as requiring a physician's prescription. Patients should be receiving active and ongoing medical care and should generally see their physician on a routine basis. Therefore, it is permissible to communicate the need for physician supervision for a medical food with a labeling phrase such as "must be used under the supervision of a physician."21 November/December 2013 Update 27

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013