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Regulatory Mismanagement of Medical Foods?

FDA published in yesterday’s Federal Register notice of a 30 day (albeit 60 days had been requested) reopening of the comment period on its Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition, updated in August 2013.  Prior versions of the guidance document had been published in May 1997 and May 2007.

The August update differed significantly from earlier versions, in particular, by addressing FDA’s thinking relating to use of medical foods under supervision by a physician; whether medical foods should be sold by prescription only; and the types of diseases and conditions that a medical food could be used to manage.  It made clear that FDA’s continued regulation of medical foods through updates to a question and answer guidance document is problematic.

The term “medical food” is defined by section 5(b)(3) of the Orphan Drug Act, as amended in 1988:

The term ‘‘medical food’’ means 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.

21 U.S.C. § 360ee(b)(3).

In November 1996, FDA published an advance notice of proposed rulemaking (ANPR) specific to regulation of medical foods; however, in 2003, FDA withdrew the ANPR, purportedly due to a lack of resources and change in priorities.  FDA also has published a Compliance Program Guide on medical foods, implemented in August 2006 and completed in September 2008.  These regulatory undertakings, while incomplete and of short duration, were nevertheless reasonable.

The real misstep in regulatory management of medical foods started when, in implementing sections 2 and 3 of the Nutrition Labeling and Education Act of 1990 (NLEA), FDA promulgated a regulation delineating characteristics of medical foods that exceeded the statutory definition, and culminated when these characteristics were used (in the August guidance document) to address the types of diseases and conditions that a medical food could be used to manage.

NLEA § 2 exempted from mandatory nutrition labeling “medical food as defined in section 360ee(b) of this title [emphasis added],” and NLEA § 3 similarly exempted from legal requirements for nutrient content claims and health claims “medical foods as defined in section 360ee(b) of this title [emphasis added].” See generally 21 U.S.C. § 343(q)(5)(A)(iv), (r)(5)(A).  Although the NLEA was explicitly clear about use of the “medical food” definition established by Congress in the Orphan Drug Act, FDA evidently had its own agenda:

The agency considers the statutory definition of medical foods to narrowly constrain the types of products that fit within this category of food.

56 Fed. Reg. 60,366, 60,377 (Nov. 27, 1991).  To ensure that this narrow constraint was made effective, in promulgating its regulation to implement the mandatory nutrition labeling exemption, FDA codified requisite characteristics of a medical food as including:

  • “It is intended for the dietary management of a patient … who has … special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone [emphasis added]”; and
  • “It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food [emphasis added].”

21 C.F.R. § 101.9(j)(8).

These eligibility requirements to qualify as a “medical food” plainly are not in the statutory definition.  Oral rehydration products, explicitly noted as a category of medical food in FDA’s Compliance Program Guide, would be ineligible under the requirements (a still unexplained inconsistency).  Moreover, these eligibility requirements were established as part of a rulemaking about mandatory nutrition labeling, not about regulation of medical foods.

The medical foods industry seemingly would be better served prospectively by a rulemaking specifically focusing on eligibility and regulatory requirements for its products, than by further revision of a guidance document premised on questionable grounds.

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