On May 12, 2016, the Food and Drug Administration (FDA) finalized its August 2013 Draft Guidance, “Frequently Asked Questions About Medical Foods; Second Edition.” Although the Draft Guidance was issued nearly three years ago and was the subject of numerous comments from stakeholders, the final Guidance reflects few changes and ignores the legal and science-based comments from the industry. In particular, FDA does not address critical research in nutritional science relevant to the role of specially formulated foods for a range of medical conditions.
By way of background, the 1988 Orphan Drug Amendments defined a “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.”1 In 1996, FDA published and then, after significant substantive comments were filed, withdrew, an Advance Notice of Proposed Rulemaking (ANPR) attempting to provide definitions and further clarity on the statutory medical foods definition.2 In place of the ANPR, FDA issued a very general guidance in 2007 in the form of questions and answers. That guidance has been revised twice, most recently by the Guidance released on May 12, 2016.
The most significant error in the Guidance is the retention of the phrase “which cannot be achieved by the modification of the normal diet alone.” That phrase is not a part of the medical food definition and not a proper part of the regulatory regime. This misplaced addition, the subject of many comments to FDA, comes from a labeling exemption that FDA placed in the regulations issued pursuant to the Nutrition Labeling and Education Act of 1990 (NLEA).3 FDA continually relies on this prong of its NLEA exemption regulations to restrict the medical foods category, claiming that it is trying to “clarify the statutory definition of a medical food”; instead, FDA is effectively adding a requirement that does not exist in the law. Numerous comments to the Draft Guidance noted this error in FDA’s approach, but the final Guidance does nothing to correct its mistake.
Moreover, the final Guidance reaffirms that FDA views medical foods as inappropriate for diabetes because the disease can be managed by modifying a “regular diet.” This is perhaps the starkest example of a disconnect between nutritional science and FDA’s approach. Many of the comments sent to FDA cite scientific research showing that individuals with diabetes benefit significantly from medical foods, and that the agency’s exclusion of diabetes from the types of conditions that may be treated with medical foods is likely to harm the public health.
Notably, FDA released the final Guidance just two days after announcing that it will reevaluate its definition of “healthy” in regulations addressing nutrient content claims. This announcement makes clear that FDA is willing to consider evolving nutrition science in its approach to certain claims. 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).
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