Update Nov Dec 2013 - (Page 26)

A Long-Awaited Update to the FDA Draft Medical Food Guidance By Barbara A. Binzak Blumenfeld, Ph.D., J.D. B oth manufacturers and patients liberally use the term "medical food," with little understanding of its actual legal meaning, to cover a wide variety of products. As the term implies, a medical food is legally regulated by the U.S. Food and Drug Administration (FDA) as a food product. It is, however, much more complex than a conventional food product. In fact, certain characteristics and uses of a medical food cause it to resemble a drug in medical practice. FDA has provided little guidance about medical food in the past sixty years, despite their existence since the mid-twentieth century. FDA's August 2013 update to its draft guidance for industry on medical food1 (hereinafter Draft Medical Food Barbara A. Binzak Blumenfeld, Ph.D., J.D., is Counsel in the FDA Practice Group at Buchanan Ingersoll & Rooney PC in Washington, D.C. She can be reached at (202) 452-7906 or barbara.binzak@bipc.com. 26 Update November/December 2013 Guidance) is, therefore, a significant step in the evolution of FDA's policy on these products. It will be left to industry to determine if the Draft Medical Food Guidance provides much-needed clarification or if it elicits even more questions. Early indications suggest that a number of groups wish to provide their comments to FDA on the latest version of the document.2 A Long but Sparse History Many types of products are legally "food," including medical food,3 "conventional" food,4 dietary supplements,5 food for special dietary use,6 and infant formula.7 Each type of food has its own legal and regulatory criteria, although the distinctions between certain product categories are often not clear. Product claims dictate the regulatory category, but it is possible that a product could fit into more than one category at the same time.8 Moreover, medical food actually functions in part as food, and in part as a drug. Congress first formally defined "medical food" in the Orphan Drug Amendments of 1988.9 However, medical food - a www.fdli.org http://www.fdli.org

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

Update Nov Dec 2013