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Medical Food FAQs: Food Law FDA Regulation

FDA issues final guidance related to medical foods.

  • Medical foods are a special sub-category of foods that are “formulated to be consumed or administered enterally under the supervision of a physician.”  Further, medical foods are “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 USC 360ee(b)(3).  FDA considers the statutory definition to narrowly constrain the types of products within the medical food category.  In 2013, FDA issued a draft guidance document providing FAQs to address common questions about the definition of and regulations for medical foods.

  • FDA has now issued a final guidance document related to medical foods.  The 12-page document contains FAQs to assist stakeholders with determining whether products meet the “medical food” definition and with understanding the labeling and other FDA regulatory requirements applicable to this product category.

  • The final guidance serves as a reminder that the category of medical foods is narrowly defined.  For instance, it bears noting that FDA does not consider pregnancy or diabetes mellitus to be conditions associated with “distinctive nutritional requirements,” and thus, FDA will not view products targeted at these populations as medical foods.  Particularly because FDA has issued Warning Letters to companies marketing products that did not fit the statutory definition, industry is encouraged to exercise caution and due diligence with respect to marketing foods in this narrow space.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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