FDA’s Revised Medical-Foods Policy Impedes Care and Violates the First Amendment

In May of this year, the Food and Drug Administration (FDA) issued a final version of “Frequently Asked Questions About Medical Foods: Second Edition.” FDA’s narrow interpretation is at odds with the broader and more flexible statutory definition of medical foods and will impede the communication of truthful, well-substantiated information concerning the benefits of food products designed to serve the nutritional needs of disease sufferers. The guidance not only fails to provide an adequate framework for the development and marketing of medical foods, it violates the First Amendment rights of manufacturers and consumers.

FDA’s interpretation of medical food restricts the ability of manufacturers to disseminate information about their products as well as healthcare consumers’ access to that information. The agency’s failure to account for the First Amendment exposes the guidance to constitutional challenge.

Perhaps by updating its policy to expand the medical foods category in line with the statutory definition as a “food” subcategory, and to align labeling requirements with First Amendment and appropriate FDCA requirements, FDA can better support the development and marketing of this important category of healthcare nutrition products.

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