Advance Notice of Proposed Rulemaking Department of Health and Human Services

Abstract

The Food and Drug Administration (FDA) is soliciting comments to initiate a reevaluation of its approach to the regulation of the broad group of heterogeneous products that are marketed as medical foods. FDA's goal is to arrive at a regulatory regime that will ensure that: These products are safe for their intended uses, especially because they are likely to be the sole or a major source of nutrients for sick and otherwise vulnerable people; claims for these products are truthful, not misleading, and supported by sound science; and the labeling of these products is adequate to inform consumers about how to use them in a safe and appropriate manner. The agency believes that there is a need to reevaluate its policy for regulating medical foods because of a number of developments, including enactment of a statutory definition of “medical food,” the rapid increase in the variety and number of products that are marketed as medical foods, safety problems associated with the manufacture and quality control of these products, and the potential for fraud as claims that are not supported by sound science proliferate for these products.