The Food and Drug Administration (FDA) has issued guidance making clear that it does not intend to interfere with implementation of a new Trump administration initiative to cover up to $500 worth of hemp-derived products each year for eligible Medicare patients.
FDA Commissioner Marty Makary wrote in a two-page memo on Wednesday that the agency “does not intend to enforce” certain sections of the Federal Food, Drug, and Cosmetic Act “with respect to an orally administered, hemp-derived CBD product solely on the basis that it contains CBD,” provided that it meets certain requirements.
In particular, in order to avoid enforcement of laws that deem a drug misbranded if its label lacks adequate directions for use and that require premarket approval for new drugs, CBD products under the new FDA guidance must meet the following conditions:
be manufactured, marketed, and labeled in a manner that would be consistent with the dietary supplement framework, including bearing a supplement facts panel and structure/function claims, not be contaminated, not be packaged or labeled in a manner that would be attractive to or marketed for children, and be provided to a beneficiary through a program of medical items or services payable under Title XVIII
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