FDA Memo Eases Enforcement for Some CBD Products Used in Medicare-Linked Programs
- The FDA announced a new enforcement policy for certain orally administered CBD products, choosing not to enforce some federal requirements under specific conditions linked to limited medical programs.
- The policy applies only if products meet multiple criteria, including federal law compliance, THC limits, proper manufacturing and labeling, absence of contamination, and no marketing targeting children.
- Enforcement discretion is restricted to CBD products provided through federally approved medical programs, requiring physician direction and integration with covered medical services.
- This update follows a 2025 executive directive from President Trump to launch a federal CBD program and expedite cannabis rescheduling, with the FDA maintaining regulatory authority over CBD despite hemp’s removal from the Controlled Substances Act.
The Food and Drug Administration (FDA) has issued a new memo outlining a shift in how it will approach enforcement for certain cannabidiol (CBD) products, indicating it will not enforce certain federal requirements under specific conditions tied to limited medical programs.
In the April 1 memo, FDA Commissioner Martin Makary said the agency does not plan to enforce sections of the Federal Food, Drug, and Cosmetic Act that generally require premarket approval and adequate directions for use, but only for a narrow category of orally administered CBD products.
The enforcement discretion applies only if multiple criteria are met. The products must comply with federal law, including applicable THC limits for CBD products, and they must be manufactured and labeled in a manner consistent with dietary supplements. They also must not be contaminated or marketed in a way that appeals to children.
The policy is limited to products furnished through certain federally approved medical programs. According to the memo, the CBD must be provided to a patient under a qualifying program, at the direction of a treating physician, and alongside covered medical services.
The move follows executive direction issued in December 2025 by President Trump calling for the launch of a federal CBD program, while also calling on Attorney General Pam Bondi to expeditiously reschedule cannabis.
The FDA notes that although hemp was removed from the Controlled Substances Act under the 2018 Farm Bill, the agency still retains authority to regulate CBD under existing federal law.