FDA’s evolving CBD position meets the CMS substance access pilot

FDA’s enforcement discretion letter

Commissioner Makary issued the letter in connection with a new CMS pilot program, the Substance Access Beneficiary Engagement Incentive (BEI), which took effect April 1, 2026. The Substance Access BEI allows participants in certain CMS innovation models to furnish eligible hemp products, valued at up to $500 per year per eligible beneficiary.

FDA has traditionally taken the position that CBD may not be lawfully marketed as a conventional food or dietary supplement because it is the active ingredient in an approved drug, Epidiolex—the only FDA-approved drug product containing CBD. Under the federal Food, Drug, and Cosmetic Act (FDCA), substances that have been approved as drugs or that are subject to substantial clinical investigation as a drug are generally excluded from the dietary supplement definition and may not be introduced into food. FDA has previously concluded that both CBD and THC are subject to this provision.

It is partly for this reason that the pilot became subject to a legal challenge shortly after it was announced, arguing that CMS exceeded its statutory authority and acted without appropriate FDA approval or rulemaking. The litigation underscores the legal tension posed by the Substance Access BEI: a federal healthcare program is sanctioning the use of hemp-derived products that are not approved drugs and cannot be lawfully marketed as foods or dietary supplements under FDA’s longstanding interpretation of the FDCA. The letter appears designed to address that tension by providing a framework for CBD products to be furnished through the pilot without triggering FDA enforcement.

According to the letter, FDA will exercise enforcement discretion where hemp-derived CBD products:

• Are manufactured, marketed, and labeled in a manner consistent with the dietary supplement framework, including use of a Supplement Facts panel and permissible structure/function claims;
• Are not contaminated;
• Are not packaged or labeled in a manner attractive to, or marketed for, children; and
• Are furnished to a Medicare beneficiary through a Medicare program under the direction of the treating physician, and ancillary to covered medical items or services.

The final condition is satisfied, at present, only by the Substance Access BEI.

Continuing uncertainty around CBD regulation

Industry stakeholders should consider Commissioner Makary's letter against the backdrop of a regulatory environment for CBD that continues to be unsettled.

In January 2023, FDA concluded that a new regulatory pathway for CBD was needed, stating that “existing regulatory frameworks for foods and supplements are not appropriate for cannabidiol.” FDA stated at the time that it did not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods and would instead work with Congress on a new legislative pathway.

No such congressional action has occurred, and CBD products remain in a regulatory gray area. Although they are widely available throughout the marketplace and many states have passed laws allowing the products to be sold under certain conditions, their sale as foods or dietary supplements remains impermissible under FDA's interpretation of the FDCA. FDA enforcement in this space has largely been risk-based, with the agency focusing on products that marketed with disease or therapeutic claims, or packaged or labeled in a manner attractive to children.

Several recent developments add to the uncertainty.

The November 2025 appropriations legislation narrowed the federal definition of hemp. When these changes take effect on November 12, 2026, a significant share of CBD products currently on the market could fall outside the amended hemp definition and be reclassified as controlled substances under the Controlled Substances Act. A December 2025 executive order acknowledged this issue and directed federal agencies to work with Congress to update the statutory definition to preserve access to appropriate CBD products.

On March 13, 2026, FDA submitted a document titled “Cannabidiol (CBD) Products Compliance and Enforcement Policy” to the White House for review. The document's text has not been made public, but OIRA has held a series of stakeholder meetings that may further shape FDA's approach to CBD.

Compliance expectations for the pilot and potentially beyond

Commissioner Makary’s letter highlights several areas of potential compliance risk for companies whose products are furnished through the CMS pilot, and for the broader CBD market as federal compliance and enforcement posture continues to develop.

• Product quality. FDA’s letter conditions enforcement discretion on products that are manufactured in compliance with the dietary supplements framework and are “not contaminated.” Companies should be aware that FDA may scrutinize quality control practices for CBD products furnished through the pilot.
• Product claims. The letter’s requirement that products be marketed with “permissible structure/function claims” reinforces that companies should carefully review their labeling and marketing materials to ensure that claims don’t cross the line into disease claims, particularly as the CMS pilot itself positions these products in a clinical care context.
• Child-safety considerations. FDA’s condition that products not be “packaged or labeled in a manner that would be attractive to or marketed for children” is consistent with its enforcement focus in this area.

Assess compliance now, with an eye on the future

FDA's approach to CBD remains in transition. The enforcement discretion letter provides a narrow pathway for CBD products furnished through Medicare programs, but it does not resolve the fundamental tension between the widespread availability of CBD products and FDA's longstanding position against the sale and marketing of such products as foods or dietary supplements. Stakeholders should assess their compliance posture in light of an FDA enforcement framework that may look different in the coming months.

Authored by Heidi Gertner and Stephanie Agu.