We got a new FDA cannabis enforcement memo on Wednesday, April 1, regarding “hemp-derived CBD research in medical research models.” The general thrust is FDA’s assurance that it won’t interfere with a new federal initiative, which covers up to $500 of hemp-derived products for eligible Medicare patients. That initiative is called the Substance Access Beneficiary Engagement Incentive (“Substance Access BEI”), and it also launched on April 1. The usual suspects are suing to block this program, of course. They’re not doing very well.
The FDA Memo is welcome guidance as to the Substance Access BEI. The memo was anticipated by some of us, but there is more at play here.
The FDA Memo on cannabis enforcement in the Substance Access BEI program
The FDA Memo is only two pages. It traces federal hemp regulation back to the 2018 Farm Bill, as reined in by P.L. 119-37, a spending bill passed in November of 2025. As we explained at the time, P.L. 119-37 closed the perceived loophole on intoxicating hemp products by re-defining “hemp.”
The FDA Memo notes that the 2018 Farm Bill “explicitly preserved FDA’s authority to regulate products containing cannabis . . . . under the Federal Food, Drug, and Cosmetic Act [‘FDCA’].” FDA issued a similar proclamation when 2018 Farm Bill broadly legalized hemp, and it has continued to assert authority over hemp-derived products ever since.
But the agency is mostly just talk. Its efforts have been limited to sending (and bragging on) sporadic warning letters to select CBD sellers, who make the wildest health claims. All the while, the U.S. hemp cannabinoids market has blossomed into a $20 billion behemoth, with scrupulous and unscrupulous parties selling their wares in a regulatory vacuum. After several years of this, in 2023, FDA concluded that it wouldn’t adopt rules to allow CBD to be marketed as a dietary supplement in conventional food products. States have been left to fend for themselves.
The FDA Memo proceeds to discuss President Trump’s Executive Order 14370 of December 18, 2025, which directed the Attorney General to reschedule marijuana as a Schedule III substance under the Controlled Substances Act (CSA); and more pertinently for this exercise, for the National Institutes of Health to “develop research methods and models… to improve access to hemp-derived cannabinoid products in accordance with Federal law and to inform standards of care.” That’s where Substance Access BEI comes in.
FDA concludes its milquetoast memo with a policy statement, included here in full:
The FDA does not intend to enforce sections 502(f)(1) or 505 of the [FDCA] with respect to an orally administered, hemp-derived CBD product solely on the basis that it contains CBD, provided that the product (1) is 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, (2) is not contaminated, (3) is not packaged or labeled in a manner that would be attractive to or marketed for children, and (4) is provided to a beneficiary through a program of medical items or services payable under Title XVIII of the Social Security Act, under the direction of the patient’s treating physician, in a manner ancillary to the covered items or services furnished under such program.
In other words, FDA will continue not enforcing federal law, due to conflicting developments, in this one specific context. Old cannabis industry heads may see parallels here with the Cole Memorandum. Once again, a branch of government has deferred enforcement of cannabis-related commerce on a prerogative basis.
Open questions for CBD and hemp-derived products, inside and outside the Substance Access BEI program
The biggest question, I think, is whether the FDA will continue non-enforcement of the FDCA as to hemp-derived products outside this specific, Medicare context—either now, or after the hemp products ban takes effect this November. My bet is FDA won’t do much prior to November, and, assuming the ban sticks, it won’t do much after. A related prediction is that FDA will maintain its position that CBD hasn’t been proven safe and effective (outside of the approved drug Epidiolex), notwithstanding the Substance Access BEI program.
Another question relates to potential tension between the “hemp threshold” adopted in the Substance Access BEI program, and the FDA Memo. This a difference was quickly noted by Jonathan Havens, on LinkedIn. He observed that the FDA Memo references a 0.4 mg-THC-per-container threshold (in keeping with P.L. 119-37), while this new Medicare program permits up to 0.3 mg of THC per serving in certain contexts. The question becomes whether a CBD product could be program-compliant, yet fall outside of FDA’s enforcement discretion policy due to THC content.
Interestingly, the answer to that question may lie with FDA. Last November, P.L. 119-37 gave the agency 90 days to further define the term “container” in relation to hemp products. The Congressional deadline of February 10, 2026 quietly passed, and we still don’t have a proposed definition of “container” to my knowledge. They don’t call it the Foot Dragging Agency for nothing, I guess.
_____________
For related posts, check out the following:
The post CBD, Medicare, and the New FDA Enforcement Memo appeared first on Harris Sliwoski LLP.
from Canna Law Blog™ https://ift.tt/F1NC2aO
via
IFTTT
