The Food and Drug Administration (FDA) has proposed a cannabis product enforcement policy to the White House for review on regulatory issues specifically related to CBD.
The Office of Information and Regulatory Affairs (OIRA) of the White House’s Office of Management and Budget (OMB) published a statement on Friday that it received the submission from the FDA, which is under the US Department of Health and Human Services (HHS).
Although the update does not include the text of the proposal now being considered by OIRA, it is titled “Cannabidiol (CBD) Product Compliance and Enforcement Policy.”
The fact that the document comes from the FDA can clarify its content, for example The agency recently missed a Congressional deadline to publish a list of known cannabinoids because federal hemp laws are set to change later this year.
Another possibility raised by industry observers is that it ties into an executive order to reorganize marijuana that President Donald Trump signed in December, which included provisions to provide federal health insurance coverage for CBD to certain patients. But that rulemaking is being facilitated by the Centers for Medicare and Medicaid Services (CMS), which is not listed as the agency that submitted the proposal to OIRA.
Marijuana Moment reached out to HHS and the FDA for comment, but a representative was not immediately available.
As part of the appropriations legislation that Trump signed into law, the 2018 Farm Bill will ban many of the hemp products that were legalized during his first term once again starting in November. The spending measure contained separate provisions, however, for the FDA and other relevant agencies to study the cannabinoid market and develop lists of cannabis ingredients.
After signing the bill, the FDA was given 90 days to publish 1) a list of “all cannabinoids known to the FDA” in cannabis 2) a list of “all cannabinoids of the tetrahydrocannabinol class that the agency believes occur naturally in the plant” and 3) a list of “binoids that have similar effects or may have effects similar to the market. cannabinoids of the tetrahydrocannabinol class”.
It was also tasked with providing the agency with “additional information and specificity” regarding the term “container” in relation to THC serving sizes of hemp product. In the bill, the term is defined as “the inner packaging, container, or container in direct contact with a final hemp-derived cannabinoid product into which the final hemp-derived product is placed for retail sale to consumers, such as a jar, bottle, bag, box, package, can, carton, or cartridge.”
The listings and information were due by February 10, but the FDA missed the deadline.
It is possible, of course, new politics The submission to OIRA is unrelated to the FDA’s mandate to create a list of cannabinoids. Others see it as the next step in expanding federal health insurance coverage, which would make CBD products available to certain patients.
An executive at a hemp company working with CMS on CBD coverage said as much last month The agency has already finalized a rule to allow for federal health insurance coverage. That rule was introduced by Trump under Title III of the Marijuana Controlled Substances Act (CSA).
Mehmet Oz, CMS administrator, spoke about the CBD components of the initiative at the order signing ceremony, with Trump and Robert F. Kennedy Jr. To the HHS secretary for “driving change” and pursuing an agenda based on a “deep passion for research.”
The plan has been to create a pilot program to give eligible patients access to hemp-derived cannabidiol that would be covered by federal health insurance plans, scheduled to launch in April, according to Oz.
While the broader rules for the CBD Medicare pilot program have yet to be released, CMS’ website briefly outlines how it navigates hemp-related issues within the LEAD, Accountable Care Organization (ACO), and Enhancing Oncology Model (EOM) regulatory models.
One outstanding question is about coverage eligibility. As the administrator described in December, it would affect those 65 and older who are eligible for Medicare, but the exact conditions were not specified. There were repeated mentions of chronic pain, particularly in relation to cancer, but the CBD eligibility criteria may include additional conditions.
While CMS issued a previous final rule this past April specifically stipulating that marijuana, as well as CBD derived from federal law hemp, are ineligible For coverage of the Medicare Advantage program and other services, the agency is revising that policy.
CMS already announced some changes as part of a rulemaking process filed late last year, It affects “marketing and communications, drug coverage, enrollment processes, special needs plans and other programming areas.” for the insurance programs it oversees. One of these changes concerned the coverage of cannabidiol.
The proposed rule would change the regulations, which currently say that “cannabis products” cannot be covered. The policy would “prevent coverage of cannabis products that are illegal under applicable state or federal law, including the Food, Drug, and Cosmetic Act.” Because hemp and its derivatives like CBD are federally legal, the change suggests that patients in states where these products are legal can make valid insurance claims to pay for alternative treatment options, as long as the product is federally legal.
Another possibility for new submissions under the OIRA review is that it is unrelated to the FDA mandate or CMS health coverage developments. The FDA has faced scrutiny for years after refusing to enact rules that allow CBD to be legally marketed in the food supply, so there are a number of regulatory issues the proposal could address.