Lots of ifs, buts and maybes but no concrete facts yet
Marijuana Moment
The Food and Drug Administration (FDA) has submitted a proposed cannabis products enforcement policy to the White House for review that concerns regulatory issues specifically related to CBD.
The White House Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) posted a notice that it received the submission from FDA, which falls under the U.S. Department of Health and Human Services (HHS), on Friday.
While the update doesn’t include the text of the proposal that’s now under OIRA review, it’s titled “Cannabidiol (CBD) Products Compliance and Enforcement Policy.”
The fact that the document is coming from FDA may shed light on its content, as the agency recently missed a congressional imposed deadline to publish a list of known cannabinoids as federal hemp laws are set to change later this year.
Another possibility that’s being floated by industry observers is that it ties back to an executive order on marijuana rescheduling President Donald Trump signed in December that contained provisions on providing federal health insurance coverage of CBD for certain patients. But that rulemaking is being facilitated by the Centers for Medicare & Medicaid Services (CMS), which is not listed as the agency that submitted the proposal to OIRA.
Marijuana Moment reached out to HHS and FDA for comment, but a representative was not immediately available.
As part of appropriations legislation that Trump signed into law, many hemp products that were legalized during his first term in office under the 2018 Farm Bill will be prohibited once again starting in November. The spending measure included separate provisions, however, to have FDA and other relevant agencies study the cannabinoid marketplace and develop lists of cannabis components.
After the bill was signed, FDA was given 90 days to publish 1) a list of “all cannabinoids known to FDA to be capable of being naturally produced” by cannabis 2) a list of “all tetrahydrocannabinol class cannabinoids known to the agency to be naturally occurring in the plant” and 3) a list of “all other know cannabinoids with similar effects to, or marketed to have similar effects to, tetrahyrocannabinol class cannabinoids.”
Further, the agency was tasked with providing “additional information and specificity about the term ‘container’” with respect to hemp product THC serving sizes. In the bill, the term is defined as “the innermost wrapping, packaging, or vessel in direct contact with a final hemp-derived cannabinoid product in which the final hemp-derived cannabinoid product is enclosed for retail sale to consumers, such as a jar, bottle, bag, box, packet, can, carton, or cartridge.”
The lists and information was due on February 10, but FDA did not follow through by the deadline.
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FDA Submits New Cannabis Products Enforcement Policy For White House Review
