Politics
FDA Is 9 Months Late In Publishing Legally Mandated Hemp Guidance, And Congressional Researchers Are Calling The Agency Out
The Congressional Research Service (CRS) is continuing to point out the that Food and Drug Administration (FDA) still hasn’t fulfilled a legal mandate to publish a list of known cannabinoids and guidance on hemp product containers as federal laws for the crop and its derivatives are set to change in a way that stakeholders argue will upend the existing market.
Hemp industry operatives have said that the agency’s failure to follow through on what lawmakers directed will make it harder to comply with the law.
Hemp derivatives with less than 0.3 percent delta-9 THC on a dry-weight basis were federally legalized under the 2018 Farm Bill that President Donald Trump signed during his first term in office. But late last year, the president signed new legislation containing provisions that redefined hemp to make it so only products with 0.4 milligrams of total THC per container would remain legal after November 12.
Now, however, under provisions included in a funding bill Trump signed in September, the effective date of the ban for most products is being pushed back to December 11 to give lawmakers more time to craft regulations for hemp derivatives. There is a carve-out, however, to allow the recriminalization on November 12 of synthetic cannabinoids “that are not capable of being naturally produced by a Cannabis sativa L. plant.”
Last year’s spending also measure included separate provisions directing FDA and other relevant agencies to study the cannabinoid marketplace and develop lists of cannabis components as well as issue guidance on hemp product containers for serving sizes.
Specifically, 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 on the same 90-day timeline. 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 nearly nine months ago, on February 10, but FDA did not follow through by the deadline—and still hasn’t published the required information.
Now, the Congressional Research Service (CRS) is noting in a report published late last month that “the Hemp Definition Amendment also directs the U.S. Food and Drug Administration (FDA), within 90 days of enactment, to publish” the guidance, but that “as of the date of the publication of this Legal Sidebar, FDA has not published any of these items.”
This is at least the third time that CRS has called out FDA for failing to meet the congressionally mandated deadline.
Marijuana Moment has sent several requests to FDA for an update on its plans to publish the required guidance and any reaction to CRS’s report, but representatives have not replied.
A spokesperson for the U.S. Department of Health and Human Services (HHS), of which FDA is a component, told Marijuana Moment earlier this year that it was the agency’s intention to provide the lists in time and that they would be published in the Federal Register. However, that’s yet to materialize—and officials did not provide clarification when asked for an update.
That causes complications for the hemp product industry.
“It is difficult to comply with the law while key definitions are still in question,” Jim Higdon, cofounder and chief communications officer of Cornbread Hemp, told Marijuana Moment in August, the last time CRS noted FDA’s delay. “Without knowing the definition of container or exact list of cannabinoids that are covered by the ban, how does one comply?”
Lawmakers from both parties have filed several bills to create regulations for hemp THC products, but none of those proposals have gained traction with congressional leadership.
