The Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) are each accepting input from stakeholders on separate proposed rules that they’ve published in recent weeks.
For FDA, the proposed regulations concern research guidance on developing cannabis-based drugs. The draft document was reviewed by the White House Office of Management and Budget and released in July. The deadline to submit feedback is September 21.
Much of the guidance—which is “limited to the development of human drugs and does not cover other FDA-regulated products”—covers the basics of conducting federally authorized research for drug development purposes such as where researchers are allowed to obtain cannabis and the importance of demonstrating the ability to “consistently manufacture a quality product.”
As of Friday, only 26 comments have been received. The director of the University of Mississippi’s National Center for Natural Products Research submitted a comment stating that while “the development of botanical drugs presents many challenges for the pharmaceutical industry and for researchers, the guidance from FDA on botanical drugs has paved the way for important new clinical research possibilities, and these certainly afford a solid basic platform for cannabis-derived botanical products.”
However, he said that “the additional barriers imposed by the controlled substance regulatory environment are essentially paralyzing.”
In particular, Ikhlas Khan said FDA’s draft guidance “highlights the difficulties we all face in the application of the strict limit of the single compound THC in a complex mixture to determine if that material is a DEA controlled substance, or not.” Recognizing that the issue would have to be resolved by DEA, however, he said “we believe a clear and unified voice from the FDA leadership, supported by NIH, other agencies, and the research community could help to get these simple and concrete steps pushed forward for the benefit of public health and safety.”
The Biopharmaceutical Research Company also weighed in, voicing support for FDA’s proposed rules. The organization said that “this draft guidance document is a positive and well supported step in the advancement of scientific understanding of cannabis-derived drugs.”
USDA recently reopened a comment period on its rules for hemp it proposed following the crop’s federal legalization under the 2018 Farm Bill. The decision to allow additional feedback—on top of the more than 4,600 comments it received during the original comment period—came amid intense pressure from stakeholders who’ve expressed serious concerns about certain proposals.
In the new announcement, the department listed 12 areas where they’re seeking additional feedback, including several that industry representatives have identified as especially consequential. People have until October 8 to send their input, but the federal Small Business Administration is pushing back and urged Agriculture Secretary Sonny Perdue to extend that deadline for at least an additional 30 days.
More than 400 additional comments for the proposed rule have been submitted since the docket reopened, and many of those appear to be iterations of the sample message crafted by the advocacy group U.S. Hemp Roundtable. It specifically urges USDA to “encourage the DEA to withdraw from this regulatory process and focus its attention on serious drug issues, as Congress intended.”
Agriculture Secretary Sonny Perdue has on several occasions stated that DEA influenced some of the more restrictive regulations it included in its original interim final rule, adding that the agency didn’t seem especially enthused about hemp’s legalization in the first place.
“I believe that the IFR is both overreaching and overly restrictive for an industry that has successfully demonstrated its ability to comply with state and federal laws,” the pre-written Hemp Roundtable message says. “I urge the DEA to withdraw the IFR.”
DEA also submitted proposed regulations on hemp and CBD. In the interim final rule, the agency explains how it plans to redefine marijuana to exclude hemp, among other statutory changes. DEA emphasized throughout its proposal that the proposed regulations are only meant to align their policies with the Farm Bill, but some stakeholders suspect that they’re really setting the stage to crack down on the newly legal market.
The deadline to send comment for those proposed regulations is October 20. So far, the agency has received more than 2,200 submissions—and about half of those concern one proposal that stakeholders worry could impact a lesser-known—but apparently increasingly popular—cannabinoid: delta-8 THC.
Finally, SAMHSA has draft rules out that would expand workplace drug testing requirements by enabling federal agencies and certain other employers to analyze workers’ hair for traces of prohibited substances. Advocates have criticized the proposal, arguing that it could set the stage for racially discriminatory workplace consequences. So far, 33 comments have been sent, and the deadline to weigh in is November 9.
Photo courtesy of Brian Shamblen.
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