Publication

July 30, 2020Client Alert

FDA Releases Draft Guidance Documents Affecting Cannabis Industry

On July 22, 2020, the White House Office of Management and Budget (OMB) received the U.S. Food and Drug Administration (FDA)’s draft policy proposal and industry guidance for regulating the cannabidiol (CBD) market, signaling that highly anticipated clarity about federal CBD regulation may be on the horizon.[1] 

If the OMB approved the proposed “Cannabidiol Enforcement Policy” draft guidance, it could be released publicly within weeks. How long the administration will take to review the proposed rule and whether it will approve the rule’s public release, however, are currently unknown. On July 23, an FDA spokesperson said that “the agency could not comment on unpublished guidance.”[2]

News of the FDA’s proposed CBD policy submission came just a day after the public release of its draft guidance on “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.” The agency had submitted the guidance, which “covers sources of cannabis for clinical research, information on quality considerations[,] and recommendations regarding calculating tetrahydrocannabinol (THC) levels,” to the OMB just under two months earlier.[3] Notably, this guidance acknowledges that the legal definition of hemp, based on the plant’s concentration of less than 0.3% THC on a dry-weight basis prior to extraction of the cannabinoid compounds, “has limited utility for intermediates such as solutions, extracts in solution… and for finished products.”[4] Therefore, it “include[s] a new rubric for how to measure the THC concentration in solutions, including intermediates, by-products and finished products” that “could come into play when the agency begins regulating CBD in dietary supplements.”[5]

As of March 2020, the FDA policy’s on CBD, which it declined to grant the status of “generally recognized as safe” in November 2020,[6] has been that “[i]t is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.”[7] Nevertheless, its recent draft guidance documents and warnings to companies marketing their CBD products as COVID-19 treatments or cures (see our Client Alert on the topic here) have CBD industry members cautiously optimistic that the agency is building momentum on the CBD regulation front. Specifically, some stakeholders have speculated that the proposed “Cannabidiol Enforcement Policy” could clarify the FDA’s regulation of CBD dietary supplements or establish a possible CBD dosage threshold.[8] Unless and until the draft guidance is released, however, we will have to wait and see.

Do you have specific questions about federal and state CBD regulation policies? Consult with a member of Michael Best’s Cannabis Practice Group. Whether you’re looking to start, operate, grow, or invest in a CBD-related business line, we’ve got you covered. 

This article was coauthored by Michael Best Intern Magdalene M. Beck.

Notes


[1] “Pending EO 12866 Regulatory Review,” Office of Information and Regulatory Affairs’s Office of Management and Budget, https://www.reginfo.gov/public/do/eoDetails?rrid=130894.

[2] Sam Reisman, “FDA Sends New CBD Guidance To White House Budget Office,” Law360, 07/23/2020, https://www.law360.com/cannabis/articles/1294855/fda-sends-new-cbd-guidance-to-white-house-budget-office.

[3] “FDA In Brief: FDA Issues Draft Guidance to Encourage Cannabis-Related Clinical Research,” U.S. Food and Drug Administration, 07/21/2020, https://www.fda.gov/news-events/fda-brief/fda-brief-fda-issues-draft-guidance-encourage-cannabis-related-clinical-research.

[4] U.S. Department of Health and Human Services, Food and Drug Administration, and Center for Drug Evaluation and Research, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Guidance for Industry,” 07/2020, 8, https://www.fda.gov/media/140319/download.

[5] Reisman.

[6] Ibid.

[7] “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” U.S. Food and Drug Administration, 03/05/2020, https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis.

[8] Reisman.

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