The U.S. Food and Drug Administration (FDA) announced Thursday that it denied three petitions seeking the agency’s intervention to allow the marketing of CBD products as dietary supplements.
Cannabis plants contain multiple cannabinoid chemicals, including cannabidiol or CBD, a non-psychoactive ingredient, unlike its main psychoactive compound, THC.
The decision follows a meeting of an FDA working group chaired by the former acting commissioner Janet Woodcock to evaluate the potential regulatory pathways for CBD products.
The agency argued that CBD products are linked to various safety issues, especially with long-term use.
Citing studies related to the CBD-based drug Epidiolex marketed by Jazz Pharmaceuticals (JAZZ), the regulator said that “it is not apparent how CBD products could meet safety standards for dietary supplements or food additives.”
“Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.”
The FDA pointed out that a “new regulatory pathway” is required for CBD products to balance the growing demand and the need to manage the associated risks. The FDA added that it intends to work with Congress to pursue a “cross-agency strategy” for regulation.
A favorable decision could have sparked investor interest in the CBD sector as FDA currently considers the compound a drug and bans its use in food and dietary supplement.
U.S. MSOs: MedMen Enterprises (OTCQB:MMNFF), Curaleaf Holdings (OTCPK:CURLF), Acreage Holdings (OTCQX:ACRHF), Cresco Labs (OTCQX:CRLBF), Green Thumb Industries (OTCQX:GTBIF), Trulieve Cannabis (OTCQX:TCNNF), Ayr Wellness (OTCQX:AYRWF), Columbia Care (OTCQX:CCHWF), TerrAscend (OTCQX:TRSSF), Clever Leaves Holdings (CLVR),
Canadian Licensed Producers: Canopy Growth (NASDAQ:CGC), Tilray (NASDAQ:TLRY), Aurora Cannabis (NASDAQ:ACB), Sundial Growers (NASDAQ:SNDL), OrganiGram Holdings (OGI), HEXO Corp (HEXO), Cronos Group (CRON)
Cannabis-focused ETF: AdvisorShares Pure Cannabis ETF (YOLO), Global X Cannabis ETF (POTX), ETFMG Alternative Harvest ETF(MJ). Amplify Seymour Cannabis ETF (CNBS)
Read: Citing FDA research, Seeking Alpha author Fade The Market highlighted long-term outlook for Trulieve Cannabis (OTCQX:TCNNF) thisn month citing potential legal amendments for CBD market.