FDA Warns Companies Allegedly Illegally Selling CBD and Delta-8 THC Products to Label and Brand More Carefully

FDA Warns Companies Allegedly Illegally Selling CBD and Delta-8 THC Products to Label and Brand More Carefully
CANNANNEW REPORT

May 6, 2022 Authors Michelle R.E. Donovan , Leslie C. Bender   For the first time, the U.S. Federal Food and Drug Administration (“FDA”) this week issued consumer warnings and sent letters to five companies, alleging that they are selling products in a way that violates Food, Drug and Cosmetic Act (the “FD&C Act”). This regulatory action has important implications for companies labeling and selling products containing delta-8 tetrahydrocannabinol (or “Delta-8 THC”). This client alert summarizes the FDA’s actions and offers practical guidance to companies marketing and selling products containing Delta-8 THC. The FDA has three main sets of concerns as follows: first, it is observing an “uptick in adverse event reporting” related to Delta-8 THC and the FDA describes a number of the adverse health effects consumers are experiencing (a significant number of them minors) over half of which required medical intervention; second, marketing, with emphasis on online marketing of Delta-8 THC products “appealing to children” and making claims or inferences about these products that have neither been verified, tested or approved in any way by the FTC; and third, significant concerns about the processes or methods by which Delta-8 THC products are being manufactured that may introduce contamination or otherwise lack quality or other control to assure the safety of the products. Since 2015, the FDA has sent warning letters to companies allegedly illegally selling unapproved cannabinoid (CBD) products. The FDA warning letters caution sellers about claims they make to market their products. Specifically, the FDA challenges the sellers’ marketing wording and labeling. In the FDA’s words, “these products diagnosed, cured, mitigated, treated or prevented various diseases.” The FDA views these claims as being tantamount to the companies selling unapproved “drugs” in violation of the FD&C Act. The FDA explains it is monitoring the selling of CBD and Delta-8 THC products out of a…

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Source : FDA Warns Companies Allegedly Illegally Selling CBD and Delta-8 THC Products to Label and Brand More Carefully

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