FDA Enforcement Action Targeted at Hemp-Derived Delta-8 Products

FDA Enforcement Action Targeted at Hemp-Derived Delta-8 Products

On May 4, 2022, the FDA issued five warning letters to companies for selling products containing hemp-derived Delta-8 THC. Notably, this is the first time the FDA has issued warning letters specifically for Delta-8 products. Previously, the agency issued and updated a consumer advisory outlining consumer safety concerns relating to Delta-8 products. Consistent with the FDA’s approach to CBD and other hemp products, the agency prioritized its limited resources to enforce against companies illegally marketing by making unlawful drug claims. In the warning letters, the FDA cites violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and core consumer protection laws, such as misbranding and adulteration. Below are key takeaways from these warning letters. The FDA Will Continue to Prioritize Enforcement Where Drug Claims Are Made These warning letters were issued to companies that allegedly violated a number of provisions of FDCA by including Delta-8 THC as a food or dietary supplement agreement and made unlawful drug claims about their products’ efficacy in treating medical conditions. This action signals that the FDA may be taking the same enforcement approach as with CBD, by limiting enforcement to products that make egregious drug or medical claims. The following are examples of unlawful drug claims cited in the warning letters: “Delta-8 consumers report many of the same effects as THC, such as . . . relief from some symptoms such as pain . . .. Delta-8 can also help with insomnia.” “Delta-8 THC Syrup from Kingdom Harvest is ideal for anybody experiencing a sleeping disorder or other ailments looking to be relieved.” “If you have cancer, rheumatoid arthritis, and migraines, Delta-8 THC can help alleviate the pain because it has immunosuppressant properties.” Delta-8-THC benefits . . . Antitumor . . . Antiemetic . . . Appetite-stimulant . . . Analgesic . . . Neuroprotective properties . . .” “[D]elta-8-THC was…

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Source : FDA Enforcement Action Targeted at Hemp-Derived Delta-8 Products

reposted by Cannabis News World

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