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10,2W,21290PM 5I-nnpsto K,( about0eIa-8al,,Jm_r,-an-,ab—l-Jepa-BTIIC FIJA 'Phe FDA is aware of the growing concerns surrounding delta -8 THC products currently being sold online and in stores. These products have not been evaluated or approved by the FDA for safe use in any context. Some concerns include variability in product formulations and product labeling, other cannabinoid and terpene content, and variable delta -8 THC concentrations. r. Additionally, some of these products may he labeled simply as "hemp products; which may mislead consumers who associate "hemp" with "non -psychoactive." Furthermore, the FDA is concerned by the proliferation of products that contain delta -8 1 H and are marketed for therapeutic or medical uses, although they have not been approved by the PDA. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of federal law, but also can put consumers at risk, as these products have not been proven to be safe or effective Phis deceptive marketing of unproven treatments raises significant public health concerns because patients and other consumers may use them instead of approved therapies to treat serious and even fatal diseases. 2. The FDA has received adverse event reports involving delta -8 THC -containing products. The FDA received 104 reports of adverse events in patients who consumed delta -8 THC products between December 1, 2020, and February 28, 2022. Of these 104 adverse event reports: 77% involved adults, 80/ involved pediatric patients less than 18 years of age, and i,% did not report age. ;,,5% required intervenLion (c.g., evaluation by emergency medical services) or hospital admission. 66% described adverse events alter ingestion of delta -8 Tl W -containing food products (e.g., brownies, gummies). Adverse events in( Indtd, bot were not limited to: hallucinations, vomiting, tremor, anxiety, dizziness, confusion. and loss of consciousness. National poison control centers received 2,362 exposure cases of de1ta-8 CHC products between January t, 2021 (i.e., date that delta 8 THC product code was added to database), and February 28, 2022 Of the 2,362 exposure cases: • 68% involved adults. 41% involved pediatric patients less than 18 years of age, and 194 did not report age. • 40% involved unintentional exposure. to delta 8 THC and 821' of these unintentional exposures affected pediatric patients. 70% required healt.a care tacihit evabmtion, of w¢ich 8'% resulted in adrl t, aini to a critical care unit: q;)% of patients requiring health care facility ecaloahon were pediatric patients. -tips. oa'—... v, n.,rran-- r,1,a-a ,ry —rrat `eta -Itis ..,