FDA issues Warning Letters for Selling Products containing Delta-8 THC

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued Warning Letters to five companies for illegally selling copycat food products containing delta-8 tetrahydrocannabinol (delta-8 THC) and introducing them into the marketplace.

Delta-8 THC May Pose Serious Health Risks

The FDA has previously warned companies for selling edible products containing delta-8 THC. From January 2021 to December 2023, the FDA received more than 300 adverse event reports involving children and adults who consumed delta-8 THC products. Nearly half of these reports involved hospitalization or emergency department visits, and about two-thirds of these adverse events followed the consumption of delta-8 THC-containing food products such as candy or brownies. Adverse events included hallucinations, vomiting, tremor, anxiety, dizziness, confusion, and loss of consciousness. The agency has previously released information expressing serious concerns about the potential health effects of delta-8 THC products.

The FDA is also concerned about the processes used to synthesize delta-8 THC, as impurities or variations in the composition process could result in products that are harmful or have unpredictable effects on consumers. In addition, packaging that is almost indistinguishable from many popular snacks can be confusing for consumers (e.g., chips, cookies, gummies or other snacks that mimic well-known snack food brands by using similar brand names, logos, or images on the packaging).

Health care providers and consumers are encouraged to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.

For more information please see FDA, FTC Continue Joint Effort to Protect Consumers Against Companies Illegally Selling Copycat Delta-8 THC Food Products.