Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

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

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued Warning Letters to five companies—Hippy Mood, Earthly Hemps, Shamrockshrooms.com, Mary Janes Bakery Co. LLC, and Life Leaf Medical CBD Center—for unlawfully selling copycat food products containing delta-8 tetrahydrocannabinol (delta-8 THC). Additionally, the FDA sent a separate warning letter to GrowGod LLC for similar violations of the FD&C Act.

Delta-8 THC has been associated with serious health risks. The FDA has previously alerted companies about the dangers of delta-8 THC in edibles. Between January 2021 and December 2023, the agency received over 300 reports of adverse effects, including hospitalizations and emergency visits, primarily linked to delta-8 THC-infused foods like candy and brownies. Reported symptoms include hallucinations, vomiting, anxiety, and confusion. Concerns also extend to the synthesis process of delta-8 THC, which may introduce harmful impurities. Additionally, misleading packaging that resembles popular snack brands poses a risk of consumer confusion. Healthcare providers and consumers are urged to report adverse reactions via MedWatch or the Safety Reporting Portal. For more details, visit the FDA and FTC’s joint statement on illegal delta-8 THC food products.