The U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued warning letters to five companies selling copycat food products that contain delta-8 THC, which violate the Federal Food, Drug, and Cosmetic Act (FDCA). The warning letters were issued to Hippy Mood, Earthly Hemps, Shamrockshrooms.com, Mary Janes Bakery Co. LLC, andLife Leaf Medical CBD Center.

FDA also independently issued a warning letter to GrowGod LLC for FDCA violations.

These letters follow a similar group of six letters issued to companies selling delta-8 THC-containing copycat food products that could be confused for foods sold by popular national brands, and all six of those companies no longer have such products in stock.

“Inadequate or confusing labeling can result in children or unsuspecting adults consuming products with strong resemblance to popular snacks and candies that contain delta-8 THC without realizing it,” said Namandjé Bumpus, PhD, principal deputy commissioner of FDA. “As accidental ingestion and/or overconsumption of delta-8 THC-containing products could pose considerable health risks, the companies who sell these illegal products are demonstrating complete neglect for consumer safety. The FDA will continue to work to safeguard the health and safety of U.S. consumers by monitoring the marketplace and taking action when companies sell products that present a threat to public health.”

FDA also warned consumers about children accidentally ingesting food products containing delta-8 THC. From the beginning of 2021 to the end of 2023, FDA received over 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 nearly two thirds of these adverse events involved food products such as candy or brownies. Adverse events included but weren’t limited to hallucinations, vomiting, tremor, anxiety, dizziness, confusion, and loss of consciousness.

Copycat food products containing delta-8 THC are particularly concerning, FDA said, as they are extremely easy to purchase and often available to youth. FDA is concerned that the processes used to synthesize delta-8 THC can have create impurities or variations that can be harmful or have unpredictable effects on consumers.

Copycat products sold by the companies included Hippy Mood’s Trips Ahoy, Earthy Hemp’s Slushers, Mary Jane’s Bakery Co. LLC Infused Sour Slizzles, Life Leaf Medical CBD Center’s Double Stuff Stoneo, and GrowGod LLC’s Flamin Hot Cheetos.

“Companies that market and sell edible THC products that are easily mistaken for snacks and candy are not only acting illegally, but they are also putting the health of young children at risk,” said Samuel Levine, director of the FTC’s Bureau of Consumer Protection. “Those that prioritize profits in front of children’s safety are at serious risk of legal action.”

FDA urged consumers to report adverse reactions associated with FDA-regulated products to MedWatch or the Safety Reporting Portal. The agency also requested that the companies, within 15 working days, state how they will address the violations and prevent their recurrence, with failure to take action potentially leading to legal actions including product seizures and injunctions.