The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have sent warning letters to six companies for illegally selling food products containing Delta-8 tetrahydrocannabinol (THC), also known as delta-8 THC. These products resemble traditional foods like chips, cookies, candy, gummies, or other snack items, and can be easily mistaken as such. The FDA is concerned that these products may be accidentally ingested by consumers, including children, or taken in higher doses than intended.
The warning letters were issued to Delta Munchies, Dr. Smoke LLC (also known as Dr. S LLC), Exclusive Hemp Farms/Oshipt, Nikte’s Wholesale LLC, North Carolina Hemp Exchange LLC, and The Haunted Vapor Room. The FDA warns that children are more vulnerable than adults to the effects of THC, with many children having become sick or hospitalized after consuming “edibles” containing delta-8 THC.
The FDA Principal Deputy Commissioner, Janet Woodcock, expressed concern that these products intentionally mimic popular snack food brands, using similar brand names, logos, or packaging designs that consumers, particularly children, may confuse with traditional snack foods. There is also a risk that adults may inadvertently consume these products, which could lead to serious consequences, especially if they are driving or have other responsibilities.
Delta-8 THC is a substance found in the Cannabis sativa plant and has psychoactive and intoxicating effects that may be dangerous to consumers. The FDA has received reports of serious adverse events experienced by people who have consumed these products, including hallucinations, vomiting, tremors, anxiety, dizziness, confusion, and loss of consciousness. The FDA is also concerned about potential harmful contaminants in products containing delta-8 THC.
Samuel Levine, the director of the FTC’s Bureau of Consumer Protection, stated that marketing edible THC products that can be easily mistaken by children for regular foods is reckless and illegal. Companies must ensure that their products are marketed safely and responsibly, especially when it comes to protecting the well-being of children.
In June 2022, the FDA warned consumers about the consumption of food products containing delta-8 THC. Adverse event reports were received by the agency, with over 125 reports related to children and adults who consumed edible products containing delta-8 THC. Some of these reports specifically mentioned the edible product being a copycat of popular snack foods.
Consumers who believe a product may have caused a reaction or illness are advised to immediately stop using the product and contact their healthcare provider. The FDA encourages healthcare providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.
The warning letters sent by the FDA outline violations of the Federal Food, Drug, and Cosmetic Act related to the addition of delta-8 THC to conventional foods. The FDA has requested written responses from the six companies within 15 working days, stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations could result in legal action, including product seizure and/or injunction.
The FDA, an agency within the U.S. Department of Health and Human Services, is responsible for assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products, as well as medical devices. It is also responsible for regulating food, cosmetics, dietary supplements, products that emit electronic radiation, and tobacco products, in order to protect public health.
