The U.S. Food and Drug Administration (FDA) recently announced that delta-8 THC, aka delta-8 tetrahydrocannabinol, a psychoactive substance found in the Cannabis sativa plant, has not been evaluated or approved by FDA for safe use in any context, including "edibles."
Delta-8 THC is one of over 100 cannabinoids produced naturally by the Cannabis plant but is not found in significant amounts in the plant. As a result, concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol.
FDA is aware of the growing concerns surrounding delta-8 THC products currently being sold online and in stores. Some concerns include variability in product formulations and product labeling, other cannabinoid and terpene content, and variable delta-8 THC concentrations. Additionally, some of these products may be labeled simply as “hemp products,” which may mislead consumers who associate “hemp” with “non-psychoactive.”
From December 2020 through July 2021, FDA received adverse event reports from both consumers and law enforcement describing 22 patients who consumed delta-8 THC products; of these, 14 presented to a hospital or emergency room for treatment following the ingestion. Of the 22 patients, 19 experienced adverse events after ingesting delta-8 THC-containing food products (e.g., brownies, gummies). Adverse events included vomiting, hallucinations, trouble standing, and loss of consciousness.
Delta-8 THC has psychoactive and intoxicating effects, similar to delta-9 THC (i.e., the component responsible for the “high” people may experience from using Cannabis). FDA is aware of media reports of delta-8 THC products getting consumers “high.” FDA is also concerned that delta-8 THC products likely expose consumers to much higher levels of the substance than are naturally occurring in hemp Cannabis raw extracts. Thus, historical use of Cannabis cannot be relied upon in establishing a level of safety for these products in humans.
Manufacturers are packaging and labeling these products in ways that may appeal to children (gummies, chocolates, cookies, candies, etc.). These products may be purchased online, as well as at a variety of retailers, including convenience stores and gas stations, where there may not be age limits on who can purchase these products. There have been numerous poison control center alerts involving pediatric patients who were exposed to delta-8 THC-containing products. Additionally, animal poison control centers have indicated a sharp overall increase in accidental exposure of pets to these products.
FDA is actively working with federal and state partners to further address the concerns related to these products and monitoring the market for product complaints, adverse events, and other emerging Cannabis-derived products of potential concern. FDA will warn consumers about public health and safety issues and take action, when necessary, when FDA-regulated products violate the law.
