09/14/2021 | Press release | Distributed by Public on 09/14/2021 08:46
Delta-8 tetrahydrocannabinol, also known as delta-8 THC, is a psychoactive substance found in the Cannabis sativa plant, of which marijuana and hemp are two varieties. Delta-8 THC is one of over 100 cannabinoids produced naturally by the cannabis plant but is not found in significant amounts in the cannabis plant. As a result, concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD).
It is important for consumers to be aware that delta-8 THC products have not been evaluated or approved by the FDA for safe use in any context. They may be marketed in ways that put the public health at risk and should especially be kept out of reach of children and pets.
Here are 5 things you should know about delta-8 THC to keep you and those you care for safe from products that may pose serious health risks:
The FDA is aware of the growing concerns surrounding delta-8 THC products currently being sold online and in stores. These products have not been evaluated or approved by the FDA for safe use in any context. 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.' Furthermore, the FDA is concerned by the proliferation of products that contain delta-8 THC and are marketed for therapeutic or medical uses, although they have not been approved by the FDA. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of federal law, but also can put consumers at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns because patients and other consumers may use them instead of approved therapies to treat serious and even fatal diseases.
From December 2020 through July 2021, the 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.
National poison control centers received 661 exposure cases of delta-8 THC products between January 2018 and July 31, 2021, 660 of which occurred between January 1, 2021, and July 31, 2021. Of the 661 exposure cases:
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). The FDA is aware of media reports of delta-8 THC products getting consumers 'high.' The 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.
The natural amount of delta-8 THC in hemp is very low, and additional chemicals are needed to convert other cannabinoids in hemp, like CBD, into delta-8 THC (i.e., synthetic conversion). Concerns with this process include:
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. As discussed above, 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. Keep these products out of reach of children and pets.
A combination of factors has led the FDA to provide consumers with this information. These factors include:
The 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. The FDA will warn consumers about public health and safety issues and take action, when necessary, when FDA-regulated products violate the law.
If you think you are having a serious side effect that is an immediate danger to your health, call 9-1-1 or go to your local emergency room. Health care professionals and patients are encouraged to report complaints and cases of accidental exposure and adverse events to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
For more information about Delta-8 THC:CDC HEALTH ALERT NETWORK (HAN)
The American Association of Poison Control Centers (AAPCC) maintains the National Poison Data System (NPDS), which houses de-identified case records of self-reported information collected from callers during exposure management and poison information calls managed by the country's poison control centers (PCCs). NPDS data do not reflect the entire universe of exposures to a particular substance as additional exposures may go unreported to PCCs; accordingly, NPDS data should not be construed to represent the complete incidence of U.S. exposures to any substance(s). Exposures do not necessarily represent a poisoning or overdose and AAPCC is not able to completely verify the accuracy of every report. Findings based on NPDS data do not necessarily reflect the opinions of AAPCC.