About Delta 8 THC Products, 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.
1. Delta 8 THC products have not been evaluated or approved by the FDA for safe use and may be marketed in ways that put the public health at risk.
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.
2. The FDA has received adverse event reports involving delta 8 THC products.
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.
3. Delta 8 THC has psychoactive and intoxicating effects.
Delta-8 THC products have psychoactive & 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.”
4. Delta-8 products often involve use of potentially harmful chemicals to create the concentrations of delta-8 THC claimed in the marketplace.
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:
- Some manufacturers may use potentially unsafe household chemicals to make delta-8 THC through this chemical synthesis process. Additional chemicals may be used to change the color of the final product. The final delta-8 THC product may have potentially harmful by-products (contaminants) due to the chemicals used in the process, and there is uncertainty with respect to other potential contaminants that may be present or produced depending on the composition of the starting raw material. If consumed or inhaled, these chemicals, including some used to make (synthesize) delta-8 THC and the by-products created during synthesis, can be harmful.
- Manufacturing of delta-8 THC products may occur in uncontrolled or unsanitary settings, which may lead to the presence of unsafe contaminants or other potentially harmful substances.
5. Delta-8 products should be kept out of the reach of children and pets.
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. Keep these products out of reach of children and pets.
Why is the FDA notifying the public about delta-8 THC?
A combination of factors has led the FDA to provide consumers with this information. These factors include:
- An uptick in adverse event reports to the FDA and the nation’s poison control centers.
- Marketing, including online marketing of products, that is appealing to children.
- Concerns regarding contamination due to methods of manufacturing that may in some cases be used to produce marketed delta-8 THC products.
