BE AWARE and BEWARE
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 quantities of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD).
Consumers must be aware that delta-8 THC products have not been evaluated or approved by the FDA for safe use. They may be marketed in ways that put public health at risk and should especially be kept out of reach of children and pets.
Here are five 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:
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 sold online and in stores. The FDA has not evaluated or approved these products for safe use in any context. Some concerns include product formulations and labeling variability, 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 the FDA has not approved them. Selling unapproved products with unsubstantiated therapeutic claims violates federal law, and it can put consumers at risk, as these products have not been proven safe or effective. This deceptive marketing of unproven treatments raises public health concerns because patients and other consumers may use them instead of approved therapies to treat severe and fatal diseases.
2. The FDA has received adverse event reports involving delta-8 THC-containing products.
The FDA received 104 reports of adverse events in patients who consumed delta-8 THC products between December 1, 2020, and February 28, 2022. Of these 104 negative event reports:
77% involved adults, 8% involved pediatric patients less than 18 years of age, and 15% did not report age.
55% required intervention (e.g., evaluation by emergency medical services) or hospital admission.
66% described adverse events after ingesting delta-8 THC-containing food products (e.g., brownies, gummies).
Adverse events included but were not limited to hallucinations, vomiting, tremor, anxiety, dizziness, confusion, and loss of consciousness.
National poison control centers received 2,362 exposure cases of delta-8 THC products between January 1, 2021 (i.e., when the delta-8 THC product code was added to the database) and February 28, 2022. Of the 2,362 exposure cases:
58% involved adults, 41% involved pediatric patients less than 18 years of age, and 1% did not report age.
40% involved unintentional exposure to delta-8 THC, and 82% of these unintentional exposures affected pediatric patients.
70% required healthcare facility evaluation, of which 8% resulted in admission to a critical care unit; 45% of patients requiring healthcare facility evaluation were pediatric patients.
One pediatric case was coded with a medical outcome of death.
3. Delta-8 THC has psychoactive and intoxicating effects.
Delta-8 THC has psychoactive and intoxicating effects, similar to delta-9 THC (i.e., the component responsible for the “high” people may experience 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, the historical use of cannabis cannot be relied upon to establish a safe level for these products in humans.
4. Delta-8 THC products often involve the 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 meager, 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. There is uncertainty concerning other potential contaminants that may be present or produced depending on the composition of the starting raw material. These chemicals can be harmful if consumed or inhaled, including some used to make (synthesize) delta-8 THC and the by-products created during synthesis.
Manufacturing delta-8 THC products may occur in uncontrolled or unsanitary settings, leading to unsafe contaminants or other potentially harmful substances.
5. Delta-8 THC 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 and at various retailers, including convenience stores and gas stations, where there may not be age limits on who can buy these products. Numerous poison control center alerts have involved pediatric patients exposed to delta-8 THC-containing products. Additionally, animal poison control centers have indicated a sharp increase in accidental exposure of pets to 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 are 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.
The FDA is actively working with federal and state partners to address further the concerns related to these products and monitoring the market for product complaints, adverse events, and other emerging cannabis-derived products of the potential problem. 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 have a severe side effect that is an immediate danger to your health, call 911 or go to your local emergency room. Healthcare 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. Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
For more information about Delta-8 THC: CDC HEALTH ALERT NETWORK (HAN)
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Information Courtesy of the
Food and Drug Administration