A cannabinoid product called delta-8 tetrahydrocannabinol (THC), sold legally and without prescription as gummies in gas stations, head shops and cannabidiol (CBD) stores in some states, has raised alarms around the country. Delta-8 is neither regulated the way medical cannabis is in several states, nor even the way recreational products are in states such as Colorado, Illinois, and Maine.

Delta-8 is unregulated because it is said to have low THC content, which leaves room for contaminants. That lack of regulation means heavy metals or other toxins could be in the product. One woman in Maryland was hospitalized after using it. She later took her bottle of the product to an independent laboratory to have it tested, according to a Baltimore Sun story quoting Will Tillburg, Executive Director of the Maryland Medical Cannabis Commission. Tillburg told the Sun that the laboratory found the product the woman was taking contained copper, which could cause liver failure and death.1

Delta-8 THC is one of more than 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 CBD, according to the FDA.2

The FDA produced a consumer update featuring "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." They are summarized here:

Delta-8 THC products have not been evaluated or approved by the FDA for safe use in any context and may be marketed online and in stores in a way that puts public health at risk, misleads consumers into thinking they are not psychoactive, and making unsubstantiated or false claims about health and medical benefits.

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, according to the FDA.

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 adverse event reports:

* 77% involved adults, 8% involved pediatric patients younger than 18 years, and 15% did not report age;

* 55% required intervention (eg, evaluation by emergency medical services) or hospital admission; and

* 66% described adverse events after ingestion of delta-8 THC-containing food products (eg, brownies and gummies).

Adverse events included, but were not limited to: hallucinations, vomiting, tremor, anxiety, dizziness, confusion, and loss of consciousness.

National poison control centers received 2362 exposure cases of delta-8 THC products between January 1, 2021, and February 28, 2022. Of the 2362 exposure cases:

* 58% involved adults, 41% involved pediatric patients younger than 18 years, 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 health care facility evaluation, of which 8% resulted in admission to a critical care unit; 45% of patients requiring health care facility evaluation were pediatric patients.

* One pediatric case was coded with a medical outcome of death.

Delta-8 THC has psychoactive and intoxicating effects, similar to delta-9 THC, the cannabinoid associated with the "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.

Delta-8 THC 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, such as CBD, into delta-8 THC (ie, synthetic conversion).

There are several concerns with this process. 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. In addition, 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.

Delta-8 THC products should be kept out of the reach of children and pets. Yet manufacturers are packaging and labeling these products in ways that may appeal to children. The products include gummies, chocolates, cookies, and candies. These products may be purchased online, and at a variety of retailers, including convenience stores and gas stations, where there may not be age limits on who can purchase these products. Numerous poison control centers have issued 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.

How to Report Complaints and Cases of Exposure

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:

* Complete an electronic Voluntary MedWatch form online or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

* To report adverse events in animals to the FDA's Center for Veterinary Medicine, please download and submit Form FDA 1932a found at: http://www.fda.gov/ReportAnimalAE.

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