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U.S. Department of Health and Human Services
National Pharmacy & Therapeutics Committee

FDA raises concerns over Delta-8 THC

What is Delta-8 THC?

Delta-8 tetrahydrocannabinol, also known as delta-8 THC, is a psychoactive substance found in the Cannabis sativa plant. Delta-8 THC is one of over 100 cannabinoids produced naturally by the Cannabis sativa plant but is not found in significant amounts. 

Is Delta-8 THC Legal? 

This is a gray area. The Cannabis sativa plant produces many different cannabinoids. Delta-9 tetrahydrocannabinol (delta-9 THC) is the cannabinoid that is believed to be primarily responsible for many of the marijuana-related effects. The Agriculture Improvement Act of 2018 (2018 Farm Bill) authorized the production of hemp, which is legal. Congress defined hemp as any part of the Cannabis sativa plant that has no more than 0.3% delta-9 by dry weight. By definition, delta-8 THC is considered hemp; however, at least 17 states have banned delta-8 since then and the products are “severely restricted” in seven more as of November 2023, according to the National Cannabis Industry Association. Delta-8 THC sales seem to be most popular in states where people don’t have legal access to recreational or medicinal cannabis.

Is Delta-8 TCH safe? 

There are a combination of factors that have led the FDA to raise concerns among consumers and health care workers regarding the safety of delta-8 THC products. The FDA highlights three primary areas of concern:

  1. Marketing, including online marketing of products, that is appealing to children. Manufacturers are packaging and labeling these products in ways that may appeal to children (gummies, chocolates, cookies, candies, etc.). These products are available online and at convenience stores, even in states where the products are banned.
    1. In a sample of 2,186 12th-grade students, 11.4% said they had used delta-8 THC in the past year, and even though weed is illegal for teens, 30.4% of the participants reported using it.
    2. Of the 295 students who reported that had they used delta-8 in the previous year, 68.1% used it at least three times, 35.4% had used it at least 10 times, and nearly 17% used it at least 40 times. Close to 91% of the delta-8 users also reported using weed.
  1. Concerns regarding contamination due to methods of manufacturing that may in some cases be used to produce marketed delta-8 THC products. 
    1. The manufacturing of delta-8 THC products often involve use of potentially harmful chemicals to create the concentrations of delta-8 THC claimed in the marketplace. 
    2. More chemicals may be used to change the color of the final product. 
    3. The final delta-8 THC product may have potentially harmful by-products (contaminants) due to the chemicals used in the process.
  1. An uptick in adverse event reports to the FDA and the nation’s poison control centers. The FDA received 104 reports of adverse events in patients who consumed delta-8 THC products between December 1, 2020, and February 28, 2022. National poison control centers received 2,362 exposure cases of delta-8 THC products between January 1, 2021 (i.e., date that delta-8 THC product code was added to database), and February 28, 2022. 
    1. Adverse events included, but were not limited to hallucinations, vomiting, tremor, anxiety, dizziness, confusion, and loss of consciousness. 
    2. Most cases involved adults but there were a number of cases involving pediatric patients less than 18 years of age . Most of the pediatric cases reported to the national poison control centers were unintentional exposures. 
    3. 55% of cases reported to the FDA and 70% of cases reported to the national poison control centers required health care facility evaluation, some that resulted in admission to a critical care unit.

How to report cases of accidental exposure or adverse events:

To help the FDA track safety issues with delta-8 THC products, report suspected adverse events to the MedWatch program   as recommended in the Indian Health Manual. Please include “IHS” in the Reporter Section (section G) of the form. Instructions for reporting can be found online at the NPTC Pharmacovigilance website.

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