The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention issued warnings to the public regarding the potential health risks of using Delta-8 THC products on September 14, 2021.

The FDA’s latest consumer update,  5 Things To Know About Delta-8 Tetrahydrocannabinol – Delta-8 THC, begins with a warning in large red letters: “DELTA-8 THC HAS SERIOUS HEALTH RISKS.”  The CDC’s Health Alert Network’s latest Health Advisory, Increases in Availability of Cannabis Products Containing Delta-8 THC and Reported Cases of Adverse Events, is intended to warn the public about the increased availability of cannabis products containing delta-8 THC and the potential for adverse events.  Among other things, the FDA and CDC are warning the public about:

• An uptick in adverse event reports to the FDA and the nation’s poison control centers related to delta-8 THC products, due to insufficient or misleading labeling as well as the mistaken belief that these products are non-psychoactive;

• Marketing, including online marketing of products, that is appealing to children (gummies and other products may look like candy);

• Concerns regarding contamination of delta-8 THC products due to methods of manufacturing.

Background Provided by the CDC and Dangers of Delta-8 THC

According to the CDC, marijuana refers to all parts of the plant Cannabis sativa L., including flower, seeds, and extracts with more than 0.3% delta-9 tetrahydrocannabinol (THC) by dry weight. Any part of the cannabis plant containing 0.3% or less THC by dry weight is defined as hemp (which was legalized by the 2018 Farm Bill).  The cannabis plant contains more than 100 cannabinoids, including THC, which is psychoactive (i.e., impairing or mind-altering) and causes a “high”.  CBD is another active cannabinoid found in the cannabis plant that is not psychoactive and does not cause a “high”.

The term THC most often refers to delta-9 THC.  Delta-8 THC exists naturally in the cannabis plant in only small quantities and is estimated to be about 50-75% as psychoactive as delta-9 THC.  However, CBD can be synthetically converted into delta-8 THC through a chemical process. According to the FDA, after chemical alteration, 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 can be harmful.

Delta-8 THC products are increasingly appearing in both marijuana and hemp marketplaces.  They are sometimes marketed as “weed light” or “diet weed.”  A wide variety of delta-8 THC-containing products have entered the marketplace, including, but not limited to, vapes, smokable hemp sprayed with delta-8 THC extract, distillates, tinctures, gummies, chocolates, and infused beverages.

The CDC states that the health effects of delta-8 THC have not yet been researched extensively and are not well-understood. However, delta-8 THC is psychoactive and may have similar risks of impairment as delta-9 THC. As such, products that contain delta-8 THC but are labeled with only delta-9 THC content rather than with total THC content likely underestimate the psychoactive potential of these products for consumers. In addition, delta-8 THC products are sold by a wide range of businesses that sell hemp and therefore may be confused with hemp or CBD products that are not intoxicating. Consumers who use these products may therefore experience unexpected or increased THC intoxication.

FDA Has Not Evaluated or Approved Delta-8 THC Products

 The FDA has not yet evaluated or approved delta-8 THC products for safe use. Some of the FDA’s 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.” The FDA also 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.

 FDA and CDC Have 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.

The FDA further reported that 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:

• 41% involved unintentional exposure to delta-8 THC and 77% of these unintentional exposures affected pediatric patients less than 18 years of age.

• 39% involved pediatric patients less than 18 years of age

• 18% required hospitalizations, including children who required intensive care unit (ICU) admission following exposure to these products.

The CDC states that delta-8 THC intoxication can cause adverse effects similar to those observed during delta-9 THC intoxication and may include:

• Lethargy

• Uncoordinated movements and decreased psychomotor activity

• Slurred speech

• Increased heart rate progressing to slowed heart rate

• Low blood pressure

• Difficulty breathing

• Sedation

• Coma

The FDA states that it is actively working with federal and state partners to further address the concerns related to delta-8 THC products and is monitoring the market for product complaints, adverse events, and other emerging cannabis-derived products of potential concern.