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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 it isn't found in large quantities. As a result, hemp-derived cannabidiol is frequently used to create concentrated amounts of delta-8 THC (CBD).

The FDA has not evaluated or approved delta-8 THC products for safe use in any situation. They could be marketed in ways that are harmful to people's health, and they should be kept out of the reach of children and pets in particular.

To protect yourself and those you care about from potentially harmful products, here are five things you should know about delta-8 THC:

1. The FDA has not evaluated or approved Delta-8 THC products for safe use, and they could be marketed in ways that put people's health at risk.

The FDA is aware of the growing public outcry over delta-8 THC products currently available for purchase on the internet. These products have not been evaluated or approved by the FDA for use in any situation. Variability in product formulations and labeling, as well as other cannabinoid and terpene content, and variable delta-8 THC concentrations, all raise concerns. Furthermore, some of these products may simply be labeled as “hemp products,” which could lead to confusion among consumers who associate “hemp” with “non-psychoactive.” The FDA is also concerned about the proliferation of products containing delta-8 THC that are marketed for therapeutic or medical purposes despite the agency's lack of approval. Not only is it illegal to sell unapproved products with unsupported therapeutic claims, but it also puts consumers at risk because these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns because patients and other consumers may use unproven treatments instead of approved therapies to treat serious and even fatal diseases.

2. The FDA has received reports of adverse reactions to delta-8 THC-containing products.

The FDA received 22 adverse event reports from both consumers and law enforcement between December 2020 and July 2021, describing 22 patients who consumed delta-8 THC products; 14 of these patients sought treatment at a hospital or emergency room after ingestion. Nineteen of the twenty-two patients experienced negative side effects after consuming food products containing delta-8 THC (e.g., brownies, gummies). The side effects included vomiting, hallucinations, difficulty standing, and loss of consciousness.

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. Among the 661 cases of exposure were the following:

Unintentional exposure to delta-8 THC was found in 41% of cases, with children under the age of 18 accounting for 77% of these unintentional exposures.

In 39 percent of the cases, children under the age of 18 were involved, and 18 percent of them required hospitalization, including children who needed to be admitted to the intensive care unit (ICU) as a result of their exposure to these products.

3. Delta-8 THC is a psychoactive and intoxicating substance.

Delta-8 THC, like delta-9 THC, has psychoactive and intoxicating properties (the component that causes people to get “high” when they use cannabis). The FDA is aware of media reports that delta-8 THC products cause people to become “high.” The FDA is also concerned that delta-8 THC products expose customers too much higher levels of the substance than are naturally found in hemp cannabis raw extracts. As a result, the safety of these products in humans cannot be determined based on previous cannabis use.

4. Many delta-8 THC products use potentially harmful chemicals to achieve the claimed concentrations of delta-8 THC in the marketplace.

Because the natural amount of delta-8 THC in hemp is extremely low, additional chemicals are required to convert other cannabinoids in hemp, such as CBD, into delta-8 THC (i.e., synthetic conversion). Some of the problems with this procedure are as follows:

To make delta-8 THC, some manufacturers may use potentially hazardous household chemicals in the chemical synthesis process. Additional chemicals may be used to change the color of the final product. The final delta-8 THC product may contain potentially harmful by-products (contaminants) as a result of the chemicals used in the process, and there is uncertainty about 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.

Delta-8 THC products may be made in uncontrolled or unsanitary conditions, resulting in the presence of potentially harmful contaminants.

5. Keep Delta-8 THC products out of children's and pets' reach.

These items are packaged and labeled in such a way that they appeal to children (gummies, chocolates, cookies, candies, etc.). These products can be purchased online as well as at a variety of retailers, including convenience stores and gas stations, where there are no age restrictions. As previously mentioned, there have been numerous poison control center alerts involving pediatric patients who have been exposed to delta 8  products. Furthermore, the number of pets accidentally exposed to these products has increased significantly, according to animal poison control centers. Keep these items away from children and pets.

Why is there a public health warning about delta-8 THC from the FDA?

Due to a variety of factors, the FDA has decided to make this information available to consumers. These are some of the elements:

The number of adverse event reports to the FDA and poison control centers across the country has increased.

Children-friendly marketing, including internet-based product marketing.

Concerns about contamination from manufacturing methods that, in some cases, may be used to create marketed delta-8 products.

To address these concerns, the FDA is actively working with federal and state partners, as well as monitoring the market for product complaints, adverse events, and other emerging cannabis-derived products of concern. When FDA-regulated products break the law, the FDA will issue public health and safety warnings to consumers.



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