FDA warns consumers of risks associated with Delta-8-THC products

On Tuesday, the Food and Drug Administration (the “FDA”) released its first statement regarding a consumer update on delta-8-tetrahydrocannabinol (“Delta-8-THC”). The agency decided to provide consumers with vital information related to the popular cannabinoid after a surge in reports of adverse events involving the substance and illicit marketing practices targeting minors.

If you follow my posts, you will know that government regulators have been dealing with these issues for months. In fact, many have either banned the substance or hired government regulators to impose strict manufacturing, testing, and marketing requirements on these products, including restricting their sale to anyone aged 21 and over.

In its Consumer Update, the FDA warned consumers about the following issues related to Delta-8-THC products:

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Delta-8 THC products have yet to be evaluated and approved by the FDA

The agency reminded consumers that Delta-8-THC products still need to be safety tested or approved by the FDA. Your main concern is the variability of product formulations and concentrations. The agency also fears that many of these products will be marketed as “hemp products,” which could lead consumers to believe that these products are not psychoactive.

RELATED: RIP Delta-8 THC: Why States And DEA Want It To Be Banned

In addition, the FDA condemns the proliferation of Delta-8-THC products that are marketed for therapeutic or medical purposes, despite their lack of FDA approval. Such marketing practices are viewed as misleading and dangerous by the FDA as they fear they could lead consumers to use Delta-8-THC products instead of approved therapies to treat serious or even fatal diseases.

Delta-8-THC products have been reported to cause serious health problems

Over the past three years, the FDA and national poison centers have received numerous reports of adverse events (from 22 patients) and exposure cases (661) that included use or exposure to Delta-8-THC, many of which were vomiting, hallucinations and Discomfort caused standing and loss of consciousness that often required hospitalization, including admission of children to the intensive care unit after exposure.

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Delta-8 THC products have psychoactive effects

The FDA is particularly concerned with the increased intoxicating effects of Delta-8 THC, as these products contain much higher levels of the substance than are naturally found in the hemp plant. Therefore, consumers cannot rely on historical cannabis use to assess the level of safety for the use of these products.

Delta-8 THC products often contain harmful chemicals

Because delta-8-THC is not expressed in sufficient concentrations in most strains of hemp to make its extraction economical, most delta-8-THC on the market is obtained from the chemical conversion of hemp-derived cannabidiol (“CBD”) . As a result, the FDA is concerned that some manufacturers may use potentially unsafe chemicals to convert Delta-8-THC through this chemical synthesis process. Also, because the manufacture of these products is largely unregulated, the agency fears that they can occur in uncontrolled or unsanitary environments, which can lead to the presence of unsafe contaminants or other potentially harmful substances.

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Delta-8 THC products are not suitable for children or pets

Manufacturers produce and market products that appeal to minors, such as gummy bears, chocolates, and candies. Additionally, many of these products can be purchased online and from retailers like 7-Eleven, where there may not be age restrictions on who can buy these products (I discuss this issue in this Refinery29 article). Many of the warnings from poison control centers triggered by Delta-8 THC concerned pediatric patients, but also pets who were accidentally exposed to the substance.

RELATED: Hemp Industries Association Calls for Regulation, Not Prohibition, of Delta-8 THC

The FDA completed its consumer update by informing the public that it is “working actively with federal and state partners to further address concerns about these products and to market to product complaints, adverse events and other emerging cannabis products of potential concern monitor”. Ironically, however, by delaying its rulemaking process and failing to make meaningful reforms to products infused with hemp-derived cannabinoids, the FDA created exactly the problem it addressed in this update and other public statements on them Products.

Hopefully the steady rise in adverse event reports will finally put pressure on the FDA to stop selling the cannabinoids and pave a legal path for these products to help self-regulated stakeholders stay in business and improve public health and safety protection.

Nathalie Bougenies is an attorney with Harris Bricken. This article was originally published on the Canna Law Blog and is republished with permission.