The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) on Tuesday issued warnings to consumers about the potential risks of the cannabinoid delta-8 THC, a psychoactive compound that has grown in popularity but exists in an especially grey regulatory space.

While lawmakers have specified that hemp is only federally legal if it contains no more than 0.3 percent delta-9 THC, the most commonly known and naturally occurring cannabinoid, there’s generally a lack of rules governing delta-8 THC, which can be synthesized using CBD from legal hemp.

FDA and CDC have taken notice of the growing availability and demand for delta-8 THC, which is being sold in states regardless of whether they’ve legalized marijuana. And the agencies say they’re seeing a significant uptick in reported adverse health effects from people who are using it.

“It is important for consumers to be aware that delta-8 THC products have not been evaluated or approved by the FDA for safe use in any context,” FDA said. “They may be marketed in ways that put the public health at risk and should especially be kept out of reach of children and pets.”

The agency said some delta-8 products are being labeled as “hemp,” which could mislead consumers who are seeking non-intoxicating cannabinoids from the plant. And from December 2020 to July 2021, FDA said it has logged 22 adverse events reports from people who’ve experience symptoms such as “vomiting, hallucinations, trouble standing, and loss of consciousness.”

“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,” it said. “Thus, historical use of cannabis cannot be relied upon in establishing a level of safety for these products in humans.”

There are further concerns that the chemical process of synthesizing delta-8 THC from CBD could lead to contaminated products.

“The rise in delta-8 THC products in marijuana and hemp marketplaces has increased the availability of psychoactive cannabis products, even in states, territories, and tribal nations where non-medical adult cannabis use is not permitted under law,” CDC said. “Variations in product content, manufacturing practices, labeling, and potential misunderstanding of the psychoactive properties of delta-8 THC may lead to unexpected effects among consumers.”

Despite issuing the warnings, however, neither agency proposed banning the production or sale of the cannabinoid. CDC encouraged consumers to be aware of possible misleading labeling and said retailers should “provide information to consumers about the psychoactive qualities of delta-8 THC.”

“Retailers selling cannabis products should report total THC content on product labeling, including ingredients like delta-8 THC that may be synthetically produced to create a psychoactive effect,” it said.

State lawmakers and regulators are also aware of the increased consumer interest in delta-8 products and have taken various steps to either enact rules around, or outright ban, the cannabinoid. In Kentucky, for example, the state agriculture department banned the distribution of delta-8 THC, while Michigan put its Marijuana Regulatory Agency in control of the product and set an age limit of 21 for its use.

Paul Armentano, deputy director of NORML, told Marijuana Moment that the rise of delta-8 THC is a result of marijuana policy conflicts that have left gaps in access to traditional cannabis products.

“We share some of these agencies’ concerns regarding the unregulated nature of these grey-market products. Of course, the artificial market demand for these products is largely an outgrowth of marijuana prohibition,” he said. “Were whole-plant cannabis available legally, consumers would have little to no interest in experimenting with these unregulated imitations. But, absent widespread regulated access to cannabis, these unregulated producers and distributers are all too happy to fill this void.”

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Photo by Kimzy Nanney.

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