CDC, FDA issue warnings about delta-8 THC safety
Yesterday the US Centers for Disease Control issued a public health advisory and the US Food and Drug Administration put up a page on the ‘serious health risks’ of the substance. The CDC warning noted that adverse events reports connected to the substance have been rising rapidly.
Rising tide of adverse event reports
CDC said that reports from the National Syndromic Surveillance Program (NSSP) that collects data from more than 4,400 emergency rooms across the country noted that the first case report mentioning delta-8 THC came in September 2020, with three more cases that year. But reports have been rapidly increasing in 2021. In January three cases were reported, rising to 29 in March and 48 in July.
Also in 2020 the American Association of Poison Control Centers introduced a product code that allowed the tracking of delta-8 THC exposures through its National Poison Data System (NPDS). According to that data, there were 660 delta-8 THC exposure events in 2021, 18% of which required hospitalization. Another 39% of those cases involved minors.
“When you see increases in numbers like that it is definitely something that should be investigated,” said Rick Kingston PharmD, of the University of Minnesota School of Pharmacy. Kingston is also president of scientific and regulatory affairs at SafetyCall International.
Delta-8 THC’s intoxicating effects
The CDC warning notes that the effects of delta-8 THC are still not fully known, but it is generally believed to have some psychoactive potential, though not as much as delta-9 THC, its better known sibling.
The CDC said the effects of delta-8 THC intoxication are determined by route of exposure and the sex, age, weight of the individual as well as other factors. But they mirror to some degree those of delta-9 intoxication, including lethargy, decreased psychomotor activity and decreased coordination, slurred speech and others.
After the passage of the 2018 federal Farm Bill, delta-9 THC is the only constituent of the Cannabis sativa plant that is still a controlled substance. Prior to the bill’s passage, the entire plant was listed on the Drug Enforcement Administration’s schedule one list of controlled substances.
Industry groups: Delta-8 doesn’t belong in hemp space
Because it is not called out by name on the DEA list, delta-8 THC exists in a regulatory gray area. The fact that it is not registered as an intoxicant as such might be part of the issue, said Marielle Weintraub, PhD, director of research and development at the supplement manufacturer Zilis. Weintraub is also president of the US Hemp Authority which provides hemp product manufacturing standards and certifications.
“I suspect some of these emergency room reports may be connected to the fact that there are no warnings on the labels,” Weintraub told NutraIngredients-USA. In that case, some consumers may become concerned after they experience some psychoactive symptoms when they weren’t expecting to have any. The CDC advisory mentioned that at least several case reports noted confusion on the part of patients about how delta-8 THC products were different from CBD formulations.
“Just to be clear, since March the US Hemp Authority has been very vocal about not certifying any delta-8 products. We have not allowed the certification of any product marketed for its intoxicating effects, nor do we believe such products are in the spirit of the Farm Bill,” she added.
The US Hemp Roundtable, a group representing hemp farmers and manufacturers, had this to say about Tuesday’s warnings:
“This new development shines yet another bright spotlight on the desperate need for regulation in this space. As a reminder, the US Hemp Roundtable believes that delta-8, as well as any other intoxicating compounds, should be regulated as adult-use cannabis. Meanwhile, non-intoxicating hemp products, like CBD should be regulated as dietary supplements and food and beverage additives.”
The CDC warning recommended that consumers be aware of the current limitations on the labeling of these products. In addition, consumers should know that some CBD/hemp products may contain delta-8 THC. CDC also recommended that consumers should make sure that children don’t have access to the products.
Question of manufacturing controls
The FDA information page that went up yesterday also noted that some delta-8 THC products may have been improperly manufactured. It’s a risk that Weintraub also mentioned, as there is not enough delta-8 THC in the raw material for standard extraction approaches to be economically viable.
“Almost all of the delta-8 THC out there will have been coverted from CBD. When you do that converstion you are using very strong acids and residual solvents and if you don’t have someone who really knows what they’re doing you could leave some unwanted compounds. And you can also inadvertently make a ton of delta-9 THC in that process some of which could be left in the product if not properly removed,” Weintraub said.
“It’s very easy if you don’t know what you’re doing to create a product that’s harmful,” she said.