How Regulatory Uncertainty Helped Give Rise to a New Street Drug

Untested delta-8-THC products are gaining in popularity

A novel cannabis drug is popping up in cities across the U.S., eliciting concern from members of the cannabis and hemp industries, state legislators, and a chemist who reviews cannabis drugs for safety. While the newly popular compound of delta-8-THC is not expressly prohibited by the Controlled Substances Act, people I spoke to are concerned that it is being produced unsafely and not receiving the same scrutiny that regulators apply to legal marijuana. 

The arrival of delta-8-THC—which is being sold in various places as a tincture, in vape pens, added to food, and sprayed on hemp flower so that it can be smoked—coincided with the passage of the 2018 Farm Bill, in which Congress repealed the federal prohibition on hemp and its byproducts. While delta-8-THC occurs in only trace amounts in hemp and cannabis, it can be synthesized from CBD isolate, the main commercial compound derived from hemp plants. 

After the farm bill passed, investment flooded into the hemp industry based on the expectation that it would be only a matter of time until farmers could sell hemp products as nutritional supplements. 

"Everyone anticipated that big grocery and pharmacy retailers would line their shelves once hemp and CBD were legal," Jim Higdon, co-owner and co-founder of Cornbread Hemp in Kentucky, tells Reason. But selling to national grocery and pharmacy retailers hinged on the Food and Drug Administration (FDA) classifying hemp-derived CBD, short for cannabidiol, as a nutritional supplement. Instead, the FDA explicitly declared that CBD could not be sold as a nutritional supplement. 

"The CBD industry in 2017 and 2018 had this rush with people wanting to get in," says Eric Steenstra, president of Vote Hemp. "In 2018, we had about 3,500 licenses for growers in the U.S. In 2019, we had over 19,000 licenses for growers." Then, when the FDA made it clear that hemp-derived CBD could not be marketed as a nutritional supplement, "you had all these people producing all this CBD, and there were suddenly way more producers than purchasers," Steenstra says. The prices of hemp and hemp-derived CBD isolate plummeted and remain low. "Lots of people couldn't sell their hemp flower and a lot of producers were sitting on CBD isolate trying to figure out what to do with it."

That's when some enterprising chemist found that CBD isolate could be synthesized into delta-8-THC, a cousin of delta-9-THC. While delta-9, the main psychoactive ingredient in cannabis, is prohibited by the Farm Bill and the Controlled Substances Act, neither piece of legislation mentions delta-8. Though it's not inherently dangerous, says Christopher Hudalla, the founder and chief science officer of ProVerde Laboratories, which provides testing services to state-legal cannabis businesses in Massachusetts and Maine, Hudalla has yet to test a delta-8-THC product that contains only delta-8. 

When he first saw products containing delta-8-THC in 2018, Hudalla says, "I thought, 'This is cool, this is novel.' But then I was like, 'What do we know about this?'"

The products Hudalla tested contained delta-8-THC, but also other THC isomers as well as chemical byproducts. "These byproducts are not found in nature. Chemists are using very, very strong reagents—strong acids, strong bases. If you don't know what you're doing, it's very possible to pass along some of those reagents to your customer."

Hudalla looked at numerous samples, finding not only chemical byproducts unfit for consumption but also chemical isolates he couldn't identify. He says that when pharmaceutical companies produce a drug and can't get rid of all the chemical byproducts, they are required to prove that the byproducts are safe. The delta-8 producers he's spoken with, many of whom are using unsophisticated labs, do not have the resources or the know-how to conduct those studies.  

Hudalla couldn't tell his clients that their delta-8-THC products were pure, so he wrote lab reports for them declaring that the products were not fit for human consumption. The decision has cost him business, and many producers have simply shopped for a lab that will write them a purity report they like. But he stands by the decision, citing lessons learned from the wave of lung injuries caused in recent years by THC vape pens sold on the black market. "I don't want to be responsible for someone hurting someone else, and I don't want a certificate of safety with my name on it found in a DEA bust," Hudalla says. 

Steenstra is equally concerned that some members of the hemp industry have turned to producing delta-8-THC. "These products are being produced who knows where, under who knows what conditions," Steenstra says. "There's been no research into whether delta-8-THC products are safe." 

Like Higdon, Steenstra is frustrated that the FDA refuses to roll up its sleeves and do the work of regulating hemp and CBD products as nutritional supplements. "These products are not being regulated by the FDA, but they should be," Steenstra says. "There are lots of good companies making good products, but they're doing it voluntarily. Which means there's a lot of poor-quality stuff out there as well." The thinking among hemp advocates is that smart regulations would give the hemp industry a path toward commercial viability, stabilize prices, and discourage the diversion of CBD isolate toward grey and black market delta-8-THC products.  

The adult-use cannabis industry is also concerned about the rise of delta-8-THC. "Very little is known about the health effects of delta-8 and almost all current production is entirely unregulated," says Morgan Fox, media relations director for the National Cannabis Industry Association. "Until we know more about delta-8, its production and sale should be regulated just like delta-9 under existing state cannabis licensing and oversight systems."

Fox also says that prohibition in general, not just the FDA's refusal to regulate hemp, is driving the delta-8-THC trend. "Keeping delta-9-THC—which is naturally present in cannabis at usable levels and has a long history of research and longitudinal data showing its relative safety—either illegal or so heavily regulated that it becomes prohibitively expensive for consumers creates an unnecessary demand for alternative inebriating cannabinoids. We are seeing that even though there is some limited demand for delta-8 in states with regulated cannabis markets, the vast majority of interest is in prohibition states."

While many defenders of delta-8 insist that it's perfectly legal under federal law, no one I spoke with thinks the legality is the most pressing issue. "It scares me that hemp is being marketed this way. It's a black eye for the hemp industry," Steenstra says. "If you go to a dispensary in a state where medical or recreational cannabis is legal, it's tested for everything and comes with a data sheet. In places where it's not legal, you're buying delta-8 at a gas station and have no idea."

No one I spoke to objected to the creation of a novel cannabis compound, they just don't want to harm consumers or erase the goodwill they've accumulated by submitting to regulation and oversight. "If someone can produce a delta-8 product that is actually delta-8 and not a garbage product, I don't have a problem with that," Hudalla adds. "That's a regulatory issue. As of right now, we're using consumers as guinea pigs."