Manufacturers of any cannabinoid product that is synthetically created or extracted, including delta-8 THC, will have to seek Food and Drug Administration approval. Beginning in July 2023, approved products can be sold at OLCC-licensed dispensaries.

Licensed dispensaries will not be permitted to sell inhalable products like vapes or flower, restricting inventory to products formulated as edibles, tinctures, pills or topicals. OLCC will make an exception for artificially derived CBN, which can be sold in non-inhalable forms until July 2023, after which those products must also be FDA-approved.

Manufacturers will be required to submit their products to the same testing process adult-use cannabis products undergo, to screen for pesticides and heavy metals. The OLCC would require synthetically derived cannabinoids to be labeled as such. 

“Oregon is being perhaps overly cautious, and it’s paradoxical given the liberalizing trends for delta-9 cannabis and psychedelics,” Daniel Kruger, a researcher at the University of Michigan who has studied use of delta-8, told Filter. 

Delta-8 is a psychoactive cannabinoid similar to the more commonly used active cannabinoid delta-9, but found in much smaller quantities. Because of this, delta-8 is often derived synthetically.

“There are genuine concerns, like contamination with heavy metals,” Kruger said. “There have been incidents of labs finding illegally high levels of delta-9. That testing and accurate labeling and maintaining the purity of the product, that’s incredibly important.”

Numerous states have considered imposing restrictions on hemp-derived products.

OLCC Hemp & Processing Compliance Specialist Steven Crowley told Filter that current testing methods aren’t suited for synthetically derived products, and that those products are already checked for pesticides and heavy metals.

Some product sellers are already opposing the ban, accusing the OLCC of regulatory overreach.

In 2018, President Trump signed into law the “Farm Bill” that legalized hemp, defined as cannabis plants with under 0.3 percent THC by weight. Delta-8, which is derived from help, is not a controlled substance, and in May a federal appeals court determined it is legal. That same month, the FDA sent its first warning letters to delta-8 manufacturers, alleging misleading marketing claims.

Numerous states have considered imposing restrictions on hemp-derived products like delta-8. In Maryland and Minnesota, those products cannot be sold to anyone under 21. The precedent set in Oregon may create momentum for regulatory changes in other states now, too.

In April, a Kansas retailer selling hemp extracts was raided and shut down by the sheriff’s office. He simply moved his store 30 miles away, but is also suing for damages.

Photograph via Centers for Disease Control and Prevention

The post Oregon to Regulate Synthetic Cannabis Products, Setting National Precedent appeared first on Filter.

Like many others in his industry, he had founded a nicotine vape company with a purpose: He wanted to help others switch from smoking cigarettes to vaping, as he had done. But as governments continued to crack down on nicotine vaping, with flavor bans and increased taxes cropping up across the United States, he didn’t see much of a path forward. Business had become more of a headache than anything else: crippling regulations like the PACT Act, which currently prohibits vaping products to be distributed in the mail; a looming EVALI crisis wrongly blamed on his industry; and never-ending pushback over a supposed youth vaping “epidemic.”

“I was burnt out,” Matthews told Filter. The dream had run its course. A few years ago, he decided to sell his vape company.

Today, Matthews grows hemp. He owns and operates a 12-acre farm in Missouri, where he produces smokable flower and edibles through his new enterprise, Top Shelf Hemp. Among his most popular products are soft chewables with Delta-8-THC—a cannabinoid usually manufactured from hemp-derived CBD. At least that’s the typical process: extracting CBD from hemp, refining it into an isolate, and synthesizing the CBD isolate into Delta 8.

Matthews markets his gummies as having “a potent combination of physically semi-sedative, uplifting and calming effects.” And the transition for him has been rewarding.

A Cannabinoid’s Comeback

Delta 8 has been studied, on and off, since the 1970s, not long after an Israeli organic chemist named Raphael Mechoulam—sometimes referred to as the “Godfather of Cannabis”—first identified Delta 9, the compound we think of when somebody mentions THC. From there, scientists began to discover additional cannabinoids, like Delta 8, but none of them took off as Delta 9 did—probably, at least in the case of Delta 8, because it occurred naturally in smaller amounts and was less potent than Delta 9.

In many ways, research and interest in Delta 8 and other cannabinoids stalled, until Mechoulam found a way to reproduce Delta 8 through isomerization: breaking the atomic bonds of one molecule, like CBD, into another that shares the same atoms but in a different arrangement.

As the crackdown on nicotine vaping continues, many manufacturers see Delta 8 and other hemp derivatives as an easy way to pick up some of their lost revenue. They have found that the consumers they’re attempting to attract have enough of an overlap with nicotine vapers, and that there is potentially a larger market. Plus, the facilities where they mix e-liquid don’t require much adjusting. 

Delta 8 is much like the CBD boom had promised. And the business is mostly legal—even in some places where cannabis sales remain firmly banned.

The resurgence of Delta 8 is thanks in large part to the 2018 Farm Bill in the United States. Signed into law by President Donald Trump, it allows for the production and sale of hemp and all its derivatives.

“I either had to be associated with the plant my state likes or the molecule my state hates.”

However, laws also vary from state to state, so while Delta 8 is technically legal on the federal level, it is not legal in every state. Any hemp in Idaho, for example, is still considered a Schedule I substance, meaning selling it could lead to a misdemeanor or even felony charge.

“It’s what CBD was sold to be,” Charles Harris, who has also largely left the nicotine vape industry to pursue a career in Delta 8, told Filter. He is pushing his new product Lit Bar as the Puff Bar of Delta 8.

John Nathan, a longtime nicotine e-liquid manufacturer and the president of the Massachusetts-based Bay State Hemp Company, had also been inching his way out of the nicotine vape space and into cannabis—but needed a defined purpose, he said. After he took a board position at the Northeast Sustainable Hemp Association, he had a decision to make.

“I either had to be associated with the plant my state likes or the molecule my state hates,” he told Filter.

“It’s a similar manufacturing process with similar customers,” said Dylan Vogtman, a consumer advocate for nicotine vaping. “But there’s also a much bigger customer base, just like with CBD. Vaping is for smokers. Delta 8 and CBD are for everyone.”

Fears for the Future

It’s already a burgeoning, crowded field, and Delta 8 is getting noticed more and more. In the past month, the cannabinoid has attracted the attention of national media outlets, and many are wondering if its soaring ubiquity spells a familiar sort of doom: first, through an impending regulatory disaster similar to nicotine vaping, with lawmakers reacting to a seemingly unseen loophole in the 2018 Farm Bill; second, through cutting into legal cannabis sales in certain states, causing the taxed market to take a hit and potentially prompting unwelcome legislative responses; or third, through falling into the hands of children, or being portrayed as doing so, prompting another scare campaign.

Those narratives are developing. At the end of March, cops apparently seized $5,000 worth of Delta 8 products at a South Carolina vape shop, according to local news reports, and the police department in Janesville, Wisconsin, issued an alert in early April about its potential effects. The West Virginia Poison Control Center has recently put out warnings against Delta 8, claiming that it has put some kids in the hospital.

“Because [it’s] not regulated, you really don’t know what you’re buying, so there could be things in there that aren’t just Delta-THC,” Dr. Elizabeth Scharman, the director of the West Virginia Poison Control Center, told a local news station. “There could be [an] actual drug product in there, or other products. So the potential for harm exists.”

In early March, The Houston Chronicle reported that if Delta 8 “keeps gaining popularity, weed legalization in Texas could become a moot point.”

Following the Farm Bill in 2018, farmers grew a surplus of hemp in the 2019 season. “Farmers and processors were looking for alternate cannabinoids that would make them their initial cost of investment back,” Alex Buscher, a cannabis lawyer in Colorado, told Filter.

Delta 8 was a boon for many of them. But now the main issue that has to be addressed is whether Delta 8—and other cannabinoids that’ll probably be making news headlines in the near future—are really synthetic.

“The DEA will raid first and fight you in court later.”

In August 2020, the Drug Enforcement Agency (DEA) released an interim final rule (IFR) bulletin, clarifying its intent and stance. It stated that all synthetic tetrahydrocannabinol remains a Schedule I substance. It also addressed work-in-progress hemp extract, clarifying that a producer could purchase industrial hemp that has been certified and confirmed as having less than 0.3 percent total Delta-9-THC, but once it’s synthesized, whatever leaves the facility must also be less than 0.3 percent Delta-9-THC. (Some members of Congress have asked the DEA to revise its position.)

“The law is extremely murky,” said John Nathan, the hemp advocate in Massachusetts. “Delta 8 is created through synthesis, but it’s [also] naturally occurring, though it cannot be naturally extracted in the concentrations we’re seeing. But it’s also an isomer.”

“In my opinion, the DEA doesn’t really have a leg to stand on,” Buscher said. “But the DEA will raid first and fight you in court later.”

In short, it’s turning into a game of Whack-A-Mole, with farmers and manufacturers fearful of overregulation but in search of the next lucrative cannabinoid. “Hemp is a very large industry,” Buscher explained. “You can make plastics, paper and biofuel. But everybody wants to make CBD. And then when CBD crashed, now they want to make Delta 8. And when Delta 8 crashes, they’re going to make Delta 10. And when Delta 10 crashes, they’re going to make whatever the next cannabinoid is, and everybody in the industry is going to do the exact same thing.”

“That’s not the future,” Nathan said. “The future is cannabinoid blends and learning how they interact with each other and target specific needs.”

A Better Business Bet Than Nicotine Vapes?

Still, none of the uncertainties around the legality of Delta 8 and its future market are stopping people in the nicotine vape industry from feeling that cannabinoids are a better bet.

Tom Wasilewski, the founder of E-Cig Outlet, NTRL and Hemp Oil Distro in Michigan, has a story typical of many adult vapers. After watching his father die from lung cancer in his mid-20s, and after trying every conceivable method of quitting (the patch, gum, hypnosis), Wasilewski transitioned from smoking to vaping. He has owned four retail vape shops since 2013, but as his state kept passing more and more legislation limiting his business, he finally opened his own manufacturing facility in 2018, in part to produce CBD. His hemp business now does 98 percent in sales of Delta 8 and 2 percent of CBD, and he has carved out a niche in nicotine vaping in Michigan, only selling products to people in his state.

Over the span of three months, he went from unloading 3,000 Delta 8 soft chews per month to 100,000 a week.

At the moment, however, Wasilewski is staying away from Delta 8 vapes.

“The biggest issue right now is the carts,” Wasilewski said. “If someone has a Delta 8 cartridge that you screw on the end of a battery and start vaping, that is raw distillate. And it’s my opinion that you cannot have a compliant raw product because you can’t purge enough Delta 9 out of it.”

“The Wild West mentality is what leads to draconian laws.”

The irony is that, as lawmakers have placed blame on nicotine vaping and not the tainted THC cartridges that brought about the previous string of EVALI cases, they may have inadvertently driven nicotine vape producers into this new, booming—and, yes, largely unregulated—market. Every nicotine vape manufacturer who has embraced Delta 8 warned of the harms irresponsible actors could bring. That could threaten a young industry with great potential to help people relieve a host of issues, including anxiety, depression, and difficult sleeping.

“Because it’s in a gray area, and the DEA has said that it’s illegal, you have a lot of businesses that aren’t following good manufacturing practices,” Buscher told Filter. “Some of this is just being made in labs, in garages—who knows where.”

“The hemp itself will have been tested, but once it goes into a product, most states don’t require any testing of that product,” he continued. “It’s really fraught, in terms of trying a good product that doesn’t have additives that can potentially make you sick.”

Among the analytical labs in the country, there is not yet much consistency in methodology to test.

“We need definitive guidelines on what’s allowed and what’s not allowed,” Nathan said. “And there needs to be a national standard on cannabinoid prep testing.”

“The Wild West mentality,” he concluded, “is what leads to draconian laws.”

Photograph by Marc Fuyà via Flickr/Creative Commons 2.0

The post What to Make of the Recent Resurgence of Delta 8? appeared first on Filter.