DEA Considers Synthetic THC Illegal

By Pat Anson, PNN Editor

The Drug Enforcement Administration considers a synthetic form of THC — the psychoactive compound in cannabis and hemp — a controlled substance that is illegal under federal law.

Hemp was legalized federally under the 2018 Farm Bill, in part because hemp contains only trace amounts of THC. However, some companies developed a synthetic form of hemp-derived THC — called THC acetate ester (THCO) — to give consumers an intoxicating effect. Because THCO was modeled after the THC found in hemp, they claimed it could be legally sold and consumed.

However, in a recent letter to Rod Kight, an attorney who specializes in cannabis law, the head of the DEA’s Drug & Chemical Evaluation Section said the agency considers delta-8 and delta-9 products containing THCO to be Schedule I controlled substances, which are illegal to sell or possess.

“Delta-9-THCO and delta-8-THCO do not occur naturally in the cannabis plant and can only be obtained synthetically, and therefore do not fall under the definition of hemp. Delta-9-THCO and delta-8-THCO are tetrahydrocannabinols having similar chemical structures and pharmacological activities to those contained in the cannabis plant,” the letter states.

Kight said he’s been telling clients and personal friends that THCO is potentially dangerous.

“Although I do not always agree with the DEA’s view on cannabis matters, I agree with this opinion and, frankly, am not surprised,” he wrote.  “It has always been my view that THCO is a controlled substance under federal law. Although it can be made from cannabinoids from hemp, THCO is not naturally expressed by the hemp plant. It is a laboratory creation that does not occur in nature, at least not from the hemp plant.”

As Kight points out in his blog, the DEA letter does not address delta-8 or delta-9 THC, which are natural and derived from hemp. Although those substances are considered legal at the federal level, over a dozen states have banned products containing them.

In states where they remain legal, delta-8 and 9 are widely available in candy, gummies, cookies, tinctures and beverages. Some companies claim the products have “uniquely potent effects on pain” and other health conditions, even while admitting there is little evidence to support those claims.

The FDA became so alarmed by the profusion of delta-8 and delta-9 THC products — and their marketing to children — that it sent letters to five companies in 2022 warning them to stop making unsubstantiated medical claims.

"These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety," FDA Principal Deputy Commissioner Janet Woodcock, MD, said in a statement. "It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children.”

The FDA says it had received over 100 reports of adverse events involving delta-8 THC, with poison control centers reporting over 2,300 cases, including one that involved the death of a child.

Lab Mice Agree: Delta-8 Just Like Taking Delta-9

By Pat Anson, PNN Editor

Laboratory mice at a research facility have figured out something that Congress failed to do when it legalized hemp in 2018: the tetrahydrocannabinol (THC) found in hemp can get you just as high as the THC found in marijuana.

That finding, in a new study led by researchers at the University of Connecticut, undermines one of the tenets of the 2018 Farm Bill, which made it possible for U.S. farmers to grow hemp again as a cash crop. The thinking at the time was that since hemp contained less than 0.3% tetrahydrocannabinol, the main psychoactive ingredient in marijuana, it couldn’t be used to get high.

The mice found otherwise. When given Delta-8 THC derived from hemp twice a day for five days, the mice showed signs of lethargy, dependence and “liking” behavior. Although not as potent as the Delta-9 THC derived from marijuana, researchers reported in the journal Drug and Alcohol Dependence that Delta-8 had similar psychoactive effects on the mice, “including evidence of dependence and abuse potential.”

“So they’re telling us the same thing people buying the stuff in gas stations tell us: (Delta-8) feels like THC,” says Steve Kinsey, PhD, a UConn School of Nursing professor and director of the Center for Advancement in Managing Pain.

Kinsey and his colleagues say Delta-8 and Delta-9 molecules are similar and act in the same way on the body. But while Delta-9 is illegal under federal law, Delta-8 is legally being sold in a wide array of edibles, beverages, tinctures and other products. Because they are made with CBD and THC derived from hemp, they can be purchased without an ID or marijuana prescription – even in states where medical or recreational marijuana is illegal.  A recent study found that some hemp-based edibles have 360% more THC than those sold in cannabis dispensaries.

“It’s creating a fight between marijuana and hemp” growers, says John Harloe, an attorney on a Colorado taskforce that is trying to address the different chemical variations of THC and their hazy legal status.

“(Marijuana) must be sold through dispensaries and pay high taxes, while hemp producers can sell essentially the same product but without the same regulations, due to the ambiguity in the Farm Bill,” Harloe said in a statement.

The Food and Drug Administration has been slow to regulate CBD products, but earlier this year the agency sent the first warning letters to companies for selling products containing Delta-8. The letters don’t take issue with Delta-8’s legal status, but focus instead on its unauthorized marketing as a treatment for chronic pain, nausea, anxiety and even cancer.

Hemp-Derived Delta-8 Raises Health Concerns

By Eric Berger, Kaiser Health News

Suzan Kennedy has smoked marijuana, and says her Wisconsin roots mean she can handle booze, so she was not concerned earlier this year when a bartender in St. Paul, Minnesota, described a cocktail with the cannabinoid delta-8 THC as “a little bit potent.”

Hours after enjoying the tasty drink and the silliness that reminded Kennedy of a high from weed, she said, she started to feel “really shaky and faint” before collapsing in her friend’s arms. Kennedy regained consciousness and recovered, but her distaste for delta-8 remains, even though the substance is legal at the federal level, unlike marijuana.

“I’m not one to really tell people what to do,” said Kennedy, 35, who lives in Milwaukee and works in software sales. But if a friend tried to order a delta-8 drink, “I would tell them, ‘Absolutely not. You’re not putting that in your body.’”

The FDA and some marijuana industry experts share Kennedy’s concerns. At least a dozen states have banned the hemp-derived drug, including Colorado, Montana, New York, and Oregon, which have legalized marijuana. But delta-8 manufacturers call the concerns unfounded and say they’re driven by marijuana businesses trying to protect their market share.

So what is the difference? The flower of the marijuana plant, oil derived from it, and edibles made from those contain delta-9 tetrahydrocannabinol, the substance that produces the drug’s high, and can be legally sold only at dispensaries in states that have legalized marijuana.

Similar products that contain delta-8 THC are sold online and at bars and retailers across much of the U.S., including some places where pot remains illegal. That’s because a 2018 federal law legalized hemp, a variety of the cannabis plant. Hemp isn’t allowed to contain more than 0.3% of the psychotropic delta-9 THC found in marijuana.

Delta-8 Contaminants

The concerns about delta-8 are largely focused on how it’s made. Delta-8 is typically produced by dissolving CBD — a compound found in cannabis plants — in solvents, such as toluene that is often found in paint thinner. Some people in the marijuana industry say that process leaves potentially harmful residue. A study published in the journal Chemical Research in Toxicology last year found lead, mercury, and silicon in delta-8 electronic cigarettes.

The FDA has issued warnings about the “serious health risks” of delta-8, citing concerns about the conversion process, and has received more than 100 reports of people hallucinating, vomiting, and losing consciousness, among other issues, after consuming it. From January 2021 through this February, national poison control centers received more than 2,300 delta-8 cases, 70% of which required the users to be evaluated at health care facilities, according to the FDA.

Delta-8 is “just the obvious solution to people who want to have access to cannabis but live in a state where it’s illegal,” said Dr. Peter Grinspoon, a primary care physician at Massachusetts General Hospital and a longtime medical cannabis provider. “You can either get in a lot of trouble buying cannabis, or you can get delta-8.”

Grinspoon described delta-8 as about half as potent as marijuana. But because of the lack of research into delta-8’s possible benefits and the absence of regulation, he would not recommend his patients use it. If it were regulated like Massachusetts’ medical and recreational marijuana programs, he said, harmful contaminants could be flagged or removed.

‘Incredible Potential as Therapeutic’

Christopher Hudalla, chief scientific officer at ProVerde Laboratories, a Massachusetts marijuana and hemp testing company, said he has examined thousands of delta-8 products and all contained contaminants that could be harmful to consumers’ health.

Delta-8 has “incredible potential as a therapeutic” because it has many of the same benefits as marijuana, minus some of the intoxication, said Hudalla. “But delta-8, like unicorns, doesn’t exist. What does exist in the market is synthetic mixtures of unknown garbage.”

Justin Journay, owner of the delta-8 brand 3Chi, is skeptical of the concerns about the products. He started the company in 2018 after hemp oil provided relief for his shoulder pain. He soon started wondering what other cannabinoids in hemp could do. “‘There’s got to be some gold in those hills,’” Journay recalled thinking. He said his Indiana-based company now has more than 300 employees and sponsors a NASCAR team.

When asked about the FDA’s reports of bad reactions, Journay said: “There are risks with THC. There absolutely are. There are risks with cheeseburgers.”

He attributes the side effects to taking too much. “We say, ‘Start low.’ You can always take more,” Journay said.

Journay said that he understands concerns about contaminants in delta-8 products and that his company was conducting tests to identify the tiny portion of substances that remain unknown, which he asserts are cannabinoids from the plant.

An analysis of 3Chi delta-8 oil conducted by Hudalla’s firm last year and posted on 3Chi’s website found multiple unidentified compounds that “do not occur naturally” and thus “would not be recommended for human consumption.” Delta-8 oil is still sold on 3Chi’s site.

Journay said the analysis found that only 0.4% of the oil contained unknown compounds. “How can they then definitively say that compound isn’t natural when they don’t even know what it is?” he said in an email.

“The vast majority of negative information out there and the push to make delta-8 illegal is coming from the marijuana industries,” Journay said. “It’s cutting into their profit margins, which is funny that the marijuana guys would all of a sudden be for prohibition.”

Delta-8 products do appear to be significantly cheaper than weed. For example, Curaleaf, one of the world’s largest cannabis companies, offers packages of gummies that contain 100 milligrams of delta-9 THC for $25, plus sales tax, at a Massachusetts dispensary. At 3Chi, gummies with 400 milligrams of delta-8 cost $29.99 online, with no tax.

Journay’s criticism of the marijuana industry holds some truth, said Chris Lindsey, government relations director for the Marijuana Policy Project, which advocates for legalization of marijuana for adults.

“We see this happen in every single adult-use legalization state,” said Lindsey. “Their established medical cannabis industry will sometimes be your loudest opponents, and that’s a business thing. That’s not a marijuana thing.”

Still, the bans might not be working fully. In New York, which banned delta-8 in 2021, Lindsey said, it’s available at any bodega.

“In an environment where whole-plant cannabis is legally available, there would be little to no demand for these alternative products.”

— Paul Armentano, NORML

In July, Minnesota implemented a law that limits the amount of THC, including delta-8, allowed in hemp products outside of its medical marijuana program. News reports said the law would wipe out delta-8. But the state cannot “control what’s being sold over the internet outside of Minnesota and shipped in,” said Maren Schroeder, policy director for Sensible Change Minnesota, which aims to legalize recreational cannabis for adults.

Max Barber, a writer and editor in Minneapolis, remains interested in delta-8 despite his state’s restrictions. Even though he could likely obtain a medical marijuana prescription because he has an anxiety disorder and chronic sleep problems, he hasn’t pursued it because pot made his anxiety worse. He used CBD oil but found the effects inconsistent. In March 2021, he tried a 10-milligram delta-8 gummy.

“It got me pretty high, which I don’t enjoy,” he said.

Then he found what he considers the right dosage for him: one-third of a gummy, which he takes in the evening. He said he now gets between six and eight hours of sleep each night, has less anxiety, and is better able to focus. “I have become kind of an evangelist for delta-8 for everyone I know who has sleep problems,” said Barber, who bought enough gummies to last for months after the new law went into effect.

To address concerns about delta-8, the federal government should regulate it and make accessing cannabis easier for consumers, said Paul Armentano, deputy director of the National Organization for the Reform of Marijuana Laws.

He pointed to a recent study in the International Journal of Drug Policy showing that the number of Google searches for delta-8 in the U.S. soared in 2021 and that interest was especially high in states that restricted cannabis use. “In an environment where whole-plant cannabis is legally available, there would be little to no demand for these alternative products,” said Armentano.

Lindsey, of the Marijuana Policy Project, isn’t so sure that would matter. When he first learned of delta-8’s growing popularity in 2021, he thought it would go the way of drugs like K2 or Spice that he said fall between the regulatory rules long enough to get on shelves before eventually getting shut down.

“That didn’t materialize,” said Lindsey. “The more that we understand about that plant, the more of these different cannabinoids are going to come out.” And that, he said, will in turn spur interest from consumers and businesses.

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

FDA Head Wants New Regulations for Kratom and CBD

By Pat Anson, PNN Editor

The head of the Food and Drug Administration says his agency will need new authority from Congress to regulate both kratom and cannabidiol (CBD), two natural substances used by millions of Americans to self-treat their pain and other medical conditions.

FDA Commissioner Dr. Robert Califf testified on Thursday before a House Appropriations subcommittee, where he was asked why the agency was slow in developing new regulations for CBD and why it remained opposed to the use of kratom. Califf said new regulatory pathways were needed for both substances because they fall between the cracks of existing law that gives the FDA broad authority to regulate food and drugs.

“I don’t think the current authority we have, on the food side and the drug side, necessarily gives us what we need to have to get the right pathway to move us forward. We’re going to have to come up with something new. I’m very committed to doing that,” said Califf.

Califf was recently confirmed by the U.S. Senate as FDA commissioner, a job he previously held under President Obama. He noted that little progress had been made at the FDA in regulating CBD and other cannabis products since he left the agency.

“You know, when you come six years later to the job you had before and nothing has really changed, that’s telling you that you can’t just keep trying to do the same thing over and over,” said Califf.

Some of the difficulty in regulating CBD comes from passage of the 2018 farm bill, which legalized hemp under federal law. At the time, it was believed that hemp had little or no psychoactive properties and would be relatively harmless. However, as PNN has reported,  some cannabis companies have found ways to concentrate delta-8 tetrahydrocannabinol (delta-8 THC) derived from hemp and are using it in edibles to give consumers a mild intoxicating effect.

The FDA considers delta-8 THC an unapproved drug, but because it comes from hemp – a legal substance – its regulatory status is unclear.

“The amazing plethora of derivatives of the cannabis plant is really quite profound and astounding, and already in widespread use in a variety of means. Most of the FDA effort so far has been spent on research to figure out what the risks, if any, are of various uses of this material in its different forms,” said Califf. “The research so far has shown that there are some risks with CBD. And so, we’re going to need a different pathway than just the standard food pathway.”

FDA Kratom Info ‘Extremely Antiquated’

Califf took a similar stance on kratom, an herbal supplement that comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. An estimated two million Americans use kratom to self-treat their pain, depression, anxiety and addiction — even though the FDA has not approved kratom for any medical condition.

In a recently updated online fact sheet, the agency said kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

That brought a rebuke from Rep. Mark Pocan (D-WI), who has supported efforts to keep kratom legal. He called the FDA’s position on kratom “extremely antiquated.”

“That update was not much of an update and I think it’s being very unfair to the consumers who are legally consuming kratom in this country,” Pocan told Califf.  “Honestly, there are not only arguable conclusions (in the update), but you are linking to outdated, incomplete and inaccurate information.“

“I hope to come back to you on kratom in a couple months,” Califf replied. “There are millions of people using kratom. We do have real adverse events, real negative things that have happened to people. And it does interact with multiple neurotransmitters.”

Kratom is banned in several states, but a federal effort to ban kratom nationwide in 2016 failed due to a public outcry. The Department of Health and Human Services (HHS) later withdrew an FDA request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused. A former HHS official said the FDA request to schedule kratom was rejected because of “embarrassingly poor evidence & data.”

Not all federal agencies take such a dim view of kratom. A 2020 study funded by the National Institute on Drug Abuse (NIDA) concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects. NIDA recently had a public hearing on kratom to further explore its therapeutic uses.

“We’ll continue to work with NIDA and we’ll go where the science takes us,” Califf said. “But like I said with regard to cannabis products, we need something different with these kinds of products that are not traditional foods, not traditional drugs.”