Since the U.S. inadvertently created a way for retailers to legally sell a compound called delta-8 THC, which comes from hemp, officials from across the government can’t seem to figure out how to regulate it.
The Food and Drug Administration said in January that Congress must create regulations to rein in hemp-derived cannabinoids, which include delta-8. In July, Congress responded, asking the FDA how it should go about doing so. All the while, the Drug Enforcement Administration has been quietly evaluating whether it will issue rules that would close the loophole entirely. The lack of action from the federal government has led a number of states to step in to restrict or even ban the compound.
The confusion stems from the 2018 farm bill, which legalized hemp. Hemp and marijuana are both cannabis plants, but hemp refers to a cannabis plant that contains 0.3% or less of delta-9 THC, the psychoactive compound responsible for the drug’s high. Marijuana, on the other hand, contains about 15%, on average.
Delta-9 THC is the best-known version of tetrahydrocannabinol, and it’s generally what people are talking about when they refer to THC. Notably, it’s the specific compound that’s mentioned when limits are set for cannabis plants.
The bill made no mention of delta-8 THC, however — a slightly different, and less potent, version of the compound. The omission makes it legal for vendors to sell the compound as long as it comes from hemp, not marijuana. Delta-8 products have soared in popularity and, with them, warnings of harm, including contaminated products and poisonings in children.
THC derived from hemp remains in a legal gray area that creates opportunity for consumer deception, experts say.
Safety concerns aren’t related to delta-8 THC itself — which weakly activates the same receptors in the body as delta-9 THC — but rather the other substances, such as chemicals or heavy metals, that unregulated delta-8 THC products may contain. There is also no federal age requirement to buy them.
“That is the highest-priority problem in my mind,” said Daniele Piomelli, the director of the University of California, Irvine Center for the Study of Cannabis. “It’s paradoxical that legislation that is meant to protect public health ultimately has created these loopholes that now jeopardize public health.”
In an emailed statement, the DEA said it is “in the process of reviewing the thousands of comments it has received while going through the rule-making process regarding the implementation of the Agriculture Improvement Act of 2018,” referring to the farm bill, adding that any rule changes may “affect a variety of regulatory controls over marijuana, tetrahydrocannabinols, and other marijuana-related substances as well as a variety of controls over hemp and other hemp-related substances.”
“Many of the potential harms of these products really do stem from a lack of regulation,” said Alyssa Harlow, an assistant professor of public health at the Keck School of Medicine at the University of Southern California. “There are policies that can be made to address these issues, and I think that is what many public health professionals would like to see.”
Natural or not?
This year, the DEA confirmed that another type of THC — a synthetic version called THC-O — is regulated under the Controlled Substances Act, which federally classifies marijuana as a Schedule I drug, making it illegal. The ruling has implications for delta-8.
Delta-8 can be extracted from hemp in two ways, one that isolates delta-8 THC that naturally occurs in the plant — which is unregulated — and another that involves chemically converting cannabidiol, or CBD, into delta-8 THC-O, which falls under the Controlled Substances Act.
The amount of delta-8 THC found naturally in hemp, however, is very low — especially compared to CBD. Because of that, experts warn that many products being sold as delta-8 THC are actually delta-8 THC-O.
“People are claiming it’s naturally derived, but a great amount is not naturally occurring, and that’s concerning,” said Brad Rowe, a drug and criminal justice policy lecturer and researcher at UCLA who specializes in cannabis law.
There have been reports of delta-8 THC’s poisoning people, including at least two children who were admitted to intensive care. According to the latest available data, from Jan. 1, 2021, to May 31, 2022, the FDA received 125 reports of people experiencing adverse events after having consumed delta-8 THC. They included hallucinations, vomiting, tremor, anxiety, dizziness, confusion and loss of consciousness. The majority — 77% — were in patients 19 or younger, including one who died after having eaten a suspected delta-8 edible.
Federal regulation unlikely
Since 2018, 15 states have enacted outright bans on products that contain delta-8 THC. A handful of other states, including Alabama, Kentucky, Michigan, Minnesota and South Dakota, are implementing restrictions from age limits to bans on delta-8 THC in certain products, such as those that appeal to kids.
Rowe said he doesn’t expect the DEA to move to regulate THC under this year’s farm bill revisions. For now, he expects it to continue to divide hemp-derived cannabinoids into two categories: natural, such as THC, and synthetic, such as THC-O.
“The way the DEA appears to be coming down is if it’s naturally occurring, they are going to exempt it from controlled substances. That goes for delta-8, delta-9 and all the other cannabinoids people are extracting,” he said. “Anything created synthetically is something I think the DEA is going to want to continue to control.”
While the FDA hasn’t made any broad recommendations on delta-8 THC, but it has issued individual warnings to companies selling delta-8 THC in ways that violate the Federal Food, Drug, and Cosmetic Act, for example by making claims that delta-8 can treat medical conditions.
The matter of delta-8 THC regulation is not likely to be settled in the next farm bill, which isn’t meant to include finished products but rather raw commodities such as hemp flowers, said Andrew Freedman, the executive director of the Coalition for Cannabis Policy, Education, and Regulation, a research and advocacy group, who is Colorado’s former cannabis czar.
“The farm bill is probably not the place where this is going to be settled. This is still probably going to be a standalone legislation,” he said.
For now, delta-8 THC regulation is expected to be left up to states.
“At this point, the path towards federal regulation is unclear, so I would expect to see more states implementing state-level policies,” said Harlow, of UCLA, adding that it’s important that policymakers get a better understanding of which policies, such as requiring contaminant testing or instating age requirements to buy delta-8 THC, are most effective at reducing harm.
This content was originally published here.