Is Delta-8 Unsafe? The FDA and the CDC Have Worries.

Delta-8 can be found on loose hemp flower, in vapes and edibles in North Texas and across the country.
Delta-8 can be found on loose hemp flower, in vapes and edibles in North Texas and across the country. Jacob Vaughn
For well over a year, products containing delta-8 THC, a nebulously legal, psychoactive version of marijuana, have been flying off the shelves across the country even as Texas considered a ban.

But this week, the Federal Drug Administration and the Centers for Disease Control and Prevention took a swipe at pot smokers' favorite legal alternative, putting out warnings about the supposed health risks delta-8 poses.

The FDA and the CDC say they've each seen a spike in negative side effects, noted concerns about the manufacturing processes and accused delta-8 companies of targeting children with their marketing.

In 2018, Congress passed the U.S. Farm Bill, which removed hemp that contains less than 0.3% THC from the Schedule I controlled substance list. A year later, Texas Gov. Greg Abbott signed into law House Bill 1325, which made it legal to cultivate, possess and sell industrial hemp with less than 0.3% delta-9 THC (the stuff in real weed that gets you stoned).

States like Texas hadn't yet made a ruling one way or the other on delta-8, which is the legal, less potent psychoactive cannabinoid found in hemp. If you drive around North Texas and hit up CBD stores, smoke shops and gas stations, you'll find plenty of delta-8 products on the shelves.

But now, health officials warn that the FDA hasn't approved delta-8, adding that they worry about the product formulas, labeling and marketing.

For example, some of these are labeled simply as “hemp products,” which may mislead people who associate “hemp” with being “non-psychoactive,” according to the FDA. “Furthermore, the FDA is concerned by the proliferation of products that contain delta-8 THC and are marketed for therapeutic or medical uses, although they have not been approved by the FDA,” the agency said.

This “deceptive” marketing of delta-8 as a treatment raises public health concerns because consumers may use these products instead of approved treatments for serious and even fatal diseases.

Between December 2020 and July 2021, law enforcement and consumers have notified health officials of “adverse events” regarding delta-8. Of 22 patients, 14 went to the hospital or emergency room after taking delta-8, and 19 experienced such "adverse events" after gobbling down delta-8 edibles.

Adverse events "included vomiting, hallucinations, trouble standing, and loss of consciousness,” according to the FDA.

This isn’t completely unfounded, especially for edible cannabis products. This is because when users digest delta-9, it turns into what's called 11-hydroxy-delta 9 THC. It's a metabolite that is estimated to clock in between 1.5 and seven times more potent than its combustible or vaped precursor.

“This is why a lot of emergency department visits are associated with cannabis edibles, rather than inhaled consumption," Dr. Adie Rae, a neuroscientist, told the website Weedmaps.

A very similar reaction occurs when users digest delta-8 through edibles. Delta-8 turns into the metabolite 11-hydroxy-delta 8 THC, which is longer lasting and up to 10 times as potent.

National poison control centers have received 661 delta-8 exposure cases between 2018 and 2021. All but one of those are from this year. Out of these cases, 41% involved unintentional exposure. More than three quarters affected children. Another 39% were intentional but involved people younger than 18. Some 18% were hospitalized. This includes children who required intensive care unit admission after consuming delta-8.

They also want users to know that delta-8 can get then high. “The FDA is aware of media reports of Delta-8 THC products getting consumers high,” they said. “The FDA is also concerned that delta-8 THC products likely expose consumers to much higher levels of the substance than are naturally occurring in hemp cannabis raw extracts.”

As a result, the FDA said historical use of cannabis can’t be relied on to establish a safety level for these products.

They also worry about the manufacturing process. Delta-8 THC is a naturally occurring compound of the cannabis plant. However, there are such small amounts in natural cannabis that manufacturers are taking CBD and converting it to delta-8 through a chemical process called isomerization.

“Adverse events included vomiting, hallucinations, trouble standing, and loss of consciousness.” – Federal Drug Administration

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CBD can be converted into several other cannabinoids with a solvent, acid and heat to produce higher concentrations than naturally found in the cannabis plant. Last year, the U.S. Drug Enforcement Administration declared all "synthetically derived THC" would remain on the Schedule I controlled substances list. Some say that includes delta-8 and delta-10, but that's not yet being enforced against products on the market today.

The FDA says some makers could be using unsafe household chemicals while manufacturing delta-8. On top of that, the agency has no way to know if delta-8 is being concocted in unsanitary environments.

Worse still, because testing of delta-8 isn’t required or consistent, there’s no telling what contaminants — heavy metals, solvents or even pesticides — find their way into the products and at what quantities.

Lastly, the FDA and CDC want to keep the stuff away from children and pets. Gummies and chocolates, for instance, probably appeal to kids, and animal poison control centers have recorded a sharp uptick in pets accidentally being exposed to delta-8.

Still, neither the FDA nor the CDC has called for delta-8 to be banned. The CDC recommended that consumers beware of misleading labels and that retailers be certain to inform customers about delta-8's psychoactive effects. They also asked healthcare providers to keep an eye out for reports of negative effects brought on by delta-8.

Meanwhile, cannabis researchers share many of these concerns, as do delta-8 manufacturers, retailers and consumers. The CBD industry comes with a lack of regulation. The same can be said for delta-8 products being manufactured and sold today. But some people want that to change.

Vince Sanders owns CBD American Shaman, which has stores across the country, including in the Dallas-Fort Worth area. Although they started with CBD they have been quick adopters of some of the other over 100 known cannabinoids. They began selling CBN, CBG and eventually delta-8 and delta-10 THC.

“We beg for government regulation,” Sanders said. “I’m not sure there’s any other industry out there that wants that, but we certainly do because without it, there’s no clarity.”

He sums up the state of the industry like this: “You want to do CBD? You want to do delta-8? Great. Go make it in your bathroom or your garage. Go throw that product on a shelf somewhere. Who knows what’s in it? Those are the problems that we face in this industry. The only way to get rid of them is with government regulation.”

Christopher Hudalla, president and chief scientific officer of ProVerde Laboratories, said he and others have been trying to sound the alarm on delta-8 for the last year and a half. ProVerde Laboratories is an analytical testing firm with facilities in Massachusetts and Maine.

"We’ve tested thousands of products and out of those thousands of products, 100% of them have significant levels of contamination that is seriously alarming," Hudalla said. "Nobody wants to talk about it. Nobody wants to admit it.”

It's certainly possible to make these products without the contaminants, he said, “but it’s expensive, and that’s the problem.”

“The problem is when they’re doing a synthesis, they’re not cleaning them up. They’re not removing the contaminants that are being created as side products," Hudalla said. In the pharmaceutical world, seeing this kind of contamination would be commonplace. "But the pharmaceutical industry has the responsibility to either remove those from the final product or study them to ensure that those byproducts that they can’t remove are not toxic," he said. "Neither of those are being done for [delta-8].”

"We beg for government regulation.” – Vince Sanders, CBD American Shaman

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Hudalla also said removing these contaminants takes a certain level of skill that all manufacturers might not have.

But he stresses that delta-8 isn't the issue; the unknowns are. Overdoses on other, older synthetic cannabinoids, like spice and K2, have been a problem in Dallas and other parts of the country. But Hudalla would argue that K2 and spice are safer than delta-8 products on the market today because studies have been conducted on these synthetic cannabinoids.

“K2 and spice are safer just because we understand them and we know them," he said. "It doesn’t mean they’re safe.”

The National Institute of Standards and Technology has a library database of chemicals. In this database, Hudalla looks up studies related to these chemicals to find more information about them.

But the compounds he sees in some delta-8 products aren't in the database. “These are novel compounds that have never been seen before, never been studied before,” he said. To Hudalla, consuming delta-8 products on the market today is "analogous to walking down the street and seeing a tablet in the gutter and picking it up and putting it in your mouth.”

He hopes delta-8 will have more regulation in the future. After all, some research suggests it has therapeutic qualities, but he expects some bumps along the road. “As states react to the current situation with delta-8, they’re just banning it," he said. "So, it’ll become forbidden and that’s going to be at the detriment of consumers who could use those therapeutics.”

Texas mulled a delta-8 ban earlier this year, but it ultimately didn't happen. Kyle Boyer of the California cannabis firm KB Consultations said he shares similar concerns about the health risks of synthetic cannabinoids on the market today. Until people lock down a safe way to manufacture these products, Boyer thinks they shouldn't be on the market.

In the meantime, though, Sanders and others are trying to self-regulate and mitigate these health risks. Sanders helped form the U.S. Hemp Authority, a company that effectively acts as a self-regulating body for the industry and conducts yearly audits. If a product has a hemp authority seal on it, Sanders said, you know what you’re getting is legit.

Just as health officials and regulators catch up with this new market, manufacturers keep making new products. The latest rage is over something being called THCO-acetate, which is reportedly as much as three times more potent than delta-8 or delta-9. 
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Jacob Vaughn, a former Brookhaven College journalism student, has written for the Observer since 2018, first as clubs editor. More recently, he's been in the news section as a staff writer covering City Hall, the Dallas Police Department and whatever else editors throw his way.
Contact: Jacob Vaughn