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FDA and CDC Issue Warnings on Delta-8 THC Products

By Leo Bear-McGuinness

Published: Sep 21, 2021   
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The US’s Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have issued warnings to consumers and retailers about the dangers of delta-8 THC products.

Jointly issued on September 14, 2021, the notices say that the popular derivative of THC comes with “serious health risks” and that those selling delta-8 products should provide information about the compound’s psychoactive qualities.

In its notice, the FDA restated that the authority has not evaluated or approved delta-8 THC for safe use. The agency also linked the compound to over 100 hospitalizations that have occurred from the start of this year.

In its release, the CDC warned that delta-8 products “may provide consumers with a false sense of safety,” given that many delta-8 products are labeled as hemp or CBD products, labels that consumers “may not associate with psychoactive ingredients.”

The rise of delta-8

Delta-8 THC has a slightly different molecular structure to its more famous relative, delta-9 THC (commonly known as THC), which has helped it partly evade many of the rules and restrictions that govern the sale THC in the US. Yet delta-8 can still induce highs comparable to its more prohibited cousin. Combined, these two factors have led to a delta-8 boom in the US over the past year or so.

But given the often clandestine way delta-8 is produced, many cannabis chemists and industry regulators are concerned that delta-8 products pose a health risk to consumers, especially minors.

“I live in a very small town, and I found delta-8 products in multiple stores that they say you have to be 21 to purchase. But I’ve also seen children buying them,” Christopher Hudalla, chief scientific officer at the cannabis testing company ProVerde Labs, recently told Analytical Cannabis.

“There’s no regulatory control. And so we know children are consuming these products without any indication about how safe they are. That’s hugely irresponsible in my opinion.”

These concerns have now been echoed by the recent notices from the FDA and CDC.

In its release, the FDA listed five facts and recommendations for delta-8 consumers:

  1. Delta-8 THC products have not been evaluated or approved by the FDA for safe use and may be marketed in ways that put the public health at risk.
  2. The FDA has received adverse event reports involving delta-8 THC-containing products.
  3. Delta-8 THC has psychoactive and intoxicating effects.
  4. Delta-8 THC products often involve use of potentially harmful chemicals to create the concentrations of delta-8 THC claimed in the marketplace.
  5. Delta-8 THC products should be kept out of the reach of children and pets.

Elaborating on its second point, the FDA revealed that national poison control centers across the US received 661 exposure cases relating to delta-8 THC products between January 2018 and July 31, 2021, 660 of which occurred this year. Of these 661 cases, around 39 percent involved pediatric patients under the age of 18. Around 18 percent of the 661 cases required hospitalizations, including children who required intensive care unit admission.

Adding to its fourth point, the federal agency detailed how some delta-8 manufacturers operate in “unsanitary settings,” which could lead the products to contain harmful contaminants.

Speaking to Analytical Cannabis this August, Chris Hudalla voiced similar concerns about the purity and safety of delta-8 products.

“What they’re selling on the market, there is some delta-8 in it,” he said. “Oftentimes, it’s high in delta-8; it might be 89 percent delta-8. But what nobody’s asking is what’s the other 11 percent? Is that other 11 percent toxic? And that’s where the problem is.”

The CDC and the clamp-down on delta-8

In its recent notice, the CDC made several recommendations to consumers, public health departments, healthcare providers, and delta-8 retailers.

“Consumers should be aware that products labeled as hemp or CBD may contain delta-8 THC, and that products containing delta-8 THC can result in psychoactive effects,” the government agency wrote.

Public health departments have also been recommended to release information to healthcare providers about the psychoactive qualities and the potential health implications of delta-8, while poison control centers have been issued a new code to better identify delta-8 exposures.

Retailers have been advised to report total THC content on product labeling, including ingredients like delta-8 THC that “may be synthetically produced to create a psychoactive effect.”

Healthcare providers were also urged to question patients about their use of CBD and delta-8 THC products.

To date, 17 US states have either heavily regulated, restricted, or prohibited the sale of delta-8. Four more states are currently reviewing the compound’s legality and Michigan plans to ban the products come October.

Despite this growing wall of prohibition, the majority of US states, including key cannabis regions like California, Nevada and Massachusetts, still don’t currently enforce any regulations on the popular THC variant. Naturally, then, sales of delta-8 products within these states continue to surge. In California, the THC compound has become the fastest-growing chemical on the hemp market for the last year or so, according to the data analytics company Hemp Benchmarks.


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