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FDA Makes First Formal Enforcement Action Concerning Delta-8 THC

The FDA issued its first set of warnings to companies over the allegedly illegal sale of products containing the popular cannabinoid delta-8 THC. Five warning letters were sent to companies that are marketing products with the intoxicating compound and making what the agency says are unsanctioned claims about their therapeutic potential. This marks the first formal enforcement action concerning delta-8 THC. Despite no formal research done to assess the dangers of delta-8, the FDA operates under the assumption that is a Class 1 substance, 

What Is Delta-8? 

While delta-9 THC is the most commonly known cannabinoid in marijuana, delta-8  is typically synthesized from legal, hemp-derived CBD. It’s sold in many states across the U.S. because of its purposefully murky legality. Both delta-9 THC and delta-8 THC produce a euphoric, fuzzy feeling, but Delta-8 causes a milder high. Often referred to as “marijuana-lite” or “diet weed,” delta-8 reduces other common side effects of THC like paranoia, anxiety, and drowsiness are also less potent.

Like most cannabis-related fields, there’s a huge lack of research on delta-8 and how it impacts overall health. Many informal reports exist about delta-8 being used alongside prescription medications to help with depression and substance abuse. Users say Delta-8 can also:

Calm nausea

Boost appetite

Ease pain relief

Boost mental health

Prevent vomiting during cancer treatments

However, experts say these benefits are mostly word of mouth. 

The FDA’s Stance

The so-called experts at the FDA have begun to regulate and penalize people for selling or marketing products with delta-8 THC. 

“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide,” FDA Principal Deputy Commissioner Janet Woodcock said in a press release. “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.”

“It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children,” says Woodcock. “We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”

They claim that they’re primarily concerned with product formulation variability and labeling. Furthermore, the proliferation of products that contain delta-8 THC marketed for therapeutic or medical uses is another concern for the Food and Drug Administration. According to the FDA, “selling unapproved products with unsubstantiated therapeutic claims is not only a violation of federal law but also can put consumers at risk, as these products have not been proven to be safe or effective.” 

The Consequences Of Unfounded Fears 

However, the FDA’s push to regulate and criminalize the sale of delta-8 comes, unsurprisingly, without plans to increase research or formally regulate its production and sale. The FDA has actually only approved four cannabis derivatives to date: three of these products are synthetic THC or similar to THC and are approved to treat nausea from cancer chemotherapy. The fourth product, Epidiolex, is made from highly purified CBD from cannabis. Delta-8 is not among these approved drugs. While the FDA has recently begun to push forward cannabis research initiatives, they remain overwhelmingly focused on regulating and enforcing the sale of cannabis and its byproducts. 

The path to proper cannabis research is still muddled, convoluted, and purposefully obtuse. Until recently, only one lab was permitted to conduct cannabis research in the United States: as of July 2021, over 41 applicants have applied to conduct cannabis research, but there is little forward movement as cannabis can still be considered a Class-1 substance. 

From 1970 until December of 2018, the definition of “marihuana” (as spelled in legal documents) included all types of Cannabis Sativa L., regardless of THC content. However, in December 2018, the Agriculture Improvement Act of 2018 (also known as the Farm Bill) removed hemp from controls under the CSA. It was this law that allowed delta-8 to be synthesized from hemp and CBD products, but due to its psychoactive properties, the FDA is pushing for its removal from shelves. 

The Anti-Cannabis Bias In Federal Regulatory Bodies

Their hypocrisy is incredibly evident to anyone who knows anything about plant-derived medicines and vitamins: thousands of supplements without FDA approval litter the shelves of shops across the country. Plants like Garcinia Cambodia are often advertised as weight loss pills, while St. John’s Wart is a popular, natural anti-depressant. Dietary supplements like the aforementioned have no FDA approval, yet are allowed to sit on shelves across America. Cannabis, on the other hand, has 4 approved medicinal uses and is still one of the most regulated substances in the country. 

Delta-8, despite having numerous word-of-mouth claims similar to other dietary supplements, is unjustly being targeted due to cannabis’ classification as a class 1 drug. The FDA is punishing sellers for doing something totally legal: it has been for over four years now. This recent decision to push back on delta-8 sales is disappointing, but not surprising. 

 


 

Their strict requirements for approval of plant-derived medicines like cannabis require researchers and manufacturers alike to jump through several hoops. The tight federal regulations have made receiving the appropriate licenses to research cannabis nearly impossible to achieve in a timely, efficient manner. Sellers of currently-legal delta-8 THC products should be cautioned that their advertising may land them in hot water. Unfortunately, we’re still not at a place where cannabis can be fully recognized for the wide breadth of benefits it provides. 

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