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Delta-8 And -9 THC-X is a Schedule 1 Controlled Substance Says DEA…

All Blogs, Education, THC-X

Home » Education » Delta-8 And -9 THC-X is a Schedule 1 Controlled Substance Says DEA…

Delta-8 THC and Delta-9 THC-X are tetrahydrocannabinols that have similar chemical structures and pharmacological activities to those contained in the cannabis plant. Although the 2018 Farm Bill legalized hemp containing up to 0.3 percent delta-9 THC on a dry weight basis, the market for natural and synthetic cannabinoids has expanded in states across the country, and the legal status of these novel cannabinoids continues to be a topic of debate.

Advocates believe that ending national prohibition and enacting sensible regulations at the federal level is the only way to responsibly regulate psychoactive cannabinoids and protect public health and safety. Despite the growing popularity of THC-X, some cannabis advocacy groups have raised concerns about its safety profile. The patchwork of state and federal laws, regulations, and policies, as well as the DEA’s recent letter statement, create confusion and challenges for the industry to navigate.

2018 Farm Bill & Hemp Legality

Are Delta-8 and Delta-9 THC-X legal? According to the Drug Enforcement Administration (DEA), they do not fall under the definition of hemp and are considered illegal controlled substances. Delta-8 THC, which can be synthetically produced from CBD or occur in trace amounts naturally in the cannabis plant, has gained popularity and is the best-known novel cannabinoid. However, its legality is a point of debate as it can cause intoxicating effects.

Attorney Rod Kight inquired about the legal status of Delta-8 and Delta-9 THC-X, which are tetrahydrocannabinols having similar chemical structures and pharmacological activities to those contained in the cannabis plant, with the federal agency last year and followed up earlier this month. DEA’s response was that the two cannabinoids do not occur naturally in the cannabis plant and can only be obtained synthetically, and therefore do not meet the federal definition of legal hemp.

View the full DEA response to Kight – click here

In a blog Monday, Kight agreed with DEA’s view on this matter and expressed concern about the proliferation of THC acetate ester (THCO), a controlled substance under federal law. Although it can be made from cannabinoids from hemp, it is not naturally expressed by the hemp plant, and is a laboratory creation that does not occur in nature. Since the 2018 Farm Bill legalized hemp containing up to 0.3 percent delta-9 THC on a dry weight basis, the market for natural and synthetic cannabinoids has expanded in states across the country. However, the legal status of these novel cannabinoids continues to be a topic of debate.

Understanding the Law

Federal statute defines hemp as “any part of” the cannabis plant, including “all derivatives, extracts, [and] cannabinoids” that contains less than 0.3 percent delta-9 THC by weight. A federal appeals court ruled last year that delta-8 is not controlled because the Controlled Substances Act (CSA) only explicitly speaks to the natural delta-9 THC. However, with the latest response from DEA, it is clear that Delta-8 and Delta-9 THC-X are not legal hemp and are considered illegal controlled substances.

How are cannabinoids affected, like THC-X?

The recent emergence of THC-X, a potent cannabinoid, has raised concerns among both advocates and regulators. While delta-9 THC and delta-8 THC are naturally occurring cannabinoids, THC-X can only be produced synthetically, making it a federally prohibited substance. The regulatory patchwork surrounding these lesser-known cannabinoids has resulted in confusion for both consumers and businesses, highlighting the need for federal regulation.

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Advocates believe that ending national prohibition and enacting sensible regulations at the federal level is the only way to responsibly regulate psychoactive cannabinoids and protect public health and safety. However, the Food and Drug Administration (FDA) has yet to enact regulations for cannabis-derived products, leaving the massive industry without any clear guidance.

FDA Position on CBD & Hemp

Last month, the FDA announced that it would not be creating rules to allow the marketing of CBD as dietary supplements or food items, despite repeated calls for administrative action from lawmakers, advocates, and stakeholders. The agency has instead been focusing on developing cannabis-based drugs and gathering additional data to fill in gaps in evidence about the safety of cannabis-derived products.

Meanwhile, Rep. James Comer (R-KY), the newly seated chair of the House Oversight and Accountability Committee, is preparing to confront the FDA over their failure to enact regulations for hemp-derived products like CBD. This follows a letter sent by Reps. Morgan Griffith (R-VA) and Brett Guthrie (R-KY) to FDA Commissioner Robert Califf in September, demanding answers over the continued lack of regulations for CBD.

In addition, the FDA recently helped a state agency crackdown on a company selling delta-8 THC gummies that were linked to “serious adverse events.” Overall, the emerging field of cannabinoids, particularly synthetic ones like THC-X, highlights the need for clear federal regulations to ensure consumer safety and industry growth.

What is the Public Response?

Disclaimer: These statements have not been evaluated by the Food and Drug Administration

Despite the growing popularity of THC-X, some cannabis advocacy groups, such as NORML, have raised concerns about its safety profile. In a study published in the Journal of Medical Toxicology, researchers warned about the potential health risks of inhaling THC-X acetate, which shares structural similarities with Vitamin-E acetate, a substance found in unlicensed THC vape cartridges that has been linked to the outbreak of EVALI lung disease. Both substances produce ketene, a highly toxic lung irritant, when heated in a vape pen, and this may be the cause of EVALI.

Given these risks, industry experts like Aaron Smith, CEO of the National Cannabis Industry Association, stress the need for responsible regulation of all psychoactive cannabinoids, both natural and synthetic. He argues that lifting national prohibition, enacting sensible federal regulations, and allowing state cannabis laws to operate across the country would best serve the public health and safety.

While the legal status of THC-X and other novel hemp-derived cannabinoids remains unclear, Michelle Bodian, a partner at the law firm Vicente Sederberg, suggests that congressional action is needed to clarify the legal framework for the industry. She emphasizes that the patchwork of state and federal laws, regulations, and policies, as well as the DEA’s recent letter statement, create confusion and challenges for the industry to navigate.

Previous Local Regulations

Delta-8 THC has been in the news recently due to the various regulations and restrictions placed on its production and sale. In May 2021, New York banned the sale of delta-8 products, while Ohio and Michigan introduced new rules to govern the production and sale of these products. In November 2021, a Texas judge issued a temporary injunction that removed delta-8 from the state’s list of Schedule I substances.

In May 2022, the Food and Drug Administration (FDA) sent out warning letters to businesses selling delta-8 products, expressing concern about the growing popularity of these products and the claims being made about their efficacy in treating medical conditions. The FDA has also expressed concern about the safety of these products, particularly in terms of their potential side effects.

In the most recent delta-8 news, Connecticut Attorney General William Tong has announced that his office is suing five retailers selling cannabis without a license, specifically in relation to delta-8 THC. Tong has emphasized that in Connecticut, cannabis products cannot be sold by unlicensed retailers and must meet rigorous testing and packaging requirements. Any unlicensed Connecticut retailer selling delta-8 THC products that purport to contain high levels of THC is breaking the law and may be subject to both criminal and civil penalties.

Overall, the regulatory landscape for delta-8 products is complex and evolving rapidly. As more research is conducted on the safety and efficacy of these products, it is likely that additional regulations and restrictions will be put in place to protect public health and safety.

Why do THC-X laws matter?

According to Jody McGinness, the executive director of the Hemp Industries Association (HIA), this substance is not hemp, and early research has shown that vaping THCO might pose significant health risks to consumers. McGinness also drew a distinction between natural products that can be synthesized, such as delta-8, and a growing category of substances that can only be chemically manufactured, such as THC-B, THC-JD, THC-H and PHC. “None of those can ever be found in nature, meaning they aren’t hemp either,” he concluded.

The 2018 Farm Bill clearly “protects hemp, extracts and cannabinoids. But that doesn’t mean it protects substances that might resemble hemp or cannabis but were made entirely in a lab,” said U.S. Hemp Roundtable General Counsel Jonathan Miller. However, the real problem, according to Miller, lies at the state level, as states are convoluting these issues. For instance, he pointed to legislation in the Old Dominion, where two bills, including HH 2294, which passed the state House, would limit hemp products to 2 mg of THC per package. Similar bills are also pending in the state of Washington, which would restrict consumable hemp products to 1 mg of THC per unit and 3 mg per package.

Miller added that the “vast majority” of full-spectrum hemp products and many broad-spectrum products would exceed the threshold under the legislation pending in Virginia. This proliferation of intoxicating products like delta-8 THC has “really impaired our ability to fight for non-intoxicating hemp products at the local level and state level,” he added. “We would like to see these products strictly regulated and kept out of the hands of minors.”

Bottom line – is THC-X Legal?

The Question Remains – How long will THC-X be around?

THC-X, a synthetic compound that produces psychoactive effects similar to those of THC, is currently legal in the United States. However, its legal status may not be assured for long. Regulatory agencies such as the Drug Enforcement Administration (DEA) have expressed concern over the proliferation of synthetic cannabinoids, including THC-X, and may take steps to limit their availability or outright ban them. The legal status of THC-X remains a complex and evolving issue. While some states have sought to regulate THC-X and other synthetic cannabinoids, others have not yet taken action. As a result, consumers should be aware of the potential risks associated with these substances, as well as the legal status of THC-X in their particular state or locality.

As the regulatory landscape continues to shift, it’s important for individuals and businesses involved in the cannabis industry to stay informed and aware of any changes that may impact their operations. Whether you’re a producer, seller, or consumer of cannabis products, understanding the legal and regulatory environment is essential for success and compliance.

At the end of the day, the legal status of THC-X and other synthetic cannabinoids remains uncertain. As with any substance, it’s important to use caution and exercise good judgment when deciding whether to consume or produce these products. Stay informed, stay aware, and always prioritize safety and legality.

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BY Summitt Labs
on February 21, 2023
Summitt Labs is a Tampa, Florida-based collaboration of like-minded innovators for botanical research. Known for its top-grossing brands such as Kore Original, Hemplitude, and Happy Time High. Today, harnessing the passion for curating a unique solution for all communities.

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