Industry peddles 'Pandora's box' of unregulated cannabinoids

Posted on November 22nd, 2022 by Bill Weinberg and tagged , , , , , , , , , .

Delta-8The legalization of hemp-derived cannabinoids by the 2018 Farm Bill has left a yawning regulatory gap that is being avidly exploited by purveyors of high-potency edibles and sketchy vape products.

That's the contention of a report just issued by the leading California cannabis trade group, warning that the law inadvertently opened a "Pandora's box" that poses threats to public health.

At issue are psychoactive cannabinoids other than Delta-9 THC — the only one that remains technically illegal. It was cannabidiol (CBD), non-psychoactive (or only subtly so) but with many salubrious properties, that lawmakers had in mind when they crafted the Farm Bill. But other, potently psychoactive cannabinoids — most prominently Delta-8 THC — are being openly sold coast to coast.

The manufacturers assert that these are legal if derived from "hemp" as opposed to (psychoactive) "cannabis." However, critics have questioned what the threshold for chemical processing should be beyond which the cannabinoid in question can no longer be said to have been "derived" from the hemp.

The new "white paper" — issued Oct. 19 by the  California Cannabis Industry Association and written by researcher and CCIA vice president Tiffany Devitt — dives into the dilemma and comes to some disturbing conclusions.

Revealingly entitled "Pandora's Box: The Dangers of a National, Unregulated, Hemp-Derived Intoxicating Cannabinoid Market," it states: "Rife with contaminants and chemical byproducts, many of these so-called hemp THC and THC-like products are sold online and in convenience stores, gas stations, and smoke shops without age-gates, testing standards, packaging and labeling requirements, marketing limitations, or even a proper understanding of their potential effects on consumers. It's a public health disaster."

Pandora and the Ninth Circuit panel 
Devitt warns that the loopholes in the Farm Bill were legitimized by a recent ruling of the US Ninth Circuit Court of Appeals in San Francisco, which has "unleashed a Wild West of intoxicants."

On May 19, a three-judge panel of the Ninth Circuit rejected arguments that Delta-8 products that are chemically synthesized from hemp-derived CBD fall outside the scope of the Farm Bill. In AK Futures LLC v. Boyd St. Distro, LLC, the panel upheld a Southern California district court's grant of a preliminary injunction in favor of AK Futures, a producer of vaping products, in a trademark infringement action against rival Boyd Street Distro. The Ninth Circuit rejected Boyd's contention that AK Futures could not hold a valid trademark for its products because federal law forbids possession and sale of Delta-8 THC.

Stated the decision: "Regardless of the wisdom of legalizing delta-8 THC products, this Court will not substitute its own policy judgment for that of Congress. If Boyd Street is correct, and Congress inadvertently created a loophole legalizing vaping products containing delta-8 THC, then it is for Congress to fix its mistake." 

It added: "[T]he source of the product — not the method of manufacture — is the dispositive factor for ascertaining whether a product is synthetic." 

In a statement after the ruling, the National Organization for the Reform of Marijuana Laws (NORML) noted that it has before expressed caution regarding the safety of commercially available Delta-8 products, "because neither the products nor their manufacturing processes are regulated. Lab analyses of unregulated delta-8 products have consistently found them to contain lower levels of the compound than advertised on the products' labels. Some products have also been found to possess heavy metal contaminants and unlabeled cutting agents."  

A brief review of some recent scholarly studies loans credence to these concerns. This October, a study by a team at the University of Missouri, "Delta-8 Tetrahydrocannabinol Product Impurities," found "several impurities in concentrations far beyond what is declared on certificates of analysis" for 10 popular Delta-8 THC products tested by nuclear magnetic resonance, mass spectrometry, and other methods.

Also in October, an article in the peer-reviewed journal Cannabis & Cannabinoid Research, soberingly entitled "The Dark Side of Cannabidiol," saw a link between the free-for-all atmosphere and cases of E-cigarette or Vaping Use-Associated Lung Injury (EVALI). It concluded: "Quality control is totally inadequate in the newly emerging Δ8-THC industry. American consumers are ingesting products that are mislabeled with many compounds that have never received any toxicological testing. EVALI cases continue to be reported with a fatality rate approaching 2% (in California)."

In July, a study in Chemical Research in Toxicology journal, "Vaping Cannabinoid Acetates Leads to Ketene Formation," vindicated suspicions that a Vitamin E acetate or Delta-8 THC acetate with a similar structure is linked to vaping-related illness. The study specifically found that it can "form the poison gas ketene during vaping." 

A January 2022 study in the same journal was entitled "Novel Δ8-Tetrahydrocannabinol Vaporizers Contain Unlabeled Adulterants, Unintended Byproducts of Chemical Synthesis, and Heavy Metals." The name rather speaks for itself.

And a recent study published by PLOS One, entitled "The inverse association of state cannabis vaping prevalence with the e-cigarette or vaping product-use associated lung injury," found that the vaping crisis was worse in states without legal cannabis use. This speaks to the reality that safety issues are worse where legal cannabis isn't available and intoxicating hemp products are prevalent.

Did the Ninth get it wrong —or did Congress?
In her white paper, Devitt suggests that the Ninth Circuit erred, stating that the ruling is "at odds with other federal statutes such as the Federal Analogue Act, which explicitly prohibits THC analogs. Approval of novel cannabinoids...rightfully falls under the purview of the US Food and Drug Administration."

And the FDA is exercising no such authority here. 

The Ninth Circuit also found that  "the only statutory metric for distinguishing controlled marijuana from legal hemp is the delta-9 THC concentration level." That's a reference to the famous 0.3% Delta-9 THC standard established as a maximum for legal hemp under the Farm Bill.

Here Devitt agrees with the ruling that further Congressional action is mandated. She writes: "All plants grown for cannabinoid content should be subject to a similar set of regulations rather than an arbitrary, unworkable THC threshold. Absent a single federally regulated cannabinoid market that oversees both hemp and cannabis, the Farm Bill urgently needs to be amended to close the loophole allowing the unregulated sale of concentrated, intoxicating, and/or synthesized cannabinoids." 

Devitt adds: "The ultimate solution is a single, federally regulatory framework that oversees both hemp- and cannabis-derived cannabinoid products for human consumption." 

Sativa semantics
Devitt's report provides some clarity on the semantic dilemma that bedevils the very terms for the discussion.

"Cannabis and hemp have a long and storied history that is, by nature, intertwined and somewhat confusing," she writes. "The bottom line is that they are the same plant species, known as Cannabis Sativa L. Historically, hemp has referred to low-resin Cannabis Sativa L that's bred for maximum fiber or seed oil content and grown for industrial purposes. Cannabis has referred to plants bred and grown for maximum resin content — in other words 'drug' plants high in naturally occurring THC and other cannabinoids consumed for recreational and medicinal purposes." 

The Controlled Substances Act of 1970 first codified what had theretofore been a "colloquial distinction," defining what is today popularly called "cannabis" (referenced in the law as "marihuana") as "all parts of the plant Cannabis sativa L" as well as "the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin." Excluded from the definition were mature stalks, fiber, sterilized seeds, and products made from the non-resinous parts of the plant — generally considered to be "hemp" products.

The 2018 Farm Bill further formalized the distinction, officially defining legal hemp as having no more than 0.3% Delta-9 THC by dry weight — regardless of its overall resin content, which was seemingly not taken into consideration. So "hemp" rich in cannabinoid-laden resins is now being cultivated "for drug rather than industrial purposes," in Devitt's words.

And it isn't just CDB, as lawmakers had certainly intended: "Many of today's 'hemp' products, which are sold online, in convenience stores, and in smoke shops and gas stations, are as intoxicating as regulated cannabis products, if not more so."

Sativa and subterfuge

Worse, the Farm Bill applies the 0.3% standard to "all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not."

Application of the standard to finished products provides an obvious strategy for packing an ingestible even with a whopping dose of "illegal" Delta-9: "If one measures THC on a percentage basis, one need only make a larger or heavier product to come up with an intoxicating dose."

But we aren't just talking about Delta-9. Manufacturers "are producing compounds not native to the plant – or not present in meaningful quantities – by extracting and concentrating CBD and then modifying it to produce new synthetic and semi-synthetic cannabinoids. Typically, this process involves the use of toxic and corrosive solvents and heavy metal catalysts, remnants of which can sometimes be found in the final product. The result is novel compounds that are often many times stronger than traditional THC."

The report names THC-P, THCjd, THC-H, THC-O, HHC, and Delta-10 THC as well as Delta-8.

One buzzkill study that appeared on Project CBD in 2019 is cited by Devitt, noting that "synthetic cannabinoids (sCB) have been reported to cause various health problems and are potentially deadly. Diffuse alveolar hemorrhage, acute respiratory failure, heart attack, stroke, seizures, and kidney damage are all possible consequences of sCB use."

Not for kids, thank you
These products fall between two chairs, so to speak — neither non-psychoactive "hemp" nor regulated "cannabis." This allows such abuses as mislabeling — and "brazen marketing to children."

Regulated "cannabis" companies in California and elsewhere are subject to THC potency caps, rigorous testing standards, stringent labeling requirements, child-resistant packaging, advertising restrictions — and age limits for sales. Marketing products in a way intended to appeal to children is verboten. In contrast, "hemp" products need not abide by any such restrictions.

This question is thrown into a harsh light by the case of Virginia mother Dorothy Annette Clements, who faces felony murder and child neglect charges after her four-year-old died — apparently from ingesting a large quantity of Delta-8 THC gummies. According to the Associated Press on Oct. 24, medical authorities in Spotsylvania County found that the cause of death was "delta-8-tetrahydrocannabinol toxicity."

Whatever the facts of this grim case may be, the danger is clearly real. Nor is this an isolated incident. Minnesota regulators recently filed a lawsuit against three companies involved in the manufacture and sale of hemp THC infused edibles, claiming that the products sickened five teenagers.

Cannabis & Cannabinoid Research in November ran a study entitled "Delta-8 THC Retail Availability, Price, and Minimum Purchase Age," which noted: "After thousands of calls to poison control centers (40% for individuals under 18 years old and 70% requiring health care facility evaluation), the Food and Drug Administration issued warnings on Delta-8 THC products, stating their psychoactive effects and that some manufacturers may synthesize Delta-8 using unsafe household chemicals." The referenced FDA warning was issued this May.
Toward a solution
In the absence of regulatory authority from the FDA, some states have issued rules barring chemically synthesized cannabinoids from their internal markets. These include California, Colorado and Vermont. Under California Assembly Bill 45 of 2021, any psychoactive cannabinoids, whether extracted or synthetic, are prohibited in all hemp products. However, Devitt finds enforcement to be "woefully lacking."

Ultimately, action needs to be taken at the national level. Devitt states: "[T]he Farm Bill urgently needs to be amended to close the loophole being exploited to sell intoxicating and/or synthesized cannabinoids outside of regulated markets... The FDA must exercise its authority to approve or disapprove of novel or synthesized cannabinoids not found in the plant in commercial quantities. These are new compounds and safety testing is necessary."

But until that happens, it is up to the states to lead the way. Devitt concludes: "Given the lack of federal leadership on cannabis policy, California has an opportunity to set an example for other states by crafting and implementing a coherent regulatory framework that encompasses all plants grown for cannabinoid content rather than industrial purposes. Now is the time to do that."

Cross-post to Project CBD

of THC molecule via Boston Hempire


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