Delta-8 cbd Delta-10, and other new unregulated products
The legalization of hemp-derived cannabinoids by the 2018 Farm Bill has created a yawning regulatory gap that is being avidly exploited by purveyors of sketchy vape products and high-potency edibles.
That’s the contention of a “white paper” report recently issued by the California Cannabis Industry Association (CCIA), a leading cannabis industry trade organization, which warned that the poorly written law inadvertently opened a “Pandora’s box” of unregulated intoxicating compounds that threaten public health. At issue are psychoactive cannabinoids other than cannabis-derived Delta-9 THC.
It was legalizing cannabidiol (CBD), a non-intoxicating compound with many salubrious properties, that lawmakers had in mind when they crafted the Farm Bill. But other intoxicating cannabinoids ostensibly derived from hemp — including Delta-8 THC and several potent synthetic THC analogs that don’t exist in nature — are being openly sold coast to coast without regulatory oversight, according to the white paper, which was written by CCIA vice president Tiffany Devitt.
DID THE NINTH CIRCUIT GET IT WRONG — OR DID CONGRESS?
Devitt warns that the loopholes in the 2018 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, 2022, 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.”
The decision added: “[T]he source of the product — not the method of manufacture — is the dispositive factor for ascertaining whether a product is synthetic.”
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 0.3% Delta-9 THC standard established as a maximum for legal hemp under the Farm Bill.
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.”
Devitt agrees with the Ninth Circuit panel 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 2018 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.”
HOW DID WE GET INTO THIS MESS?
Cannabis prohibition is codified by the 1970 Controlled Substances Act (CSA), a legislative travesty that defines “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 are mature stalks, fiber, sterilized seeds, and products made from the non-resinous parts of the plant.
THC and CBD are both sourced from cannabis resin; hence both compounds are deemed illegal by the CSA. By redefining “marihuana” as cannabis with more than 0.3 percent THC in any part of the plant, the Farm Bill legalized the cultivation of hemp for industrial purposes, as well as for CBD extraction, provided that the hemp crop does not exceed the 0.3 percent THC threshold (as is often the case).
But here’s the problem: the language in the 2018 Farm Bill applies the 0.3% standard to “all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not [emphasis added].”
Application of this standard to finished products provides both a loophole and strategy for packing an ingestible “hemp” product with a whopping dose of Delta-9 THC. “If one measures THC on a percentage basis, one need only make a larger or heavier product to come up with an intoxicating dose,” the CCIA white paper notes.
And we aren’t just talking about Delta-9 THC. 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 white paper names THC-P, THCjd, THC-H, THC-O, HHC, and Delta-10 THC, as well as Delta-8, as among the sketchy compounds that are proliferating in the unregulated “hemp” market. And many of these compounds are found in products tailored to appeal to underage consumers.
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