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.<\/p>\n
That\u2019s the contention of a \u201cwhite paper\u201d report recently issued by the California Cannabis Industry Association (CCIA<\/span>), a leading cannabis industry trade organization, which warned that the poorly written law inadvertently opened a \u201cPandora\u2019s box\u201d of unregulated intoxicating compounds that threaten public health. At issue are psychoactive cannabinoids other than cannabis-derived Delta-9 THC<\/span>.<\/p>\n It was legalizing cannabidiol (CBD<\/span>), 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 \u2014 including Delta-8 THC<\/span> and several potent synthetic THC<\/span> analogs that don\u2019t exist in nature \u2014 are being openly sold coast to coast without regulatory oversight, according to the white paper, which was written by CCIA<\/span> vice president Tiffany Devitt.<\/p>\n Entitled \u201cPandora\u2019s Box: The Dangers of a National, Unregulated, Hemp-Derived Intoxicating Cannabinoid Market,\u201d it states: \u201cRife with contaminants and chemical byproducts, many of these so-called hemp THC<\/span> and THC<\/span>-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\u2019s a public health disaster.\u201d<\/p>\n Devitt warns that the loopholes in the 2018 Farm Bill were legitimized by a recent ruling of the US<\/span> Ninth Circuit Court of Appeals in San Francisco, which has \u201cunleashed a Wild West of intoxicants.\u201d<\/p>\n 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<\/span> fall outside the scope of the Farm Bill. In AK<\/span> Futures LLC<\/span> v. Boyd St. Distro, LLC<\/span>, the panel upheld a Southern California district court\u2019s grant of a preliminary injunction in favor of AK<\/span> Futures, a producer of vaping products, in a trademark infringement action against rival Boyd Street Distro. The Ninth Circuit rejected Boyd\u2019s contention that AK<\/span> Futures could not hold a valid trademark for its products because federal law forbids possession and sale of Delta-8 THC<\/span>.<\/p>\n Stated the decision: \u201cRegardless of the wisdom of legalizing delta-8 THC<\/span> 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<\/span>, then it is for Congress to fix its mistake.\u201d<\/p>\n The decision added: \u201c[T]he source of the product \u2014 not the method of manufacture \u2014 is the dispositive factor for ascertaining whether a product is synthetic.\u201d<\/p>\n The Ninth Circuit also found that \u201cthe only statutory metric for distinguishing controlled marijuana from legal hemp is the delta-9 THC<\/span> concentration level.\u201d That\u2019s a reference to the 0.3% Delta-9 THC<\/span> standard established as a maximum for legal hemp under the Farm Bill.<\/p>\n In her white paper, Devitt suggests that the Ninth Circuit erred, stating that the ruling is \u201cat odds with other federal statutes such as the Federal Analogue Act, which explicitly prohibits THC<\/span> analogs. Approval of novel cannabinoids \u2026 rightfully falls under the purview of the US<\/span> Food and Drug Administration.\u201d<\/p>\n Devitt agrees with the Ninth Circuit panel that further Congressional action is mandated. She writes: \u201cAll plants grown for cannabinoid content should be subject to a similar set of regulations rather than an arbitrary, unworkable THC<\/span> 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.\u201d<\/p>\n Devitt adds: \u201cThe ultimate solution is a single, federally regulatory framework that oversees both hemp- and cannabis-derived cannabinoid products for human consumption.\u201d<\/p>\n Several peer-reviewed studies and cannabis industry scientists lend credence to the concerns expressed in the CCIA<\/span> white paper. A few examples:<\/p>\n An October 2022 report by University of Missouri researchers found \u201cseveral impurities in concentrations far beyond what is declared on certificates of analysis\u201d for ten popular Delta-8 THC<\/span> products. \u201cI cannot imagine another legitimate industry that would be permitted to operate with such irresponsibility.\u201d<\/p>\n \u201cI continue to be disappointed and dismayed by the lack of concern for the distribution of contaminated synthetic cannabis derivatives into the consumer market,\u201d Christopher Hudalla, founder of Proverde Labs, told The Cannabis Scientist. \u201cAfter testing thousands of products based on synthetic isomerizartion processes, 100 percent of the samples we have tested contained significant amounts of residual synthetic reagents and\/or synthetic byproducts, most of which do not exist in nature and, as such, have no demonstrated safety profile.\u201d<\/p>\n To make matters worse, according to Hudalla: \u201cMost analytical laboratories that are providing testing for these products are ignoring the presence of these unknown compounds and do not report their presence on the resulting Certificates of Analysis\u2026 Instead these contaminated products continue to be distributed without oversight, putting consumer\u2019s health and safety at risk \u2026 all for the sake of maximizing profits. I cannot imagine another legitimate industry that would be permitted to operate with such irresponsibility.\u201d<\/p>\n Cannabis prohibition is codified by the 1970 Controlled Substances Act (CSA<\/span>), a legislative travesty that defines \u201cmarihuana\u201d as \u201call parts of the plant Cannabis sativa L\u201d as well as \u201cthe resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.\u201d Excluded from the definition are mature stalks, fiber, sterilized seeds, and products made from the non-resinous parts of the plant.<\/p>\n THC<\/span> and CBD<\/span> are both sourced from cannabis resin; hence both compounds are deemed illegal by the CSA<\/span>. By redefining \u201cmarihuana\u201d as cannabis with more than 0.3 percent THC<\/span> in any part of the plant, the Farm Bill legalized the cultivation of hemp for industrial purposes, as well as for CBD<\/span> extraction, provided that the hemp crop does not exceed the 0.3 percent THC<\/span> threshold (as is often the case).<\/p>\n But here\u2019s the problem: the language in the 2018 Farm Bill applies the 0.3% standard to \u201call derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not [emphasis added].\u201d<\/p>\n Application of this standard to finished products provides both a loophole and strategy for packing an ingestible \u201chemp\u201d product with a whopping dose of Delta-9 THC<\/span>. \u201cIf one measures THC<\/span> on a percentage basis, one need only make a larger or heavier product to come up with an intoxicating dose,\u201d the CCIA<\/span> white paper notes.<\/p>\n And we aren\u2019t just talking about Delta-9 THC<\/span>. Manufacturers \u201care producing compounds not native to the plant \u2013 or not present in meaningful quantities \u2013 by extracting and concentrating CBD<\/span> 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<\/span>.\u201d<\/p>\n The white paper names THC<\/span>-P, THC<\/span>jd, THC<\/span>-H, THC<\/span>-O, HHC<\/span>, and Delta-10 THC<\/span>, as well as Delta-8, as among the sketchy compounds that are proliferating in the unregulated \u201chemp\u201d market. And many of these compounds are found in products tailored to appeal to underage consumers.<\/p>\n From the website: \u201ca solid\u2026high with only half of a cookie\u2026\u201d<\/p>\n<\/div>\n Such products fall between two chairs, so to speak \u2014 neither non-psychoactive \u201chemp\u201d nor regulated \u201ccannabis.\u201d This allows such abuses as mislabeling \u2014 and \u201cbrazen marketing to children.\u201d<\/p>\n Regulated \u201ccannabis\u201d companies in California and elsewhere are subject to THC<\/span> potency caps, rigorous testing standards, stringent labeling requirements, child-resistant packaging, advertising restrictions \u2014 and age limits for sales. Marketing products in a way intended to appeal to children is strictly verboten. In contrast, \u201chemp\u201d products need not abide by any such restrictions.<\/p>\n This issue was 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 \u2014 apparently from ingesting a large quantity of Delta-8 THC<\/span> infused gummies. According to the Associated Press (Oct. 24, 2022), medical authorities in Spotsylvania County found that the cause of death was \u201cdelta-8-tetrahydrocannabinol toxicity\u201d \u2013 or more likely from lethal contaminants in the gummies.<\/p>\n 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 \u2013 Northland Vapor Moorhead, LLC<\/span>, Northland Vapor Bemidji, LLC<\/span>, and Wonky Confections, LLC<\/span> \u2013 involved in the manufacture and sale of hemp THC<\/span> infused edibles, claiming that the products sickened five teenagers in Iowa.<\/p>\n In November 2022, Cannabis &<\/span> Cannabinoid Research published a study, \u201cDelta-8 THC<\/span> Retail Availability, Price, and Minimum Purchase Age,\u201d which noted: \u201cAfter 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<\/span> products, stating their psychoactive effects and that some manufacturers may synthesize Delta-8 using unsafe household chemicals.\u201d<\/p>\n In the absence of regulatory authority from the FDA<\/span>, several 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, intoxicating cannabinoids, whether extracted or synthetic, are prohibited in all hemp products. However, Devitt finds enforcement to be \u201cwoefully lacking\u201d in the Golden State.<\/p>\n \u201cThe ultimate solution is a single, federally regulatory framework that oversees both hemp- and cannabis-derived cannabinoid products for human consumption.\u201d<\/p>\n And \u201cthe sale of psychotropic, hemp-derived cannabis products remains legal in 29 states and in Washington, DC<\/span>, and online sales may render state regulations ineffective,\u201d the Journal of the American Medical Association asserted in an alarming report (Nov. 4, 2022), \u201cClosing the Loophole on Hemp-Derived Cannabis Products: A Public Health Priority,\u201d that validated the conclusions of the CCIA<\/span> white paper.<\/p>\n Ultimately, action needs to be taken at the national level. Devitt states: \u201c[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 \u2026 The FDA<\/span> 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.\u201d<\/p>\n But until that happens, it is up to the states to lead the way. Devitt concludes: \u201cGiven 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.\u201d<\/p>\n Read White Paper<\/p>\n Bill Weinberg, a Project CBD<\/span> contributing writer, is a 30-year veteran journalist in the fields of drug policy, ecology and indigenous peoples. He is a former news editor at High Times magazine, and he produces the websites CounterVortex.org and Global Ganja Report. Copyright, Project CBD<\/span>. May not be reprinted without permission.<\/p>\n \u00a0<\/p>\n<\/div>\nDid the Ninth Circuit Get It Wrong \u2014 Or Did Congress?<\/h2>\n
Safety Concerns<\/h2>\n
\nAlso in October 2022, the journal Cannabis &<\/span> Cannabinoid Research published a report entitled \u201cThe Dark Side of Cannabidiol,\u201d which saw a link between the free-for-all atmosphere and cases of E-cigarette or Vaping Use-Associated Lung Injury (EVALI<\/span>). It concluded: \u201cQuality control is totally inadequate in the newly emerging \u03948<\/span>–THC<\/span> industry. American consumers are ingesting products that are mislabeled with many compounds that have never received any toxicological testing. EVALI<\/span> cases continue to be reported with a fatality rate approaching 2% (in California).\u201d
\nA recent study published by PL<\/span>oS One, entitled \u201cThe inverse association of state cannabis vaping prevalence with the e-cigarette or vaping product-use associated lung injury,\u201d found that the vaping crisis was worse in states without legal cannabis use. This speaks to the fact that safety issues are worse where legal cannabis isn\u2019t available and intoxicating hemp products are prevalent.
\nAnd a January 2022 study in Chemical Research in Toxicology, published by the American Chemical Society, was entitled \u201cNovel \u03948<\/span>-Tetrahydrocannabinol Vaporizers Contain Unlabeled Adulterants, Unintended Byproducts of Chemical Synthesis, and Heavy Metals.\u201d The title speaks for itself.<\/p>\nHow Did We Get into This Mess?<\/h2>\n
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<\/div>\nNot for Kids, Thank You<\/h2>\n
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<\/p>\nToward a Solution<\/h2>\n
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