DEA Interim Final Rules Breakdown
Until August 21, 2020, Delta-8 Tetrahydrocannabinol (Delta-8 THC) was enjoying life in a precious (though precarious) legal grey area: unless an express prohibition against it existed at the state level, it was permitted in cannabis products. As such, the common cannabinoid has continued to be a part of nearly all cannabis supply chains. As of today, however, the vast majority of Delta-8 is illegal in the United States.
On the August 21, 2020, the DEA ( Drug Enforcement Agency) released their interim rules regarding Delta-8 THC and Work In Progress Hemp Extracts (WIPHE) as defined in the Agricultural Improvement Act of 2018 (2018 Farm Bill), and coinciding with the Controlled Substances Act (CSA). This effectively outlaws any product containing more than 0.3% THC, regardless of stage of production or intended use (full rules can be found here). While the industry continues to work tirelessly to ensure that patient/consumer-ready finished products meet this standard, the entire supply chain (to the point of retail-ready product) remains dependent on the ability to deal in “hot” (north of 0.3% THC) product.
While the newly announced rules are deemed temporary, with public comments accepted through close of business, October 20, 2020, many view this as a last-ditch attempt by the DEA to maintain control over a failed war on drugs. What is clear is that should these directives stand, it would impose grievous harm on the medical and therapeutic arms of the hemp industry, with effects felt across the country.
In many respects, the DEA has left itself in an untenable position, both scientifically and legally. The interim directives state: “The purpose of this interim final rule is to codify in the Drug Enforcement Administration (DEA) regulations the statutory amendments to the Controlled Substances Act (CSA) made by the Agriculture Improvement Act of 2018 (AIA), regarding the scope of regulatory controls over marihuana, tetrahydrocannabinols, and other marihuana-related constituents.” The new rules continue to say, “This interim final rule merely conforms DEA’s regulations to the statutory amendments to the CSA that have already taken effect, and it does not add additional requirements to the regulations”, however, the contents and effect of these rules do not align with this summation.
To better understand the new rules (and the contested issues), we’ve broken it down into bite-sized pieces through an examination of what WHIPE (Work In Progress Hemp Extract) means to the industry and patients/consumers.
The (Critical) Significance of WIPHE
The DEA position is as follows:
“[T]he definition of hemp does not automatically exempt any product derived from a hemp plant, regardless of the D9 -THC content of the derivative. In order to meet the definition of “hemp,” and thus qualify for the exemption from schedule I, the derivative must not exceed the 0.3% D9 -THC limit. The definition of “marihuana” continues to state that “all parts of the plant Cannabis sativa L.,” and “every compound, manufacture, salt, derivative, mixture, or preparation of such plant,” are schedule I controlled substances unless they meet the definition of “hemp” (by falling below the 0.3% D9 -THC limit on a dry weight basis) or are from exempt parts of the plant (such as mature stalks or non-germinating seeds). See 21 U.S.C. 802(16) (emphasis added). As a result, a cannabis derivative, extract, or product that exceeds the 0.3% D9 -THC limit is a schedule I controlled substance, even if the plant from which it was derived contained 0.3% or less D9 -THC on a dry weight basis.”
Dissection:
In polling our team, there are a few important takeaways worth unpacking here: (1) The legal pretense for this ruling is completely flawed, (2) the DEA position on this issue is effectively a “Who Killed The Electric Car?” moment for hemp, and (3), the presentation of the agency’s position is either carelessly or intentionally racist. While these “nuclear event” and racially charged issues are significant, the focus of this examination is on the question of the legality of the agency’s ruling (over the next week, we’ll unpack the issue of race and game-over for hemp in additional posts from our advocacy team).
Regarding the legal aspects of the conversation, the position, on its face, seems reasonable, unless you understand that WIPHE is a necessary state for nearly every consumer-ready product on the market. The bottom line is that making ‘hot’ WIPHE illegal will have devastating effects on the industry (any product that isn’t smokable flower or an industrial commodity (like fiber) is therein beholden.
The 2018 Farm Bill defines legally grown hemp as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
This guidance is fairly straightforward, though the harm is hidden in the language. The first worthwhile consideration is that both the 2018 Farm Bill, and its predecessor in 2014, show that extracts, isomers, acids, and salts are all expected products that should be covered under the legal definition of “Hemp.” This further shows that congress would have considered WIPHE as a part of this bill, as there is no way to go from dry weight products to any form of patient/consumer-ready SKU without passing through a “wet” stage. Even industrial practices like decortication and fiber production include a separation process that could lead to “hot” readings.
Under the DEA’s August 21 interim rules, it is entirely likely that a wholly industrial hemp farm, growing and processing for fiber, runs a significant risk of handling a controlled substance. When separating the parts of the plant into SSS (Stalks, Stems, & Seeds) and the more trichome rich flowers or buds, an operator will always have non-SSS materials with raised THC levels. When considering CBD production through botanical extraction (whether for full spectrum or Advanced Pharmaceutical Ingredients (APIs)), there is nearly no way to avoid producing at least one WIPHE or waste material with THC levels in excess of the 0.3% THC limit. So, if the industry is barred from handling or possessing these materials, what is it left with? The rules are akin to preventing the gasoline industry from ever coming into contact with crude oil at any point in the refining process.
With both extracts and individual cannabinoids considered clearly legal under the 2018 Farm Bill, it’s only reasonable to assume the unavoidable stages surrounding their creation were both considered and deemed legal. This long-arm reach into previously-regulated FDA territory via the DEA interim rule is a significant departmental overreach, though the stretch doesn’t stop there.
The Interim Rule also appears to be a direct violation of the intent of the 2018 Farm Bill. The idea of the Farm Bill was to differentiate between Cannabis Sativa as either “hemp” or “marihuana” (Their spelling , not ours) . This can be evidenced by the obvious legalization standards of the bill, and the less obvious prevention of allowing sales of products that don’t fall under the 0.3% THC limit, which when combined show a clear set of findings:
1: Congress intended for hemp extracts under 0.3% THC to be legal
2: Congress intended for the farm bill to prevent the sale of extracts over .3% THC
3: Congress must have contemplated WIPHE as a means to reconcile this disparity
* WIPHE Must be legal while in a dynamic state to allow the legal end product to be produced from the legal source product
4: The DEA ruling against WIPHE is in clear violation of the intent of the 2018 Farm Bill
Conclusion
In conclusion, it should be evident that the current IFR from the DEA does not stand on its own merits. It’s inconsistent and contradictory, putting it in direct opposition to the current (necessary, and presently unavoidable) operating state of the industry as regulated by the USDA and FDA.
At Vanguard Scientific, we are dedicated to raising our voices regarding safe and legal access to all forms of efficacious plant medicine. We invite you to join us in voicing industry concerns by submitting comments to the DEA, opposing their current rules which are harmful for the industry and are in direct violation of the law.