On October 27, 2020, I sat down with Josh Swider, CEO of Infinite Chemical Analysis Lab, one of the nation’s most trusted licensed testing companies, to discuss the DEA’s latest assault on the nation’s Hemp industry and to explain the new interim rule.

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AUTHOR: Heather Allman

PUBLISHER: CANNABIS LAW REPORT

The Drug Enforcement Agency (DEA) has released a new rule that hemp will be considered a Schedule 1 drug if at any point during the THC threshold exceeds 0.3%. 

This unexpected decision has infuriated the hemp industry, with many players joining forces to file a petition against the DEA in the U.S. Court of Appeals.

 

Interim Interference: Hemp Industry Expert and CEO Josh Swider of InfiniteCAL Discusses DEA’s Interim Rule

CONTEXT

The Hemp Industry Responds to the DEA Rule With a Lawsuit 

Nathalie Bougenies, September 28, 2020:

On August 21, the Drug Enforcement Agency (the “DEA”) released an Interim Final Rule (the “Rule”), which, in part, suggests that in-process hemp extract shall be treated as a schedule I controlled substance during any point at which its THC concentration exceeds 0.3 percent on a dry weight basis. 

“Any point” includes even fleetingly during the processing phase and includes situations where the THC percentage is brought back into legal compliance for the finished product.

In response to this threat, close to 2,500 hemp stakeholders have already expressed their opposition to the Rule by submitting comments via the federal public docket. But some have taken their opposition one step further by suing the DEA. 

On Friday, September 18, the Hemp Industries Association (“HIA”) and RE Botanicals, a South Carolina hemp CBD manufacturer, filed a petition against the DEA and its acting administrator, Timothy Shea, in the U.S. Court of Appeals for the District of Columbia.

The petitioners claim that the Rule is unlawful because it exceeds the DEA’s authority and violates the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”). 

Specifically, the Rule contradicts the plain language and the intent of the 2018 Farm Bill, which legalized hemp, its derivatives, extracts and cannabinoids so they could be regulated as agricultural commodities, and thus, fall outside the DEA’s jurisdiction.

In addition, HIA and RE Botanicals argue that the DEA failed to issue the Rule in compliance with administrative procedures imposed under the Administrative Procedure Act (the “APA”). Indeed, Mr. Shea implemented the Rule without providing the public with notice and the opportunity to comment before the Rule went into effect.

Instead, the Rule provides that its content “merely conforms DEA’s regulations to the statutory amendments to the [Controlled Substances Act] that have already taken effect, and it does not add additional requirements to the regulations.” (Emphasis added).

While the Rule clearly suggests that the DEA is exceeding its authority and is attempting an illegal power grab over lawful hemp activities, only time will tell whether the U.S. Court of Appeals for the District of Columbia will be receptive to the petitioners’ arguments. 

Yet, one thing is certain, the hemp industry is determined to protect the lawful production of hemp that Congress established when it enacted the 2018 Farm Bill.”

SEC. 297A. DEFINITIONS.

“In this subtitle:

“(1) HEMP.—The term ‘hemp’ means 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

 

On October 27, 2020, I sat down with Josh Swider, CEO of Infinite Chemical Analysis Lab, one of the nation’s most trusted licensed testing companies, to discuss the DEA’s latest assault on the nation’s Hemp industry and to explain the new interim rule.

Cannabis Law Report: As if talking to an educated, discerning hemp brand or business owner, explain the basics of the newly released rule.

Josh Swider: The DEA’s interim final rule would classify hemp and hemp products as a schedule I controlled substance if the total Tetrahydrocannabinols level exceeds 0.3% at any time during the grow,  production process. or final products.

This means if a hemp plant passes the  tetrahydrocannabinols level prior to production during the manufacturing process and the tetrahydrocannabinols concentration exceeds 0.3% limit that material would be classified as a schedule I controlled substance.

The interim rule also expands on the definition of tetrahydrocannabinols to include all derivatives of tetrahydrocannabinols found in the plant, extracts and their isomers with similar chemical structure.

They specifically name 1 cis or trans tetrahydrocannabinol, and their optical isomers 6 cis or trans tetrahydrocannabinol, and their optical isomers 3, 4 cis or trans tetrahydrocannabinol, and its optical isomers which are d9, d8, and d10-THC. 

These are definitions by the World Health Organization published by the World Health Organization Committee on Drug Dependence. 

CLR: What does this new rule say and what does it mean for the national hemp program and hemp brands, namely the general areas of the rules that you feel will prove to be most helpful to readers. 

Josh Swider: This new rule would deem CBD production illegal if at all during the production process tetrahydrocannabinols levels exceed 0.3%, even if the finished product is in compliance with the regulations laid out in the 2018 Farm Bill. 

CLR: Speak to the unrealistic nature of this policy and the variance in THC between raw hemp and the final manufactured products. 

Josh Swider: This policy completely disregards the chemical nature of the plant and fails to recognize the steps a producer must take to create high purity CBD products. Most hemp brands we’ve worked with, they are striving to create products with non-detect levels of tetrahydrocannabinols.

Typically, after the biomass extraction the tetrahydrocannabinols are above 0.3%, but the final product such as a lotion or a cream will have less than 0.3% tetrahydrocannabinols.

Furthermore, if a producer wants to make high potency CBD isolate from hemp biomass, they’ll need to extract and concentrate the cannabinoid through distillation and crystallization.

When you concentrate one cannabinoid, you’ll further concentrate the others as well. For example, if the goal is 10x concentration of CBD, then THC level will be 10x concentrated as well. This raw concentrate will not leave the premises as is, though.

Further processing allows a producer to isolate the CBD and dispose of the THC and other cannabinoids, leaving the final product with little to no THC. Unfortunately, this new ruling would make the process to get there illegal. If anything, the DEA should be more concerned with the proper disposal and destruction of THC-containing waste, since it is an inevitable byproduct of the manufacturing process that is meant to produce THC-free goods.

CLR: Discuss specific obstacles currently being faced by your organization or brand, noting how the new rules will specifically hinder current/ongoing progress in the hemp program? 

Josh Swider: The California Department of Food and Agriculture (CDFA), which oversees the state’s hemp cultivators, does take into account the conversion of THCA in delta-9-THC (total THC) when testing raw hemp material prior to harvest.

So luckily, this new rule will not affect CBD production as they will already know the peak Total THC concentration after decarboxylation. 

CLR: In light of this new DEA rule, what is one key element or overarching plan to maintain existing high caliber hemp brands, businesses, and ancillary services?

Josh Swider: From here on out, every hemp cultivator should be testing their raw material for Total THC, not just delta-9-THC. Crops will have to be harvested earlier, with a smaller return and less CBD to work with, but it will be necessary to avoid DEA involvement. 

Cultivators and manufacturers will have to look for specific plant genetics that have low ratios of tetrahydrocannabinols if they plan to extract and stay within the 0.3% threshold. Even trace amounts of tetrahydrocannabinols in hemp biomass can be concentrated above the legal limit during extraction that would make the entire process illegal.

You can’t make CBD isolate to infuse CBD products without the risk of concentrating tetrahydrocannabinols as well. Of course, we hope the DEA recognizes the contradictory nature of their ruling and overturns it.

CLR: What responsibility does your company or organization feel to clients, etc., concerning these new hemp rules? 

Josh Swider: As an analytical quality and safety testing lab, we are responsible to help our clients understand and stay within regulations to the best of our ability.

We’ve always tested total THC (d9-THC and THCa) as opposed to solely delta-9-THC, so hopefully our hemp clients will have a better understanding of where they’ll stand during production in regards to this new rule. 

Our lab has the responsibility to keep our clients in compliance. The DEA needs to provide a specific formula for calculating total tetrahydrocannabinols.

There’s a plethora of tetrahydrocannabinols including, but not limited to THCa, d9-THC, d8-THC, d10-THC, THCV, THCP; how long of a list do we need to compile to give the true tetrahydrocannabinols value?

What happens if a lab can’t test for one of these analytes and another can?

Specific CAS numbers for analytes need to be provided and defined to create consistency across the nation.

If producers are still uncertain, our chemists are always available to help address questions and concerns.

CLR: As key players in the hemp market, what keeps you awake at night?

Josh Swider: As an analytical chemist operating a quality and safety testing laboratory, I believe regulators are more focused on the political battle surrounding CBD products rather than the safety of CBD consumers.

We need to take a step back from the hemp vs. marijuana debate and recognize that more and more people are relying on the plant as medicine. THC levels should not be the only analytical measure taken into consideration but definitely fully defined.

We need to be testing for dangerous contaminants such as pesticides, microbials, mycotoxins, heavy metals, solvents, and additional additives that may be carcinogens or cause sickness and or death. Like we witnessed with the E-cigarette or Vaping Product Use-Associated Lung Injury (EVALI) crisis last year, unregulated products with zero safety standards can cause serious harm to unsuspecting consumers, and with CBD quickly becoming the most popular alternative prescription medicine the consequences of a similar crisis could be even more dire.

CLR: What is your personal vision or hopes for the national hemp program next year, or in 3 years? 

Josh Swider: InfiniteCAL’s biggest concern is consumer health and safety. In the next year, we’d like to see steps taken to require safety testing for safety panels such as pesticides and heavy metals.

The cannabis products we test for state compliance must pass up to nine tests depending on the product type before being able to go to retail.

In the next three years we’d like to see the hemp industry shift focus to the overall safety of a product and require testing on final products in addition to the initial crop.