A Reliable Path to Working with CBD in the U.S.

In August of this year, the U.S. Drug Enforcement Administration (DEA) distinguished some critical language within its Interim Final Rules defining hemp vs. marijuana. The most significant piece of the DEA’s announcement is its decision to uphold the regulation of THC content throughout the entire lifecycle of the product.

The agency is likely to consider any product containing more than 0.3% THC at any time during the cultivation, harvest, extraction, manufacturing, distribution, etc. to be a criminal violation of federal narcotics law.¹ Discretion in prosecution or safe-harbor levels in excess thereof remains to be seen. The latest news undoubtedly puts pressure on the CBD industry, but precise definitions are a necessary evolutionary step toward responsibly growing the multi-billion-dollar industry.

U.S. Hemp Production Off to a Rocky Start
There is evidence that true agricultural hemp has been native to North America since before the 16th century.² While hemp is a resilient crop and can grow in many climates, it inevitably takes time for the cultivars to naturalize to their environment, and for farmers to understand their crop selections in order to produce consistent levels of active compounds. However, after 1970, when hemp was placed on the Controlled Substances Act, centuries of experience working with acclimatized cultivars were destroyed. Today we are left with no remaining U.S. legacy hemp strains.

“The U.S. was in the ‘dark ages’ on hemp production,” explained John Kathrein, of Applied Food Sciences. “For over 40 years, we were unable to cultivate it, commercialize it, consume it, and had limited access to research it. While the rest of the world was standardizing their industry and establishing time-tested hemp varietals, the U.S. was on its way to a significant shortage of trustworthy, industrial hemp seeds.”

This year, the United States Pharmacopeia (USP) Cannabis Expert Panel published specifications for cannabis chemotypes. The panel established three chemotypes for product labeling to provide better information to consumers, product manufacturers, and regulatory agencies:³

• THC dominant (Type I) “marijuana”
• THC/CBD-intermediate (Type II) “marijuana-hybrids”
• CBD dominant (Type III) “hemp”

A growing concern is that while the DEA and other agencies are firming up rules distinguishing hemp vs. marijuana, much of the U.S. is producing commercial hemp utilizing hybrid strains of type II cannabis with THC/CBD intermediate levels of phytocannabinoids. The noticeable void left from missing legacy strains seems to be leading to a harsh reality for U.S. hemp farmers over the next few years. While seeds of this varietal are engineered to conform to lower THC levels, many U.S. hemp suppliers are finding it difficult to reach the mark of less than 0.3% THC.   

Federally Certified Seeds?
While the U.S. is playing catch up and investing millions in hemp trial plots and research, the genetics are simply not there yet. As we progress toward implementing hemp that is more fibrous for industrial use, more seed-bearing for proteins and oils, and/or more floral for CBD production, the biggest hurdle is still regulating higher THC levels than are permitted by law.

Beau Whitney of Whitney Economics is one of the leading experts on the business-side of hemp production. Whitney is also an advisor and chief economist for the National Industrial Hemp Council. In his report titled, “The Field of Dreams: An Economic Survey of the United States Hemp Cultivation Industry,” Whitney charts that in less than 12 months, Departments of Agriculture from 34 states had issued more than 20,000 licenses for hemp cultivation, processing, and wholesale distribution.⁴ The rush to populate more than 500,000 licensed acres of land with hemp only compounded the issues with seed genetics. It was basically a guessing game with little guidance from regulating agencies as to which varietals of hemp seeds farmers would use. Whitney is in the process of refreshing his analysis for the 2020 harvest season.

“Hemp farmers are under a lot of pressure,” explained Whitney. “I don’t think that the USDA or others are considering the lack of maturity of the genetics in U.S. hemp varietals to get to the point where active levels are predictable and sustainable. So, farmers are going to run into this for the next few years until the genetics stabilize. But even that process is proving to be challenging right now because of the lack of maturity at the testing area of the supply chain.”

Current strategies by farmers include “taking a chance” and accepting the risk, while others are attempting to prematurely harvest their crops in hopes of having THC at that 0.3% mark. Unfortunately, neither of these solutions is ideal. As we have learned from the DEA, the risk then moves on to the next level of extraction or distillation, where methods can concentrate the actives to 5-10 times the amount found in the biomass. The current landscape presents a significant risk for extractors and product manufacturers going forward.

“Based on my survey of farmers across the U.S. this year, growers will have to take a chance on their genetics. They will either get lucky, testing below 0.3%, or come up hot. While these results seem to be digital in nature, we have already begun to see government intervention and crops getting destroyed,” Whitney continued. “Ultimately, I see this going to a certified seed model to which results are more predictable, but it will take several years for this to deploy and mature. Overall, the DEA needs to improve its messaging by adding better guidance that indicates a willingness to work with farmers and be flexible. Because if regulatory actions are super draconian out of the gate, it is rather untenable and will not work at this stage of the industry’s development.”

There is a Clear Path Today to Work with CBD Reliably
The U.S. hemp industry is suffering. The raw state of return since the passing of the 2018 Farm Bill only highlights the consequences of hemp’s lengthy ban in the U.S., where we could not cultivate it, commercialize it, consume it, and had limited access to research it. However, while the U.S. is getting back up to speed, we can rely on other parts of the world that are much further along.

The most closely related market is Europe, which is decades ahead in cultivating, researching, registering, and regulating true agricultural hemp strains to form certified seed banks. To become a certified E.U. hemp varietal, there is a five-year process to prove cannabinoid content’s stability, especially concerning THC.5 Stable, validated genetics ensure cannabinoid values do not exceed the legal limit of THC regardless of growing conditions. The European Commission recognizes 64 varieties of authorized (non-narcotic) industrial hemp in the E.U. Plant Variety Database.⁶

According to Applied Food Sciences (AFS), a leading supplier of E.U.-certified hemp extracts in the U.S., the certified seeds provide the best path to get product to market legally. The Austin, TX-based company works with only specific multi-generational strains of E.U.-certified hemp that fall under the USP chemotype “Type III” classified as non-narcotic industrial hemp. AFS has a sound model that provides stable, consistent sources of hemp to the U.S. that is well below the threshold of 0.3% THC, as indicated by the DEA and USDA. To add validity to its branded hemp extracts, AFS also ensured its hemp ingredients are USDA Certified Organic and Generally Recognized As Safe (GRAS), an important determination for certain approved safe uses in U.S. food and beverages.

“In many ways, Europe is even more stringent in its regulation of genetic strains of hemp,” explained Chris Fields, vice president of scientific affairs at AFS. “Genetic strains above 0.2% THC, such as U.S. hybridized Cannabis strains, are illegal Cannabis in the E.U. Furthermore, suppose any seed bank certified hemp strain exceeded 0.2% THC, on a farm located anywhere in Europe. In that case, the seed would have an immediate and permanent ban in the E.U. as a narcotic plant. The specific hemp strains we procure for AFS hemp extracts fall under these strict conditions
as well.”


Best Practices for Product Manufacturers
Manufacturers must do their due diligence. Stick to the documented facts and avoid marketing tactics that tell you what you want to hear. With credible third-party analysis, suppliers should demonstrate that they comply at every stage of the process—from cultivation, harvesting, extraction, and beyond.

“Realistically, it will take 3-5 years for the U.S. to develop as a consistent, viable source of high-quality ‘industrial’ hemp,” explained Kathrein. “It is not just the inconsistencies in phytocannabinoid content and crops coming in ‘hot’ for THC, but also the inherent experience required to supply products that are free of toxins like pesticides, heavy metals, and microbial contamination. The U.S.’s expertise will come, but it will take time, which we are already behind on.”

If you are considering making a product containing CBD today, manufacturers should seek a vertically integrated company that can provide full control and traceability of its hemp. E.U. seed banks certify non-narcotic Type III Industrial hemp seed genotypes, but manufacturers ought to look for other quality markers as well.

In Kathrein’s conclusion, he affirmed, “AFS provides comprehensive third-party analytical reports for every step of our processing, from farm level assays, through the manufacturing process, and even a finished product Certificate of Analysis. Most importantly, our hemp is Generally Recognized As Safe (GRAS) for approved intended uses in U.S. food and beverages. We transparently provide all our documentation, ensuring all parties involved that our hemp is in full compliance with the DEA and the agency’s ongoing evaluation of hemp.”

Ultimately, Whitney noted, “With stable genetics and expansion of hemp into the U.S. food and beverage markets, as well as into other industrial applications, the hemp industry is poised for significant growth throughout the next decade and beyond. The future is bright for hemp.”


References
1. DEA Interim final rule with request for comments. https://www.federalregister.gov/d/2020-17356/
2. MITJournal Volume 13, Number 2: Sep./Oct., 2000.
3. J. Nat. Prod. 2020, 83, 4, 1334–1351; April 13, 2020. https://doi.org/10.1021/acs.jnatprod.9b01200
4. Whitney, Beau. The Field of Dreams—An Economic Survey of the United States Hemp Cultivation Industry. November 2019
5. French Interprofessional Organisation for Seeds and Plants. https://www.gnis.fr/en/soc-official-service-for-control-and-certification-of-seeds-and-plants-in-france/
6. EU Plant variety database. https://bit.ly/3jBmJQt

Additional Resources:
AFS branded hemp ingredients: https://appliedfoods.com/hemp
DEA Interim Final Ruling: https://www.federalregister.gov/d/2020-17356/
USDA Interim Final Ruling: https://www.ams.usda.gov/rules-regulations/hemp
EU Hemp Certification Process: https://www.gnis.fr/en/soc-official-service-for-control-and-certification-of-seeds-and-plants-in-france/
USP hemp genotypes: https://pubs.acs.org/doi/abs/10.1021/acs.jnatprod.9b01200
National Industrial Hemp Counsel: https://hempindustrial.com/