As cannabinoid-based consumer goods continue to be researched and launched by major brands poised to contribute to the estimated $23.6 billion worldwide CBD industry (2025),1 the time is now for executives and formulation teams to explore and educate themselves on the vast application hemp can have for their product lines.

The millennial-old plant species of Cannabis has had its share of adversity, from its early medicinal use in China to being the main target of the War on Drugs in the U.S. during the mid-late 20th Century. As a new, more positive limelight shines back on the plant, 21st Century consumer products hold the key for promising new applications of hemp and its naturally present cannabinoids, terpenes, flavonoids, and other natural molecules still to be discovered.

Seed & Soil
Associated Certifications: Good Agricultural Practices (GAP) & Organic Certification

Agricultural experts and farmers agree that the starting inputs for any crop will impact the overall yield, quality, and growth pattern. Hemp is no different than traditional crops in many capacities, with the exception that stable genetics, resistance to weeds, pests, and weather extremes, are still being developed. (Think of the progression of corn varietals during the past few decades.)

In addition to the ongoing development of stable genetics, hemp has the unique characteristic of being a “phytoremediator.” Phytoremediation is the quality that allows hemp to “clean up” the environment (soil and air) in which it is grown. The “contaminants” collected through phytoremediation are generally stored within the plant’s tissue and can cause challenges when determining final use in a hemp product.

Leading agricultural universities focused on hemp growth agree that these two inputs, seed and soil, can make or break the future of hemp as a viable crop rotation for farmers. Oregon State University’s Global Hemp Innovation Center (OSU GHIC) focuses on research and education for hemp farmers. By researching and teaching agricultural methods such as crop rotations, soil health, and growth patterns in different geographical locations, OSU GHIC is able to help farmers mitigate the risks associated with soil-borne pathogens (fusarium, botrytis, etc.) and enhance natural bug resistance through strong soil amendments and proper plant spacing. The use of sound agricultural practices, be it traditional-scalable agriculture, regenerative growing philosophies, or organic certifications, each have their unique benefits and drawbacks for farmers.

While one growing method is neither better nor worse than another, each aspect of the hemp plant and environment must be taken into consideration in order to produce a safe product. For example, the use of pesticides on hemp is controlled by the U.S. Department of Agriculture (USDA) which has approved a short list of acceptable pesticides for use. These pesticides can be concentrated when hemp is processed into concentrates, a common starting ingredient for product formulators.

Farmers, universities, government agencies, and private businesses are working year-round to solidify research supporting the best agricultural practices for hemp. By taking into consideration hemp’s ability for phytoremediation and risk mitigation associated with proper agricultural practices, farmers can use hemp as a viable crop rotation. Currently, limited certificates demonstrating best farming practices for hemp exist. However, Good Agricultural Practice (GAP) certification, a general farming certification, is available to hemp farmers. In addition, hemp grown under the guidelines of the 2018 Farm Bill may apply for organic certification through the USDA.2

Harvesting & Drying
Associated Certifications: GAPs

Following a successful hemp growing cycle, farmers must consider how they will remove the annual plants from the ground and prepare the biomass for processing. In 2019, Hemp Benchmarks estimated that only 15% of cannabinoid-grown hemp (e.g., hemp grown for the flower/cannabinoids as opposed to for the fiber/stalk or for seed/food) was successfully harvested from U.S. fields, dried, and utilized in products.3

This dismal overall harvest was due both to swift and drastic weather changes that fueled mold and microbial growth in the field, and to a lack of automated harvesting and drying capacity. This lack of equipment and technology has fostered rapid innovation, which holds promise for a more successful 2020 harvest.

Many large-scale agricultural operations must consider how they will harvest in a timely manner before moist air increases the risk of in-field degradation and mold. Hemp farmers have explored wet-bale silage methods with little success, as degradation of cannabinoid content and microbial growth all appear to limit the application of this wet-harvest method, though new technology is evolving. Tractor attachments have recently been manufactured to harvest the valuable portions of the plant while mostly leaving behind the fiber portion of the plant—which has different value applications.

Historically, hemp farmers have utilized whole-plant drying methods whereby barns were lined with plants and kept cool until the moisture content was low enough to inhibit the growth of mold and bacteria. While this traditional method appears to preserve cannabinoid content, the space requirements can be challenging for a small- to medium-sized farm.

While hang drying appears to be the most common method for smokable hemp flower, the use of medium-scale mechanical dryers for extraction biomass is increasing. With high-heat mechanical drying applications, farmers must consider the initial moisture content and overall temperature to protect against cannabinoid degradation and loss of volatile terpenes. This means utilizing cannabis-specific dryers is a viable option for overall crop preservation.

Extraction
Associated Certifications: Current Good Manufacturing Practices (cGMPs), Chapters 111 & 117

While harvesting and drying appears to have been one of the largest hurdles for farmers to tackle in 2019, the limited capacity of extractors also affected the after-harvest supply chain for hemp by reducing biomass prices through oversupply.

Further, hemp extractors themselves struggled to sell hemp concentrates to large consumer product manufacturers due to murky regulatory guidance, lack of education, and risk aversion by corporate legal departments. While interim rulings released by the USDA and Drug Enforcement Administration (DEA) have both impacted and challenged the hemp extraction sector, these agencies have set forth clear guidance that hemp and hemp-derived concentrates, with 0.3% delta-9-tetrahydrocannabinol (D9THC) and lower, are clear for interstate commerce.

The main premise of extraction is to concentrate valuable biomass natural products into cannabinoid-rich concentrates for use in consumer goods and in bio-pharmaceutical formulations. Extraction methods generally fall within the below categories:

Solvent-less

• Water (considered a true solvent-less method)

             o Water Extraction Technology
             o Cavitation
             o Steam

• Mechanical (considered a true solvent-less method)

            o Rosin Press
            o Bubble Hash/Ice Bubble Hash

• Lipid Soaking

            o MCT Soaking

• CO2 (requires further processing with chemical solvents)

            o Sub-critical CO2
            o CO2

Traditional Solvent (requiring further refinement)

• Hydrocarbon

            o Mixtures of/or only one: propane, butane, hexane,
               pentane, etc.

• Ethanol

            o Sub-critical ethanol
            o Cold-ethanol
            o Ethanol

Although each method is believed to have its appropriate applications, many risks are posed by extraction of hemp biomass. For extraction employees, these risks include physical hazards associated with high-pressure vessels, temperature extremes, and exposure to solvents that can penetrate deeply into the skin and lungs. Further contamination risks within the concentrates themselves include microbials, mycotoxins, heavy metal accumulation via phytoremediation, residual solvents left by improper processing, and pesticide concentration due to the use of solvents.

Best practices include the review of solvents utilized during extraction and refinement. A true solvent-less, chemical-free, extraction method is preferred. A third-party-verified Certificate of Analysis (COA) that includes measures for potency, microbial, mycotoxins, pesticide, residual solvents (as applicable), and heavy metals should be automatically provided and be immediately reproducible by
concentrate manufacturers.

Many in the hemp industry have aligned themselves in preparation for additional guidelines from the U.S. Food and Drug Administration (FDA). These self-imposed guidelines include meeting the standards of current Good Manufacturing Practices (cGMPs) as well as meeting common rules and standards within the food, beverage, nutraceutical, and cosmetic industries. These cGMP guidelines, while not formally required, hold promise for standardization of safety within the extraction supply chain and production process.

Other Considerations
The final consideration formulators and consumer goods manufacturers must consider are the environmental impacts of the hemp seed to sale supply chain. Each step in the supply chain process should be scrutinized to uphold the roots of cannabis, to make for a cleaner and safer planet for all.

Reduction of drying space through extraction methods that don’t require dried biomass, and new technologies which utilize low emissions to reduce carbon impact, should be explored and utilized where possible. Reusable and recyclable extraction techniques will become the industry standard. Spent biomass, or biomass that has been extracted for cannabinoids, is also being researched for value creation, including applications for animal feed, fuel palletization, and processing into hemp paper and packaging.

Hemp is a unique plant that can advance the environmentally conscious application of circular economies where waste streams turn into value-added products. Businesses in all sectors can consider these goals and apply for B-Corp certification through a third-party accrediting establishment.

Conclusion
From soil to waste-stream value creation, hemp has the unique ability to have a major positive impact on our planet and on the fellow humans with whom we share its habitat, turning a new leaf for this once-taboo plant. Formulators of cosmetics, dietary supplements, and ingestible applications will need to be educated on the hemp supply chain in order to identify potential risks, risk mitigation, and creative solutions, many of which already exist to address these potential challenges. There is no doubt hemp and hemp concentrates are here to stay.

While this article specifically discusses applications of hemp and its concentrates, many of the supply chain risks and solutions are applicable to both hemp and high-THC cannabis (or Cannabis in general). The viewpoints expressed in this article are those of the author and do not necessarily reflect those of any competent authority or the respective company. The purpose of this article is to guide and inform the reader. The reader is encouraged to verify any opinions and facts the author present.

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About the author: Nicole Foss MBA, MSN, RN is vice president, Nextraction Inc. She can be reached at [email protected].


References:
1. https://www.grandviewresearch.com/industry-analysis/cannabidiol-cbd-market
2. https://www.ams.usda.gov/sites/default/files/media/NOP%202040%20Hemp%20Instruction.pdf
3. https://www.hempbenchmarks.com/hemp-market-insider/how-much-hemp-planted-2019/


Key Hemp Industry-Related Definitions
Agriculture Improvement Act of 2018: Commonly referred to as the “2018 Farm Bill” or “Farm Bill.” Legislation signed into effect in December 2018 that legalizes cultivation of hemp botanical (flower) and hemp concentrates, which contain no more than 0.3% delta-9-tetrahydrocannabinol (D9THC), on dry weight basis testing, commonly measured via high pressure liquid chromatography (HPLC).

Broad-Spectrum Concentrate: A hemp-derived concentrate containing cannabinoids, terpenes, flavonoids, and other natural hemp products. Closely mimics the cannabis plant’s natural phytocompound profile but is extracted/concentrated or refined so it does not include any traceable amount of D9THC.

Cannabis: Referring to formal naming of flowering annual plant genus within the Cannabaceae family. Can be further defined into species: Cannabis sativa, Cannabis indica, and Cannabis ruderalis.

Concentrate: Cannabis industry term referring to phytocompounds including phytocannabinoids (cannabinoids), terpenes, flavonoids, and other natural products extracted or concentrated from the Cannabis plant. Concentrates can be hemp-derived (less than 0.3% D9THC) and are considered legal under the 2018 Farm Bill. Or concentrates may be high-THC cannabis derived, containing more than 0.3% D9THC, and fall under (some) state and Drug Enforcement Administration (DEA) regulations.

Full-Spectrum Concentrate: A hemp-derived concentrate containing more than three cannabinoids, terpenes, flavonoids, and other natural plant products. Considered to most closely mimic the extracted hemp’s natural phytocompound profile. Typically includes traceable amounts of D9THC.

Hemp: Also referred to as “industrial hemp.” A definition set forth under non-herbaceous classification. Generally referred to as Cannabis that has been bred to express cannabidiolic acid (CBDA) in higher quantities than tetrahydrocannabinolic acid (THCA). Delta-9-tetrahydrocannabinol (D9THC), a neutral product of THCA via degradation (decarboxylation), must fall under a 0.3% by dry weight testing method to be considered “hemp” or a “hemp-derived product” (U.S. standard).

High-THC Cannabis: Previously referred to as “marijuana.” A non-herbaceous classification of Cannabis that has been bred to express tetrahydrocannabinolic acid (THCA) in higher quantities than cannabidiolic acid (CBDA). Delta-9-tetrahydrocannabinol (D9THC) is allowable, by definition, to be above 0.3% on a dry weight basis. Generally regulated, taxed, and falls under government (state and federal) oversight.

Isolate Concentrate: A refined hemp concentrate which includes only one isolated cannabinoid (typically cannabidiol, CBD). Typically created through harsh chemical refinement of synthetic chemical reactions. Does not retain other natural plant molecules or mimic the plant’s natural profile.