Safe and well-characterized THC key for medicinal and CPG uses

Solution chemistry methods to convert CBD to THC are not GMP certifiable and will not produce suitable THC for medicinal use or as approved dietary ingredients in food and beverage CPG.

CBD-derived THC has the potential to disrupt the medical and adult-use cannabis markets in the US and abroad. The cannabis industry has mastered the art of selling THC-infused candies and snacks. In the last year, the industry has seen a spike in the number of companies focused on CBD- and THC-infused beverages.

Aphria (APHA.TO) (APHA) and Tilray (TLRY) completed their merger in early 2021, shortly after Aphria acquired Sweetwater Brewing Company for $300 million. The combination is set to compete with Canopy Growth and Constellation Brands. HEXO Corp. (HEXO.TO) (HEXO) is entering the cannabis beverage vertical via a strategic partnership with Molson Coors Brewing (TAP). Companies like Heineken-owned Lagunitas (Hi-Fi Hops) and Pabst Brewing (Pabst Labs) have entered the vertical through partnerships and licensing deals.

Few in the industry have managed to increase volume to CPG scale while maintaining quality. Most rely on established extractors to supply THC, and are reliant on the manufacturing and quality control of their suppliers. Leading THC-infused food and drink manufacturers have professionalized their operations, in some cases achieving Current Good Manufacturing Practices (cGMP) certification for downstream food processing facilities – including multiple rounds of testing of THC ingredients and final products, but the overwhelming majority of their THC suppliers have not.

Despite the attention garnered by adult use marijuana and THC-infused foods and beverages, a large number of cannabis consumers buy and use the plant for medical and wellness reasons:

  • Chronic pain

  • Epilepsy

  • Anxiety

  • Musculoskeletal injuries

  • Sleep

To meet emerging consumer demand for clean and safe THC, companies focused on medicinal use are moving aggressively to demonstrate the safety of their manufacturing processes and end products, and requiring their suppliers to do the same.

The goal is GMP certification. GMP is a set of rules that ensure the quality and safety of products manufactured by a company. The US, Canada and the European Union require all food and drug products sold in their respective markets to be manufactured in GMP facilities.

For medicinal and wellness applications, flower does not require product development in the traditional sense. Consumers select strains they believe address the health issues that led them to use cannabis. But where cannabis derived products – vape cartridges, edibles, or pills – there is no room for variability.

This trend is apparent in the THC-infused food and beverage market. To prepare for federal adult use legalization in the US, a small but growing number of companies are spending as much as $500,000 per THC product to prepare New Dietary Ingredient (NDI) notifications to secure FDA clearance to incorporate cannabis extracts in food and beverage CPG.

Tunability, repeatability, and safety

Edibles are an instructive example. Most edibles products have onset times that range from 45 minutes to two hours, too long for consumers accustomed to the narrower onset time windows of OTC medications. Duration of effect and dosage are highly variable also. Reducing variability in onset time, duration, and dosage makes THC infused products more accessible to patients and consumers alike. From a manufacturing standpoint, these products can be easily scaled and mass-produced at low cost and with product uniformity.
 
To achieve GMP certification and NDI approval, catalysis chemistry is qualitatively superior to the current solution chemistry-based SOTA:

  • Precise control of THC dosage (potency, cannabinoid ratio, side products)

  • Consistency of output

  • Absence of toxic solvents or reagents

  • Limited presence of well-characterized side products

  • Precise dose control (potency,