Research and NPD opportunity: CBD obtained by synthetic means descheduled from US drugs act

25 Nov 2019 --- Cannabidiol (CBD) obtained by “synthetic means” is now excluded from the US Controlled Substance Act (CSA) regulatory controls, as long as it contains no more than 0.3 percent tetrahydrocannabinol (THC). This is according to a letter from the US Drug Enforcement Agency (DEA) received by Purisys, a producer of major cannabinoids relevant to pharmaceutical and consumer products, as well as degradants, metabolites and analytical reference standards. Over 30 other cannabinoids have also been descheduled from Schedule I of the CSA. The company expects that this will encourage research and, based on sound clinical and safety studies, create a broader path for cannabinoids’ use in pharmaceutical and consumer products.

“With the de-scheduling of synthetic CBD, we are able to collaborate with a broader customer base within the US. This means we can start with our strong roots in pharmaceuticals and extend them to personal care, over-the-counter, food and beverage as well as nutritional supplement segments. Research and development centers in those segments no longer need to have DEA licenses to receive and develop their products,” Joshua Hoerner, Chief Innovation Officer and Managing Director at Purisys Athens, tells NutritionInsight.

The company’s next steps are to take the cannabinoid technologies and associated applications into consumer product segments, with as much force as regulations allow. This information from the DEA unlocks access to a number of new markets otherwise inaccessible to CSA regulated substances, notes Hoerner. Purisys also plans to further invest in people and technology resources to advance its intellectual property positions, while expanding its portfolio of cannabinoid (and related compound) offerings across all market segments.

Customers in the pharmaceutical, personal care and food and beverage spaces will now be able to more easily conduct the research that will be important to the use of cannabinoids in a wide range of products. “At Purisys, we stand ready to back this research, with our applications support, analytical reference standards and small-scale current Good Manufacturing Practice (cGMP) manufacturing. Of course, this is backed by our world-scale supply capability for commercial production,” says Jim Mish, CEO of Purisys.

The descheduling of these compounds will also ease the regulatory compliance activities by companies developing consumer products, according to Tim Jones, Vice President of Global API and OTC for Purisys. “DEA’s descheduling formally states that our cannabinoids are no longer subject to DEA controls that affect quotas, aggregates, secure vault storage and more. Descheduling means our customers no longer need DEA registrations to work with Purisys materials.”

The company’s next steps are to take the cannabinoid technologies and associated applications into consumer product segments.Purisys is exclusively a broad-range ingredient and solutions provider to pharmaceutical and consumer products companies looking to use CBD and other cannabinoid-based ingredients. It was formed as a spinoff of Noramco at the start of last month in a bid to provide a “laser-like focus on the types of support that the different markets will require.” This followed the news in July that Noramco and Willow Biosciences, a developer of biosynthetic production systems for plant-derived active pharmaceutical ingredients (APIs), are collaboratively developing a yeast-based biosynthesis platform for the production and distribution of CBD.

Hoerner notes that Purisys enables and accelerates research in various areas by providing access to pure, easy-to-formulate cannabinoids along with comprehensive technical data packages. The company has also been working to develop a portfolio of applications data and technologies, specifically for the aforementioned industry segments.

The legalization journey
Legalization of CBD is a hot topic, although the details are often murky. Earlier this month, the German government confirmed that CBD will be classified as a novel food. This move aligns the country’s position on the ingredient with that of the EU. In January, the European Commission ruled that CBD and all products containing it are to be considered novel throughout Europe and cannot be marketed without authorization.

Meanwhile, NHS England recently approved the reimbursement of some cannabis-based medicinal products, including GW Pharmaceuticals’ Epidyolex, containing CBD, and Sativex, made of nabiximols, a mix of CBD and THC.  

However, research by the Grocery Manufacturers Association showed that consumers are increasingly confused regarding what CBD is, what it does and whether it is safe or not. One in three US consumers uses CBD and 76 percent of CBD users assume that products are subject to federal regulations and safety oversight. This highlights the need for federal agencies to implement a uniform regulatory framework. 

Further research into CBD is also desperately needed, with a recent study finding that one-time exposure to cannabinoids – both synthetic and natural – during early pregnancy, can cause growth issues in developing embryos.

By Katherine Durrell