Following Brexit, European cannabidiol (CBD) companies seeking to obtain “novel food” authorization in the U.K. are engaging in a separate process than the European Union (EU) has established. This means more applications, more tests and more scrutiny from regulators.
Hemp Grower spoke with business professionals who work at the first companies to be validated to proceed through the U.K. Food Standards Agency’s (FSA) novel food application process for CBD.
CBDepot, which has Czecho-Slovak roots, is behind 12 of the 43 products on the list as of May 11. Boris Baňas, founder and chief sales officer at CBDepot, said the business co-applied with CANNABIS Pharma, which holds shares in CBDepot, and U.K. company 4MP Technologies to have their CBD products authorized as novel foods in the U.K. These products include medium-chain triglyceride (MCT) and inert chewable tablet formulations; some use CBD manufactured by chemical synthesis, and some source the cannabinoid from European-grown hemp, or what Baňas called a "highly purified derivative of the resin" of the crop.
“The final approach to a novel food authorization is now underway,” Baňas said. “Since the validation and the publication of the public list, we are now entering the risk assessment phase as the scientific evaluation starts by the U.K. ACNFP [Advisory Committee on Novel Foods and Processes] on the safety of our CBD application in proposed formulations and recommended daily intakes."
Ireland’s Pureis has 11 synthetic CBD products—capsules, oral sprays and oral drops—on the FSA’s list. The raw material is manufactured in the U.S. and is registered by the U.S. Food and Drug Administration (FDA), said Pureis co-founder and chief scientific officer Caroline Glynn.
Pureis founder and CEO Chanelle McCoy said: “We have been busy on the sidelines for six years, adopting these clinical studies, having our raw material FDA-registered to be able to bring a safe product to the market.”
CBDepot and Pureis are working to manufacture CBD and get it certified and authorized by the book, though exactly which types of CBD products government agencies will authorize remains to be seen. In the 1990s, the EU created the novel food class of products and the U.S. Federal Drug Administration (FDA) established New Dietary Ingredients (NDIs).
CBDepot has applied for both EU and novel food classes. For its plant-based products, CBDepot contracts with farmers across the European Union who are required to deliver compliant extractable starting material. Each batch of the biomass must comply with all relevant criteria in the European Pharmacopoeia.
“All of the varieties we use have to be listed in the EU plant variety database,” said Michal Tőzsér, one of CBDepot's directors responsible for biomass procurement. "The supply chain must not have breached the breeders' rights by practices such as feminization. All biomass has to come from pollinated hemp plants with a demonstrable proof-of-evidence .... Such are the criteria which we understand are falling under the definition of hemp, and of course, the U.K. still adopted a large part of the European legislation after Brexit, so it should also be applicable there."
Baňas said CBDepot sister company CB21 Pharma also produces pharmaceutical-grade CBD manufactured under the EU's Good Manufacturing Practices (GMP) protocols, which the European Medicines Agency defines as "basic requirements for active substances used as starting materials." He adds that the company purchases its starting material from suppliers with Good Agricultural and Collection Practices (GACP) certification.
Meanwhile, CBDepot also has an application for CBD manufactured by chemical synthesis that is under risk assessment by the European Food Safety Authority (EFSA).
Pureis is also undergoing EFSA assessment while it seeks novel food authorization in the U.K., Glynn said, adding that the former criteria could prove similar to the latter.
“I suppose, in a way, we're a little bit more comfortable because we're coming towards the end of our assessment in Europe,” she said. “We submitted our dossier into Europe over a year ago, so we've been liaising back and forth with European Commission and their scientific committee, EFSA …. So, we have an idea of some of the questions that the U.K. FSA may bring up.”
Glynn predicts that earning novel food authorization won’t be simple. “We talk about the toxicology studies that are required, but I think there's a huge suite of studies that needs to be done on the raw materials—the analytical chemistry part—which isn't that cheap to do, either,” she said.
The four CBD dossiers that are under risk assessment with EFSA are all for products that are created using synthetic CBD, Hemp Grower confirmed with the agency. “It’s interesting that a plant[-derived product] hasn't been put through yet,” McCoy said.
Looking at the U.S., McCoy said she thinks the FDA should regulate CBD and advise the industry on legislation, adding that "the FDA are actually being quite irresponsible at the moment" by not doing so. "We're not talking about medicinal cannabis or marijuana—we're not talking about that at all," she said. "We're literally talking about CBD as a food supplement."
Why Synthetic CBD?
European companies such as CBDepot and Pureis synthesize CBD to ensure no other cannabinoids are present in the end product.
McCoy cited a study of CBD products sold in the U.K. in which researchers found that 55% of products had “measurable levels”—a mean content of 0.04%—of psychoactive cannabinoid delta-9 tetrahydrocannabinol (THC) and 34% of products had less than 50% of their advertised CBD content.
“There can be very harsh methods of extraction with the plant if you're looking for ultra-pure CBD,” McCoy said. “I know plant companies will say, ‘Well, we want the other components there. We want the entourage effect.’ That's fine. That's for a cohort of people. But the cohort of people that we're speaking to are people who genuinely just want pure CBD and don't want traces of anything else.”
As for CBDepot, Baňas said the company synthesizes CBD to ensure no other cannabinoids are detectable in its end product in order to adhere to specific requirements such as the use of the product in professional athletics. For this reason, CBDepot partnered with 4MP Technologies to develop formulations and products specifically for athletes.
“The main reason 4MP embraces synthesized CBD was for its use in the professional sports segment because according to the WADA—the World Anti-Doping Agency—rules, only cannabidiol is exempted from restricted substances on the cannabinoid chapter,” Baňas said. “So, even residues of cannabidivarin, which is an impurity in [hemp-based] isolated CBD, would be a compromising factor."
While the industry awaits novel food authorization in the U.K., Baňas summed up CBDepot’s approach to its business: “We have to stay humble, hardworking and move step by step, and reach authorization one [step] at a time ....”