After a landmark decision from the United Nations Commission for Narcotic Drugs ruling that cannabidiol (CBD) is no longer a narcotic drug, CBD manufacturers have banded together to submit applications to sell their products in the European market.
In February 2019, the European Food Standards Agency (FSA) classified CBD as a “novel food,” meaning safety studies are required for each ingestible CBD product sold into the EU to prove they are safe for human consumption.
In February 2020, the U.K. FSA set a deadline of March 31, 2021, for companies to submit safety dossiers and receive validation for products that are already on shelves in England and Wales. Companies that do not yet have products for sale in the U.K. may not begin selling products until they receive authorization, which could take around two years to receive.
And, if companies do not submit applications by March 31, they face their products being removed from shelves across the U.K. (Other countries in the EU have their own ways of enforcing novel foods regulations, much like states in the U.S. have different ways of interpreting rules from federal agencies.)
The novel food applications allow CBD companies - including those in the U.S. - to sell their products in a regulated market, allowing for broader confidence from both retailers and consumers.
But submitting an application is both expensive and extensive. Garrett Bain, president of EcoGen Biosciences, says it took him several months to pull together the data needed to submit the application. It requires numerous pieces of information about each product, including:
the history of use of the novel food and/or of its source
proposed uses and use levels and anticipated intake
absorption, distribution, metabolism and excretion
toxicological information and allergenicity
According to estimates from the European Industrial Hemp Association (EIHA), an individual company registering a single product under Novel Food guidelines needs to invest between €350,000 and €500,000 (about $420,000 to $600,000).
Fortunately, the industry has joined forces across country borders to share the costs. Heading up that initiative are two European organizations: the EIHA and the Association for the Cannabinoid Industry (ACI). The two organizations formed consortiums to submit dossiers on behalf of multiple companies to help reduce the costs for each business. The consortiums, which facilitated toxicology studies for each product that was part of the group, required companies to submit specific datasets about their products.
The ACI submitted its dossier in February. Of the 18 companies part of its consortium , five are based in the U.S.
“I am delighted to submit these dossiers on behalf of the ACI-[Advanced Development and Safety Laboratory] CBD safety consortium and support an industry on the cusp of transitioning from a grey area to a fully legally compliant market,” said Parveen Bhatarah, Ph.D., regulatory and compliance associate with ACI who led the consortium, in a news release. “Well done to our consortium members who have delivered on the substantial data requirements that were asked of them. We’re very pleased to lead the way to a sustainable cannabinoid industry.”
Meanwhile, Nutritional Outlook reports the EIHA has submitted a dossier based on participation from 183 companies, some of which were also from the U.S.
The EIHA says in a press release it estimates it spent £3 million (about $3.6 million) financing toxicological studies as part of its applications.
But organizations weren’t the only ones facilitating applications. In the U.S., EcoGen Biosciences, a Denver-based producer, manufacturer and supplier of hemp ingredients, has been working with companies it’s done business with to help them submit dossiers for their formulations. (EcoGen develops various hemp-based cannabinoid formulations for the beverage, food, cosmetics, wellness, and pharmaceutical industries.)
Bain says the company worked with hundreds of products across at least ten brands on submitting their dossiers.
“Every single formulation, to include variation by flavor, has to be validated,” Bain says. “We’ve provided a lot of brands the opportunity to … leverage the work we’ve already done and put their products on our dossier.”
EcoGen was part of both the EIHA and ACI consortium.
What It Means for U.S. Companies
Over the past several years, the European market has provided an opportunity for U.S. companies to expand their footprint and sell their products to a broader swath of consumers.
Dr. Stuart Titus, CEO of Medical Marijuana Inc., says the company’s products have been on the European market since 2017.
“2018 and 2019 were phenomenal. In 2019, we sold more product in Europe than we did in the U.S.,” says Titus, who was also a part of the EIHA consortium. “There have been some challenges with some saying CBD was a narcotic - it hurt some sales and development efforts - but it’s nice to see the United Nations got together and has revisited the outlook on cannabis as a scheduled narcotic.”
Now that the EU has begun regulating CBD, manufacturers are confident it will boost sales in the area.
“[The] novel foods [designation] is going to potentially give the regulatory framework and confidence to a lot of big box retailers to bring these products in because there has been regulatory approval and an approved list of products and brands,” Bain says.
“We’re quite excited about getting this formal registration so each European country can feel comfortable and confident [about selling CBD],” Titus says.
Meanwhile, as companies await a regulatory framework for CBD in the U.S., Bain says he doesn’t think the EU’s actions will have much of an influence on the U.S. Food and Drug Administration (FDA).
Still, he believes regulations from the FDA are coming soon.
“I’m hopeful that will happen this year based on indications from the new administration,” Bain says.