The UK Food Standards Agency (FSA) has now advanced a total 2,847 CBD products to the second stage of its three-stage approval process for new (or “novel”) foods. In the most recent development, 2,692 CBD isolate products submitted in a joint application from EIHA projects GmbH, a consortium of the European Industrial Hemp Association, were moved to the “validated” category on the FSA’s register.
FSA is sorting out applications for roughly 12,000 individual products as it works to clarify a flourishing gray market that has seen retail outlets flooded with CBD products over the past several years, raising safety concerns.
The EIHA consortium has another 2,205 products in a second application for CBD distillates which remains at the first stage of the FSA’s review, “awaiting evidence.”
A second consortium organized under the UK’s Association for the Cannabinoids Industry (ACI) also had products in a joint application recently “validated” by the FSA. Those applications cover 29 isolate and distillate products but ACI said they could carry the fate of up to 4,000 products.
The validated products now face safety assessment based on reviews for toxicology and other technical benchmarks.
400 products removed
A total of 400 product applications are now in the “removed” category and are no longer in the running to receive market approval. FSA does not disclose the causes for removals, but has said they reflect withdrawal by applicants, or that the products in some way failed to meet the agency’s criteria. Products struck from the list may no longer be offered to consumers under FSA rules.
More than 300 product applications that have been removed were from JM Wholesale Ltd. of the UK. But that company still has more than 400 products that continue in the first stage of the review. British Cannabis, which submitted the most products (1,471) to the FSA review process, has seen 15 products disqualified; and RX Pharmatech, the No. 2 applicant (801), had eight fall off the list but still has nearly 800 in contention.
To get onto the FSA’s public list of CBD products – and therefore remain on the market pending final approval – products already in distribution had to have been on sale before Feb. 13, 2020. Those introduced to the market after that date were not eligible for the agency’s consideration.
FSA’s challenge
FSA was inundated with CBD applications early last year after stakeholders complained about the review process that guides the one-time chance for producers to get their gray-market products legal. The agency eventually reopened the application window by one full year, which eventually brought a flood of products to the list, nearly quadrupling the original number under review from roughly 3,500 to more than 12,000.
FSA said it expects the first CBD products to be fully authorized during the latter half of 2023 if the evidence necessary for safety assessments is complete. The authorization process can take more time if additional studies are required, according to the agency.
ACI has estimated the domestic CBD market at roughly £690 million ($830 million/€785 million).