By This is the final part of a four-part series discussing cannabis regulation in Europe. Click here for part 1, Part 2 is here and Part 3 is here. Part 4 concludes the series with:
Where does the future of CBD lead?
When considering these various jurisdictions, the EU, the UK, and the US, it is clear that CBD testing to ensure public safety is paramount to the continuity of business and indeed the survival of the industry. In the UK, active participation in the new food licensing system is essential to remaining on the market. In the EU, it is essential for a legitimate market.
In the United States, it is an imperative, not because of the FDA or Congress, but rather because as the U.S. market matures, product liability lawsuits pointing to the lack of toxicology reporting and how it is done are almost inevitable. It’s very possible. The product was manufactured or sold. Until the FDA takes a stronger role in establishing safety standards for CBD in food, the best way for companies to protect themselves is to ensure the safety of their new food-inspired products. By using the exam system.
What this means for the CBD industry
Companies are looking for a clear path to investing in the CBD space. Especially in a litigious society like the United States, lawsuits are predictable as companies prepare toxicology reports that satisfy the FDA. There are clear winners and losers in the CBD market, but this is likely based on toxicology reports.
EFSA, FSA, FDA, various state-level hemp associations across the country, and, more interestingly, companies that see testing requirements as a legal means of eliminating less-funded competition all require testing. I support it. This is not surprising. There is no future in betting on the unknown. Anything short of clear safety standards is just guessing about people’s health and, ultimately, the future of your company.
So what remains?
It is clear that a toxicology report prepared on behalf of the CBD sector is required. And the other thing is about CBD, not as a medicine, but as a nutritional supplement. It’s worth noting that Mr. Miller also mentioned how Epidiolex contains high doses of CBD. It should be made clear that the medical research on Epidiolex does not match the research on non-medical levels of CBD when used as a supplement.
The biggest challenge currently facing CBD product manufacturers, whether in the US, EU or UK, is the lack of controlled studies and therefore the inability to account for the toxicology reports required for their portfolios. In the United States, the FDA has stated that it cannot be concluded that CBD meets “generally recognized as safe” (GRAS) standards for use in human or animal food. Therefore, the future of CBD will depend on companies’ ability to demonstrate through research and accompanying toxicology reports that their brands are firmly compliant with the necessary safety and data standards.
This is where the EU and UK could benefit from involvement in the novel food application and licensing process. The legal security necessary for marketing CBD products can only be achieved through approval as a Novel Foods. The expected cost for individual companies to register CBD isolates and full-spectrum distillates under the Novel Food guidelines is an investment of €3.5 million. As this is prohibitively expensive for most companies, EIHA announced at its June 2019 general meeting the creation of a consortium to jointly submit novel food applications and share these costs among its members. proposed.
“EIHA project GmbH” partnership structure
Founding members of EIHA Projects GmbH enjoy preferential affiliation rates. As a partner, I can sublicense his products or brands within the EU. This license will be valid in the UK once the application is verified and placed on the EU list, and will be valid in the US as well.
The Atlantic Ocean is getting smaller, and it seems very likely that the FDA will decide that the United States needs the same safety standards as Europe that apply to its products. Sublicensing is clearly an inexpensive means for American brands to claim toxicology and safety testing, as well as gain access to the EU market. It is imperative for future companies to adapt to the evolving regulatory environment while seriously considering their future business goals and confirming their commitment to approved, high-quality products.
