One Month Until the Deadline, There’s Still Some Confusion Around CBD Novel Foods Applications in the UK
The UK’s CBD sector is about to enter a new era. Come March 31, the industry will split into two factions: the “legitimate” businesses that have submitted a novel foods application with the country’s Food Standards Agency (FSA) and “illegitimate” companies that haven’t.
And many of these unauthorized businesses may not make it past April Fool’s Day.
After the FSA became the key regulator of CBD foods and supplements in the UK last year, it warned that any company caught without a novel foods application will have their oils, drinks, and treat products “taken off the shelves” from April 1 this year.
Despite this intimidating ultimatum, plenty in the UK industry welcomed the regulation and began drafting their applications. Now, with just over a month to go until the deadline, many dossiers have been sent off.
Yet, even among these prepared companies, confusion persists about what exactly a novel foods application should include. Two key issues remain: how should businesses be sourcing the required toxicological data on CBD? And should that data pertain to the CBD product manufacturer or the company that provided the initial CBD ingredient?
When the futures of countless CBD companies hang in the balance, these aren’t questions to be answered quickly. So, to get some carefully considered responses, Analytical Cannabis caught up with some key CBD analysts.
Dazed and refused
“You know, we really applauded the FSA,” says Wendi Young, president of Triverity Laboratories, a cannabinoid testing company with labs in Colorado and Northern Ireland. “It was really great to hear a regulator say, ‘this is your path to compliance.’”
Young only opened her lab up for business in the past few months, but given the incoming novel foods deadline, business is already booming.
“Novel foods, novel foods all day, every day right now,” she says as she describes her schedule.
The work may be welcome, but it’s not always straightforward. The application process outlined by the FSA, Young says, could have benefited from more clarity.
“It seemed great,” she says, “unlike in the US, where we’re still waiting on the FDA to do anything. But over the course of the last year, it has gotten extremely complicated and extremely confusing. From whether or not brands need an application, to what really the February 2020 requirement of being on the market means. Is it product related? Is the product the ingredients? Or is it [down to] the brands that use that?”
“You ask the FSA, and you get an answer, and you feel like you understand that answer,” she says. “And then you hear that somebody else got one that could be interpreted completely opposite,”
Without complete coherence of the rules, Young has had to take her best guess for some aspects of the applications. On the issue of whether the dossiers should pertain to the individual CBD company or the CBD ingredient provider, for instance, she opted for the latter. But even now, there’s doubt in that decision.
“The majority of the information in the novel food application is on the ingredient,” she says. “I explain to these customers, ‘That is my opinion, you don't need an app [application]. But I could be wrong.’”
Fortunately, the issue around toxicology data seems to be a little clearer. The FSA’s own guidance states that “applicants will need to include details of the toxicological studies they have undertaken, or propose to undertake with clear details of the reasoning for these particular tests.” So, as long as a CBD company has or will have access to relevant toxicology data (likely from a rodent study), its application should be verified.
It’s just a pity, says Young, that so many CBD companies took on this research requirement themselves before that guidance was clarified last September.
“There’s a lot of companies out there that are doing these toxicology studies,” she says. “And they’re paying thousands of pounds[…] and they’re all doing the same studies, essentially, on the same molecule.”
“I think it’s just a shame to have that many animals in studies that possibly don’t need to be,” she adds.
An ACI for detail
Not every CBD company in the UK rushed into a toxicology study, however. Some saw the benefits of collaboration early on and joined consortiums with other companies.
The Association for the Cannabinoid Industry (ACI), for example, launched its CBD toxicity consortium back in September. With a starter group of 16 CBD companies and a contract research organization on board to carry out the studies, the coalition promised to be one of the more comprehensive and affordable routes to toxicology data.
“The cost shared between ten, twenty, thirty members is a lot less than doing it on your own,” Dr Paul Duffy, the ACI’s lead toxicologist, told Analytical Cannabis in November. “And I believe we’re closest[…] to having the information to support a valid novel food application by next March.”
Whether in first place or not, Duffy’s team were certainly out in front. And on February 16 this year, they announced that they had successfully submitted their novel foods application on behalf of ACI’s members.
“I feel really proud that we are here now today,” Dr Parveen Bhatarah, the ACI’s regulatory lead, told Analytical Cannabis. “I've just gone to the final checks – there are a few things I wanted in the novel foods applications to be corrected. And I’m pretty confident, before five o’clock, we will be pressing the button to submit.”
But celebrations aside, the applications aren’t quite done yet, says Bhatarah. The ACI’s toxicology study may be underway, but that’s just the tip of the iceberg.
“I don’t think the journey is complete yet,” Bhatarah cautions, “because it will carry on until the tox study is completed. And after that the companies will need assistance in reading across the toxicological data generated here.”
The analysis of these toxicological data could take months to complete, but at least Bhatarah is confident they’re checking the right data. Like Young, she too submitted the primary CBD ingredient information rather than data the final products from the high street.
“What data we are generating is on the primary CBD,” she says. “Depending on your finished product, which is commercially available on the market, you can translate or read across the toxicological information into your secondary products, and hence, you can justify why the commercial product on sale is safe because of this toxicological study,” she explains.
The UK’s CBD sector may be a bit hectic at the moment, but at least a consensus is finally forming around the incoming requirements. No, not every company needs to undertake its own toxicology study. And no, that toxicology data doesn’t need to come from every CBD product on UK shelves.
But with only month left before the dawn of enforced regulations, has every CBD company had time to learn these lessons? Sadly not, says Young.
“It’s an incredible lack of clarity [from the FSA],” she tells Analytical Cannabis. “And, frankly, it’s so high risk for the smaller manufacturers out there. If they don’t guess right, then they potentially are going to be off the market in April. And that’s just really unfortunate.”