[This is the first in a series of stories looking at the CBD certification process in the UK]
(This story was updated April 27 to reflect that eight of 23 products absent from the original FSA list have now been added and are in the second stage of the approval process. The changes are indicated in a list at the end of this post.)
Several CBD makers have asked the UK’s Food Standards Agency (FSA) to explain why their products were disqualified from the food safety approval process while critics have suggested that some products which did reach the second stage of the three-part review should not have been advanced.
The questions come after the FSA on March 31 listed 3,536 products from 70 approved applications that continue to move through FSA’s system for certifying new or “novel” foods.
In setting a legal path to market for CBD producers in the UK, FSA has embarked on the process of clarifying a flourishing gray market that has seen thousands of CBD products show up in retail outlets over the past several years. To qualify, products already in distribution had to have been on the market before Feb. 13, 2020 under FSA guidelines. Any products introduced after that date were not eligible for the agency’s consideration.
Those that made the list may remain on sale while those that failed FSA scrutiny are noncompliant and must be removed. Some applications for new products that had not previously been on the market have also survived the FSA approval process so far.
Companies whose products failed to make the list can be expected to mount aggressive challenges as they seek to find a place in the UK’s growing market for consumer CBD products, estimated to be worth £690 million (~€814.5 million; ~$905.7 million) in 2021, according to the Association for the Cannabinoid Industry (ACI). From 2019 to 2021, CBD sales more than doubled in the UK, making the non-EU country the world’s second-biggest consumer market in the world behind the USA, ACI has said.
Major retailers scramble
Meanwhile, a list released this week by The Grocer website identified 23 products* that have been sold at major retailers which failed the FSA review. That has left key sellers such as Amazon, grocery giant Sainsbury’s, and the Holland & Barrett health food stores scrambling to check their shelves for non-compliant products while the makers of those brands may be gearing up to challenge the FSA.
A total 680 of roughly 900 novel food dossiers – most of which carried multiple products – submitted by CBD producers since the application deadline Jan. 1, 2021 have now been rejected by the agency or withdrawn by producers, according to ACI. Dossiers for the 23 failed products mentioned by The Grocer were among those rejections.
Sixty-five of the 70 applications approved this month — bearing 3,479 products – are now in the pre-validation (or “awaiting evidence”) stage. The remaining five applications, bearing 57 products, have reached validation (or “risk assessment”), the second stage, and await FSA’s decision on full authorization, the final stage.
In addition to the pushback by those who missed the FSA list, the agency’s process has led to some confusion, as in the case of Ireland-based Pureis, which produces own-brand CBD products and is also a bulk supplier to other brands. While Pureis had its products approved, those from Cellular Goods – which purchases white label (bulk) supplies from Pureis parent Chanelle McCoy Health (CMH) — were rejected.
Publicly-traded Cellular Goods saw its shares suffer this week after the company announced that three of its ingestible products were stricken from the FSA list. The company, however, contends that inclusion is not necessary in order for the products to remain on the market.
Cellular Goods said its products underwent safety and toxicology studies as part of a complete data package that meets the FSA requirements to receive a validated novel foods application.
“The company fulfills FSA guidance as this is not a new product to market and all the FSA required details are clearly stated on the labeling such as product name (Pureis), legal address, product code and supplier which is the same as that of the validated CMH products featured on the FSA list,” the company said.
Responding in a press statement, FSA said “[Cellular Goods] had not provided evidence that their products were on the market before 13 February 2020. Any products not on sale before February 2020 are not eligible for the public list.”
FSA said white label products sold on the gray market before that qualifying date “cannot be rebranded after the cut-off date until the product is authorized.”
What about Pureis?
Meanwhile – and further complicating the situation – some stakeholders claim already-approved Pureis-branded products themselves do not qualify under FSA rules because they also were not on sale in the UK before Feb. 13, 2020.
Cefyn Jones, of the UK consultancy The Hemp Hound Agency, cited lab reports from Pureis – one of the first companies to have products listed and advance to the second (“risk assessment”) stage of the three-phase process – which he says demonstrate those products could not have been on the market before the FSA deadline.
“Simply by looking at their first lab report it can be seen that they had no product available in the UK before Feb. 13, 2020,” Jones suggested.
Pureis, led by pharmaceuticals veterans Chanelle McCoy, CEO, and Caroline Glynn, CSO, makes a range of CBD capsules and oils.
“This is not some freshly set up CBD company who’s just got round to sorting their lab reports out. It’s a pharmaceutical company, which means it’s reasonable to assume that those lab reports were posted on their website on the day the products were first available,” Jones said.
In addition to the question of timing, some stakeholders say they have also spotted products on the FSA-approved list which have volumes of THC that go drastically beyond guidance from the Advisory Council on the Misuse of Drugs (ACMD).
Kyle Esplin of the Scottish Hemp Association and member of the UK’s Cannabis Industry Council said his early analysis showed some products contain THC amounts as high as 200 milligrams per 100ml sales unit, which doesn’t sync with normal consumption patterns compared to ACMD’s recommended limit of 50 micrograms of THC per serving.
Esplin and Jones also criticized the FSA for not distinguishing between naturally-derived CBD products turned out through traditional extraction methods and those derived through synthesis, suggesting that while the former are proven to be safe, the latter were developed after 1997 – the definition for novel foods, under a UK rule which is based on that date in EU regulations.
“How can synthetic cannabinoids not be subject to more stringent requirements for their novel food applications?” Jones asked.
The FSA has also failed to give specific labeling rules for synthetic products, Esplin noted. “There is no requirement for companies who manufacture synthetic CBD products to label them as such,” Esplin said. “For example, if a product is made from two isolates with added terpenes it should not be called ‘full spectrum.’ If a product contains synthetically produced CBD, then the consumer should be informed of this.”
“The novel foods update highlights that in addition to being a massive waste of time and money, the process now lacks any credibility,” Esplin said.
Legal challenges ahead?
Stakeholders have suggested some excluded brands may consider legal challenges to the FSA’s decisions if they don’t get a reasonable response from the agency. Steve Moore, ACI’s founder told The Grocer he agrees there may be cases for which there is “definitely a legal challenge to be had.”
Moore said some adjustments are likely in the coming weeks due to errors, but says many brands not on the FSA approved list failed to submit appropriate plans to provide toxicology data to the agency. “No one without toxicology data is going to get on the list,” Moore told The Grocer.
ACI said it is “in continuous contact with the FSA, Trading Standards and local authorities and will be issuing a statement from our founders next week regarding the status of the list.” The association has said there is no way to predict how many of the products that remain active in the FSA process could reach full authorization.
Forty-six of the 70 successful applications announced March 31 came through ACI. All had their products approved.
EIHA Projects GmbH, a consortium organized by the European Industrial Hemp Association, also submitted multiple applications for CBD products. The consortium has said it observed “inaccuracies, inconsistencies and indeed a few surprising absences on this list,” which it has taken under review.
FSA has said the list published earlier this month should not imply endorsement and applicants successful so far could fail the authorization process at a later stage. Further advancement or explusion from the food safety process depends on whether “the application is credible and the FSA has, or is shortly expecting to receive, significant scientific evidence from the applicant with which to judge safety,” the agency has said.
Voluntary removal sought
The list released March 31 is intended to guide local authorities, retailers and consumers in making informed decisions about what they stock and buy, FSA said.
Producers have been encouraged to voluntarily remove unapproved products from the market, and Trading Standards officers are said to be monitoring retail sellers. Companies that continue to sell unlisted CBD products put themselves at risk of enforcement action.
FSA said it has “advised local authorities to take a proportionate approach to enforcement against CBD products and we understand it may take time for the market to reduce and for certain products to be removed from circulation.”
The FSA list covers products sold in England and Wales. Northern Ireland is also under EU rules as per the UK’s Brexit protocols.
*23 non-compliant products
In addition to Cellular Goods, the products below failed to meet novel food guidelines as per the FSA’s original list of preliminarily approved products. Eight have now been added to the updated and expanded list released April 27.
- Body and Mind*
- Cannabi Relief
- CBD Guru
- Drink 420*
- Hatters Hemp
- Holistic Herb*
- Lady A
- Lo Bros
- Simply CBD
- The Leaf Life*
- Vita Coco*
*Approved as per the FSA’s updated list released April 27, 2022.