[This is the first in a series of stories looking at the CBD certification process in the UK]
Several CBD makers have asked the UK Food Standards Agency (FSA) to explain why their products were excluded from the food safety approval process while critics suggested that some products that made it to the second stage of the three-part review should not have advanced . .
Questions come after the Free Syrian Army on April 1 included 3,536 products from 70 approved applications continue to go through the FSA system to certify new or “new” foods.
In establishing a path to market for CBD producers in the UK, the Financial Services Authority has embarked on the process of illustrating the burgeoning gray market that has seen thousands of CBD products appear in retail outlets over the past several years. To qualify, products under distribution must have been on the market prior to February 13, 2020 under Financial Services Authority guidelines. Any products submitted after this date are not eligible for agency consideration.
Those who made the list may still be for sale while those who failed FSA scrutiny are non-compliant and should be removed. Some applications for new products that were not on the market before have also escaped the approval process of the Financial Services Authority so far.
Companies whose products failed to make the list are expected to face serious challenges as they seek to find a place in the growing UK market for consumer CBD products, estimated It could be worth £690 million (~€814.5 million; ~$905.7 million) in 2021, according to the Association of the Cannabis Industry (ACI). The ACI said that from 2019 to 2021, sales of CBD in the UK doubled, making the non-EU country the second largest consumer market in the world after the USA.
scrambling big retailers
Meanwhile, this week’s list has been released by grocer The website identified 23 products* sold at major retailers that failed FSA audit. That has left major sellers like Amazon, grocery giant Sainsbury’s and health food stores Holland & Barrett scrambling to check their shelves for incompatible products while makers of those brands may prepare to challenge the FSA.
According to the ACI, a total of 680 of about 900 new food files — most bearing multiple products — submitted by CBD producers since the January 1, 2021 application deadline have either been rejected or withdrawn by producers. Files for 23 failed productions mentioned by The Grocer were among those rejections.
Sixty-five of the 70 applications approved this month – carrying 3,479 products – are now in the pre-validation (or “pending evidence”) stage. The remaining five applications, which carry 57 products, have reached the verification (or “risk assessment”) stage, the second stage, and are awaiting the FSA’s decision on the full authorization, the final stage.
In addition to the opposition of those who missed the FSA list, the agency’s operation has led to some confusion, as in the case of Ireland-based Pureis, which produces its own branded CBD products and is also a wholesale supplier to other brands. While Pureis products have been approved, products from Cellular Goods — which purchases white label (bulk) supplies from Pureis parent company Chanelle McCoy Health (CMH) — have been rejected.
Publicly traded Cellular Goods saw its stock take a hit this week after the company announced that three of its digestible products had been taken off the FSA list. However, the company claims that inclusion is not necessary for the products to remain on the market.
Cellular Goods said its products have undergone safety and toxicology studies as part of a complete data package that meets the requirements of the Financial Services Authority to receive a new validated food application.
“The company meets FSA guidelines as this is not a new product on the market and all details required for FSA are clearly stated on the labels such as product name (Pureis), legal address, product code and supplier which is the same as the product name FSA validated CMH products listed, The company said.
In response to a press release, the Free Syrian Army said:[Cellular Goods] It has not provided evidence that its products were on the market prior to February 13, 2020. Any products that were not on sale prior to February 2020 do not qualify for the public listing.”
The FSA said white-label products sold on the gray market before that qualifying date “cannot be rebranded after the discontinuation date until the product is licensed.”
What about Boris?
Meanwhile – and complicating the situation further – some stakeholders claim that already approved Pureis-branded products do not qualify under FSA rules because they were not on sale in the UK prior to 13 February 2020.
Seven Jones, of UK advisory agency The Hemp Hound, cited lab reports from Pureis – one of the first companies to It has products listed and progress to the second stage (“risk assessment”) of the three-stage process – which he says shows these products cannot be on the market before the FSA deadline.
“Simply by looking at their first lab report, we can see that they did not have any product available in the UK prior to 13 February 2020,” Jones suggested.
Pureis, led by pharmaceutical veterans Chanelle McCoy, CEO, and Carolyn Glenn, CSO, manufactures a range of CBD capsules and oils.
“This is not a newly created CBD company that just sorted through their lab reports. It is a pharmaceutical company, which means that it is reasonable to assume that these lab reports were posted on their website the day the products were first available,” Jones said.
In addition to the issue of timing, some stakeholders say they have also discovered FSA-listed approved products that contain amounts of THC that significantly exceed ACMD’s guidance.
Kyle Esplin of the Scottish Hemp Association and a member of the UK Cannabis Industry Council, said his early analysis showed some products contained amounts as high as 200 milligrams per 100ml sales unit, which did not coincide with normal consumption patterns compared to the ACMD 50 recommended limit. micrograms of THC per serving.
Esplin and Jones also criticized the FSA for not distinguishing between naturally-derived CBD products obtained through conventional extraction methods and those derived through synthesis, suggesting that while the former has been shown to be safe, the latter was developed after 1997 – a novel definition Foods, under UK rules which are based on that date in EU regulations.
“How can industrial hemp not be subject to more stringent requirements for their new food applications?” Jones asked.
Esplin noted that the FSA also failed to give specific rules for labeling synthetic products. “There is no requirement for companies that make synthetic CBD products to classify them as such,” Esplin said. “For example, if a product is made from two isolates with terpenes added, it should not be called ‘full spectrum.’ If the product contains synthetically produced CBD, the consumer should be informed.”
“The new Foods update highlights that in addition to being a colossal waste of time and money, the process now lacks any credibility,” Esplin said.
Next legal challenges?
Stakeholders suggested that some of the excluded brands may consider legal challenges to FSA decisions if they do not get a reasonable response from the agency. Steve Moore, founder of the ACI, told The Grocer that he agreed that there may be cases where there is “definitely a legal challenge that needs to be lodged”.
Moore said some adjustments are likely to be made in the coming weeks due to errors, but he says many brands not on the FSA’s approved list have failed to submit appropriate plans to provide toxicology data to the agency. “Nobody without data on toxins will be included in the list,” Moore told The Grocer.
ACI said it “is in constant contact with the Financial Services and Trade Standards Authority and local authorities and will issue a statement from our founders next week regarding the status of the list.” The association said there is no way to predict how many products that remain active in the FSA process can reach full authorization.
Forty-six of the 70 successful apps announced on April 1 came through ACI. All of their products are approved.
EIHA Projects GmbH, a consortium organized by the European Industrial Hemp Association, has also submitted multiple applications for CBD products. The consortium said it noted “inaccuracies, inconsistencies, and indeed some surprising omissions on this list,” which it has taken under review.
The FSA said the list published earlier this month should not indicate endorsement and that successful applicants so far may fail the authorization process at a later stage. Further progress or explanation of the food safety process depends on whether “the application is credible, and the Financial Services Agency has reported, or expects soon to receive, significant scientific evidence from the applicant from which to judge safety.”
Voluntary removal sought
The list, released April 1, aims to guide local authorities, retailers and consumers in making informed decisions about what they stock and buy, the Financial Services Authority said.
Producers have been encouraged to voluntarily remove unapproved products from the market, and trade standards officials are said to be monitoring retailers. Companies that continue to sell unlisted CBD products run the risk of enforcement action.
The FSA said it has “advised local authorities to take a proportionate approach to enforcement against CBD products and we understand that it may take time for the market to reduce and remove some products from circulation.”
The FSA list covers products sold in England and Wales. Northern Ireland is also subject to EU rules under the Brexit protocols.
* 23 incompatible products
In addition to cellular goods, products identified by The Grocer in the UK that fail to meet new dietary guidelines and are due to be removed from major retail outlets are:
- body and mind
- cannabis relief
- CBD expert
- drink 420
- Hemp Hatters
- holistic herb
- Lou Bruce
- Simply CBD
- paper life
- Vita Coco