Advice/Guidance on the ‘Novel Foods’ Threat

1. The FSA made an announcement on 13th February 2020 stating:
“Having considered the many issues at play, the FSA has set a deadline of 31 March 2021 to submit, and have validated, your novel food authorisation applications. After 31 March 2021, only products which have a fully validated application will be allowed to remain on the market; all other novel CBD products will be removed from sale.”

2. Since that date CannaPro has been working on developing advice and guidance on how CBD suppliers should respond. We have questioned the FSA in email correspondence and over the phone. We have consulted with lawyers, both solicitors and a barrister. Here we set out our recommendations.

3. The malevolent influence on the FSA of the Centre for Medicinal Cannabis and the Association for the Cannabinoid Industry (CMC/ACI) and the FSA’s evident lack of understanding of the market and CBD products is an existential threat that we must resist.  This is an attempted hijack by big business and bureaucrats of a market built by small, independent businesses.

4. CannaPro would support further, sensible, evidence-based regulation of the CBD market. In our view the FSA has demonstrated repeatedly that it is incompetent on the subject and has not taken any steps to improve its knowledge or understanding. The MHRA has failed consistently to enforce the Human Medicines Regulations 2012 which proscribe medicinal claims for unlicensed products and the Home Office has an institutional prejudice against anything cannabis-related and regularly publishes guidance that is inconsistent with the law.

5. Given the failure of the regulators (accepting that there are, of course, rogue suppliers and products) we consider that the core of the industry has achieved an exemplary standard of self-regulation. All members of the CTA and CannaPro Certified businesses can be regarded as legitimate suppliers offering genuine products.  It is our ambition that this market will be properly regulated by an independent, government-authorised regulator as soon as possible.

6. WARNING. Nothing can protect you or your business from a trading standards, environmental health or police officer using their lawful power to seize your products. If you resist such action then you will be liable to arrest.  If this happens it is important you co-operate but register a protest explaining why your products are not novel foods (as set out below) and get a receipt for all items seized. Then contact CannaPro.

7. These recommendations are predicated on the FSA’s own words. “CBD extracts, isolates and other novel forms of CBD are novel foods as defined within the EU Regulation 2015/2283”. Source: Email dated 17th March 2020.

8. “CBD is one of many chemicals called cannabinoids. It is found within hemp and cannabis. CBD extracts can be derived from most parts of hemp/cannabis plants. They are selectively extracted, concentrating CBD and removing or reducing other chemical components. This process means the final product is different from hemp. Hemp and related products, such as cold-pressed oils, are not novel because there is evidence to show a history of consumption before May 1997. This is not the case for CBD extracts.” Source: FSA website last updated 19 March 2020

9. All CannaPro Certified businesses sell whole plant oil derived from low-THC cannabis known as hemp.  They would not be certified by CannaPro unless this was the case.  Therefore, the products are not “CBD extracts, isolates and other novel forms of CBD”. They are not “selectively extracted, concentrating CBD and removing or reducing other chemical components”. They are not “different from hemp”.

10. We recommend that CannaPro Certified businesses take the following steps in the way they describe their products both in packaging and all forms of marketing communications.  These changes can be introduced gradually before 31st March 2021 so that you can use up existing stock.
a. Remove the term CBD (or cannabidiol) from all product names.
b. Avoid the use of the word ‘extract’
c. Rename your products Hemp Oil or Low-THC Cannabis Oil.
d. Detail the CBD content in the ingredients and dosage information.
e. Describe your product as a ‘whole plant oil derived from hemp (or low-THC cannabis), preserving the natural balance of compounds from the plant’.
f. Add the descriptor ‘An exempt product under the Misuse of Drugs Regulations 2001’

 

 

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