Latest Release – CBD

Selling using and recommending CBD products in the UK

Little has changed in the UK. Some companies talk about the limits being 0.2% THC and/or no more than 1mg of THC per finished unit of sale.  However the Home Office – Drug Licensing Factsheet  If a CBD ‘product’ contained any controlled cannabinoids, unintentionally or otherwise (e.g. THC or THC-V), then it is highly likely that the product would be controlled….. Against this background, the presumption has to be one of caution – that is, that a CBD containing product would be controlled under the MDA 1971 /MDR 2001 as a result of its other cannabinoid content.

The Advertising Standards Authority have updated their page on CBD containing products to state that ‘It remains a marketer’s responsibility to establish which Regulatory regime applies to their individual product in order to establish if and how the product can be marketed’ before going on to recommend that marketers read the Home Office – Drug Licencing Fact Sheet and  ‘…seek specialist legal advice before taking any further steps to bring a CBD product to market.’

Selling using and recommending CBD products in other countries

In the UK and in Germany the existing laws seem to be erratically applied by local enforcement agencies making the use, the supply, and the recommendation of CBD products, a real danger-zone for practitioners. This is not the case in other parts of Europe where the law is very much clearer.

Bulgaria – After initial reports that Bulgaria had issued certificates permitting the sale of products containing CBD which ‘comply fully with relevant requirements of the Law on Foodstuffs of Republic of Bulgaria and of Regulation (EC) No 852/2004 of European Parliament and the Council on the hygiene of foodstuffs’ the Bulgarian authorities now appear to have rescinded the certification.

Ireland – The Food Safety Authority of Ireland (FSAI), responding to a question on the wide availability of CBD oil extract have advise that These products have been placed on the market without authorisation and are not permitted for sale. As we become aware of such products their status on the market is addressed.’ The FSAI went on to say ‘No health claims relating to hemp or CBD are authorised for use under Regulation (EC) No 1924/2006 (see FSAI’s Information on Nutrition and Health Claims).

Italy –   The highest judicial body in Italy, the Court of Cassation has recently ruled that selling cannabis derivatives is a criminal act and ‘cannot be sold under any circumstances…’.  It is the uncertainty around the variability of THC content which leaves suppliers facing not just fines for breeching Novelty Food regulations, but criminal prosecution under narcotics laws.

Sweden – After completed supervision cases the Swedish Medicines Agency has determined that products containing CBD are drugs.  ‘Since the pharmaceutical legislation requires that medicines be approved or registered, the sale of these products is illegal.’ https://lakemedelsverket.se/Alla-nyheter/NYHETER—2018/CBD-produkter-ska-folja-lakemedelslagen/

USA –    The USA’s Food and Drug Administration (FDA) states that ‘Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective.’ In regard to selling THC or CBD as a dietary supplement the FDA says ‘Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)].’

https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers#dietary_supplements

Financial enforcement

There have to date been only a limited number of actions against sellers and distributors of CBD products by local enforcement agencies. Banks and payment processing providers on the other hand taking a much more robust approach. The big four (Barclays, Lloyds, HSBC, and Natwest) have now joined PayPal in listing businesses using CBD products or trading in CBD products as ‘high risk’.  This has led to business accounts being closed and payment processing services being withdrawn.

There is still an option to use E-money companies such as Paytriot Payments who offer High Risk payment processing in the UK however these are also subject to FCA regulation and may soon encounter the same legality issues.

Quality concerns

The market is being flooded with high dose and adulterated CBD products heightening the risk of an adverse reaction. The Centre for Medical Cannabis blind-tested 30 products advertising themselves as CBD, bought on the High Street and online. It found almost half (45%) had measurable levels of THC, making them technically illegal in the UK. One sample, bought at a high street pharmacy chain, had no CBD in it at all and was selling for well over £50. Only 38% of the products tested had levels of CBD within 10% of the amount advertised on the bottle.

Our Advice

  • The legal status of CBD products in Europe remains complex with a wide range of enforcement approaches. FNTP continue to urge caution if choosing to use CBD products.
  • Consideration should be given to the use of alternatives such as palmitic acid monoethanolamide (PEA)
  • If you are using the FNTP Block Scheme Insurance, make sure that you have provided the insurer with answers to the additional Referrals Relating to CBD Oil sheet and paid the additional premium.
  • If you are using another insurance contact the provider and get confirmation in writing that you are covered for CBD products.
  • Do not store quantities of CBD products.
  • If you are visited by Trading Standards or the Police please contact the FNTP Support Teams via the live Online Support facility, by telephone or email.

We will continue to monitor the situation closely.

Issued 08.08.19

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