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Expert's Compliance Warning

Compliance expert warns vaping industry that legacy product submissions previously approved by regulators could come back to bite manufacturers and affect retail sales

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Compliance expert warns vaping industry that legacy product submissions previously approved by regulators could come back to bite manufacturers and affect retail sales. Thousands of vaping products face being shut out of the British retail market if producers fail to seek comprehensive validation as required by the Medicines and Healthcare products Regulatory Agency (MHRA).

Compliance submissions for vape products originally accepted as correct by the European Common Entry Gateway (EUCEG) may now not be enough, so manufacturers need to check that they have listed all necessary components.

The warning comes from Lee Bryan, managing director of Arcus Compliance Ltd, leading advisers to the vaping industry and many of its biggest brands.

Arcus Compliance was established in 2017 to help clients implement best-practice compliance. The company develops robust processes to support customers’ regulatory compliance and product stewardship while providing ongoing advice and education through online content.

The directors have more than 25 years’ collective experience across the vaping sector, serving some of the world’s best-known brands and working closely with decision-makers, regulatory bodies and enforcement agencies. Arcus Compliance is a full board member of the UK Vaping Industry Association and sits on the Standards and Membership committees.

After Britain’s exit from the EU, the MHRA invested in its own Submission Portal to keep a check on new vaping products, a process previously handled through the EUCEG.

Attention is now being turned to some 40,000 EUCEG submissions dating back to 2016 which required only signed declarations of conformity with the regulations rather than more in-depth validation.

The EUCEG submission process took on trust that a product did not breach the Tobacco Products Directive, such as a vaping recipe lacking toxicology data for all ingredients.

Bryan says: “An issue would only be flagged up if one of the competent authorities opened the submission and looked at it in detail. Without doubt, there are products on the market that require attention.

“We are now seeing many more brands being asked to provide more information – or being forced to exit the market.”

Bryan continues: “It’s somewhat concerning, the lack of regulatory awareness in this industry. If companies are operating in this market and don’t know what’s in their products, they should pull out.”

At the moment, there is no legal requirement or other incentive for manufacturers to go through their legacy submissions and resubmit them through the MHRA portal.

Bryan adds: “However, if the regulators and enforcement agencies did decide to use the new portal to review legacy data, we could see a massive change.

“They will catch up one day, so it’s a good idea to review your submissions. Brand owners have to ask themselves: do I want to be in the market in five years’ time?”


Dave Cross avatar

Dave Cross

Journalist at POTV
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Dave is a freelance writer; with articles on music, motorbikes, football, pop-science, vaping and tobacco harm reduction in Sounds, Melody Maker, UBG, AWoL, Bike, When Saturday Comes, Vape News Magazine, and syndicated across the Johnston Press group. He was published in an anthology of “Greatest Football Writing”, but still believes this was a mistake. Dave contributes sketches to comedy shows and used to co-host a radio sketch show. He’s worked with numerous vape companies to develop content for their websites.

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