Legacy approvals may not be enough for vape products to remain on market, expert warns

Legacy product submissions previously approved by regulators could come back to bite manufacturers and affect retail sales, a vaping compliance expert has warned.

Lee Bryan, managing director of Arcus Compliance Ltd, leading advisers to the vaping industry and many of its biggest brands, said 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, he added.

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.

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

Bryan noted that the lack of regulatory awareness in the industry is a matter of concern. “If companies are operating in this market and don’t know what’s in their products, they should pull out,” he said.

While there is no legal requirement or other incentive at the moment for manufacturers to go through their legacy submissions and resubmit them through the MHRA portal, he said this could change if the regulators and enforcement agencies did decide to use the new portal to review legacy data.

“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,” he said.