A significant number of e-cigarette products are being sold on the US market without authorisation, according to research by ECigIntelligence, an independent data analysis resource for the tobacco-alternatives industry.
E-cigarette retailers and other industry stakeholders could lose millions in revenue if the US Food and Drug Administration (FDA) chooses to enforce its regulation on unauthorised products on the market.
Tim Phillips, ECigIntelligence managing director said: “There appears to be some disconnect between product authorisation and product availability. Any new product that has undergone a degree of change since August 2016 should need a PMTA [pre-market tobacco authorisation] to be on the market and FDA records do not show this as happening.”
New e-cigarette products should not have entered the US market from August 2016 without official authorisation. (Subscribers to ECigIntelligence can read a report on authorisation pathways.)
But ECigIntelligence believes dozens of new hardware products have been launched in the space of one quarter alone, after looking at some of the most popular US online vaping retail sites.
While it is possible that some of these products have been rebranded or re-labelled, ECigIntelligence has been told by confidential sources that there are definitely unauthorised products on the market.
It now appears that the FDA may be planning inspections to crack down on products unapproved for sale – and although it is the responsibility of manufacturers and importers to ensure their devices comply with FDA regulations, it could be retailers that end up paying the price if available stock is suddenly severely curtailed.
Enforcement would mean a return to 2016 market inventory. This means all the advances and innovations that happened in the last two years would suddenly be unavailable for American vaping consumers.
Retailers will lose business if the products are suddenly no longer available. Public health may also suffer if the withdrawal of unauthorised devices means some vapers return to conventional cigarettes.
The FDA has not made any moves towards enforcement beyond sending out a few cease-and-desist warning letters. But a request for proposals to fulfil a new inspection contract suggests this could change at any point.
Phillips added: “It could be that manufacturers and importers are gambling on non-enforcement or even a rollback of the FDA regulations governing e-cigarettes. But such thinking could prove to be costly and undermines the significant work and investment a few companies have made in ensuring their products are legitimate and in line with regulations.”
ECigIntelligence suggests retailers, importers and manufacturers ensure all of their devices comply with FDA regulations.