With an interim commissioner set to take over in the next few days, the US Food and Drug Administration (FDA) remains highly focused on the e-cigarette industry – while the industry itself is no doubt watching developments at the FDA just as closely.
While stand-in chief Ned Sharpless is not expected to change tack sharply from the course set by outgoing commissioner Scott Gottlieb, he will be stepping into a busy office, not knowing how long he is likely to occupy it.
Earlier this month, the FDA revealed details of its planned crackdown on flavoured e-cigarettes, which appears to be an attempt to establish a legal route for removing certain products from the market.
Under the agency’s new policy, most flavoured vaping products will need to enter the premarket tobacco product application (PMTA) process a full year before other products, with submissions due by 8th August 2021.
When the new policy is finalised, non-exempt flavoured products – all those with flavours others than tobacco, menthol or mint – will no longer be allowed to be sold “in locations that minors are able to enter at any time”. This has been interpreted as an attempt to prevent their sale in convenience stores.
The new policy also imposes restrictions on online sales.
The FDA has said it will act against products that “are targeted to minors or likely to promote use of ENDS by minors”. It has released a draft of the new measures, saying that it intends to review comments and then finalise it “as quickly as possible”.
Outgoing commissioner Gottlieb observed: “Manufacturers and retailers are on notice that we’ll continue to be vigilant about efforts to make tobacco products that appeal to kids.”
Industry stakeholders have warned that the flavour restrictions could impose such a heavy burden on e-cig firms that the cost of compliance could force many small businesses to go bust.
“A lot of smaller companies will fall by the wayside,” Ray Story, CEO of the Tobacco Vapor Electronic Cigarette Association (TVECA), told ECigIntelligence.
“The reality is, to fight the process, no one is going to be on your side. Big Tobacco doesn’t care because they have plenty of money.”
Eliminating the competition
He claimed that Big Tobacco would welcome the elimination of the competition. And he is not alone in his concerns for small businesses.
Global law firm Keller & Heckman, which consults on the vaping and tobacco sector, agrees that the time-consuming and complicated PMTA applications will be problematic for many in the industry.
The PMTAs are “complicated applications that require quite a bit of analysis of non-critical and critical studies that take time to complete,” Keller & Heckman partner Azim Chowdhury told ECigIntelligence. He added: “This is going to hurt people who wanted to meet the  deadline.”
Estimates of the costs of the PMTA process range from $300,000 to $5m per application and hundreds, perhaps thousands, of hours.
- For an in-depth analysis of the US FDA flavour ban restrictions, country-by-country trackers of vaping restrictions, and detailed country profiles of e-cig legislation, inquire about subscription packages and pricing.
– ECigIntelligence staff
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