The FDA will issue guidance soon that bans pod- and cartridge-based vaping products that contain flavors other than tobacco and menthol, the Wall Street Journal reported late Tuesday. The move has been the subject of intense rumors since just before Christmas.
The action will not apply to open-system products like bottled e-liquid and mods.
The move is described by White House insiders as a compromise between the complete flavor ban some Trump administration officials (and Trump family members) want, and the hands-off approach Trump campaign officials have sought. The administration announced a ban on all flavored products in September, then backed off its plan after grassroots opposition from vapers and small businesses appeared to threaten Trump’s reelection chances.
The ban will mostly affect RJ Reynolds (Vuse), Imperial Tobacco (Blu), and independent e-cigarette pioneer NJOY. All three companies sell pod- and cartridge-based products in fruit flavors, mostly in c-stores and gas stations. Convenience store market leader JUUL stopped selling flavors other than tobacco and menthol last year.
The action is a temporary reprieve for vape shops and online e-liquid sellers. While it may appear to be a victory for open systems, all manufacturers still face a May deadline to submit premarket tobacco applications (PMTAs) or remove products from the market. The deadline, imposed by a federal judge last year, is the subject of a lawsuit by the Vapor Technology Association (VTA), and an appeal by the FDA.
The FDA guidance being announced soon is unlikely to address the PMTA deadline, or a separate PMTA path for open system products—something small manufacturers have called for. It probably will simply be notice that FDA will use its enforcement discretion to allow vape retailers to continue to sell deemed open flavored products for the time being, which means it is merely a postponement of the PMTA death sentence imposed by the FDA Deeming Rule.
Vaping360 will have complete coverage of the new FDA guidance when it is announced.
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Author: Jim McDonald