TOBACCO
A Category in Flux — Again C-store retailers are cautiously optimistic about the vapor category despite its challenges By Renée M. Covino IT WOULDN’T BE the “e” category without constant eruption. Electronic cigarettes and vapor products are the subject of much attention in tobacco news and regulation, and convenience store retailers are responding with mixed reactions.
On the regulation front, the biggest news revolves around the Food and Drug Administration’s (FDA) still-ongoing decisions for or against the premarket tobacco applications (PMTAs) filed by suppliers for their electronic nicotine delivery system (ENDS) products. Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the tobacco product would be appropriate for the protection of public health. The FDA must approve PMTA bids for e-cigarette and vapor products to stay on the market. As of mid-December, the FDA had given the greenlight to just seven products. The agency handed out its first approval on Oct. 12, authorizing R.J. Reynolds
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Vapor Co.’s Vuse Solo END system and its accompanying tobacco-flavored e-liquid pods for the U.S. market. The FDA, though, also issued 10 marketing denial orders (MDOs) for the flavored ENDS products submitted under the Vuse Solo brand. On Oct. 19, the agency granted PMTA approval to four oral tobacco products manufactured by U.S. Smokeless Tobacco Co. LLC under the Verve brand. The products include Verve Discs Blue Mint, Verve Discs Green Mint, Verve Chews Blue Mint, and Verve Chews Green Mint. Verve, however, has been discontinued since 2018. Before authorizing a tobacco product via the PMTA pathway, the FDA puts it through the lens of: the likelihood that current tobacco users will stop using tobacco products; and the likelihood that current nonusers will start using tobacco products. The agency received PMTAs for more than 6.5 million tobacco products by its Sept. 9, 2020 deadline. As of late October, the FDA said it was close to wrapping up its sweeping review. The agency is already being sued for several of its refusals. Retail associations have been pressing the FDA to release a list of the ENDS products given denial orders