Pre-market tobacco application decisions shrink vape category as marketing denial orders hit more than 900,000 vape and e-cigarette products.
On Aug. 26, the Food and Drug Administration (FDA) lowered the hammer on approximately 35,000 flavored e-cigarette items by issuing marketing denial orders (MDOs). The ruling prohibits interstate commerce for these products, resulting in convenience stores, vape shops and tobacco retailers immediately pulling them from store shelves.
One week later, the FDA released approximately 300,000 more MDOs on flavored vape and e-cigarette products. Then, on the court-mandated deadline of Sept. 9, the FDA stated it had taken action on approximately 93% of the more than 6.5 million pre-market tobacco applications (PMTAs) accepted, including MDOs for more than 946,000 flavored vape and e-cigarette products.
“We know that flavored tobacco products are very appealing to young people; therefore, assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed,” said Acting FDA Commissioner Janet Woodcock.
“Right now, our main concern is that the FDA is aiming to clear the market of all but a handful of tobacco-derived nicotine vaping products. FDA is leaving adult smokers behind by trying to limit this category to only tobacco and menthol products. The end result will be disposables, e-liquids and pods being made with synthetic nicotine, which the (FDA) Center for Tobacco Products is not empowered to regulate,” said Gregory Conley, president of the American Vaping Association (AVA). “Efforts will eventually be made to restrict these products at the federal and state level, but as long as they remain legal, there will be a very large market for them.”
“JUUL is the one that makes me the most nervous about FDA decisions regarding the big brands. To use an old-school term, they’ve had a bullseye on their back,” said Anna Bettencourt, senior category manager for Haffner’s convenience store chain, which is owned by Energy North Inc. Headquartered in Lawrence, Mass., the company also runs car washes and foodservice sites.
Anne Baye Ericksen – CStore Decision – 2021-10-14.
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