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FDA Mulls Banning Flavored E-Cigs From C-Stores

Commissioner cites ‘surge’ in teen use, while association points improved to age-verification compliance

WASHINGTON -- In what could be the most ominous sign for convenience-store retailers selling electronic cigarettes, the commissioner of the U.S. Food and Drug Administration (FDA) publicly targeted the channel for a potential ban on flavored e-cigarette sales, reported CNBC.

In an Oct. 19 interview on “Squawk Box,” Scott Gottlieb, commissioner of the FDA, said the agency was considering prohibiting some e-cigarette sales from c-stores, opting instead to sell those products at vape shops, CNBC reported.

He said use of e-cigarettes “surged” 77% among high school students and 50% among middle school students in the past year, calling the levels “epidemic.”

“We’re looking at what can be sold in brick-and-mortar stores and whether flavored products can be sold in regular stores such as a 7-Eleven and a truckstop and a gas station, or whether flavored products on the market should be confined to adult vaping shops, which generally tend to do a better job of checking ID,” Gottlieb said.

In response to the commissioner’s comments, Alexandria, Va.-based NACS called for the agency to work with NACS and other age-verification entities such as We Card to reduce underage sales of tobacco products to minors, but in the same statement, NACS also sent a sharp note of criticism.

“The FDA has refused to share the data it has on the inspections it has carried out of vape shops and other stores that would allow the industry to evaluate and address any shortcomings,” said Lyle Beckwith, senior vice president of government relations for NACS. “All the information available shows that the convenience industry has consistently improved compliance through improved training to prevent underaged sales and that indeed the industry has succeeded in achieving compliance much higher than required by the federal government under the Synar [Amendment] requirements” for states to issue laws to prohibit the sale of tobacco products to minors.

“If the FDA thinks otherwise, it needs to have some factual basis for it,” Beckwith said. “Banning the convenience industry from selling e-cigarettes would be counterproductive as it would simply mean that minors will seek e-cigarettes from less-regulated channels of sale.”

Calling Gottlieb’s comments “insightful,” Bonnie Herzog, managing director of consumer equity research for Wells Fargo Securities, New York, said in a recent newsletter that the FDA is expected to release a “preponderance” of evidence to back Gottlieb’s statements, which may lead to certain outcomes. She identified three “more likely than not” possible scenarios:

  1. The FDA bans online sales of e-cigs until it is able to formulate appropriate restrictions via regulation.
  2. The agency possibly restricts the sale of cartridge-based e-cigs to vape shops, potentially removing them from the c-store channel.
  3. The FDA bans or restricts certain e-cig flavors with high youth appeal.

The agency conducted a “blitz” over the summer, using undercover operatives to identify stores that allegedly allowed the sale of e-cigarettes to minors. The largest coordinated enforcement effort in FDA history, the process resulted in the FDA issuing more than 1,300 warning letters and fines to retailers who illegally sold products from San Francisco-based Juul Labs and other e-cigarettes to minors.

The FDA also conducted several inquiries into the marketing and sales practices of numerous manufacturers in recent weeks.

For their part, manufacturers have agreed to cooperate with the FDA inquiries and said they adhere to strict guidelines with regard to keeping product out of the hands of minors, also saying they comply with FDA rules on the manufacture and sale of their products.

In a statement responding to the FDA actions targeting manufacturers, officials with Charlotte, N.C.-based Fontem Ventures said their products were available in the United States prior to the Aug. 8, 2016, FDA “deeming” deadline and that it will provide supporting information to the FDA.

“We fully recognize the challenge faced by the FDA in balancing the positive public health potential of vapor products with legitimate concerns regarding youth access and responsible marketing,” Fontem officials said. “Fontem is committed to creating something better for the world’s smokers. Vaping provides a unique opportunity to switch smokers to a healthier alternative but this can only be achieved by responsible businesses operating in appropriately regulated markets.”

Photograph: Shutterstock

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