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How The FDA May Be Overstepping Bounds With New E-Cigarette Policy

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How The FDA May Be Overstepping Bounds With New E-Cigarette Policy
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The Food and Drug Administration aims to extend Obama-era policies restricting e-cigarette sales to teen consumers.

As early as next week, FDA Commissioner Scott Gottlieb will deliver a plan to:

  • Tighten age verification for online sales;
  • Advance a ban on menthol flavoring in combustible cigarettes; and
  • Ban flavored e-cigarette sales in gas stations and convenience stores.

The latter policy would exclude tobacco-, menthol- and mint-flavored products, according to The Washington Post.

Any such action would expand the concentrated efforts of cities and states to restrict sales in the name of youth health. The New York government announced earlier this week its intention to ban flavored e-cigarettes as early as 2019.

Overstepping?

The administration may see pushback, particularly on the restricted sale of certain flavored e-cigarettes. Height Capital Markets perceives no jurisdiction for the FDA to target distributors under the Tobacco Control Act.

“It appears illegal to us for FDA to use its so-called ‘enforcement discretion’ of premarket tobacco product applications (PMTA) as a means to pick and choose retail outlets for tobacco products,” analyst Stefanie Miller wrote in a note. “We think the agency might be able to exercise its authority to recall certain tobacco products to achieve this goal. No matter what, these actions are highly likely to face legal challenges and we think it is going to be a steep hurdle on the part of FDA to defend its actions under current law.”

Additionally, Miller doesn't expect the FDA to threaten the industry for combustible cigarettes.

“Our best guess is that the menthol issue will get some serious lip service but no new, meaningful regulatory activity,” Miller wrote. “The FDA currently has two pending advance notices of proposed rulemaking (ANPRMs) that could impact menthol cigarettes: one that explicitly targets these products and another that targets flavors of tobacco products more broadly. We think it is most likely Gottlieb will reference these ongoing efforts and possibly commit to redoubling work here, but we do not see a path forward in any reasonable timeline for FDA to ban menthol cigarettes.”

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The Duel Over The JUUL: FDA Zeroes In On E-Cigarette Industry, Teen Use Concerns

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