The FDA hopes that the data gathered from these brands will assist the agency device an effective strategy to evaluate marketing plans when reviewing premarket tobacco product applications (PMTA).
The FDA said that a Center for Tobacco Products (CTP) analysis found that most leading ENDS brands use multiple social media platforms to market their products and do not use age-restriction tools to prevent youth exposure to their marketing. Moreover, added the agency, vape businesses are marketing through brand ambassadors and influencers, or people with a large social media following who can be compensated to promote products.
The four companies selected by the FDA have 60 days to respond to the letters sent on March 17th. Failure to respond could result in enforcement action by the FDA.
Vape brands receive warnings for not filing PMTAs
Earlier this year, the agency issued warning letters to 10 vape businesses which are still manufacturing and selling electronic nicotine delivery system (ENDS) products, without first obtaining a premarket tobacco product application (PMTA).
In a release on its website, the FDA had explained that for companies that submitted applications by the set deadline, the FDA generally continues to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by the FDA on the application.
PMTA list made public
Moreover, last September the agency had also announced that the normally secretive PMTA process will be made public, and the agency will be publishing a list of all the products subject to the deadline which have filed applications. The announcement was made by Mitch Zeller, director of the FDA’s Center for Tobacco Products, via a blog post, by which time the agency had already received applications for approximately 2,000 e-cigarettes and other newly regulated tobacco products.
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