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FDA deeming regulations update: PMTA approval process finalized

Earlier today, the U.S. Food and Drug Administration (FDA) issued a press release announcing the completion of its guidelines for the Pre-Market Tobacco Application (PMTA) process.  Though the FDA deeming regulations of the 2016 regarding federal oversight of the e-cigarette and vaping industries is nothing new, the PMTA process itself has remained only partially defined.

With no definitive PMTA pathway for approval clearly detailed within the original multi-page document of the FDA deeming regulations, vape retailers and wholesalers around the world have been left largely in the lurch.  The original verbiage only states that any vaping companies wanting to sell vapor products in the USA to submit an application for approval on all products originally released to market after February 2007.

However, numerous questions immediately began to surface regarding the FDA’s initial demands for supporting documentation that would accompany the PMTA, and FDA officials didn’t know how to answer most of them.  So, the FDA began issuing a series of deadline extensions, which enraged anti-vaping activists and eventually, a whole lot of politicians on Capitol Hill.

Related Article:  Vaping cheers as Gottlieb extends FDA e-cig regulations to 2022

The initial deadline for PMTA submission of August 2018 has been extended at least twice by the former FDA Commissioner Scott Gottlieb.  The current deadline is August 2022, which seems to be still intact. Gottlieb’s replacement, Acting FDA Commissioner Ned Sharpless, issued the following statement which does not specifically identify a new or revised submission date.

“The FDA’s ongoing oversight of e-cigarettes and other ENDS products is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine and tobacco-related disease and death. The FDA is committed to providing a solid, science-based regulatory foundation to ensure that ENDS products authorized for marketing are appropriate for the protection of public health...” 
 
“The final guidance issued today provides companies seeking to market e-cigarette and ENDS products with recommendations to consider as they prepare a premarket tobacco product application to help the FDA evaluate the public health benefits and harms of a product. There are no authorized e-cigarettes currently on the market and we encourage companies to use this valuable document now as a guide to submit applications. At the same time, the public can be assured that the FDA has been and will continue to take all necessary actions to protect children as part of our Youth Tobacco Prevention Plan, including maintaining our focus on enforcement actions and policies aimed at ensuring e-cigarettes aren’t being marketed to, sold to or used by kids.”
 

The release of the completed guidelines arrives about one month after a Maryland District Court judge ruled against a lawsuit filed against the FDA by the American Academy of Pediatrics and other public health advocacy groups.  Judge Paul W. Grimm’s ruling document (Case No.: PWG-18-883) essentially says that the FDA acted illegally by allowing vapor and e-cigarette products to remain on the market until March 2022 without an approved PMTA.  The judge also gave the plaintiffs 14-days to propose recommended remedial actions to the FDA, and less than 30-days later, the FDA published its updated PMTA guidelines.   

Related Article:  Judge orders FDA to begin approval process for vaping devices immediately

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