The FDA finally finalizes premarket tobacco product application

June 24, 2019

guidance for E-Cigarettes, and it's not as insane as we once feared.  Last week, the U.S. Food and Drug Administration  finalized its guidance for manufacturers submitting new tobacco product applications through the premarket tobacco product application pathway for electronic nicotine delivery systems.

The new process includes reviewing a product’s components, ingredients, additives, constituents and health risks, as well as how the product is manufactured, packaged and labeled. “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,” said Acting FDA Commissioner Ned Sharpless, M.D.

“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,” he added.

Sharpless also added that in the meantime the FDA will keep doing everything possible to combat teen vaping. “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 draft guideline was released just weeks before former Commissioner Scott Gottlieb’s left the big chair a few months prior.  This move was actually one of Gottlieb’s priorities following the backlash over the alleged increase in teen vaping.  This guidance had called for the ban of flavored products with the exception of tobacco, mint, or menthol flavoring eLiquids, from retail stores that minors can access easily, such as convenience stores, drug stores, gas stations and other medium sized grocery or pharmacy stores.

Additionally, the document had also announced that the infamous premarket tobacco product application deadline which the FDA has been heavily criticized for, was now to be moved a year forward from 2022 to 2021. Back in March, U.S. Rep. Nita Lowey, had repeatedly drummed up scaremongering rhetoric against Gottlieb for the delay, saying that it was a “big, big whopping mistake” and that it helped fuel the alleged rise in teen vaping.

Under the new premarket tobacco product application pathway, manufacturers and importers must demonstrate to the agency that marketing of the new tobacco product would be appropriate for the protection of the public health. The agency’s evaluation also includes reviewing a tobacco product’s components, ingredients, additives, constituents and health risks, as well as how the product is manufactured, packaged and labeled.

Following an extensive review of input from the public on the previous draft guidance, the recently issued guidance further clarified the premarket tobacco product application process for electronic nicotine delivery products and points out information the agency recommends applicants include in a submission. Importantly, it also includes recommendations for how applicants should address public health issues in the design and manufacture of their products, such as accidental nicotine exposure and battery safety.

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