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FDA Finalizes Guidance For Premarket Tobacco Product Applications For Electronic Nicotine Delivery Systems

The FDA finally released it’s guidelines last week for vapes

The U.S. Food and Drug Administration finalized its guidance for manufacturers submitting new tobacco product applications through the premarket tobacco product application (PMTA) pathway for electronic nicotine delivery systems (ENDS), such as e-cigarettes or “vapes,” and the liquid nicotine and nicotine-containing e-liquids used with such products, as part of the agency’s continued commitment to its oversight of tobacco products.

“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. 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.”

Under the PMTA pathway, which is the marketing pathway most likely to be pursued for ENDS products, manufacturers or importers must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health. That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. The FDA must also consider the likely impact of the products on people’s behavior—specifically, the likelihood that existing users will stop using such products and the likelihood that those who do not use tobacco products will start using such products. This is especially important for youth. 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.


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