US
The US Food and Drug Administration (FDA) has finalized its guidance for manufacturers submitting new tobacco product applications through the pre-market 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.
Acting FDA Commissioner Ned Sharpless, MD, said, “The final guidance issued [June 11] 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.”
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.