Under the PMTA pathway, manufacturers or importers must demonstrate to the agency that marketing of new tobacco products 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, including users and non-users of tobacco products, the press release said. For example, the agency is recommending that manufacturers provide information describing the kind of packaging their product will be sold in to mitigate the risk of accidental exposure to e-liquids, such as child-resistant, exposure-limiting packaging or nicotine exposure warnings on labels.
“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,” Acting FDA Commissioner Ned Sharpless, M.D. was quoted as saying. “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,” he said. According to Sharpless, 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”.