The FDA has finalized its guidance for manufacturers submitting premarket tobacco product applications for electronic nicotine delivery systems, such as e-cigarettes or “vapes.”
According to an FDA release, this guidance also extends to liquid nicotine and nicotine-containing e-liquids used in e-cigarettes.
“The final guidance issued today provides companies seeking to market e-cigarette and [electronic nicotine delivery system] 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,” Ned Sharpless, MD, acting FDA commissioner, said in the release. “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.”
With the new premarket tobacco product application (PMTA) pathway guidance, manufacturers or importers must demonstrate to the FDA that the marketing of new tobacco products would be appropriate for the protection of public health, among other guidelines.
This statutory standard requires that the FDA consider:
- the risks to both users and non-users as well as benefits to the population as a whole;
- the likelihood that existing users will stop using such products;
- the likelihood that those who do not use tobacco products will start using such products;
- the tobacco product’s components, ingredients, additives, constituents and health risks; and
- how the product is manufactured, packaged and labeled.
According to the FDA release, the agency is recommending that manufacturers provide information describing the packaging of their product, such as child-proofing and nicotine exposure warnings, to mitigate the risk of accidental exposure to e-liquids.
Additionally, the agency recommends that applications contain battery information, including amperage, voltage, wattage, battery type (chemistry) and whether the battery is consumer-replaceable.
The FDA is also exploring product standards to prevent injuries from known tobacco product risks that include "vape" battery explosions, according to the statement.