WASHINGTON —Manufacturers of electronic cigarettes and vaping devices now have a road map for how to apply for new-product authorization from the U.S. Food and Drug Administration (FDA) to officially enter the U.S. market, with the agency announcing the release of its final guidance document for premarket tobacco product applications (PMTAs).
Regarding electronic nicotine delivery systems (ENDS), the FDA raised several concerns in the document, including battery safety and the balance between migrating smokers to less harmful nicotine options vs. the potential of young people becoming addicted to nicotine.
“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 Ned Sharpless, acting commissioner of the FDA. “The final guidance … 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.”
Following an extensive review of input from the public on the previous draft guidance, the FDA said the guidance issued June 11 further clarifies the PMTA process for ENDS products and the FDA’s current thinking about what applicants should include in a PMTA submission. It also includes recommendations on addressing public health issues in the design and manufacture of their products, such as accidental nicotine exposure and battery safety, the agency 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. Examples include child-resistant, exposure-limiting packaging or nicotine exposure warnings on labels.
Also, to enable the FDA to assess the risks of batteries in a particular product, the agency is recommending that applications include information on amperage, voltage, wattage, battery chemistry, whether the battery is consumer-replaceable, testing certificates for any voluntary electrical standards for the battery or device (including UL 8139, the recently published standard specifically for ENDS products) and under- or overvoltage protections. Other concerns include the likelihood of use and foreseeable misuse leading to overheating, fire and explosion during operation, charging, storage and transportation for distribution.
The guidance also includes recommendations for component or chemical testing, applying existing scientific literature or analyses about similar products to the proposed new tobacco product.
As part of the FDA’s ongoing strategies around tobacco and nicotine regulation, the agency also said it will explore measures to make tobacco products less toxic, appealing and addictive, “with an intense focus on youth,” it said.
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