FDA Issues Final Guidance Around PMTA Pathway for Electronic Nicotine Delivery Systems

SILVER SPRING, Md. — Electronic cigarette and vapor companies now have some direction when filing product applications with the Food and Drug Administration (FDA).

On June 11, the agency finalized its guidance for manufacturers submitting new tobacco product applications through the premarket tobacco product application (PMTA) pathway for electronic nicotine delivery systems (ENDS). The guidance covers e-cigarettes and vapor products, and liquid nicotine and nicotine-containing e-liquids.

"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," said Acting FDA Commissioner Ned Sharpless.

"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," he added.

To view the guidance, click here.

According to Sharpless, the final guidance provides companies recommendations to consider while they are preparing PMTA applications for ENDS products they want to market in the United States.

To date, the FDA has not approved authorized any e-cigarette currently on the market, he added. Under its authority to regulate tobacco products, the agency must approve a PMTA to commercialize any tobacco product not on the market as of Feb. 15, 2007.

Under the PMTA pathway, 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 agency explained.

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.

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.

Among other recommendations, the final guidance recommends 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 guidance also includes recommendations for constituent or chemical testing, applying existing scientific literature or analyses about similar products to the proposed new tobacco product, including multiple distinct products in a single submission, and referencing tobacco product master files.

In October, the FDA held a two-day public meeting that put its regulatory product review process in the spotlight, as Convenience Store News previously reported.

The hearing gave the FDA an opportunity to gather information on several fronts, including:

• General scientific principles relevant to substantial equivalence reports;
• Exemption requests;
• Premarket tobacco product applications; and
• Modified risk tobacco product applications.