FDA Releases Proposed Rule On E-Cig Applications

Law360 (September 20, 2019, 3:24 PM EDT) -- The U.S. Food and Drug Administration on Friday laid out a proposed rule setting requirements for companies seeking approval of their e-cigarette products, including keeping records on the legal marketing of their products.

The FDA said that when finalized, the proposed rule will help make sure that applications for premarket approval of e-cigarettes would contain details about the product’s potential public health benefits and risks. It will also set in place how the agency will review the applications, according to the FDA.

“Our review of premarket product applications will help evaluate the public health benefits and harms of a tobacco product...

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