FDA’s New Product Approval Process: Here’s What’s at Stake

From: CSPnet.com

Can any independent electronic cigarette afford the application process?

By Melissa Vonder Haar, Tobacco Editor, CSP

BOSTON — Last week, for the first time ever, the U.S. Food and Drug Administration (FDA) authorized the marketing of new tobacco products through the premarket tobacco application (PMTA) pathway. The decision, which applied to eight new Swedish Match snus products, was lauded as a landmark in tobacco regulation.

“Today’s action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed as long as the public health can be protected,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.

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