PRESS RELEASE: Regulate Smarter Applauds FDA Reevaluation of PMTA Framework

Chairman Burr: The choice before the Agency is clear: accelerate authorization of legal, smoke-free alternatives so adult consumers can find what they want in the regulated marketplace or continue with a status quo that is fueling a massive illicit market

WASHINGTON, D.C. – Today, Richard Burr, chairman of the Coalition for Smarter Regulation of Nicotine (Regulate Smarter) and former U.S. Senator, issued the following statement after the U.S. Food and Drug Administration (FDA) announced its intent to evaluate changes to the Premarket Tobacco Product Application (PMTA) regulatory framework:

“FDA’s announcement signals an encouraging and long-overdue course correction. This is FDA’s chance to regain control of a marketplace now dominated by illicit, unregulated products.  Millions of American adults are moving away from smoking to smoke-free nicotine products that public health authorities agree are much less harmful.  With youth nicotine use reaching historic lows, the choice before the Agency is clear: accelerate authorization of legal, smoke-free alternatives so adult consumers can find what they want in the regulated marketplace or continue with a status quo that is fueling a massive illicit market putting both kids and adults at greater risk. The Administration’s focus on enforcement is a meaningful step in the right direction, but enforcement alone is not enough. FDA must meet adult consumers where they are and build a legal, regulated market – where FDA can far more effectively protect kids and adults.”

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The Coalition for Smarter Regulation of Nicotine (Regulate Smarter) is comprised of members representing manufacturers, distributors, and retailers committed to operating responsibly within the U.S. Food and Drug Administration (FDA)-regulated marketplace. Regulate Smarter supports an FDA regulatory system that delivers on the original harm reduction vision of the Tobacco Control Act. Chaired by former U.S. Senator Richard Burr (R-NC), the Regulate Smarter Coalition is committed to advancing a modern, common-sense approach to regulating tobacco and nicotine that is grounded in science. To learn more, visit: https://www.regulate-smarter.org/