PRESS RELEASE: “FDA Misses Opportunity To Help Adult Smokers And Protect Public Health”

Regulate Smarter remains committed to working alongside FDA toward common sense policies that provide adult consumers reduced harm products while stemming the influx of illicit nicotine products from China targeting underage users

WASHINGTON, D.C. – Today, former U.S. Senator Richard Burr (R-NC), chairman of the Coalition for Smarter Regulation of Nicotine (Regulate Smarter), issued the following statement in response to draft guidance issued by the U.S. Food and Drug Administration (FDA) regarding flavored electronic nicotine delivery systems (ENDS) premarket applications:

“The draft guidance on flavored premarket tobacco applications published by the FDA misses the mark. The key to solving the illicit nicotine product market is to authorize more legal, less harmful choices for adult consumers. Without more authorized products that can be sold through channels with appropriate safeguards against youth access, illegal Chinese products will continue to target young people and threaten adult consumers seeking reduced harm options. Unfortunately, the draft guidance ignores that reality. Almost 8 in 10 vapor products in this country are illegal, most come from China, and often intentionally target underage users. If there is a non-tobacco flavored vapor product on the market, it’s illegal and most likely from China. FDA’s guidance does nothing to help reduce the illicit marketplace and will potentially exacerbate the crisis by ensuring that the only flavored products on the market are those smuggled across our borders. While we remain committed to working with FDA toward common-sense policies that provide adult consumers regulated products they are seeking while stemming the influx of illicit products, this latest guidance unfortunately falls short.”

Since its inception in 2025, Regulate Smarter has been advocating for common-sense reforms to address the flood of illegal and unregulated tobacco and nicotine products into the U.S., effectively enforce the Tobacco Control Act (TCA) and restore order to the marketplace, emphasizing the need for both enforcement and authorization as part of a comprehensive approach.

Regulate Smarter’s web site is available here https://www.regulate-smarter.org/

###

The Coalition for Smarter Regulation of Nicotine (Regulate Smarter) comprises 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/