PRESS RELEASE: Burr-Led Coalition Urges Immediate FDA Action To Stem Illegal Nicotine Crisis

Regulate Smarter applauds Commissioner Makary for recent commitment to address illicit nicotine products & outlines five concrete reforms to restore order to the marketplace, adopt a science-based regulatory framework & effectively enforce the Tobacco Control Act

WASHINGTON, D.C. - In a new letter addressed to Dr. Marty Makary, Commissioner of Food and Drugs for the U.S. Food and Drug Administration (FDA), the Richard Burr-chaired Coalition for Smarter Regulation of Nicotine (Regulate Smarter) outlined five concrete and 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.

In addition to Burr, a former senator from North Carolina and Ranking Member of the Senate Committee on Health, Education, Labor and Pensions, Regulate Smarter, which launched in May 2025, is a coalition of regulated manufacturers and trade organizations representing distributors and retailers committed to operating responsibly within the FDA-regulated marketplace and supporting an FDA regulatory system that delivers on Congress’s original harm reduction vision.

In the letter, which is available here, the Coalition commends Makary’s recent commitment to address the illicit market of nicotine products and observes that, “During the Biden Administration, illicit Chinese vaping products, without any regulatory oversight or consumer protections, began flooding our market. Produced overseas without meeting FDA safety standards or common tobacco product manufacturing practices, these illicit vapor products are deliberately avoiding compliance with the law, and many are intentionally marketed to underage users with youth-appealing features for example, Gummy Bear flavors and gaming device screens.”

At the same time, there are over 20 million adult consumers of vapor and nicotine pouches, a number that grows as more consumers understand the benefits of switching to less harmful alternatives. Yet, FDA has left these adult vapor and nicotine pouch consumers with far too few authorized smoke-free options to choose from and failed to give the market clear information regarding which specific products cannot be sold. Today, 85% of vapor products are unauthorized, many of them imported illegally from China. To address this mass-scale illicit market crisis, Regulate Smarter’s letter urges FDA to advance a comprehensive, effective regulatory framework that will:

1. Accelerate and streamline authorization of innovative, smoke-free nicotine products for adult consumers seeking less harmful, FDA-authorized options within the legal marketplace.

2. Rigorously enforce the law against companies manufacturing, distributing, and selling illicit vapor, pouch, and other products flooding the U.S. market from China and elsewhere – so that bad actors understand it’s not optional to avoid FDA oversight.

3. Provide clear information to regulated industry so that businesses can help prevent illicit product from being sold to consumers.

4. Empower adult smokers with accurate information on the benefits of switching from cigarettes to FDA-authorized, smokefree products to ensure adult consumers have the benefit of science-based information to make informed choices.

5. Use regulation and oversight of the industry to drive down underage use and ensure consumer protections for adult tobacco and nicotine consumers to realize the public health goals of the TCA.

“President Trump’s vision of a safer, healthier and more prosperous America is achievable, but it requires bold and immediate action to restore order to the marketplace,” said Burr. “We applaud Dr. Makary for his commitment to address the illicit nicotine market, and we stand ready to assist with the advancement of a modern regulatory framework grounded in science. It’s time that FDA step up to the plate and become an effective, science-driven regulator.”

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