PRESS RELEASE: Regulate Smarter Commends AEI Report & Encourages FDA To Address Illicit Nicotine Market & Modernize Authorization Process For Smoke-free Nicotine Products

New AEI report outlines 15 reforms that FDA should take – authors urge approach that focuses on increased enforcement and authorization to address illicit nicotine market & meet growing demand without changes to law

WASHINGTON, D.C. – Highlighting the “significant public health opportunity for millions of cigarette smokers to switch to far safer alternatives,” a powerful and comprehensive white paper published by the American Enterprise Institute (AEI) outlines 15 practical and simplifying reform proposals to the U.S. Food and Drug Administration's (FDA) authorization process for smoke-free alternatives like vaping devices, nicotine pouches, and heated tobacco products.

Noting that “adult demand for safer nicotine products is large and growing,” the report notes the “hurricane-force headwinds” facing new products attempting to enter the marketplace legally. The authors describe the FDA as “missing in action, leaving a vital pro-health marketplace in a state of lawlessness and chaos.”

To combat the “flourishing black market that bypasses the FDA with unauthorized and unregulated products supplied mainly from China,” the report suggests the imbalance will never be fixed solely with more enforcement (which is necessary but not sufficient),” and instead outlines an approach focused on:

• Escalating enforcement action to hold down illicit sales;

• Significantly increasing authorizations to meet adult demand for less harmful alternatives to cigarettes.

The authors urge the FDA to greatly increase the number and diversity of authorized smoke-free products, and outline 15 practical and simplifying reform proposals to do so.

The full list of recommendations and entire report is available here.

“This report clearly makes the case that the nation’s leading health regulator has instead become the prime culprit of the illegal vape trade in our country today, and lays out a roadmap toward getting the system back on track without changing the law,” said Senator Richard Burr, chairman of the Coalition for Smarter Regulation of Nicotine (Regulate Smarter) and a former Ranking Member of the Senate Committee on Health, Education, Labor and Pensions. “It’s clear that fully harnessing the potential of innovation and the next generation of lower risk smoke-free products requires an FDA committed not just to enforcement but also authorizing less harmful products to meet the growing demand of adult tobacco consumers seeking to avoid cigarettes. The FDA has been MIA, and without course correction, risks squandering one of the greatest health opportunities of our time.”

Titled “Regulating the Tobacco and Nicotine Market in the American Public Interest: A Reform Agenda for the FDA,” the report’s authors include:

• Sally Satel, a senior fellow at the American Enterprise Institute; the medical director of a local methadone clinic in Washington, DC; and a lecturer at Yale University School of Medicine.

• Clive Bates, the director of Counterfactual Consulting and the former director of Action on Smoking and Health in the UK.

• Donald Kenkel, the Andrew Dickson White Professor in the Department of Economics at Cornell University.

• Brad Rodu, professor of medicine and the Endowed Chair in Tobacco Harm Reduction Research at the Brown Cancer Center at the University of Louisville.

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

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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/