We are the Coalition for Smarter Regulation of Nicotine
We are a community of industry members united in our commitment to operate responsibly within the regulated marketplace and advocate for a U.S. Food and Drug Administration (FDA) system that’s focused on harm reduction.
This includes FDA using science-based regulation of legal products to drive down underage use, protect adult consumers, and critically, provide adult consumers access to smoke-free options proven to be less harmful than cigarettes.
That was Congress’s original vision when it gave FDA comprehensive authority of this industry in 2009.
Today, underage use of tobacco and nicotine products is at the lowest levels in a generation [1]. But there is a widespread consensus that FDA regulation is falling far short of Congress’s harm reduction vision [2].
FDA and the scientific community agree that while nicotine is addictive, it is smoke from conventional cigarettes that causes all or almost all tobacco-related harm [3].
But as millions of adult consumers move from cigarettes to less harmful, smoke-free options like vapor and pouches, FDA has legalized only a small fraction of the products these adult consumers seek [4].
FDA’s authorization approach has left nearly 20 million adult vapor consumers, and millions more adult pouch consumers, without the less harmful options they are seeking in the legal marketplace.
The result has been a massive outbreak in illegal vapor, pouch, and other nicotine products flooding the U.S. from China – products that evade all FDA oversight, review, or accountability [5].
The explosive growth of an alternative unregulated marketplace – operating outside FDA oversight – is a major threat to youth, to adult consumers, and to FDA regulation itself.
At the same time, FDA has done little to inform adult consumers, physicians, or policymakers about the significant differences in risk between smoking and using authorized smoke-free alternatives. Today, a majority of consumers and health care professionals incorrectly believe that these smoke-free alternatives like vapor and pouch products are just as harmful, or more harmful, than cigarettes [6].
Our Priorities
We believe the time has come to fully modernize FDA’s Center for Tobacco Products and set a clear direction toward harm reduction.
That means adopting neutral, science-based regulation that focuses on authorization, education, and enforcement.
To establish a well-regulated marketplace, FDA should:
Accelerate and streamline the authorization process to provide adult consumers access to the less harmful smoke-free products they are moving to; and support rather than impede a transformation of the marketplace for the better.
Educate adult consumers on the benefits of authorized smoke-free options over conventional cigarettes – empowering them with the information to help them make better choices.
Use FDA’s most powerful enforcement tools to reverse the tide of illicit vapor, pouch, and other products flooding the U.S. from China and elsewhere – and ensure all industry members are playing by the same rules.
Use regulation of legal products to drive down underage use and ensure basic consumer protections for the tens of millions of adult tobacco and nicotine consumers in the U.S. – goals that are too important to leave to illicit markets.
By modernizing FDA regulation, we can create a framework that supports a responsible, common sense regulatory approach that meets the needs of today’s society.