PRESS RELEASE: Regulate Smarter Urges FDA to Embrace Fundamental Reforms, Outlines Three-Pronged Plan

Coalition files formal comments in response to March 2026 “Draft Guidance for Industry: Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk”

WASHINGTON, D.C. – In response to the U.S. Food and Drug Administration’s (FDA) March 2026 Draft Guidance addressing how it reviews flavored e-cigarettes (ENDS) for authorization, the Coalition for Smarter Regulation of Nicotine (Regulate Smarter) filed comments urging FDA to fundamentally reform its system for authorizing e-cigarettes for legal sale to adult consumers. 

“The FDA regulatory system is in full blown crisis today – and the only way out of that crisis is more lawful choices for adult consumers,” said Richard Burr, Regulate Smarter Chairman and former U.S. Senator.  “While the enforcement discretion policy FDA announced last week is a good first step, what’s needed is more permanent reform of the system. The process FDA built for reviewing less harmful options has made it so hard for flavored ENDS to reach the legal market that almost none has.  FDA’s stated hope was to limit the availability of flavors, but it’s had the opposite and much more dangerous effect – a thriving, multi-billion-dollar illicit market filled with vastly more varieties of flavored e-cigarettes than FDA says it wants, and in forms and designs far more dangerous than anything the Agency would or should authorize.”

The full comments are available here.

Regulate Smarter’s comments call attention to the consequences of an FDA that has failed to meet the needs of the 25 million American adults choosing smoke-free nicotine options over smoking, urging the FDA to restore the original harm reduction intent of the bipartisan Tobacco Control Act and build a well-regulated legal market that provides adult consumers access to smoke-free, less harmful alternatives to cigarettes, while protecting youth and preventing underage access, by:

1. Fully enforcing the law on companies of unregulated, illicit products that have circumvented FDA regulation and are now reaping billions in revenue for having done so and, in the process, endangered American lives.

   
   

2. Reforming the authorization system to deliver within the legal marketplace the less harmful products adult consumers want as better alternatives to smoking, including flavored e-cigarettes.

3. Educating adult consumers on the facts about authorized smoke-free products so they can make the fully informed decisions they have every right to make.

Regulate Smarter, whose members account for the large majority of tobacco and nicotine products operating within the FDA-regulated system, note that the FDA’s assumption that flavors primarily drive youth use is not supported by data, especially recently-released National Youth Tobacco Survey (NYTS) data showing that underage use of e-cigarettes has dramatically declined since 2020 – precisely as flavored e-cigarettes massively proliferated throughout the U.S. through the surging illicit market.  Instead, the current policy has handed the flavored nicotine market to bad actors who ignore all FDA rules, including youth protections.

Since the enactment of the TCA in 2009, FDA has authorized only nine individual e-cigarette devices – less than 1% – of the millions of applications it has reviewed. Meanwhile, the illicit flavored e-cigarette market has exploded in size and scope, with estimates that it now comprises as much as 85% – mostly Chinese – of the $12.1 to $14.5 billion U.S. e-cigarette market.

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