After the repeated failures of the Biden Administration, President Trump has put the Food and Drug Administration (FDA) and its Center for Tobacco Products (CTP) under the microscope—and rightly so.
For far too long bureaucratic delays at the CTP in reviewing smoke-free products created confusion in the marketplace and ignored its required responsibility to promote public health through tobacco harm reduction, not prohibition.
With the confirmations of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. and FDA Commissioner Dr. Martin Makary, the agency has an opportunity to make the necessary reforms needed. One welcome step towards these changes came in March, when the administration took bold steps at the CTP by changing ineffective leadership.
Just days after these changes, the Supreme Court weighed in on the FDA v. Wages and White Lion case, involving the agency’s haphazard and shifting standards for evaluating premarket tobacco applications (PMTAs).
While the court upheld the FDA’s decision to deny flavored e-cigarette products, it also acknowledged concerns about the agency’s decision to ignore marketing plans “for the sake of efficiency,” and sent the issue back to the 5th Circuit for further review.
This is a pivotal moment for tobacco regulatory reform. CTP should embrace tobacco harm reduction, a principle grounded in science, not politics. That means authorizing smoke-free products that are better alternatives than continued smoking, which is the most harmful way to consume nicotine. These innovative products can help adults who smoke leave cigarettes behind for good which, in turn, can benefit the public health–but only if the CTP moves swiftly to review the massive backlog of pending applications.
While American businesses await regulatory clarity, illicit and unauthorized Chinese vapor products now account for an estimated 60 percent of the American market. This is not just a public health concern, but an economic one. Law-abiding U.S. manufacturers are being undercut by an unregulated illicit market that the FDA has failed to control, endangering American adults and hurting businesses of all sizes.
Congress gave CTP authority to regulate tobacco products in 2009, but what we’ve seen are delays, and an inconsistent agency that too often stifles innovation. Louisiana’s very own House Speaker Mike Johnson and House Majority Leader Steve Scalise must seize the opportunity and encourage the Trump Administration to enact long overdue reforms. We need action that puts American adults in control of their decisions, especially when it comes to their health.
The path forward is clear: cut the red tape, enforce the law, and empower adult consumers with the best innovative options. It’s time to bring CTP into the 21st century.
Alton Philips
