The Food and Drug Administration is hoping to take a page out of John Kerry’s flip-flopping playbook. While running for president in 2004, Kerry tried to explain his blatant inconsistency on a spending bill by saying he was for it before he was against it. Kerry’s attempt at rhetorical origami didn’t work then, and it won’t work for the FDA now.
Under federal law, tobacco and vaping products are not to be sold until they have been reviewed and authorized by the FDA. That requirement isn’t unreasonable, especially since Congress directed — not asked — the FDA to act on applications within 180 days. But during the Biden administration, the FDA essentially stopped reviewing tobacco and vape products, ballooning the average review to nearly 1,000 days from the date an application is submitted. The Trump administration inherited that backlog, and the president is trying to fix it.
However, the FDA is going about it the wrong way. Instead of simply enforcing the law and accelerating reviews, the agency has adopted a risky workaround. As scientists work through product applications, the FDA has said that companies are free to sell their products, even though Congress required products to receive authorization before entering the market. Not only does this approach flout a congressional directive, it also puts public safety at risk by ignoring the threat posed by illicit vapes, which are flooding the United States.
The FDA’s blind eye doesn’t just put untested and sketchy products on the market: it is now the subject of a major federal lawsuit. A coalition of public health organizations argues that the agency’s new guidance violates the Tobacco Control Act by effectively allowing products onto store shelves before completing the scientific review Congress required. At a time when illicit vaping products, many imported from China, already dominate the marketplace, the last thing the FDA should be doing is creating new confusion about which products have been tested and found safe, and which ones haven’t.
Bureaucrats at the FDA’s headquarters invited this complaint by refusing to follow the process that Congress established. The agency’s 180-day review deadline may require discipline, but it is attainable. Rather than inventing legally dubious and possibly dangerous shortcuts, the agency should do its job: review applications promptly, approve those that satisfy the law, and keep unauthorized and dangerous products off store shelves.
That principle is also the unavoidable lesson of Loper Bright Enterprises v. Raimondo. Those of us who believe the Supreme Court was right to end automatic judicial deference to agency interpretations must apply that principle consistently. Agencies may exercise discretion that Congress has actually delegated, but they may not treat statutory commands as optional or use enforcement policy to accomplish what the statute does not permit. Here, Congress established both a premarket-authorization requirement and a review timetable. The FDA cannot answer its failure to meet one congressional command by effectively suspending the other.
The FDA’s inaction has fueled the rise of a massive illegal market. Federal authorities recently launched Operation Red Mist, seizing more than 18 million unauthorized e-cigarette products worth an estimated $175 million after investigators uncovered shipments deliberately mislabeled to evade customs. Those seizures followed coordinated raids across six states that removed another $86 million in illicit vaping products from circulation.
That may sound significant, but those efforts barely put a dent in an illegal market reported to be in the billions each year. Former FDA Commissioner Marty Makary estimated that 54% of vapes on store shelves are unauthorized. That number may be too low. A leading consumer expert told lawmakers last year that close to 90% of vaping products sold are illegal, with most of them smuggled in from China.
Everyone should be concerned about this. China has a history of putting the health of the public in jeopardy. Whether it’s COVID-19 or the precursor chemicals for the production of crystal meth and fentanyl, China is responsible for countless deaths. China is either failing to stop the export of high-risk goods to the U.S., or worse, deliberately permitting it. So why would we trust them with vaping products?
President Donald Trump has made public safety a priority. His administration has brought down violent crime to its lowest level in half a century. Protecting consumers from the dangers of unregulated vapes is no less important to the safety of people. Enforcement actions to date are welcome, but absent consistent vigilance, the black market will adapt, and untested vaping products will proliferate.
AMERICA’S DEADLIEST PRODUCTS ARE LEGAL. THE SAFER ONES ARE IN COURT
That’s why the FDA’s new guidance is so puzzling. Instead of restoring confidence in a regulated marketplace, it creates uncertainty for consumers, retailers, and manufacturers. It puts consumers at risk while exposing the agency to unnecessary litigation.
The agency that was for regulating vapes now seems disinterested — at least in the short term. Neither the president nor Congress should allow the FDA to skirt its duties for the sake of convenience. Americans deserve better.
David Safavian is a conservative lawyer and the chief operating officer of Unify.US. Andrew Langer is a longtime conservative activist and the president of the Institute for Liberty.