The FDA Praises Fixing a Problem It Caused

The surge in illegal vapes imported from China into the U.S. poses serious dangers to Americans’ health. As these unregulated products enter the marketplace, they put consumers at risk and undermine the public’s trust in products that reduce the potential for harm from traditional cigarettes. The U.S. Food and Drug Administration (FDA)—in tandem with other agencies such as the U.S. Postal Service—is cracking down on illegal vapes for good reason. However, the FDA could easily stem the supply of these illegal products by embracing a lighter-touch regulatory approach that would allow agency-vetted vaping products to come to market. The FDA is stuck trying to solve a problem it created in the first place.

History offers a predictable lesson: banning things that bureaucrats don’t like leads to more dangerous versions of the same products. Unsurprisingly, the agency’s crackdown on vaping and the absence of pre-market approvals for regulated vapes have led directly to a rise in illegal vaping products entering the market. A Truth Initiative study published in November 2024 found that 34 e-cigarette products authorized for marketing by the FDA make up only 13.7 percent of the e-cigarette market. The remaining 86.3 percent consists of illegal e-cigarette products that lack market authorization.

The FDA has had to divert personnel and taxpayer dollars to seize these illegal products. On September 10, the U.S. Department of Health and Human Services (HHS), through the FDA and in coordination with U.S. Customs and Border Protection (CBP), announced the seizure of 4.7 million units of unauthorized e-cigarette products with an estimated retail value of $86.5 million—the largest-ever seizure of this kind. 

“We will never allow foreign actors to threaten the health of America’s children,” said HHS Secretary Robert F. Kennedy, Jr. “Today, we took decisive action to protect kids from illegal vape products. Thank you to President Trump and Attorney General Bondi for their leadership in helping us shut down this black market.”

“The FDA and our federal partners are taking strong actions to shore up America’s borders and stop the flow of illegal vaping products into our country,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Americans – especially our children – should not be using potentially dangerous, addicting products that have been snuck into the U.S. If a product has not been authorized by the FDA, CBP will seize, detain or destroy it.”

The FDA’s approach is akin to being on a boat with a hole in it that is taking on water. Instead of plugging the hole, the FDA is trying to scoop the water out to prevent sinking. Plugging the hole would require the FDA to start approving tobacco harm reduction products in significant numbers. Unfortunately, policy appears to be shifting away from that approach. According to a recent analysis by Vaping360 contributor Jim McDonald, the FDA “has issued just one authorization of a vaping product during the first seven months of the Trump administration” contrasted with 40 denials. It doesn’t help that, in the Triton case decided earlier this year, the Supreme Court held that the FDA is permitted to act as judge, jury, and executioner on vaping approvals and change its requirements on a dime.

If the FDA had focused on doing its job and approving regulated tobacco harm reduction products from the start—rather than fighting truth and science with campaigns against vaping—the U.S. wouldn’t be facing the rising black market it is seeing now. Consumers deserve regulated and effective products that meet FDA standards, but they barely have any legal options today to choose from. The FDA can right its ship and stop the flood of illegal shipments by embracing a smarter and more flexible regulatory approach.