REAL CLEAR HEALTH: Congress Calls Out The FDA's Regulatory Failures And The Surge Of Illicit Chinese Vapes

As Food and Drug Administration (FDA) Commissioner Califf faced bipartisan scrutiny from members of both the House Oversight and Appropriations Committee, the agency's failed enforcement issues and glaring inadequacies in tackling the spread of illicit Chinese vapes flooding the American market became crystal clear. These hearings served as a stark reminder of the FDA's failures to properly regulate the rapidly evolving vaping landscape.

During his opening statement, House Oversight Committee Chairman James Comer's (R-KY) scathing critique of the FDA's sluggish authorization process encapsulated the frustration felt by lawmakers, responsible manufacturers, and concerned citizens. Since 2020, thousands of illicit vapor brands have flooded the market, with foreign manufacturers blatantly disregarding FDA all regulation. Since then, the FDA has been slow to respond and their inaction has allowed these brands to now make up more than half the market. With only 23 e-cigarette products authorized out of 26 million applications over 15 years, the FDA's regulatory framework appears more like an insurmountable obstacle course rather than a streamlined pathway for compliance and approval of products that are scientifically proven to be less harmful for adult smokers. 

These hearings laid bare the agency's neglect of its duty to protect America's youth from the lure of illicit vapes. According to the most recent National Youth Tobacco Survey, three of the top five most popular vape brands middle and high school students reported using are illicit. The FDA has issued minor warning letters and fines to vape these manufacturers but these efforts have been unsuccessful and useless given there has been no real change. The FDA also failed to go after major manufacturers, leaving the most influential players in the market held to little to no accountability. What makes it even more clear these efforts have been ineffective is that over 50% of the products named in these warning letters are still on the market, highlighting a clear lack of follow-through and enforcement capability on the part of the FDA.

Meanwhile, American shelves are overwhelmed with unscrupulously manufactured illegal Chinese products, casting doubt on the FDA's commitment to enforcing the very rules the agency established. In the Appropriations Committee hearing focused on the FDA's fiscal year 2025 budget request, Subcommittee Chairman Rep. Andy Harris (R-MD) emphasized that addressing the illicit vapor market should be the agency’s top priority, not coming up with new rules that further exacerbate the illicit market.

Rep. Byron Donalds (R-FL) further addressed these concerns and highlighted that the unintended consequences of the FDA’s failures have created fertile ground for the illicit trade, posing additional risks to public health. He went on to push the commissioner to recognize that strict regulatory barriers and a slow-moving approval process for American manufacturers have benefited brands overseas who easily bypass any oversight or regulatory approval. One would hope that Chinese manufacturers capitalizing on the vaping craze in the United States would serve as a wake-up call to the FDA, but there has been little to no sense of urgency from any FDA leader or official.

At the House Oversight hearing, Rep. Raja Krishnamoorthi (D-IL) displayed one of these illicit products - a new Mike Tyson-branded flavored vape - and demanded answers on why the FDA has ignored Congressional inquiries on the issue. When questioning the commissioner, he highlighted that "on December 7th, 2023, a dozen of us wrote to you asking for a comprehensive approach to dealing with these illicit Chinese vapes [...]The reason why you didn't respond to us with your approach to clearing the shelves of these illicit vapes from China is perhaps because you don't have an answer" and warned that these products are "the next chapter in this youth vaping epidemic, and it is time we take this seriously."

Rep. Virginia Foxx (R-NC) rightly highlighted the paradox of an already bloated bureaucracy failing to meet its own deadlines, most notably the FDA has yet to complete its review of premarket tobacco product applications, which is over two years past the court-ordered deadline. Despite doubling in size and receiving substantial funding, the Center for Tobacco Product (CTP) remains mired in inefficiency, leaving manufacturers in limbo and consumers vulnerable to unvetted products. Given that the agency has adequate resources to address this crisis, it should be fully capable and prepared to step up enforcement efforts and approve well-regulated alternative products.

If the recent hearings are any indication, the FDA remains woefully unprepared to create a well-regulated vaping market in the U.S. The agency must heed the impassioned pleas of lawmakers and stakeholders, prioritize the swift approval of harm-reduction products, and intensify efforts to combat illicit imports. Failure to do so not only perpetuates the youth vaping problem, but also jeopardizes the promise of tobacco harm reduction for adult smokers. It's time for the FDA to step up, fulfill its mandate, and protect the public from the perils of unregulated vaping.

Susan B. Aiken, Anderson, S.C. is a retired mother, grandmother, elected as national delegate to republican national convention 5 times, including 2024, and former aide to U.S. Sen. Tim Scott, U.S. Sen. Jim Demint, U.S. Congressman Gresham Barrett