Food and Drug Administrator (FDA) Robert Califf testified before the House Oversight and Accountability Committee about the agency’s activities, including healthcare and implementation of the Tobacco Control Act of 2009.  The issues considered at the April 12, 2024, hearing included the substantial lag in FDA approval of premarket tobacco product applications (PMTAs), specifically for tobacco harm reduction (THR) products.  

To date, the FDA has only authorized 45 products out of 26 million product applications.  In lieu of mitigating the problem, the FDA is more focused on talking about death due to tobacco-related illnesses.  A March 9, 2023, Centers for Disease Control (CDC) report found that in 2021, among American adults currently using e-cigarettes, 40.3 percent had formerly smoked cigarettes.  THR products help adult smokers quit and are a less dangerous alternatives to traditional cigarettes, yet the FDA sits on its hands. 

The government red tape contributing to the backlog of PMTAs has resulted in an influx of unregulated foreign-made products to meet consumer demand.  And even with the FDA’s crackdown on THR products, the number of unique e-cigarette devices sold in the U.S. has tripled to more than 9,000 since 2020.  This increase is, unfortunately, driven mainly by unauthorized disposable vaping products from China.  Concern with such products led the FDA to issue warning letters to 187 retailers across the country on June 22, 2023, for selling Elf Bar and Esco Bars products. These letters were preceded by May 25, 2023, warning letters to Shenzhen Innokin Technology Co. Ltd., the maker of Esco Bars, and Breeze Smoke, LLC, which imports and distributes Breeze products.  According to the FDA, those firms have been manufacturing, distributing, and importing unauthorized tobacco products in the U.S.

A February 7, 2020, Citizens Against Government Waste blog post predicted that China would be the largest driver of illegal vaping products now pouring into the U.S. marketplace.  The blog post stated, “Tobacco is a legal product in the U.S., and even if Congress could ban it, there is little doubt that China, which grows the most globally, and other sources wouldn't immediately create a black market.  The same result will occur if vaping flavors are banned.  Current adult users, who also like sweet and fruity flavors, will either go back to combustible cigarettes or take the chance and purchase products illegally, which will create a real crisis and endanger the health of millions of Americans.”

The demand for vaping products is undeniable; instead of approving safe and effective tobacco harm reduction products, the FDA would rather open the floodgates to unregulated markets that put consumers at risk.  Now is the time for the FDA to implement a functional regulatory process and do its job to improve and expedite the approval process to reduce risks and help save Americans’ lives.