PrintHow the FDA delays tobacco-related products
In an attempt to discourage vaping and nicotine use among adolescents, the U.S. Food and Drug Administration (FDA) has been strengthening its regulations surrounding the sale of alternative tobacco products. At the heart of that campaign lies the FDA’s Premarket Tobacco Product Applications (PMTAs) process, a regulatory safeguard designed to ensure that all new products entering the market meet rigorous safety and public health standards. While the PMTA process has been a vital component of FDA regulation since 2016, the requirement for manufacturers to obtain marketing authorization from the agency has been more strictly enforced since September 2020, following a wave of anxiety about a so-called “vaping epidemic” among America’s youth.
The problem is, the PMTA process is gruelingly slow. According to the FDA’s official website, it can take one to three years or longer for a new tobacco product to receive approval. And while the Tobacco Control Act (the “Act” of 2009) requires that the FDA conduct its “substantive review” phase -- the most extensive component of a tobacco product application -- within 180 days, the timeline for making application determinations is much longer in practice, usually extending one to two years. The application review process is so lengthy that in December, U.S. senators Ted Budd, Rand Paul, and Joe Manchin sent a letter to Food and Drug Administration Commissioner Robert Califf demanding an overhaul of the current federal regulatory landscape for harm-reduced products.
“Since 2009, more than 26 million premarket tobacco product applications (PMTAs) have been submitted for new tobacco products in the U.S.,” the senators wrote. “Of those 26 million applications, the CTP [Center for Tobacco Products] has authorized fewer than 50.”
“Remarkably, it has also authorized a total of only 16 modified-risk tobacco products (MRTPs) for only four unique products and their accessories. This miniscule authorization rate is not in keeping with the CTP policy acknowledging that tobacco products fall on a continuum of risk,” the senators continued, noting the dangers that a limited pool of authorized nicotine options could have on “smokers using riskier products.”
The CTP likes to say that this backlog is due to staffing shortages. But remarkably, the Center’s staff has grown from 426 employees in 2013 to now over 1,110, according to CTP Director Mitch Zeller. Additionally, the CTP’s budget has increased significantly since the early days of the “Act” in 2009, with the Center collecting $712 million annually in tobacco industry user fees since 2019. So why the regulatory paralysis?
According to data from the Centers for Disease Control and Prevention (CDC), cigarette smoking is the leading cause of preventable death in the United States, accounting for more than 480,000 deaths a year. In a country where nearly 31 million Americans smoke -- and fewer than eight percent will be able to quit -- it is imperative that the marketplace for smoke-free products remains innovative and competitive, offering smokers the best chance they can get to wean off cigarettes.
As new products like Altria’s on! PLUS oral nicotine pouches come to market, the FDA must streamline its byzantine tobacco regulations in order to improve harm reduction access for Americans in need. Smokers deserve safe and reliable “lesser harm” alternatives to help them make the switch and end their combustible cigarette use.
Nathalie Voit is a Young Voices contributor and an alumni of the University of Florida. Her writing regularly appears on C3 Solutions.
