Congress Must Urge FDA To Accelerate Tobacco Harm Reduction

On Tuesday, September 10th, the Health Subcommittee of the U.S. House Energy and Commerce Committee will hold a hearing entitled “Evaluating FDA Human Foods and Tobacco Programs.” The hearing will feature testimony from Dr. Brian King, Director of the Center for Tobacco Products at the U.S. Food and Drug Administration (FDA), and James Jones, Deputy Commissioner for Human Foods at the FDA.

House Energy and Commerce Chair Rep. Cathy McMorris Rodgers (R-Wash.), and Health Subcommittee Chair Brett Guthrie (R-Ky.) issued a joint statement expressing their intent to provide members with a “chance to hear … how the FDA is helping adult smokers quit, keeping illegal products away from kids, and ensuring a safe food supply.” These topics have been recurrent in Congressional inquiries. In April, FDA Commissioner Robert Califf testified before the U.S. House Oversight and Accountability Committee, while Dr. King recently appeared before the U.S. Senate Judiciary Committee in June.

Coinciding with the hearing, the Centers for Disease Control and Prevention released preliminary results from the 2024 National Youth Tobacco Survey. The survey revealed a significant decline in youth e-cigarette use to record lows, with only 5.9 percent of middle and high school students reporting usage in the past month. This marks a 23.4 percent decrease from 2023 and a 70.5 percent decrease from 2019, when 20 percent of youth reported using e-cigarettes.

Public health organizations and advocates have reasons to celebrate these declines, which have occurred alongside increased e-cigarette sales in the states. Although largely unauthorized, the recent survey data highlight that e-cigarettes are predominantly used by adults, many of whom use them as a smoking cessation aid.

The Taxpayers Protection Alliance annually reviews CDC data on adult and youth tobacco and vapor product use, publishing these insights in our “Tobacco and Vaping: 50 State Analyses.” According to their latest report (in the states represented on the Health Subcommittee), 13.1 percent of adults were smoking in 2022, down 4.5 percent from 2021. Additionally, 7.3 percent of adults were vapers in 2022, which represents a 14.1 percent increase from the previous year. Both smoking and vaping rates in these states are slightly below the national averages of 13.7 percent and 7.7 percent, respectively.

While adult smoking rates have reached historic lows, combustible cigarettes continue to inflict significant health-related costs, exceeding $106 billion in 2022 among the states represented by the subcommittee.

The FDA possesses authority to further reduce these costs and the prevalence of combustible cigarettes by accelerating the authorization of tobacco harm reduction products, including e-cigarettes, heated tobacco, and oral nicotine products.

Most tobacco harm reduction products are required to undergo the draconian regulatory application process known as the premarket tobacco application (PMTA). The PMTA costs to manufacturers are astronomical, while the regulatory requirements are obscure at best. To date, the FDA has only authorized 56 products under the PMTA pathway.

Given the current low rate of youth e-cigarette use and the high number of adults using novel tobacco products, there is a pressing need for the FDA to adapt its authorization strategies to better serve adults seeking to quit smoking through these alternatives. Lawmakers are urged to advocate for this necessary shift in FDA policy.