June 12, 2024 – In an unusual display of bipartisan unity, members of the U.S. Senate Judiciary Committee called out the FDA and DOJ for what they perceive as insufficient action in tackling the nation’s youth vaping crisis. The senators underscored their concerns during a committee hearing, highlighting a perceived lack of urgency and effectiveness from these agencies.
Background of the Issue
Nearly three years ago, a federal court found that the FDA violated the Tobacco Control Act by allowing e-cigarette products without FDA pre-authorization to remain on the market. Despite the court’s mandate, the FDA has missed its September 2021 deadline to review e-cigarette manufacturers’ applications.
Testimonies and Senate Responses
At Wednesday’s hearing, an FDA official stated that addressing youth vaping is a “top priority.” However, Senator Dick Durbin (D-Illinois) criticized the FDA for not taking more decisive action post-deadline. “After the court-ordered deadline passed on September 9, 2021, the FDA could have ordered every single unauthorized e-cigarette off the market, and that’s what it should have done,” Durbin said. He further highlighted the ongoing sale of unauthorized, youth-targeted flavored vapes in close proximity to the FDA’s headquarters.
Sen. Marsha Blackburn (R-Tennessee) expressed frustration, noting, “It’s disappointing to hear you kind of talk in circles about what you are planning to do, but you haven’t established a plan, and you’re not certain what your way forward is going to be.”
Current State of Youth Vaping
According to a 2023 National Youth Tobacco Survey, approximately 2.1 million youths are currently using e-cigarettes, with many favoring flavored products. Although this is a decrease from 5.3 million in 2019, the numbers remain significant. About 10% of high school students and nearly 5% of middle school students reported using e-cigarettes, with over a quarter of these users vaping daily.
Health Risks and Enforcement Challenges
The CDC warns that nicotine is highly addictive and poses unique dangers to young people, including harming the developing adolescent brain and increasing susceptibility to addiction to other substances.
Dr. Brian King, director of the FDA’s Center for Tobacco Products, noted that the FDA has conducted thousands of inspections and issued nearly 900 warning letters to manufacturers and distributors. However, enforcement remains challenging, with the FDA needing to rely on the DOJ and other agencies for more stringent actions.
New Task Force Formation
In response to the ongoing challenges, the FDA and DOJ announced the creation of a multi-agency task force to address the illegal sale and distribution of e-cigarettes. This task force will utilize criminal and civil tools to combat the issue, aiming to remove unauthorized products from the market and reduce youth access.
Arun Rao, deputy assistant attorney general for the DOJ’s Civil Division’s Consumer Protection Branch, acknowledged that the DOJ has been actively seizing illegal products in collaboration with the US Marshals Service and the FDA. However, he admitted that many manufacturers exploit the premarket authorization process by making minimal changes and resubmitting applications.
Industry and Public Reactions
Tony Abboud, executive director of the Vapor Technology Association, criticized the FDA’s authorization process, describing it as a “hot mess.” He emphasized the need for a clear pathway through the approval process to prevent the persistence of an illicit market.
High school senior Josie Shapiro from Seattle shared her personal struggles with vaping, describing how the accessibility of flavored vapes has significantly impacted her and her friends’ lives. “They thought vapes were harmless because of the fun flavors and colorful packaging,” she testified.
Conclusion
The hearing underscored the urgent need for more robust action from the FDA and DOJ to address the youth vaping epidemic. With the formation of the new task force, there is hope for more effective enforcement and regulatory measures to combat the illegal sale and distribution of e-cigarettes. The bipartisan call to action reflects a growing consensus on the importance of protecting young people from the dangers of vaping.
Contact: lori@vapevision.org
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