Rare Bipartisan Agreement in Senate Judiciary Committee Criticises FDA and DOJ for Failing to Address Youth Vaping Crisis
Three years after a federal court deemed FDA’s actions in violation of the Tobacco Control Act for permitting unapproved e-cigarette products, Senators express frustration as FDA misses deadline for review of e-cigarette makers’ applications.
A recent study reveals a concerning trend: approximately 2.1 million children have taken up e-cigarettes regularly since a pivotal federal court ruling three years ago. What’s more alarming is that the majority of these young users are attracted to flavoured e-cigarette products, raising concerns about their appeal to minors.
Senator Dick Durbin of Illinois sharply criticised the FDA for its sluggish response to this escalating crisis. He slammed the agency for failing to act decisively after missing the court-imposed deadline in September 2021, allowing unauthorised e-cigarettes to flood the market. Durbin’s frustration peaked when he discovered flavoured vapes being sold near the FDA headquarters, highlighting the audacity of their availability despite lacking FDA approval.
Dr. Brian King, director of the FDA’s Center for Tobacco Products, defended the agency’s enforcement priorities amidst mounting criticism. He cited the overwhelming influx of 27 million applications for e-cigarette products as a significant challenge, requiring careful allocation of resources.
However, Senator Marsha Blackburn of Tennessee expressed disappointment with the FDA and the Department of Justice representatives’ lack of a coherent plan of action. She emphasised the need for a clear strategy moving forward, expressing concern over the agencies’ seeming inability to chart a path forward in addressing the youth vaping epidemic.
One significant obstacle highlighted by Dr. King was the absence of a funding mechanism for the FDA’s oversight of the e-cigarette market. Unlike pharmaceutical and medical device companies, e-cigarette makers do not pay user fees to fund the agency’s regulatory efforts. This funding gap poses significant challenges for the FDA in effectively regulating the rapidly evolving landscape of e-cigarette products.
The changing landscape of tobacco products poses unprecedented challenges in terms of time and resources for the FDA, according to Dr. King. Despite this, the agency has authorised a mere 23 e-cigarette products since June, none of which are flavoured, while hundreds of thousands of applications await review. Senator Cornyn highlighted a staggering 1,500% increase in flavoured tobacco products sold in the US from 2020 to 2023, presenting flavoured vape products purchased by his staff as evidence of their appeal to children.
Dr. King acknowledged that flavoured varieties often attract youth consumers, with around 90% of e-cigarette users in this demographic opting for flavoured options. Although there has been a decline in overall e-cigarette use among middle and high school students over the past five years, flavoured e-cigarettes remain popular among teens and young adults.
The FDA and DOJ emphasised the enforcement challenges during the hearing, citing thousands of inspections and warning letters issued to manufacturers, distributors, and retailers. However, they admitted limitations in their authority, relying on collaboration with other agencies to combat illegal sales. Recently announced, a task force comprising multiple law enforcement entities will utilise criminal and civil measures to tackle the illicit distribution of e-cigarettes.
Dick Durbin, expressing frustration, directed a pointed question to Arun Rao of the Justice Department’s Consumer Protection Branch: ‘What have you been waiting for?’ Rao defended the department’s actions, citing collaborations with agencies like the US Marshals Service and the FDA to seize illicit products. However, Rao admitted to loopholes in the premarket authorization process, exploited by manufacturers who make minor alterations to resubmit their products. Overseas makers sometimes falsify shipments to bypass regulators, contributing to the accessibility of illegal e-cigarettes.
Concerns were raised about China’s ban on flavoured e-cigarettes, contrasting with their availability in the US, prompting criticism from Senator Cornyn. Dr. Susan Walley of the American Academy of Pediatrics highlighted the dangers of nicotine addiction among teens, emphasising its detrimental effects on brain development. She underscored the ease of access to flavoured products, presenting a purchased e-cigarette near a school as evidence.
Walley demanded swift action from the federal government to remove illegal products from the market. Even representatives from the vaping industry expressed dissatisfaction with the FDA’s authorization process.
Tony Abboud, representing the Vapor Technology Association, described the current situation as chaotic, emphasising the lack of a clear pathway through the approval process for vaping products. He warned that without a defined process, the market would continue to be flooded with illicit products.
A Seattle high school senior, Josie Shapiro, shared her firsthand experience with the committee, highlighting the ease of access to vaping products and their misleading perception of harmlessness due to enticing flavours and packaging. Shapiro revealed the impact of vaping on her life and that of her friends, expressing feelings of helplessness and isolation as they struggled to quit amidst addiction. She described how vaping dominated their thoughts and hindered their ability to enjoy quality time together.
