In a rare show of agreement, Republicans and Democrats on the US Senate Judiciary Committee voiced their frustration and criticism towards the US Food and Drug Administration (FDA) and the US Department of Justice (DOJ) for their perceived lack of action in addressing the country's youth vaping epidemic. The committee accused the FDA of violating the Tobacco Control Act by allowing unauthorized e-cigarette products to remain on the market without FDA pre-authorization, despite a federal court ruling three years ago.

During Wednesday's hearing, an FDA official, Dr. Brian King, testified that addressing the youth vaping epidemic was a "top priority" for the agency. However, the FDA failed to meet the court-ordered deadline of September 2021 to complete its review of e-cigarette manufacturers' applications to sell their products. This delay has allowed an estimated 2.1 million children to regularly use e-cigarettes, with the majority opting for flavored products.

Senator Dick Durbin of Illinois expressed his disappointment in the FDA's inaction, stating that the agency should have ordered all unauthorized e-cigarettes off the market after the court-imposed deadline passed. Durbin even highlighted the availability of illegal e-cigarette products, designed to appeal to children through flavors like Red Bull, strawberry, dragonfruit, and watermelon bubble gum, just a mile away from the FDA headquarters.

Senator Marsha Blackburn of Tennessee also criticized the representatives from the FDA and the DOJ, expressing her dissatisfaction with their lack of a concrete plan to address the issue. Dr. King revealed that the FDA has received a staggering 27 million applications for e-cigarette products, but the agency lacks the authority to collect fees from e-cigarette makers, unlike the fees paid by drug and medical device manufacturers to fund the agency's work.

To date, the FDA has authorized only 23 e-cigarette products, none of which are flavored, and a significant number of applications are still pending. This lack of progress raises concerns, especially given the alarming 1,500% increase in flavored tobacco products sold in the US from 2020 to 2023, as highlighted by Senator John Cornyn of Texas.

Dr. King acknowledged that flavors appeals to kids and that 90% of youth who use e-cigarettes prefer flavored varieties. According to the US Centers for Disease Control and Prevention, approximately 10% of high school-age adolescents and nearly 5% of middle school students use e-cigarettes. While there has been a 60% decline in e-cigarette use among middle and high school students over the past five years, the prevalence of flavored e-cigarettes among teens and young adults remains a concern.

Furthermore, the enforcement of existing laws poses a significant challenge for the FDA and DOJ. Although the FDA has conducted numerous inspections and issued hundreds of warning letters to manufacturers and retail stores, their authority is limited to the issuance of warnings. To combat the illegal sale and distribution of e-cigarettes, the FDA and several law enforcement agencies recently announced the creation of a task force utilizing criminal and civil tools.

During the hearing, Deputy Assistant Attorney General Arun Rao of the DOJ recognized that many manufacturers exploit the premarket authorization process, making slight alterations and resubmitting their products for approval. Additionally, some overseas manufacturers misrepresent shipments to avoid regulatory scrutiny, while others produce their own e-cigarette products locally.

The Senate hearing also featured testimonies from Dr. Susan Walley, who emphasized the harmful effects of nicotine on developing brains, and Josie Shapiro, a high school senior who shared her personal struggle with addiction to vaping products.

The hearing shed light on the urgent need for concerted efforts from the FDA, DOJ, and the federal government to combat the youth vaping epidemic. Senators called for stronger enforcement measures, clearer pathways for product authorization, and increased funding for the FDA to address the challenge posed by the rapidly evolving tobacco product landscape.

As the youth vaping epidemic continues to impact millions of children across the country, the pressure is mounting on regulatory bodies to take swift and decisive action to protect the health and well-being of the younger generation.