"Why aren't you taking action on the youth vaping crisis?" Senators question FDA and DOJ.
Around three years back, a court verdict decided that the Food and Drug Administration (FDA) had violated the Tobacco Control Act by allowing e-cigarette products that didn’t have FDA authorization to stay marketable.
An FDA official stated during a hearing on Wednesday that the issue was a “top priority,” but the agency failed to meet the September 2021 deadline that the court set for the agency to complete its review of e-cigarette manufacturers' applications to sell their products.
As a result, a study discovered that an estimated 2.1 million children have been using e-cigarettes regularly during this period. The majority of them preferred flavored products.
Sen. Dick Durbin, a Democrat from Illinois, questioned an FDA official about the issue during the hearing. "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," he remarked. "Instead, thousands of unauthorized e-cigarettes flooded the market."
Durbin's staffers found e-cigarettes with flavors like Red Bull, strawberry, dragonfruit, and watermelon bubble gum at a store near FDA headquarters, he noted. "Not a single one of these products has been authorized by the FDA. None of them. These illegal products, clearly designed for kids by their flavors, are being sold even in the shadow of FDA headquarters," he added.
Holding one of the unauthorized products in his hand, Durbin questioned how the FDA allowed such sales to take place.
The official responded, "The volume of those applications and the volume of the market requires us to prioritize our enforcement efforts."
Sen. Marsha Blackburn, a Republican from Tennessee, also criticized the FDA and the Department of Justice. "I think 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," she said.
The FDA has received 27 million applications for e-cigarette products, but unlike with companies that make prescription drugs and medical devices, the FDA isn't allowed to collect fees from e-cigarette manufacturers. The official asked the Senate committee for the authority to fund this increased workload.
"The rapidly changing tobacco product landscape presents an unprecedented time and resource challenge that no other center at FDA has ever faced," the official said.
Since June, the FDA has authorized only 23 e-cigarette products - none of them flavored; many more have been denied. There are still hundreds of thousands of additional applications pending.
From 2020 to 2023, there was a 1,500% increase in flavored tobacco products sold in the US, said Sen. John Cornyn, a Republican from Texas. He also presented flavored e-cigarette products his staffers bought, including watermelon bubble gum, apple melon berry, and one called Tyson Heavyweight.
"Dr. King, those are clearly designed for consumption by children, correct?" Cornyn inquired.
"I can't speak to the intent of the manufacturer, but I can say that flavors do appeal to kids. Ninety percent of youth who use e-cigarettes use flavored varieties," the official testified.
Approximately 10% of high school students and nearly 5% of middle school students use e-cigarettes, according to the US Centers for Disease Control and Prevention. Over the past five years, there has been a 60% decline in the number of middle and high school students using e-cigarettes, the official said. But when teens and young adults use e-cigarettes, they are much more likely to use flavored ones than adults.
"More work is definitely needed," he testified.
Ensuring the law is enforced is the other issue the FDA and DOJ addressed during the hearing. The FDA conducted thousands of inspections of e-cigarette manufacturers and distributors, resulting in nearly 900 warning letters, he said. More than 500 warning letters were sent to retail stores, King noted, but if these letters are disregarded, the FDA must rely on the DOJ and other agencies. It was only this week that the FDA and multiple law enforcement organizations announced the creation of a task force that would use criminal and civil tools to combat the illegal sale and distribution of e-cigarettes.
"What the hell have you been waiting for?" Durbin inquired of Arun Rao, a deputy assistant attorney general for the Civil Division's Consumer Protection Branch in the Department of Justice.
"Senator, we have been acting on a number of fronts," Rao answered. He acknowledged that "many manufacturers have exploited the premarket authorization process."
Rao testified that many manufacturers whose products have been denied FDA authorization make minor alterations and resubmit for approval. Some overseas e-cigarette makers misrepresent shipments to slip past regulators, and some stores fabricate their own products.
"Taken together, these factors have made illegal e-cigarettes all too accessible," Rao concluded.
"It's not allowed to sell them in China, but you can definitely sell them in the United States, leading our kids to become addicted to these nicotine-delivering devices," said Senator John Cornyn. Dr. Susan Walley, the previous chair of the American Academy of Pediatrics' Section on Nicotine and Tobacco Prevention and Treatment, pointed out that nicotine is extremely addictive and has detrimental effects on children's developing brains. Research suggests that it negatively impacts cognitive functions like working memory and attention.
Walley also argued that flavored products are alluring and easily available. She shared an example by bringing with her a flavored e-cigarette product called "OMG Blow Pop," which she claimed to have bought close to a school.
"This is simply unacceptable," she emphasized. "We need the federal government to remove these illegal products from the market."
Even industry representatives testified their displeasure with the FDA's authorization process. Tony Abboud, the executive director of the Vapor Technology Association, expressed his concerns about the lack of a clear approval pathway, stating that without one, "we'll keep seeing a flourishing black market."
A high school senior, Josie Shapiro from Seattle, also shared her experience. She admitted starting vaping because several of her friends tried it. She believes that people turn to these products because of their appealing flavors and colorful packaging. Josie has made several attempts to quit, but vaping has become a constant presence in her life and the lives of her friends: "I've felt entirely powerless, unable to concentrate on anything else without thinking about when we'll get our next hit," admitting that it has taken over both her and her friends' lives.
Read also:
The official mentioned during the hearing that the volume of e-cigarette applications and the size of the market require the FDA to prioritize its enforcement efforts, which implies that not all unauthorized e-cigarette products are being addressed simultaneously.
In response to Sen. Marsha Blackburn's criticism, the FDA official asked for the authority to collect fees from e-cigarette manufacturers to fund the increased workload required to review their applications, suggesting that limited resources are hindering the agency's ability to regulate the e-cigarette market effectively.
