” What are you waiting for ? Senators question FDA, DOJ over lack of action on youth vaping epidemic


Republicans and Democrats on the US Senate Judiciary Committee showed rare agreement on Wednesday by taking their comments to task. the U.S. Food and Drug Administration and the U.S. Department of Justice for what they described as inaction on the nation’s youth vaping epidemic.

Nearly three years ago, a federal court ruled that the FDA was violating the Tobacco Control Act by allowing e-cigarette products that did not have FDA approval. pre-authorization to remain on the market.

An FDA official testified Wednesday that the topic was a “top priority,” but the agency failed the September 2021 deadline the court set for the agency to complete its review of e-cigarette makers’ applications to sell their products.

Since then, about 2.1 million children have used e-cigarettes regularly, according to one study, and the majority use flavored products.

“After the court-imposed deadline expired on September 9, 2021, the FDA could have ordered each unauthorized e.cigarette out of the market, and that’s what she should have done,” Sen. Dick Durbin, D-Illinois, told Dr. Brian King, director of the FDA’s Center for Tobacco Products, during Wednesday’s hearing . “Instead, thousands of unauthorized e-cigarettes have flooded the market.”

In fact, Durbin said, his employees found vapes in flavors like Red Bull, strawberry, dragon fruit and watermelon bubble gum at a store just a mile from FDA headquarters.

“Not a single one of these products has been cleared by the FDA. None of them. These illegal products, clearly designed for children in their flavors, are sold” even in the shadow of FDA headquarters, he said.

Placing one of the products in front of him, Durbin asked how the FDA could allow such sales.

“The volume of these requests and the volume of the market requires us to prioritize our enforcement efforts,” King testified.

Sen. Marsha Blackburn, Republican of Tennessee, also told FDA and Justice Department officials that she was unhappy.

“I think it’s disappointing to hear you talking in circles about what you plan to do, but you haven’t made a plan and you’re not sure what path to take,” she said. declared.

King said the FDA has received 27 million applications for e-cigarette products. But unlike companies that make drugs and medical devices, which pay user fees to fund the agency’s work, the FDA is not allowed to collect fees from e-cigarette makers. King asked the Senate committee for authorization to fund this increased workload.

“The rapidly changing tobacco product landscape presents an unprecedented time and resource challenge that no other FDA center has ever faced,” King said.

Since June, the FDA has authorized only 23 e-cigarette products – none flavored – and denied many others. Hundreds of thousands of additional requests are still pending.

From 2020 to 2023, there was a 1,500% increase in flavored tobacco products sold in the United States, said Sen. John Cornyn, R-Texas. He also brought flavored vaping products that his employees purchased, including watermelon bubble gum, melon berry and another called Tyson Heavyweight.

“Dr. King, these are clearly designed to be consumed by children, correct?” asked Cornyn.

“I can’t speak to the manufacturer’s intent, but I can say that the flavors appeal to children. Ninety percent of young people who use e-cigarettes use flavored varieties,” King testified.

About 10% of high school-aged adolescents and nearly 5% of middle school students use e-cigarettes, according to the U.S. Centers for Disease Control and Prevention. Over the past five years, the number of middle and high school students using e-cigarettes has declined by 60 percent, King said. But when vaping, teens and young adults are much more likely to use flavored e-cigarettes than adults.

“We definitely need to do more work,” he testified.

Enforcement is the other challenge, the FDA and DOJ said at the hearing. The FDA has conducted thousands of inspections of e-cigarette manufacturers and distributors, resulting in nearly 900 warning letters, King said. More than 500 warning letters have been sent to retail stores, King said, but if the letters are ignored, the FDA can’t go that far, so it must rely on the DOJ and other agencies. Just this week, the FDA and several law enforcement agencies announced the creation of a task force that will use available criminal and civil tools to combat the illegal sale and distribution of e-cigarettes .

“What were you waiting for?” Durbin asked Arun Rao, deputy assistant attorney general in the Consumer Protection Branch of the Justice Department’s Civil Division.

“Senator, we have acted on several fronts,” Rao replied. He said the The Justice Department has worked with the U.S. Marshals Service and the FDA on seizures of illegal products, but it admitted that “many manufacturers have exploited the premarket approval process.”

Rao testified that many manufacturers whose products have been denied FDA clearance make minimal changes and resubmit them for approval. Some overseas e-cigarette makers will also misrepresent their shipments in an effort to evade regulators, and some stores make their own products.

“Taken together, these factors have made illegal e-cigarettes too accessible,” Rao said.

Many products come from China, but that country has banned flavored e-cigarettes and the products are not sold in Chinese stores – a point that was not lost on the committee.

“You can’t sell them in China, but you can sell them in the United States and essentially victimize and addict our children to these nicotine delivery devices,” Cornyn said.

Nicotine is highly addictive and harms children, testified Dr. Susan Walley, immediate past chair of the American Academy of Pediatrics’ Section on Nicotine and Tobacco Prevention and Treatment. According to studies, nicotine can permanently harm an adolescent’s brain development, impairing working memory and attention.

Flavored products are too tempting and easy to access, said Walley, who brought with her a flavored e-cigarette product called OMG Blow Pop which she said she bought within walking distance of a school.

“Simply put, this is unacceptable,” she said. “We need the federal government to remove these illegal products from the market. »

Even representatives of the vaping industry testified that they were unhappy with the FDA authorization process.

“It’s an absolute disaster right now,” said Tony Abboud, executive director of the Vapor Technology Association. He complained that there was no clear path through the approval process and said that without such a path, “we are going to persist in an illicit market.”

Josie Shapiro, a Seattle high school student, told the committee that vaping products are too easy to access. She said she started vaping after several friends did so.

“They thought vapes were harmless because of their fun flavors and colorful packaging,” Shapiro testified.

Shapiro said she tried to quit several times, but vaping took over her and her friends’ lives.

“I felt completely out of control, helpless and alone,” she said. “I couldn’t spend quality time with my friends without thinking about when we were going to get our next hit.”

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