WASHINGTON -- Senators on both sides of the aisle took the FDA to task Wednesday for what they said was too slow of a response to the vaping epidemic among teens.
"In 2017, the Trump administration delayed FDA oversight of existing e-cigarette products by 4 years," Sen. Patty Murray (D-Wash.), ranking member of the Senate Health, Education, Labor, & Pensions (HELP) Committee, said at a hearing on the epidemic. "In the years since the Trump administration decided to hit the 'snooze button' on making sure e-cigarettes meet even the most basic standards, youth tobacco use has skyrocketed, driven by e-cigarette use -- which has more than doubled among high school students since 2017."
"Three years after FDA said it had the authority to regulate e-cigarettes, why aren't there any rules in effect about what standards e-cigarettes and vaping products need to meet?" asked Sen. Lamar Alexander (R-Tenn.), the HELP Committee's chairman.
Zeller Cites FDA Actions
Mitch Zeller, JD, director of the FDA's Center for Tobacco Products in Silver Spring, Maryland, tried to reassure committee members. "I want to assure the committee of the seriousness with which FDA takes its responsibilities," he said. "I'm here today representing hundreds of staff at FDA working tirelessly to prevent kids from using any tobacco products including e-cigarettes, and we're working with the CDC to get to the bottom of what's causing these lung injuries." He was referring to a mysterious illness among e-cigarette users that has resulted in 39 deaths so far in the U.S.
Since May 2016, when the FDA was granted regulatory authority over e-cigarettes, the agency has sent more than 10,000 warning letters to and filed more than 1,500 civil monetary penalty complaints against both online and brick-and-mortar e-cigarette retailers for illegal sales to youth, Zeller said. In addition, the agency issued warning letters to six e-cigarette companies telling them they need to remove a combined total of more than 140 products from the market.
Zeller also touted the FDA's marketing campaigns to warn middle and high school students about the dangers of vaping, noting that from late 2017 through the end of next year, the FDA "will wind up investing $150 million in a massive multimedia public education campaign."
Alexander, however, was unimpressed. "Obviously we're not making much progress with youth use" despite those efforts, he said. In his opening remarks, Alexander noted that according to the CDC, as many as 1 in 4 teenagers are using e-cigarettes.
White House Intent Questioned
Murray wondered why Zeller hadn't mentioned the Trump administration's Sept. 11 announcement that it planned to ban all flavored e-cigarettes as a way to discourage youth vaping. "I can only say we're doing everything we can to prevent youths from using any tobacco product," Zeller responded, referring further questions on the matter to the White House.
Sen. Tim Kaine (D-Va.) was particularly impatient with the agency -- and with Zeller's response to Murray. "The White House won't send witnesses here," said Kaine. "I think we're entitled to an answer from you .... Is it still the Trump administration's intent to clear the market of flavored e-cigarettes?"
"There is no final answer as of now," Zeller eventually responded. Kaine was not happy. "I do not like being played games with," he said. "You're the person responsible; you should know the answer to this question."
Sen. Mike Enzi (R-Wyo.) pointed out that the FDA's earlier attempt to put graphic warning labels on cigarettes was struck down in court. "The purpose of it was to get people to quit smoking, and I think the reason it went to court is because it was working," Enzi said. "I congratulate you on the attempt to do graphic warning labels." However, Enzi wondered why a new proposed rule on cigarette warnings focused on some of the lesser-known consequences of smoking, such as diabetes and bladder cancer, rather than more widely known effects such as lung cancer.
Zeller responded that the focus on these lesser-known conditions following the successful court challenge to the previous warning effort "was a deliberate strategic move on our part [to] give us the best chance of surviving a court challenge" if there is another one. The agency plans to finalize the new rule by next March, Zeller said.
Paul Questions Panel's Approach
Sen. Jacky Rosen (D-Nev.) asked the other witness at the hearing, CDC principal deputy director Anne Schuchat, MD, to comment on the dangers of second-hand vaping. "According to a number of experts, when a user of a vaping product exhales, they're actually releasing nicotine and other particulate matter into the air," Rosen said. "This can be especially harmful to children."
"E-cigarette aerosol has a lot of different compounds in it, which can include heavy metals from the devices, organic compounds, nicotine, and ultrafine particles that can be found deep in the lungs," Schuchat said. "We're really at the beginning stages of our understanding of the aerosol effect of second-hand smoke. Our view is that e-cigarette aerosols have fewer substances [than combustible cigarette smoke] but that doesn't mean they don't have harmful substances."
Sen. Rand Paul, MD (R-Ky.), took a different approach entirely, and was one of the few senators to speak of vaping's benefits for some people. "People say politics is the art of looking for trouble, finding it everywhere, diagnosing it incorrectly, and finding the wrong remedies," he said. "It would have been nice to hear from somebody testifying about the lives saved [through] vaping. Four hundred eighty thousand people die from smoking each year ... I'm not so sure making flavors illegal is going to make the problem better; it might actually make the problem worse."
"We should ask the question, 'Are there lives saved from vaping?'" he continued. "It's already illegal for kids to vape. If you don't want more kids to vape, why not increase the penalty on people selling to kids? By banning flavors, you're going to affect the adult market also," including adults who may be vaping as a way to quit smoking combustible cigarettes.
Sen. Mitt Romney (R-Utah), whose state has a vaping rate six times the national average, had a different question. "Those of us on this side of the room need to take action and provide authority," he said. "[Sen. Lisa] Murkowski [R-Alaska] put in legislation a year ago to restrict flavors and we don't act. Why haven't we done something to restrict flavors?"