FDA Commissioner On Vaping Crisis: We 'Should Have Acted Sooner'
September 26, 2019
The federal government may be getting close to cracking down on e-cigarettes amid concerns about the risks of vaping.
The US Food and Drug Administration is expected to finalize its policy on flavored e-cigarettes and vaping products in the coming weeks, acting FDA Commissioner Dr. Ned Sharpless said Wednesday.
In response to questioning during a House subcommittee hearing on Wednesday, Sharpless said that in retrospect the FDA "should have acted sooner" to avoid the vaping crisis.
"We should have begun regulating these devices sooner," he said. "But we're going to catch up."
The FDA policy as it has been described would require all flavors other than tobacco to be taken off the market and then get "premarket authorization" before attempting to return to the market.
"FDA intends to enforce existing law that limits the marketing of such products," he said. "This policy would not mean that flavored e-cigarettes could never be marketed. If a company can show through an application to FDA that a specific product meets the standard set forth by Congress, then the FDA would authorize that ENDS product for sale."
E-cigarettes are sometimes referred to as ENDS, short for electronic nicotine delivery systems. Consuming them is generally known as vaping, and flavored varieties are seen as the kind most appealing to young people.
Earlier this month, President Donald Trump announced that the FDA would put out "some very strong recommendations" regarding the use of flavored e-cigarettes. During that same announcement, US Health and Human Services Secretary Alex Azar said that enforcement policy would require flavored e-cigarette companies to take their products off the market.
"It'll take several weeks for us to put out the final guidance that will announce all the parameters around the enforcement policy, and then there will likely be about a 30-day delay to effective date, as is customary," Azar said at the time. But "at that point all flavored e-cigarettes other than tobacco flavor would have to be removed from the market."
By May 20, 2020, he said, e-cigarette companies making tobacco-flavored products would have the chance to file for approval by the FDA. At that time, flavored-product manufacturers would also have the opportunity to file, but their products would be off the market until approved.
'An epidemic that's really in the making'
The United States currently faces a multi-state outbreak of lung injuries associated with vaping, which is under investigation by the US Centers for Disease Control and Prevention and the FDA.
Dr. Anne Schuchat, principal deputy director of the CDC, said during Wednesday's hearing that new cases are being confirmed daily and that the agency expects the number of vaping-related illnesses reported this week to be "hundreds higher" than last week.
The CDC is expected to update the number of illnesses on Thursday. There have been 530 confirmed and probable cases of lung injury related to e-cigarettes as of September 17, the CDC said.
There also have been nine known deaths related to vaping -- two in California, two in Kansas, and one each in Illinois, Indiana, Minnesota, Missouri and Oregon.
Dr. Lee Norman, secretary of the Kansas Department of Health and Environment, testified in Wednesday's hearing and called these injuries and deaths "just the tip of an iceberg."
"What we're seeing is an epidemic that's really in the making," he said in a phone interview with CNN following the hearing. "We support the Trump administration's plan to remove flavored vape solutions and we think that that's a good first start."
On Wednesday, Rhode Island Gov. Gina M. Raimondo signed an executive order directing the state's health department to establish "emergency regulations" forbidding the sale of flavored vaping products.
On Tuesday, Massachusetts Gov. Charlie Baker called for a temporary four-month ban on the sale of all e-cigarettes and vaping products in his state in response to the outbreak. That same day the Los Angeles Board of Supervisors voted unanimously to ban flavored e-cigarettes.
Earlier this month, Michigan banned the sale of flavored e-cigarettes and New York banned most flavored e-cigarettes. In June, San Francisco became the first US city to effectively ban all e-cigarette sales.
Opinions about whether flavored e-cigarette products should be taken off the market have seemed to shift among medical professionals who work directly with adults who are smokers or former smokers, said Dr. Peter Shields, a thoracic oncologist at the Ohio State University Comprehensive Cancer Center in Columbus.
That shift has been toward issuing some type of regulation.
Striking a balance
Tobacco use is the leading cause of preventable disease, disability and death in the United States, according to the CDC. Nearly 40 million adults in the United States still smoke cigarettes, and some might be interested in turning to e-cigarette products as a way to quit, even though e-cigarettes are not approved by the FDA as a smoking cessation tool.
Meanwhile, there has been a rise in young people using e-cigarettes.
"The question is: How do you figure out this balance of how many kids might get addicted to nicotine and not smoke versus how many smokers you get to quit?" Shields said, adding that the research remains unclear on whether e-cigarettes are effective for helping smokers quit.
"With what's going on with kids and holding on to this concept that we have to protect smokers at all costs -- and that includes not banning flavors -- at least in my mind, there's been a shift," he said.
In Shields' opinion, "it's probably prudent to ban the flavors," he said. "It may make it harder to increase the number of people quitting, but as long as we have tobacco flavor or tobacco with menthol still on the market, at least that will mimic what they're doing so we'll at least get smokers to try an alternative for something they're used to. That's my own personal view."