Senators from both parties emphasized to the Food and Drug Administration on Thursday that more should be done to curb youth vaping beyond the Trump administration’s decision a day earlier to ban e-cigarette flavors.
Acting FDA Commissioner Ned Sharpless briefed the senators in a morning meeting that the organizer, Minority Whip Richard J. Durbin, D-Illinois, described in positive terms. Last week, Durbin called on Sharpless to resign if the FDA did not restrict flavored e-cigarette sales, but Durbin said Thursday that Sharpless “responded to my letter in a positive way and I want to give him a chance to show that he’s serious.”
With flavors potentially coming off the market in the next few months, lawmakers say the FDA should do more to regulate devices used for vaping. They call that necessary because the hundreds of illnesses and six deaths linked to vaping in recent months are potentially caused by illicit substances used in commonly available vaping devices.
With vaping devices still on the market, lawmakers worry that federal officials may not be able to stop illegal sales of flavored nicotine liquids.
“We’re going to have a tough time policing it to make sure the flavors are not sold on a black market,” Durbin said.
While Durbin has been calling on the FDA to ban flavors for years, he said the proposed ban on flavors alone “is not going to solve all the problems that we face because of e-cigarettes.”
Young people who have become addicted to nicotine through e-cigarettes may move on to combustible cigarettes, lawmakers warned.
“We don’t want [youth] to turn to tobacco cigarettes. That would be a disastrous outcome,” Durbin told reporters Thursday.
FDA officials told the senators that once the flavor ban is in effect — 30 days after issuing a guidance that should come out within a few weeks — that big retailers will likely comply, according to a Durbin aide who described the meeting to CQ Roll Call. The e-cigarette manufacturer Juul — which has already voluntarily restricted some flavor sales — said in a statement Wednesday that it would adhere to the policy.
The Durbin aide suggested that the bigger problem will be smaller vaping shops and online sales. While the FDA conveyed that the agency “will go after them hard” for noncompliance, the aide said Congress might need to consider providing more resources for enforcement.
At a minimum, Congress seems likely to build on the FDA’s action this year by raising the nationwide smoking age to 21. The cries to do more are also coming from beyond the expected sources like public health groups and Democratic lawmakers. Some Republicans are calling for tougher restrictions as well.
FDA officials are “pursuing a process under their regulations which I think is appropriate,” Sen. Mitt Romney, R-Utah, told CQ Roll Call. “I think it’s up to us in Congress to put in place legislation that does three things,” including adding taxes on e-cigarettes and having the FDA require that any approved e-cigarettes are tamper-proof so that users wouldn’t be able to add marijuana or other unregulated substances.
Romney also called for outlawing flavors permanently, he said.
The FDA’s proposal may only temporarily take flavored e-cigarettes off store shelves, as companies will have the ability to apply for sales approval. If they can meet certain public health criteria — such as proving that the flavor is necessary to help adult smokers quit and won’t prompt nonsmokers to try — some flavors may return.
To be sure, lawmakers acknowledge that the FDA already has the authority to do much of what they’re demanding. A 2009 tobacco control law allows the agency to forbid the sales of any new tobacco products until they go through the agency’s review process. The FDA doesn’t have to allow any e-cigarettes on the market.
While the flavor ban announcement demonstrated the FDA’s willingness to use its discretion to enforce the law, some lawmakers say it’s time for the FDA to fully enforce the law and require a review before any e-cigarettes can be sold.
“We need to go back and assert what congressional intent was on this effort,” said Rep. Rosa DeLauro, D-Connecticut. “We’ve got to demand that there is pre-market review.”
In embracing more restrictions on e-cigarettes, however, lawmakers are prompting some criticism that the flavor crackdown will exacerbate the future problems they’ve identified — and potentially worsen the outbreak of lung disease associated with vaping.
Michael Siegel, a public health professor at Boston University, predicted two outcomes as a result of the flavor ban. “No. 1, they are going to go to the black market to be able to continue vaping what they’re used to vaping,” he said. “No. 2, they are just going to give up and go back to smoking.”
He urged lawmakers to consider a way to keep more e-cigarettes on the market but have “meaningful regulation in terms of quality-control procedures and ingredient disclosures that companies have to follow.”
While health officials haven’t identified the exact cause of the lung illness outbreak, the Centers for Disease Control and Prevention noted that many of the patients reported vaping THC, the psychoactive ingredient in marijuana. The CDC says people should consider not using e-cigarettes and recommending that people who do use e-cigarette products avoid buying things “off the street” or adding any substances “not intended by the manufacturer.”
By acting to limit vaping devices more broadly, proponents of restrictions argue that it would help people avoid exposure to the substances that are causing the illnesses.
Siegel argued that the opposite would be true and predicted that the flavor ban could send teens the message that nicotine vaping should be avoided rather than marijuana vaping.
“This may actually accelerate rather than stem the outbreak because it will result in fewer youth actually discontinuing their use of marijuana vape products,” he said.