The Food and Drug Administration is pressing ahead on regulating tobacco products, but a long-simmering battle has erupted over the future of e-cigarettes.
Anti-tobacco groups say it's time for vaping companies to submit information about their products to the FDA, while e-cigarette manufacturers say such a demand is burdensome, unnecessary, and would create a black market of dangerous products. Meanwhile, tobacco companies are hoping to cash in by creating their own inhalant alternatives that would heat, rather than burn, nicotine.
Adding to the tension is the desire to settle lingering
questions over the extent to which vaping is safer than traditional
cigarettes and whether it can be effective at helping people quit.
The process of regulating the tobacco market, granted to the FDA through a 2009 law, is expected to take several years, though two initiatives began in March. The FDA asked for feedback on bringing nicotine in cigarettes to non-addictive levels and on how flavors in tobacco, such as menthol, affect people's smoking habits.
Though anti-smoking advocates support those actions, they object to a separate change the FDA made on e-cigarettes that they say threatens to undercut the other actions. The agency last year extended a deadline by four years for e-cigarette manufacturers to submit applications for products that went on the market after February 2007. The requirement had been set to go into effect in August.
Anti-smoking groups are particularly concerned about the impact the extension will have on teens, among whom the use of e-cigarettes has climbed by 900 percent. Health advocates are concerned that nicotine, which is addictive, will harm developing brains. Opponents also see the devices as a gateway to smoking traditional cigarettes.
"We do not want to lose another generation to tobacco addiction and the use of tobacco products," said Erika Sward, assistant vice president of national advocacy for the American Lung Association.
She noted that not enough data exist to determine the long-term effects of vaping, but the group is concerned about lingering chemicals in the lungs.
In response to the FDA's delay, healthcare groups, including the American Lung Association and the American Academy of Pediatrics, waged a lawsuit against the agency in late March. The lawsuit argues that the FDA is exceeding its authority and that it violated the Administrative Procedures Act by not allowing public comment on the delay.
Dennis Henigan, director of legal and regulatory affairs at the Campaign for Tobacco-Free Kids, which also was involved in the suit, said the lawsuit came only recently because the groups did not take its actions lightly.
"We wanted to indicate our objection ... in the hope that we could convince them to return to the original policy," Henigan said. "When it became clear that it wasn't going to happen, we determined that filing a lawsuit was really our only alternative."
The groups also oppose a deadline extension to August 2021 for cigars, which was included in the lawsuit. One of the main differences between the products, however, is that e-cigarettes are an area that manufacturers of traditional cigarettes are embracing as they look ahead to government regulations.
Altria Group, the parent company of Philip Morris, has praised the FDA's announcement on changing the timeline for e-cigarettes, calling it a "meaningful step forward in developing a comprehensive regulatory policy that acknowledges the continuum of risk."
"It’s important to understand that any proposed rule such as a nicotine product standard must be based on science and evidence, must not lead to unintended consequences, and must be technically achievable," the company said.
Philip Morris roughly a year ago submitted documentation to the FDA for iQOS, an electronically heated device. The company is seeking approval to market the product and is hoping the FDA will determine it is less harmful than traditional cigarettes. British American Tobacco, the owner of Reynolds American Inc., plans to submit its Glo product to the FDA this year.
FDA Commissioner Scott Gottlieb has said he is open to exploring whether e-cigarettes can help people quit traditional cigarettes, alongside the other actions the agency will take. Providing more time to file applications for review would allow the different components to happen around the same time, Gottlieb has said. He has vowed as well that the FDA will double-down on its efforts to lower e-cigarette use among minors.
"We need to make sure we strike the right balance between FDA fulfilling its vital consumer protection role while also fostering innovation when it comes to potentially less harmful forms of nicotine delivery," he said when announcing the delay in July 2017.
The liquid in e-cigarettes often comes in multiple flavors intended to mimic fruits or desserts, leading to charges from opponents that they are aimed at children. Despite the extension, the FDA has left the possibility open of regulating the flavors, which come in dozens of varieties such as rainbow candy, raspberry slushie, and cookies and cream.
Henigan said that goal is precisely why e-cigarettes should undergo review. E-cigarette manufacturers, he said, have the "opportunity and obligation to come forward to show that the products aren't attractive to kids and that they help current smokers quit." Without review, he said, the country will "preserve the wild, wild west of the unregulated e-cigarette market for years to come."
"FDA exists and regulates tobacco for the purpose of making these scientific determinations," he said.
But vaping proponents counter that the regulations would have put nearly all of their manufacturers out of business, and they oppose having to submit applications to the FDA. The process, they note, is costly.
"What we are looking at is over 99 percent of products being removed from the market," said Gregory Conley, president of the American Vaping Association, a nonprofit advocating for e-cigarettes. "This will happen not because the product poses any unique risk to consumers, but because independent vapor companies do not have cigarette sales to subsidize the necessary science to remain in business," he continued, referring to tobacco companies breaking into the market.
The organization supports preventing minors from accessing their product. It has not stated a position on lowering nicotine levels, which could extend to e-cigarettes.
"Our position is not concrete yet," Conley said. "We need to see the evidence that this strategy will actually work and won’t just create a new black market."
The FDA began including e-cigarettes under its umbrella of regulated tobacco products beginning in August 2016. Other possible actions will include requiring cigarette manufacturers to post graphic warning labels and reducing the levels of cancer-causing ingredients in chewing tobacco.
Public health experts say higher taxes, health warning labels, and laws limiting where people can light up have contributed to a decline in cigarette smoking. During the past five decades, smoking rates fell from 42 percent to 15.5 percent in 2016, according to the latest figures from the Centers for Disease Control and Prevention.
Despite that reduction, smoking remains the top cause of preventable death in the U.S., contributing to 480,000 deaths a year.
Asked whether a potential shift to e-cigarettes was preferable to a growth in traditional smoking, Sward said it presented a false choice.
"What we ultimately want is fewer tobacco products on the market and less disease and death," she said. "FDA's job isn't to find industry winners and losers but to protect the public's health."
