The Food and Drug Administration said Thursday that it intends for the first time regulate the booming market of electronic cigarettes, as well as an array of other products such as cigars, pipe tobacco and hookahs.
The move would begin to place restrictions on e-cigarettes, a nearly $2 billion industry that for years has operated outside the reach of federal regulators. If adopted, the government’s plan would force manufacturers to curb sales to minors, stop handing out free samples, place health warning labels on their products and disclose the ingredients. Makers of e-cigarettes also would be banned from making health-related claims without scientific evidence.
The FDA’s proposal stops short of broader restrictions sought by many tobacco-control advocates. Regulators at this point are not seeking to halt online sales of e-cigarettes, curb television advertising, or ban the use of flavorings such as watermelon, grape soda and piña colada — all tactics that critics say are aimed at attracting young smokers and that have been banned for traditional cigarettes.
Those restrictions might come eventually, FDA officials said, but not before more rigorous research can establish a scientific basis for tougher rules.
“Right now, for something like e-cigarettes, there are far more questions than answers,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
He said Thursday’s action is about expanding FDA’s authority to products that have been “rapidly evolving with no regulation whatsoever,” in order to create a foundation for broader regulation in the future, adding, “It creates the framework. We’re calling this the first step. . . . For the first time, there will be a science-based, independent regulatory agency playing a vital gate-keeping function.”
E-cigarettes vary from brand to brand, but they generally resemble the size and shape of traditional cigarettes. Instead of burning tobacco, the battery-powered devices heat up flavored, nicotine-laced liquid, turning it into a vapor that the user inhales, or “vapes.” Supporters say that makes e-cigarettes an attractive alternative to their cancer-causing tobacco counterparts.
Congress passed a law in 2009 giving the FDA broad power to regulate cigarettes, including requirements for new warning labels, restrictions on ads and explicit approval of new products. The law also gave the FDA the authority to broaden its jurisdiction over other tobacco-related products. While the agency has indicated for years that it planned to do just that, action has been slow in coming.
Reactions to Thursday’s announcement from the e-cigarette industry, public health officials and consumer advocates was swift — and mixed.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, called the FDA’s action an important step but said that it is “inexcusable” that the agency had taken so long to act. “In the absence of any meaningful regulation, the e-cigarette manufacturers have acted as if it’s the wild, wild West, with no rules and no restraints,” Myers said. “Their advertising is exactly the same type of advertising that made cigarettes so appealing to young people” decades ago.
He said FDA needs to move quickly to finalize Thursday’s proposal and conduct the scientific research it will need to put more stringent rules in place down the road on marketing practices and flavors.
“They can’t move forward at the same pace that they have been moving and do their job protecting public health,” Myers said. “We can’t waste another five years; this cannot take that long. There is a moral and public health imperative for them to treat this with the urgency it deserves.”
Still, whatever changes are coming won’t happen overnight. The public will have 75 days to comment on the proposal. After the FDA sorts through a likely tidal wave of responses and finalizes its regulations, companies will have to begin complying almost immediately with the proposed age and identification restrictions. But they will have two years to submit applications to the FDA to approve their products, which can remain on the market in the meantime.
The FDA’s effort to begin overseeing the sprawling e-cigarette market comes at a critical time. Sales have doubled year after year, with no signs of slowing, according to some industry analysts. That pales in comparison with the estimated $80 billion-a-year U.S. market for conventional tobacco products, but the gap is shrinking steadily. In addition, tobacco giants such as Lorillard, Reynolds and Altria have entered the e-cigarette market in recent years, joining hundreds of smaller manufacturers.
Some industry advocates worried Thursday that federal regulation will benefit only a handful of those large companies, who have established distribution channels and the money and manpower needed to file the streams of paperwork that will now be required to seek FDA approval of all e-cigarette products.
“This is worse than I expected,” said Greg Conley, a board member of the American Vaping Association, who said he welcomed the age-restriction rules but had hoped the FDA would grandfather in existing products, rather than force e-cigarette makers to file lengthy applications for any product on the market dating to early 2007. “A lot of these companies, they are supporting several employees, investing any profits back into their buisness ... They can’t afford this, and it’s going to lead to a whole lot of consolidation and increased prices for consumers.”
Not everyone in the e-cigarette industry bristled at Thursday's proposal. Indeed, some of the larger players in the e-cigarette market praised FDA for committing to a science-based regulatory process, which they hope will allow them to make a strong case that e-cigarettes have the potential to reduce tobacco-related harm and be an overall positive for public health.
“What they did today was very encouraging ... We’ve already done many things to prepare ourselves and act responsibly,” said Miguel Martin, president of Logic Technology Development one of the nation’s leading e-cigarette companies. “At least speaking for my company, this will not be the tobacco wars of the 80s and 90s.”
The move toward federal regulation comes amid an impassioned debate over simple questions that so far have no simple answer: Will e-cigarettes eventually cause more people or fewer to smoke? Will the devices emerge as a healthier alternative that makes cigarettes obsolete, or will they act as a gateway to smoking and undermine a half-century of efforts to reduce tobacco-related deaths, which still kill an estimated 480,000 Americans annually?
“There’s such a huge debate over whether e-cigarettes are a good thing or a bad thing for public health,” said Kenneth Warner, a tobacco researcher and professor of public health at the University of Michigan. “But we’re in a kind of factual vacuum. There are not that many [reliable] studies. . . . We really don’t know the right answer.”
Warner said the FDA will have to walk a fine line in the way it treats e-cigarettes. On one hand, the agency must set reasonable restrictions, such as keeping nicotine-delivery devices out of the hands of minors and creating safe manufacturing standards. On the other hand, if e-cigarettes do hold the potential to help some people quit smoking, the agency doesn’t want to stymie innovation and crush an industry that’s quickly evolving.
“It’s a tricky balance,” Warner said. “Even in an environment devoid of politics and lawsuits, it would be a challenge to come up with the right mix of regulations. . . . Figuring out how to do this is going to be hard, and it isn’t going to happen quickly.”
The cigar and e-cigarette industries have long been preparing for the inevitability of federal regulation — and working hard to try to shape it. For example, makers of “premium cigars” have been lobbying intensely not to be lumped in with the fruit-flavored corner-store varieties that public health experts say target kids — a distinction FDA officials have said they are willing to consider.
E-cigarette executives have been every bit as aggressive, making their case over the past year in meetings with FDA regulators, members of Congress, and state and local officials, seeking to avoid some of the stringent rules that govern conventional cigarettes. In essence, they have argued that e-cigarettes vapor is far less harmful than cigarette smoke, with its cancer-causing toxins, and can actually help smokers kick the habit. Therefore, the manufacturers say, they should be subject to kinder, gentler oversight — and lower taxes — than traditional cigarettes.
At the same time, manufacturers have been fighting growing regulation in cities and states. Numerous cities, from Los Angeles to Chicago to Boston, have banned e-cigarettes in public places, and dozens of state attorneys general have urged federal regulators to speed up restrictions on marketing the devices to young people.
The e-cigarette industry also has faced questions about the safety and accessibility of its products. The Centers for Disease Control and Prevention reported this month that calls to poison centers involving e-cigarettes have surged in recent years as the products have gained in popularity, with most of the incidents involving children younger than 6 who have accidentally ingested the liquid nicotine.
Last year, the CDC reported a dramatic increase in the number of high school students who said they had tried e-cigarettes, including some who had never smoked. That fueled concerns among some public health officials that the devices could lead users toward traditional smoking. E-cigarette advocates argue there’s little evidence to support such a claim.
According to the FDA, hard evidence will be key from now on. People on every side of the argument agreed that reliable research should dictate how the FDA regulates e-cigarettes going forward, even as what that research will show remains a source of disagreement.
“It will move from theory and conjecture and gut feelings to a science-based regulatory framework,” said Jason Healy, founder and president of blu eCigs, which was acquired by Lorillard in 2012. “Both sides have to now be accountable for their statements. You’re going to have to put science behind it.”
However that ends up shaping the industry, Healy said, that approach ultimately could prove positive for consumers.
“There’s been so much uncertainty,” he said. “Now, everyone will know where we stand.”