Public health advocates have touted the Food and Drug Administration's release this week of finalized regulations on electronic cigarettes as a step toward quelling the popularity of the devices among the nation's youth.
The new rules, which ban the sale of e-cigarettes to those under age 18 have been well-received. But some question whether the regulations may inadvertently benefit tobacco companies, since the new regulations may squeeze out some e-cigarette producers.
Small producers of the battery-operated devices that turn nicotine into inhalable vapor might not be able to afford the costs associated with the new FDA approval process, while the largest e-cigarette brands on the market are owned by manufacturers of tobacco cigarettes.
E-cigarette companies have two years to submit their product applications to the FDA, and then must wait another year for the agency to review them. The review process applies to products introduced after 2007, which includes nearly all of them.
Those companies must submit details on all their ingredients and their production process. They must also report on any health risks and whether their devices "present less risk that other tobacco products .”
Dr. Michael Siegel, a professor of community health sciences at Boston University estimated it could cost a company at least $300,000 to submit an application for just one of its devices. If that company sells multiple products, the cost could run into the millions.
That is a "capital cost that only a very, very large manufacturer can sustain,” Siegel said. “This is really going to put most of the market out of business.”
If smaller manufacturers are able to meet the new requirements, they'll likely increase the cost of their products, which will reduce the savings smokers receive by switching from tobacco to e-cigarettes.
The new rules set a higher standard for approval than that currently required for tobacco cigarettes, which health experts generally view as a more harmful product, Siegel said. There isn't much current scientific consensus on the risks or advantages of "vaping" e-cigarettes.
Electronic smoking devices and related vaporizers are projected to become a $4.1 billion market this year, according to figures from Wells Fargo. But after growing rapidly over several years, their sales have recently begun to slow as the result of negative publicity and safety questions.
“The biggest problem here is that the FDA is regulating electronic cigarettes much more stringently than real cigarettes,” said Siegel, who has been a supporter of e-cigarettes as a less harmful alternative to tobacco. “Real cigarettes were grandfathered into the market, and the cigarette companies didn't have to do anything to keep their products on the market.”
Cynthia Cabrera, executive director of the Smoke-Free Alternatives Trade Association said in a written statement that the e-cigarette industry has adhered to licensing regulations and a ban on sales to minors, in addition to adopting child-resistant packaging.
“(The) final rule pulls the rug out from the 9 million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year, and costs the U.S. more than $300 billion in annual healthcare expenses,” she said.
E-cigarettes were first developed in China in 2003 and arrived three years later to the U.S. and Europe.
Public health advocates have called for tougher oversight of e-cigarettes, in light of their increased use among young people in recent years. More than 15% of high-school students report using e-cigarettes, up more than 900% over the past five years, according to federal figures.
Campaign for Tobacco-Free Kids spokesman Vince Willmore said the new rules are a good first step toward reducing young people's use of the devices. He said the regulations could incentivize e-cigarette makers to invest in the kind of research and development that proves the devices help smokers with tobacco cessation.
“E-cigarettes could benefit public health if they are shown to help smokers quit cigarettes completely,” Willmore said. “We need FDA authority to prevent use of these products by kids, but also ... to make sure that smokers have accurate information about which of these products are most effective.”
The rules go into effect in August.
The Associated Press contributed to this report.