FDA eases into regulating e-cigarettes

Most everyone agrees a ban on selling them to children would be a step forward.

But health and public policy experts cannot say for certain whether the electronic devices are a good thing or a bad thing overall, whether they help smokers kick the habit or are a gateway to ordinary paper-and-tobacco cigarettes.

The proposed rules, issued Thursday by the Food and Drug Administration, tread fairly lightly. They would ban sales to anyone under 18, add warning labels about the risks of nicotine and require FDA approval for new products.

The rules do not immediately propose changes that some had expected, such as a ban on television advertising. They also do not set product standards or restrict the wide array of flavorings that are commonly used in e-cigarettes.

James Xu, majority owner of Avail Vapor LLC, which has nine retail stores that specialize in e-cigarettes, including two in the Richmond area, said the FDA’s 241-page outline of its proposals mostly shows that the agency is looking for more scientific data on e-cigarettes before taking further action.

But he said he was surprised that the FDA did not immediately propose a ban on online sales and TV advertising.

“We think the document shows that the FDA has recognized that this product has huge potential, and that is why they want to handle it scientifically,” he said.

The devices, which heat a nicotine solution to produce an odorless vapor without the smoke and tar of burning tobacco, have grown in popularity.

A retail market has developed specializing in e-cigarettes. At least eight retail stores that primarily or exclusively sell e-cigarettes have opened in the Richmond area. Numerous convenience stores now sell mass-market e-cigarettes alongside conventional tobacco products.

“We are already complying with pretty much everything they (the FDA) proposed” so far, Xu said.

Industry analyst Bonnie Herzog with Wells Fargo Securities said in a note to investors Thursday morning that the proposed FDA regulations were “not as bad as feared.”

“Our main concern remains around e-cig/e-vapor innovation which, if stifled, could dramatically slow down industry growth and conversion from combustible cigs, which would ultimately result in net negative public health impact,” Herzog wrote.

While the proposed rules did not go as far as some expected, some of the regulations still could pose problems for the fledging e-cigarette market, as well as makers of specialty products such as cigars, said Bryan M. Haynes, a partner with the Troutman Sanders law firm in Richmond who has represented e-cigarette, cigar and pipe tobacco companies.

For instance, the agency would require companies to submit for approval products that were not on the market prior to Feb. 15, 2007, or that have been changed since then, he said.

“That covers probably every single e-cigarette and most, if not all, premium cigars,” Haynes said, adding that the requirement would be burdensome for companies.

A proposed ban on providing free samples of products even to adults also could be a problem for e-cigarette makers, Haynes said.

Some public health experts say the FDA’s measured approach is the right one.

They think that the devices can help smokers quit.

“This could be the single biggest opportunity that’s come along in a century to make the cigarette obsolete,” said David Abrams, executive director of the Schroeder Institute for Tobacco Research and Policy Studies at the American Legacy Foundation.

Still, some wonder whether e-cigarettes keep smokers addicted or hook new users and encourage them to move on to tobacco.

Mitch Zeller, the director of the FDA’s Center for Tobacco Products, said: “There are far more questions than answers.”

Some states, including Virginia, already have banned the sale of e-cigarettes to minors. Other states and cities have taken action to prohibit their use in public places.

The FDA said the public will have 75 days to comment on the proposed rules. The agency will evaluate those comments before issuing a final rule, but there is no timetable for when that will happen.

Sales of e-cigarettes are estimated to have reached nearly $2 billion in 2013, still small compared with conventional cigarettes, but growing.

Tobacco company executives have noted that they are eating into traditional cigarette sales, and their companies have jumped into the business.

Henrico County-based tobacco giant Altria Group Inc., for instance, introduced its first electronic cigarette under the MarkTen brand name in test markets last year. The company plans to expand sales of the brand nationally in the next few months.

It also bolstered its presence in the category in April when one of its subsidiaries completed an acquisition of the e-cigarette seller Green Smoke Inc.

Altria backed FDA regulation of the tobacco industry and has expressed support for extending appropriate regulatory authority over e-cigarettes and cigars.

“We believe FDA should adopt a regulatory framework that recognizes the differences in tobacco products and fosters innovation that may benefit public health,” the company said in a statement released Thursday. “The framework must be grounded in science and evidence. FDA is in the best position to assess the science and determine how best to communicate relative risk information to consumers.”

Public health groups also have raised concerns about the widespread use of flavorings in e-cigarettes, arguing that the fruity, sweet or menthol flavorings mixed into the liquid nicotine are appealing to children.

Xu, the Avail Vapor store owner, said the array of flavorings is something that adult users prefer.

With traditional cigarettes, “you have no choice but the tobacco flavor,” he said. “Now, people have a choice (with e-cigarettes). They, of course, like to have as many different choices as they can.”