E-cig industry on tenterhooks ahead of U.S. regulation

Lobbyists for electronic cigarette companies have been beating a path to the White House, hoping to prevent the administration from imposing strict, and possibly costly, rules on the burgeoning $2 billion industry.

In November and December, more than 35 organizations including e-cigarette companies, cigar and tobacco makers, trade associations, physician groups, lawyers, lobbyists and public health advocates trooped through the doors of the White House's Office of Management and Budget.

OMB has been reviewing a rule proposed by the Food and Drug Administration that would bring e-cigarettes under its jurisdiction and could potentially require companies to register and pay fees, list the ingredients in their products, obtain prior approval for new products and restrict online sales and marketing to children.

The OMB, which reviews proposed regulations to assess, among other things, their economic impact, has not given a date for when it will be finished with its review, but officials have not had a meeting with outsiders since January 17 according to public records, suggesting they have heard all they need, or are willing, to hear.

At stake is the future of an industry that some analysts believe will eventually overtake the $80 billion-a-year tobacco business. Advocates of e-cigarettes, which are battery-powered cartridges filled with nicotine liquid that when heated creates an inhalable vapor, say they are less dangerous than tobacco products and can help smokers quit. Public health experts fear they may act as a gateway to smoking for the uninitiated.

Mitch Zeller, head of the FDA's tobacco division, said in an interview that there is a "continuum of risk" among nicotine products currently on the market, with cigarettes on one end and medicinal nicotine on the other. He declined to say where on the spectrum he expects e-cigarettes to fall or what is contained in the FDA's proposals. In general, he said, people smoke for the nicotine and die from the tar.

"I'm not saying nicotine is benign, but when compared to the risk associated with regular tobacco, it pales," he said.

Some, therefore, expect the FDA to exercise flexibility in regulating e-cigarettes.

"It's not just a matter of a blanket dropping in of the current regulations over additional products," said Diane Canova, vice president of government affairs at the anti-tobacco American Legacy Foundation, "Some of the current restrictions may not fit."

TOBACCO CONTROL ACT

A law passed in 2009 gave the FDA the authority to regulate cigarettes, smokeless tobacco and roll-your-own tobacco. It also gave the agency the power to deem other tobacco products to be within its jurisdiction but it must first issue a rule to that effect. E-cigarette companies believe they should be exempt from the full spectrum of regulations, saying they would stifle innovation, damage small business and hurt consumers trying to quit smoking.