WASHINGTON -- The giants of the tobacco industry know what it's like to face heavy government regulation. So as the makers of Marlboro, Newport and Camel enter the booming market for electronic cigarettes, they are pressing to keep their new products free of such strict oversight.
With the consumption of e-cigarettes projected by some analysts to surpass that of traditional cigarettes within the next decade, exactly how e-cigarettes are defined -- and what kinds of regulations and taxes they will face -- are critical to the industry's future.
At the moment, that future looks very bright, with sales roughly doubling every year and projected to approach $2 billion this year.
The Food and Drug Administration has said it intends to start regulating the sprawling e-cigarette industry for the first time this month, under the 2009 tobacco-control law.
Industry executives have been making their case in high-level meetings at the FDA's Center for Tobacco Products in Rockville, Md., and with members of Congress who oversee the agency. Their main pitch: The battery-powered devices, which deliver nicotine, flavor, and other chemicals in the form of a vapor, are essentially harmless, especially compared with the cancer-causing toxins in regular cigarette smoke, and therefore should get friendlier treatment.
E-cigarette makers large and small also have been lobbying across the country as cities and state legislatures debate how steeply to tax e-cigarettes and where people should be allowed to use them.
Late last month, attorneys general from nearly 40 states wrote to the FDA, urging the agency to treat e-cigarettes like traditional cigarettes and impose restrictions on marketing them to young people. Around the same time, top Democrats on the House Energy and Commerce Committee wrote to Margaret Hamburg, head of the FDA, asking that the agency move quickly to regulate e-cigarettes. The letter cited a recent report from the Centers for Disease Control and Prevention that said e-cigarette use among middle and high school students has been rising rapidly. The lawmakers also asked the Republican chairman of the committee to schedule a hearing on the health effects of e-cigarettes and other tobacco products.
Since September 2012, the FDA's tobacco center has held at least a dozen meetings with representatives of the e-cigarette industry, according to agency records and multiple participants. These "listening sessions" have been held at the companies' request, the FDA said, and those who have participated describe them as a "one-way conversation," with agency officials providing few clues to their thinking about e-cigarettes.
While e-cigarettes vary from brand to brand, they generally look like cigarettes but do not burn tobacco. Instead, when a user pulls air from the end, an atomizer converts liquid inside the device into a vapor. A starter kit, which typically includes two e-cigarettes, extra batteries and various nicotine cartridges, can cost anywhere from $20 to $200.
Regulators say too little research exists to understand how much nicotine or other potentially harmful chemicals are inhaled during e-cigarette use, or whether they might act as a stepping stone to getting children and non-smokers hooked on conventional cigarettes. In the meantime, many anti-smoking activists complain that the industry is spending lavishly on advertising to glamorize e-cigarettes, potentially undermining decades of work to reduce smoking rates.
After the FDA formally declares that e-cigarettes fall under its regulatory umbrella -- a decision that, before the government shutdown, had been expected this month -- the agency eventually could make an array of other moves. E-cigarettes could in time face restrictions on how they are marketed, where they are sold and who can buy them. Manufacturers could be subject to FDA inspections, and they could be forced to turn over detailed ingredient information to the agency and seek its approval before putting any new products on the market.
As they await specific FDA proposals, lobbyists for the industry say they are contacting lawmakers and their staffs, with a focus on those who sit on committees with jurisdiction over the FDA -- the Senate Health, Education, Labor and Pensions Committee and the Energy and Commerce Committee in the House.
"Our current approach is to make a few friends in Congress, educate them on a product they're probably not too familiar with, lay out the industry's best practices and relay some concerns about potential regulatory hurdles," said John Scofield, whose firm began lobbying for NJOY, an e-cigarette maker, in the spring.
Those registered to lobby on behalf of NJOY include Scofield and Jeff Shockey, both former top House Appropriations Committee aides, as well as a former top adviser to House Majority Leader Eric Cantor, R-Va. Federal disclosure records show their firm was paid $40,000 for its lobbying for NJOY in the second quarter of this year. The firm, Shockey Scofield Solutions, also lobbies on behalf of V2, an e-cigarette maker owned by National Tobacco that paid $60,000 over the first six months of the year for the firm's services.
Lorillard -- best known for its Newport cigarettes -- entered the e-cigarette market in 2012 with its purchase of blu eCigs and has started to lend some of its lobbying might to the cause. The company spent $2.35 million last year on lobbying, according to federal disclosure filings, and is on track to exceed that this year. The company's lobbying team at Dickstein Shapiro includes former House Speaker Dennis Hastert and several other former members of Congress. This year, Dickstein Shapiro began to list "all federal and legislative action related to e-cigarettes" among its lobbying issues.
Lorillard officials say they try to educate members of Congress, their staffs and other policymakers about the product. "We always have an e-cigarette on hand so they can see it," said Michael Shannon, vice president of external affairs at Lorillard Tobacco.
While Lorillard, NJOY and other e-cigarette makers say they welcome FDA regulation, Shannon said, "We just want to make sure that regulation is appropriate and recognizes the differences between e-cigarettes and traditional cigarettes."
In the traditional cigarette business, new products must be approved by federal officials, television ads aren't permitted and packages must carry warning labels about the health risks of tobacco.
E-cigarettes have only become widely available in recent years, but their rapid growth contrasts sharply with the steadily declining sales of traditional cigarettes.
The question of how to regulate e-cigarettes has lingered for years. In 2010, a federal judge sided with manufacturers who had challenged the FDA's authority to regulate e-cigarettes as a drug delivery device, which could have meant a strict set of regulations.
Ray Story, the e-cigarette company owner who prompted the lawsuit, now heads the Tobacco Vapor Electronic Cigarette Association. He is trying to convince regulators on both sides of the Atlantic to adopt a uniform set of what he calls "common-sense regulations," such as safe manufacturing standards, tight restrictions on sales to minors and limits on marketing, steps that many industry executives also say they support.
"All these different regulatory bodies are doing their own thing," he said in a call from the Netherlands. "They all dance to their own beat."
Greg Conley, legislative director for the Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group, has spent much of the past couple of years crisscrossing the country, from Maryland to Connecticut to California, fighting local usage bans on e-cigarettes, pushing state legislators to impose far lower taxes than on normal cigarettes and trying to sway federal regulators.
"It's an incredibly important time, because so much could go either way," he said.
Conley's group makes weekly "calls to action" to its thousands of members. A potential e-cigarette usage ban in Duluth, Minn., the possibility of a prohibition on e-cigarette stores in Seal Beach, Calif, an ordinance in New York that could outlaw flavored e-cigarettes -- each has been met with an e-mail blast asking members to contact local officials or show up en masse at public meetings.
Mitch Zeller, director of the FDA's tobacco center, has expressed concern about young people smoking e-cigarettes but left open the possibility that the devices could help existing smokers wean themselves off conventional cigarettes.
"There is promise with e-cigarettes. But to date, the evidence is anecdotal," he said this summer on "The Diane Rehm Show" on NPR. "Right now, we have far more questions than answers."
Conley said the e-cigarette industry's future will depend heavily on how the FDA interprets those answers in coming years. "FDA is in the position to either foster a new market that's helping smokers to quit, or decimate it and drive much of it underground," he said. "We're cautiously optimistic."nation - health - science
First Published October 12, 2013 8:00 PM