Drumbeat Intensifies for Electronic Cigarette Regulations September 12 2014

Federal and state officials are pushing for a rapid end to the current laissez faire regulatory environment for electronic cigarettes, which is characterized by hundreds of companies vying for customers with diverse device and flavor options.

The Food and Drug Administration is preparing draft regulations, with a target release date sometime in October, for the battery-powered vapor machines marketed as a healthy alternative to carcinogen-packed conventional cigarettes.

If the FDA chooses to apply the Tobacco Control Act of 2009 to e-cigarettes, advertising would be tightly regulated and popular flavors may be banned. That law, enacted with the support of cigarette company Phillip Morris, banned flavored cigarettes and restricted advertising and health claims.

Sen. Sherrod Brown, D-Ohio, told reporters during a Wednesday conference call he believes the FDA already has authority under the Tobacco Control Act to regulate e-cigarettes. He said he would be meeting with FDA Commissioner Margaret Hamburg and two unnamed Senate colleagues later in the day “to press [the FDA] to regulate tobacco products to the full extent of their power.”

Brown alleged that e-cigarette makers are directly linked to the conventional cigarette industry and said flavored liquid is being used to recruit a new “crop of customers.”

“Cigarette smoking, we know, kills close to a half million people in the United States every year,” Brown said. “The tobacco industry, they know that between 400,000 and 500,000 customers die every single year and that means… they have to find 400,000 to 500,000 new smokers every single year [and] they set their sights on the latest nicotine market.”

He added: “The longer they can be marketed to children, the more our hard-fought gains to prevent teens from being addicted to tobacco are lost. If more young people get hooked on e-cigarettes, the chances of their smoking – when they are older – regular cigarettes increase. … If making cigarettes is addicting children and killing them, that’s the most important factor here.”

Brown joins other Democratic senators in urging regulation of e-cigarettes. Sen. Richard Blumenthal, D-Conn., told U.S. News last week he would like the FDA to ban flavor options and the online sale of e-cigarettes. It’s “completely disingenuous,” Blumenthal claimed, for e-cigarette advocates to say fruity flavors are primarily used by adults.

Brown and Blumenthal both said they would support legislation if the FDA doesn’t act first.

Advocates of e-cigarettes say they support age restrictions, but they are urging officials to hit the brakes before enacting regulations.

“Like Sen. Blumenthal, Sen. Brown is acting without adequate data,” said Gregory Conley, legislative director of the Consumer Advocates for Smoke-free Alternatives Association. “Sen. Brown is encouraging a ban on flavored e-cigarettes without having asked for evidence showing that flavored e-cigarettes are actually being targeted or marketed to teens, or actually being used by teens. He certainly doesn’t seem to have any regard for electronic cigarettes as ways to get smokers to stop inhaling burning smoke.”

Conley added: “Mr. Brown sure knows from the negotiations back [in 2009] that eliminating flavored cigarettes from the market made no measurable impact on public health because no adolescents were actually using them.”

The urging by Brown comes one day after 37 state attorneys general signed a letter asking the FDA to apply the Tobacco Control Act to e-cigarettes. The state officials, led by Democrat Martha Coakley of Massachusetts and Republican Mike DeWine of Ohio, alleged children are enticed by flavors. They also pointed to two small companies that have used animated monkeys in their marketing and another company that offers various “skins” to modify the appearance of their e-cigarettes.

“E-cigarettes contain fruit and candy flavors – such as cherry, chocolate, gummy bear, and bubble gum – that are appealing to youth,” the state attorneys general wrote. “The FDA has banned such flavors from cigarettes and should take the same action regarding e-cigarettes.”

The FDA has not yet responded to the letter, but aims to unveil proposed regulations for e-cigarettes sometime in October. “FDA is moving to release for public comment a proposed rule to regulate additional categories of tobacco products,” FDA spokesperson Jennifer Haliski told U.S. News. “FDA cannot comment on the contents of the proposed rule.”

The latest push for regulation was boosted by data released Sept. 5 by the Centers for Disease Control and Prevention, which found 10 percent of high school students tried an electronic cigarette at least once. The “current” use rate – defined as use in the preceding month – was 2.8 percent for e-cigarettes. More than 92 percent of high school students who tried an e-cigarette had also smoked a tobacco cigarette, but the CDC did not ask which they tried first. The data was released weeks ahead of corresponding data for conventional tobacco products. Data is not routinely collected on the percentage of students who have ever tried a tobacco cigarette, CDC spokesman Joel London told U.S. News, but it’s estimated that between one-third and one-half of students have done so. In 2011, the most recent year for which data is available, the CDC found 18.1 percent of high school students were “current” conventional cigarette users.

Leaders of the Smoke Free Alternatives Trade Association, an e-cigarette industry group, are conducting a “fly in” October 3-4 to meet with federal lawmakers in Washington, D.C.

SFATA President Phil Daman told U.S. News & World Report he opposes “simply rolling [e-cigarettes] under the purview of federal and state statutes designed for tobacco products,” such as the Tobacco Control Act.

“They do not fit the mold of a tobacco product and the Tobacco Control Act was not created to address issues concerning these types of products,” Daman said. “These products are technology products, not tobacco products [and] adult consumers want and should have access to this technology, and a diverse variety of flavors if they so choose.

Amid the frenzied push for new regulation, Daman advises “greater and increased communication between the industry, our elected officials, consumers and the FDA to best understand this new technology so that fair and reasonable regulations, if any, are tailored to what these unique products actually are.”

E-cigarettes don’t meet the strict definition of a “cigarette” in the Tobacco Control Act, because that law defers to a standing definition of cigarettes as “any roll of tobacco wrapped in paper or in any substance not containing tobacco” or “any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette.” But the FDA claims authority to regulate e-cigarettes under a 2010 ruling by the U.S. Court of Appeals for the District of Columbia in Sottera v. FDA. The court said products “made or derived from tobacco” can be regulated as “tobacco products” under the Tobacco Control Act.

Possible regulation of e-cigarette flavors hits a particularly raw nerve for many users. Conley, who blends his own flavor to mimic the taste of Hi-C, observed “flavors are such a big deal for a lot of people, including myself. … When they’re coming out saying, ‘these flavored e-cigarettes are targeted to children’,” he said, “there are so many people out there who immediately have a visceral reaction because they are using the flavors.”