October 28, 2013

FDA: No Surprises Planned for E-Cigarette Regs

From: MedPageToday

By Crystal Phend, Senior Staff Writer

When the FDA finally issues its proposed regulations on electronic cigarettes, which may be as soon as the end of the month, what will they look like? Probably pretty familiar, experts said.

The first step is likely to be just bringing the nicotine-vapor devices officially under the agency’s tobacco control authority and up to speed with the age, marketing, and packaging restrictions that have long been in place for conventional cigarettes.

“Right now it’s kind of the Wild West,” said Peter G. Shields, MD, a cancer prevention expert at Ohio State University in Columbus. “As every day goes by without regulation, we have more of an issue with people using and liking a product [that is] potentially causing harm.”

While the agency has been putting the issue on its agenda for years, a proposed rule has now been sent to the federal Office of Management and Budget (OMB).

The due date had been set for the end of October, although an FDA press officer noted that the OMB review had to wait until the partial government shutdown ended.

That delay is just the latest in a heavily criticized wait for even deeming regulations that will officially declare e-cigarettes under the FDA’s purview through the 2009 federal Tobacco Control Act.

“Right now it’s falling into some sort of no man’s land,” explained food and drug lawyer Brian J. Malkin of Frommer Lawrence & Haug in Washington.

“It’s not really a drug device; it really should be a tobacco product, but FDA has not issued any sort of regulations on it yet….anyone can just order them online. There might be age restriction in some stores but that would be by their own internal procedures,” he explained.

The European Parliament voted earlier this month to regulate e-cigarettes similar to combustible tobacco, instead of the tighter regulation as a medical device proposed by health officials there.

That hasn’t been the question in the U.S. The FDA announced in 2011 that it would give up its bid for tight control after a federal appeals court ruled the products only fit under the agency’s authority to regulate tobacco as long as no health claims are made.

Forecast for Regulations

Other than the revelation that e-cigarettes will be classed as tobacco products, regulators have been “remarkably quiet” on their intentions, gathering input in meetings with e-cigarette makers and others, but not articulating their own thinking on the matter, noted David B. Clissold, a food and drug lawyer at Hyman, Phelps & McNamara in Washington.

“FDA has been very consistent in that they think e-cigarettes should be regulated, but the $64,000 question is how is the FDA going to do that,” he told MedPage Today.

In all likelihood, the proposed rule will mainly wrap e-cigarettes under the same restrictions as other tobacco products, Malkin suggested.

That first step banning sales or marketing to minors is critical because e-cigarettes are being aggressively sold to kids through youth-oriented marketing and flavors, according to Stanton Glantz, PhD, director of the University of California San Francisco’s Center for Tobacco Control Research and Education.

Flavored tobacco accounted for fully 40% of middle and high school smoking, based on data from the school-based National Youth Tobacco Survey study. The study, released by the CDC last week in the Journal of Adolescent Health, linked “flavored little cigar” use (another unregulated product) to a higher rate of having no intention to quit. Little cigars are comparable to cigarettes in terms of shape, filters, and packaging, but are marketed as a low cost alternative to cigarettes.

“Flavored tobacco products aimed at kids are a tried and true tobacco industry tactic,” Paul Billings, of the American Lung Association said in a statement that called on the FDA to act on the study’s findings.

Some self-regulation has been happening in the absence of federal regulation, but “as with any industry, there are people that have different standards,” explained Miguel Martin, former general manager of cigarette maker Altria and now president of LOGIC Technology Development, one of the largest U.S. e-cigarette companies.

Industry appears largely to welcome the FDA’s proposed rule in that it will level the playing field.

“Since the rules apply to everybody, that is a fair and equitable environment in which to conduct business,” Martin said. “An environment where the FDA does regulate the sale and marketing of products is a good thing.”

Once regulated, “[e-cigarette companies] are going to have to follow things like registration, product listing, ingredient listing, good manufacturing requirements, there’ll be the user fees, adulteration and misbranding provisions will fall into place…FDA can come in and inspect facilities,” Malkin noted. “It’s a big change from what they have now.”


It’s less clear if the FDA’s initial proposed rule will address kid-appealing flavors like bubblegum and watermelon or where sales would be allowed.

Internet sales ought to be done away with because of the difficulty of age verification, suggested John Wiesehan, Jr., CEO of Ballantyne Brands, which makes Mistic brand e-cigarettes.

Another possible feature would be a requirement for standardization.

Currently, there’s no requirement for labeling or standards for the devices or liquids they convert to vapor, noted David B. Abrams, PhD, of the anti-tobacco American Legacy Foundation’s Institute for Tobacco Research and Policy Studies in Washington.

“Liquids contain varying amounts of nicotine or none at all,” he told MedPage Today. “A liquid may have additives, flavors, and contaminants in it to varying degrees, albeit at very low levels when compared with burning the tobacco as in cigarettes, hookah, and cigars.”

At least some in the industry support that move, like Wiesehan, who called for testing and limits on nicotine levels.

But the FDA could have more surprises up its collective sleeve, Clissold pointed out.

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