Delayed FDA rule on e-cigarettes draws fire

While e-cigarette supporters say the Food and Drug Administration's proposed rule to regulate electronic cigarettes will hamper efforts to get smokers to abandon deadly tobacco cigarettes, many public-health advocates fear the new rules don't go far enough to regulate these new products whose health effects are still unknown.

The long-awaited rule, issued last week, would ban the sale of e-cigarettes to anyone under 18, require producers to stop giving free samples, and require warning labels stating that nicotine is addictive. Manufacturers would have to disclose ingredients and could not say their products are safer than tobacco products.

Both e-cigarette supporters and critics agree the proposed rules are merely a first step rather than the government's final word. Some observers say the FDA chose to move cautiously because of legal and political pressures and because of how little is known about the products.

The agency's action has been delayed for years by legal battles that began in 2009 when it first attempted to regulate e-cigs as a drug-delivery device under the Food, Drug, and Cosmetic Act. E-cigarette makers sued to challenge that designation, saying e-cigs should be considered tobacco products, not medical devices. In 2010, a federal appeals court sided with e-cigarette manufacturers.

Since then, e-cig sales have taken off, with no regulatory oversight. As many as 200 brands are now sold. E-cigarette sales reached nearly $2 billion in 2013. Industry analysts predict sales will eclipse the $80 billion-a-year tobacco-cigarette market by 2040.

The proposed rule did not impose restrictions on TV advertising, online sales, or flavored e-cigarettes, which critics say appeal to minors. Stanton Glantz, a professor at the Center for Tobacco Control Research and Education at the University of California, San Francisco, said the agency likely faced pressure from the Obama administration to proceed cautiously. “This is really not the FDA's rule, it's President Obama's rule,” Glantz said. “The Office of Management and Budget sat on this for months.”

Dr. D. Kyle Hogarth, medical director at the University of Chicago Medical Center's Pulmonary Rehabilitation Program, said the proposed rules are too timid. He scoffed at arguments that e-cig regulations should be lighter because the products can help tobacco users kick their deadly habit.

“If this was really a product designed to replace the (tobacco) cigarette, then this thing would have been totally geared only for adults,” he said. But the commercials, he added, are frequently targeted to young people, and the flavored products are geared mainly to minors.

E-cigarette supporters criticized the rule's requirement that producers seek FDA approval before making claims that their devices are less hazardous than tobacco cigarettes. They say the process to get such designation would prove too timely and costly for smaller manufacturers.

“We don't claim it is a stop-smoking device,” said Thomas Kiklas, co-founder and chief financial officer of the Tobacco Vapor Electronic Cigarette Association, a trade group. But, he said, evidence is mounting that e-cigs, which heat a liquid nicotine solution to form a vapor that is inhaled, are in fact a safer alternative to the estimated 4,000 chemicals known to be produced when a tobacco cigarette is smoked.

Some physicians agree. “There's no question in my mind that these products are safer than cigarettes,” said Dr. Michael Siegel, a professor of community health sciences at Boston University. “To not allow these companies to tell the truth doesn't make any sense to me.”

Still, many health experts argue that too little is known about e-cigarette ingredients to judge their safety or effectiveness as a tobacco-cessation aid, and they say the draft rule does not go far enough to reduce the use of e-cigs among young people. The number of middle-school and high-school students who reported using an e-cigarette doubled from 3.3% in 2011 to 6.8% in 2012, according to the Centers for Disease Control and Prevention.

The FDA will accept public comment on the proposed rule over the next 75 days. Once the final rule goes into effect, companies would have up to two years to submit applications to the FDA to get approval to continue selling certain existing and new products. But companies can continue selling their devices during the review process.

Glantz said he's pessimistic that the FDA will strengthen the rule based on public comments. It would have been better for the agency to start from a strong regulatory position and then water down the rules based on comments, rather than starting with what he called a “tepid” rule. “My expectation is the final rule is going to pretty much be what (the proposed rule) is,” he said.

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