Healthcare Business News

FDA's proposed e-cig rule: Too far or not far enough?

By Steven Ross Johnson
Posted: April 24, 2014 - 4:15 pm ET

The federal government's plan to regulate electronic cigarettes is drawing criticism from those who believe restrictions on the product will interfere with smokers' efforts to switch to a less-harmful habit. But many public-health advocates fear the new rules don't go far enough.

The Food and Drug Administration's proposed rule (PDF) would prohibit the sale of e-cigarettes to anyone under the age of 18 and require makers to include health warnings on their products stating that nicotine is addictive. Manufacturers would also be required to disclose ingredients to the FDA and would not be able to claim their products are safer than tobacco products.

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Efforts to reduce the known harms of tobacco products have been a major driver behind the stark rise in e-cigarette sales in the last few years and a key argument of their supporters, who defend a product under increasing scrutiny by public health officials. Some cities, including Chicago and New York , have banned their use in indoor public spaces.

E-cigarette sales reached nearly $2 billion in 2013 and are expected to climb even further in the coming years. Industry analysts believe e-cigarette sales are on pace to eclipse the $80 billion-a-year tobacco cigarette market by 2040. Users of the devices, many of whom are former tobacco smokers, claim they switched because they believed e-cigarettes were a safer alternative.

“We've never made claims that they are safer than tobacco. We don't claim it is a stop-smoking device,” said Thomas Kiklas, co-founder and chief financial officer for the Tobacco Vapor Electronic Cigarette Association, a leading industry trade organization that is nevertheless opposed to prohibiting e-cig makers from making such claims. “We just simply claim that it is an improved version of centuries-old technology. We're glad that they [the FDA] have made some recommendations for the regulation of the technology itself, but some aspects are troubling.”

Kiklas and others say evidence has been mounting for years showing e-cigarettes, 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 docs say e-cigs safer

Some physicians agree. “There's no question in my mind that these products are safer than cigarettes,” said Dr. Michael Siegel, a physician and 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 and advocates argue that too little is known about the ingredients used in e-cigarettes to judge their safety or effectiveness as a tobacco cessation aid, and they feel the draft regulations do not go far enough toward establishing further safeguards to help reduce the use of e-cigs among young people.

The proposal would not prohibit online sales of e-cigarettes, television advertising or the production of flavored-nicotine solutions, which critics say target young users.

“If this was really a product designed to replace the cigarette and designed to allow the smoker to get the nicotine they require without having actually smoked, then this thing would have been totally geared only for adults,” said Dr. D. Kyle Hogarth, medical director for the University of Chicago Medical Center's Pulmonary Rehabilitation Program. “When you see their commercials it's always hip and young and they have flavored ones [e-cig solutions], which are always geared towards kids.”

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 a report released last year by the Centers for Disease Control and Prevention.

In 2009 the FDA attempted to regulate e-cigs as a drug-delivery device under the Food, Drug, and Cosmetic Act, which would have required makers to subject their products to lengthy clinical trials to determine their safety and effectiveness.

E-cigarette manufacturers filed a lawsuit challenging the designation, and in 2010 a federal appeals court ruled in favor of the manufacturers, who argued that e-cigs were not medical devices and should be considered tobacco products. Since that time, the industry has exploded in the absence of federal oversight, with as many as 200 brands now sold.

The FDA will accept public comment on the proposal for 75 days beginning Friday.

Follow Steven Ross Johnson on Twitter: @MHsjohnson

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