Tuesday, July 15, 2014

FDA wants authority over electronic cigarettes; manufacturers say more research is needed

The U.S. Food and Drug Administration has proposed rules to give it authority over electronic cigarettes, but manufacturers argue that regulations should have to wait until the FDA completes a study on e-cigarettes, even though the study isn't expected to be completed until 2018. (Associated Press photo)

The Tobacco Control Act, signed into law in 2009, gave the FDA authority to issue regulations on cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, according to the proposal, which would add e-cigarettes to that list. The public comment period is open until Aug. 8.

The proposed rules include a ban on sales of tobacco products to anyone under 18 and requiring manufacturers to disclose their ingredients to the FDA, Stacy Simon reports for the American Cancer Society. Even if the proposal is passed it could take more than a year to go into effect.

FDA Commissioner Margaret A. Hamburg said in a statement: "Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products. Science-based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth.” (Read more)

A Cancer Society poll found that 62 percent of respondents "favor prohibiting e-cigarettes in places where smoking is already banned," Jim Collar reports for Post-Crescent Media in Wisconsin, which in 2010 banned indoor smoking in public places. "The popularity of e-cigarettes has grown faster than research, and the effects aren’t known for either the user or those exposed to secondhand vapor, health officials say," Collar writes.

The Wisconsin Legislature did not pass a bill this year that would have exempted e-cigarettes from the state’s indoor-smoking ban on indoor smoking. Several other states have passed laws including e-cigs in their bans on sale of tobacco products to minors.

FDA researchers are spending $270 million on 48 studies to determine the risks of e-cigarettes, Sharon Begley reports for The Columbus Dispatch. "Final results might not be available before 2018, according to researchers leading the FDA-funded projects. That timetable underscores how the slow pace of science is contributing to a regulatory vacuum, allowing makers of e-cigarettes to sell their products virtually unchallenged."

"The e-cigarette industry, which Wells Fargo Securities estimates will make $2 billion in global sales this year, says the FDA must wait for the results of the research before it issues regulations, or manufacturers risk being driven out of business by unproven fears about their products," Begley writes. Lawyer Bryan Haynes, whose firm represents e-cigarette manufacturers, told Begley, "There shouldn’t be regulations akin to those for cigarettes without evidence of similar health impact, especially since the preliminary evidence is positive for the industry” when comparing e-cigarette vapor to tobacco smoke.

According to the most recent data from 2012, more than 14 million adults and nearly 2 million children have used e-cigarettes, with rates among high school students doubling from 2011 to 2012, Begley writes. "The missing science includes basic questions such as what compounds are in the vapor produced by e-cigarettes. It also includes complicated ones such as whether flavors such as butterscotch and bubble gum entice children to vape, how e-cigarette displays in online stores affect teenagers’ desire to buy vaping liquid, and, perhaps most important, whether e-cigarettes will reduce the number of smokers or produce millions of new nicotine addicts." (Read more)

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