FDA regulation of e-cigarettes: huge costs, little or no benefit, says CASAA

WASHINGTON, April 28, 2014 /PRNewswire-USNewswire/ -- Last week, the U.S. Food and Drug Administration (FDA) released its long-awaited draft regulations for electronic cigarettes (e-cigarettes) and other low-risk alternatives to smoking. The regulations offer little benefit, according to The Consumer Advocates for Smoke-free Alternatives Association (CASAA), the leading advocate for the current and future consumers of low-risk alternatives to smoking. However, CASAA believes that should the FDA finalize the rule in its current form, it will inflict devastating harm on consumers.

"This is a classic case of government imposing a 'solution' and then looking for a problem," said CASAA President Julie Woessner, J.D. "The regulations do nothing to address real concerns, and instead are a slow-motion ban of the high quality e-cigarettes that have helped so many smokers quit. The rules would mostly require busy-work filings that impose huge costs with little apparent benefit."

The proposed regulations are based on a faulty understanding of the science, reports CASAA Scientific Director, Dr. Carl V. Phillips. "FDA has cherry-picked the available evidence," says Phillips, "blindly accepting any assertion that favors aggressive regulation and ignoring the overwhelming evidence about the harms that these regulations would cause."

Although the regulations do not openly ban the refillable devices that are preferred by experienced users, they impose a costly registration and approval process that would effectively eliminate them. Such registrations offer minimal benefits, but ensure that only a few large companies who mass-produce small and disposable products would be able to afford the necessary filings. Additionally, while the regulations do not immediately ban the variety of popular flavors for e-cigarette liquid, they signal an intention to do so in the future.

"Our research and others' shows that higher-quality hardware and appealing flavors are important for smoking cessation," says Phillips. "Many former smokers report that they were always tempted to go back to smoking while using the smaller devices with imitation tobacco flavoring, but they quit smoking for good when they found better hardware and flavors that no longer reminded them of smoking."

It is estimated that as many as a million American smokers have quit or substantially reduced their smoking thanks to e-cigarettes, and many are already making plans for a black market if these regulations take effect. Those smokers who are using e-cigarettes in a transition stage could easily return to smoking--and future potential switchers may never be able to make the transition--if the restrictions on high-quality products are imposed.  Woessner, who quit smoking thanks to e-cigarettes, fears such impacts.  "If I had been limited to only those products that would exist under this regulation, I would probably still be smoking."

CASAA is preparing a response that will point out the flaws in the proposed regulations and is organizing its members and hundreds of thousand of other e-cigarette users in an attempt to persuade FDA about the harms this regulation would cause. Should that fail, it plans to fight the regulations in court.

CASAA is a 501(c)(4) nonprofit, public health, membership NGO. It does not represent the interests of industry. Donations are not tax-deductible as a charitable contribution.

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SOURCE Consumer Advocates for Smoke-free Alternatives Association




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