April 24, 2014
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FDA proposes regulations for electronic cigarettes

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The FDA today released its proposed regulations for electronic cigarettes.

The new regulations extend the Tobacco Control Act to include coverage of e-cigarettes and other “novel tobacco products.” The proposed rules include banning the sale of e-cigarettes to anyone younger than 18 years and a requirement for buyers to provide photo identification for purchases. Vending machine sales of e-cigarettes will be prohibited unless in a venue closed to anyone younger than 18 years, and e-cigarette manufacturers will be required to include health warnings on labels.

Marketing of the liquid nicotine devices, unlike traditional tobacco products, has not been banned, but advertising campaigns “cannot make misleading statements,” and the distribution of free samples is not permitted. E-cigarette manufacturers will be required to register with the FDA and provide a list of products and ingredients, and can only make direct or implied claims of reduced risk “if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole.”

Kathleen Sebelius

Kathleen Sebelius

“This proposed rule is the latest step in our efforts to make the next generation tobacco-free,” outgoing Health and Human Services Secretary Kathleen Sebelius said in a press release. The FDA has invited public comment on the issue.

Due to lack of classification, e-cigarettes entered the market outside the scope of normal regulatory channels. The cigarettes use an ignition system to vaporize liquid containing nicotine and flavorings, but little is known about what other ingredients may be present.

"We believe the rule falls short by allowing industry to continue to advertise e-cigarettes, often with attractive and seductive flavorings, and increases the risk that we will raise yet another generation addicted to nicotine, before we even fully understand the health dangers of these new nicotine-delivery products. We must increase the pace of research, and understand the full range of health consequences, before we allow this Trojan horse of nicotine back into society," American Heart Association CEO Nancy Brown said in a press release.

In January, the FDA announced tobacco research priorities, including the study of new nicotine delivery products, such as dissolvable and liquid forms. Among its goals, the initiative seeks to identify the bioavailability of nicotine from different delivery system designs and identify any toxicities, adverse health risks and cognitive or behavioral issues associated with the devices.

Earlier, limited laboratory testing by the FDA on some e-cigarette fluids revealed inconsistencies among batches and labeling. Researchers found that some fluids labeled as “nicotine-free” contained nicotine, whereas nicotine concentrations varied among e-cigarette cartridges with the same label, according to an FDA Web page.

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Voluntary reports from consumers and health professionals have indicated pneumonia, congestive HF, disorientation, seizure, hypotension and other health problems as adverse events, but it is unknown whether e-cigarettes or other conditions caused the problems, the FDA stated on its e-cigarette consumer information Web page.

Some research on the use of e-cigarettes has linked the devices to smoking reduction or cessation. Other studies show an increase in popularity of e-cigarettes among adolescents, but little has been done to determine what health risks may be associated with inhaling the vapor, known as “vaping” by users.

“It is imperative that the FDA regulates all tobacco products, including e-cigarettes and cigars, and prohibit the sale and marketing of these products to children,” Margaret Foti, MD, PhD, chief executive officer of the American Association for Cancer Research, said in a press release. “The proposed rule is an important step forward in expanding the FDA’s regulation of tobacco and protecting the health of the American people.”

Margaret Foti, MD, PhD

Margaret Foti

The International Union Against Tuberculosis and Lung Disease called for immediate regulation of e-cigarettes in November. This month, the CDC reported a rise in calls to poison centers related to e-cigarette use.

Some have expressed concern that the fruit flavors available for e-cigarettes, as well as other marketing tactics, will entice young smokers. “If they continue to be irresponsibly marketed, they could make smoking look glamorous again and undermine decades of work to reduce youth smoking,” Susan M. Liss, executive director of the Campaign for Tobacco-Free Kids, said in a press release.

Liss’ comments followed an inquiry by a congressional group on April 14 that investigated the popularity and marketing of e-cigarettes. The investigation group, led by Sen. Dick Durbin, D-Ill., highlighted industry use of celebrity endorsements including Jenny McCarthy, social media campaigns and sweet flavors for nicotine cartridges to entice buyers.

Adverse health effects and the possibility of luring children into nicotine use have not been the only concerns expressed about e-cigarettes. A representative from St. Joseph’s Hospital in Syracuse, N.Y., confirmed reports of a fire that was ignited by a patient using an e-cigarette while also receiving oxygen. The hospital has since banned the use of e-cigarettes on its premises.  -- by Shirley Pulawski