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FDA proposes regulation of electronic cigarettes

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Agency also intends to extend authority to other tobacco products, including cigars and hookahs.

Electronic cigarettes have been promoted as a safer alternative to conventional cigarettes. Credit: Patrice Masante/ABACA/Press Association Images

US regulators have today announced their first plans to rein in the burgeoning electronic-cigarette industry.

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As part of a wider package, the Food and Drug Administration (FDA) laid out proposals to control an assortment of tobacco products, including cigars, pipe tobacco and hookah tobacco. But it is the proposed governance of electronic cigarettes or 'e-cigarettes' — controversial devices that deliver nicotine-laced water vapour — that has drawn the most attention.

The FDA already regulates sales of cigarettes, cigarette tobacco and smokeless tobacco products. The proposal announced today would prohibit the sale of the newly designated tobacco products, including e-cigarettes, to people younger than 18 years old. It would also require health warnings on these tobacco products, and for the FDA to review those products before they are marketed.

E-cigarettes, which contain nicotine extracted from tobacco leaves, have been hailed by some as a safer alternative to cigarettes, and one that may help those who want to stop smoking. But a study released in March1 found no such benefit, and some worry that unfettered marketing of these pseudo-cigarettes will attract new users — particularly children — to the world of tobacco products. In 2013, researchers at the US Centers for Disease Control and Prevention found2 that e-cigarette use by middle- and high-school students had doubled between 2011 and 2012.

The FDA proposal will be open to public comment for 75 days, and a final ruling may be issued after those comments have been reviewed. “We are eager to see this process move forward,” says FDA commissioner Margaret Hamburg. Placing e-cigarettes and the other tobacco products under FDA regulation would open the door to subsequent rules, including those that could restrict how the products are advertised. The FDA is also evaluating whether it should limit the flavours being marketed. E-cigarettes, for example, come in candy-like flavours that may be particularly appealing to children.

One key benefit of the FDA’s proposal is that it would require manufacturers of e-cigarettes to report the ingredients in their products, says Vaughan Rees, who studies tobacco-control measures at the Harvard School of Public Health in Boston, Massachusetts. Some studies have found traces of heavy metals and other contaminants in e-cigarettes, he notes.

But some researchers worry that the regulations will hinder efforts to use e-cigarettes as tools to reduce cigarette smoking — a habit that is considered the leading cause of preventable death and disease. “It is not clear yet how high will be the hurdle to obtain the FDA approval,” says Peter Hajek, director of the Tobacco Dependence Research Unit at the Queen Mary University of London. “If this proves difficult and expensive, it may harm product development.”

References

  1. Grana, R. A., Popova, L. & Ling, P. M. J. Am. Med. Assoc. Int. Med. http://dx.doi.org/10.1001/jamainternmed.2014.187 (2014).

  2. Corey, C. et al. Morb. Mortal. Week. Rep. 62, 729-730 (2013).

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FDA's electronic cigarette proposal

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Ledford, H. FDA proposes regulation of electronic cigarettes. Nature (2014). https://doi.org/10.1038/nature.2014.15105

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