US electronic cigarettes face safety review
Print Edition
HUNDREDS of electronic cigarette brands will have to undergo federal review to stay on the market under new rules that have the potential to upend a multi-billion dollar industry attempting to position itself as an alternative to traditional cigarettes.
The Food and Drug Administration yesterday released long-awaited rules that bring the burgeoning industry under federal oversight.
The changes will limit e-cigarette sales to minors and require new health warnings. In a shift vigorously opposed by the industry, manufacturers must seek federal permission to continue marketing all e-cigarettes launched since 2007, making up the vast majority of the market.
Most companies will have to submit premarket applications that will undergo review to assess their impact on the “public health.” Those that don’t submit the required information or don’t meet federal standards would have their products removed from the market.
E-cigarettes are battery-powered devices that turn nicotine into an inhalable liquid vapor. Though nicotine can be addictive, e-cigarettes lack the chemicals and tars of burning tobacco.
Yet the devices haven’t been extensively studied and there’s no scientific consensus on any potential benefits or harms from “vaping,” including whether it leads young people to become regular smokers.
The FDA action comes five years after the agency first announced its intention to regulate e-cigarettes and more than two years after it floated its initial proposal. Public health advocates applauded the news.
“Ending the tobacco epidemic is more urgent than ever, and can only happen if the FDA acts aggressively and broadly to protect all Americans from all tobacco products,” said Harold Wimmer, president of the American Lung Association.
The new requirements are likely to set up a legal showdown with manufacturers, who have warned that the costs of complying with FDA regulation could wipe out their industry.
The agency has stumbled before in its efforts to regulate the industry. In 2010, a federal appeals court threw out the agency’s plan to treat e-cigarettes as drug-delivery devices, rather than tobacco products. The ruling was seen as a win for manufacturers who opposed the stringent and expensive requirements of conducting pharmaceutical-style studies.
House Republicans are pushing industry-backed legislation that would prohibit the FDA from requiring retroactive safety reviews of e-cigarettes that are already on the market and exempt some premium and large cigars from those same regulations. E-cigarette products introduced in the future would still undergo the safety reviews.
Lawmakers have long enjoyed a close relationship with the tobacco industry, which has already given more than US$1.8 million to members of Congress this election cycle, according to the Center for Responsive Politics.
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