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FDA's Proposed E-Cigarette Regulations Released

By Brett Snider, Esq. on April 24, 2014 | Last updated on March 21, 2019

The FDA has announced new proposed regulations for e-cigarettes, attempting to get a handle on a now multibillion-dollar industry. The public will soon have a chance to comment.

The proposed rules not only cover e-cigs, but also pipe tobacco and cigars. The FDA wants to prohibit these products from being sold to minors, reports The New York Times.

Will the FDA be successful in its latest attempt to regulate e-cigs?

FDA Tries Again With E-Cigs

This isn't the first time the Food and Drug Administration (FDA) has attempted to regulate e-cigarettes. In 2010, a federal appeals court in Washington, D.C., ruled that e-cigarettes can't be regulated by the FDA as a drug or medical device.

The appellate court ruled that the e-cigs should be regulated, but under the Tobacco Control Act passed in 2009. This act barred tobacco products with different flavors (excepting the all-popular menthol) and gave the FDA the power to oversee and regulate many aspects of tobacco packaging and marketing.

One of the more contentious marketing claims is that e-cigs can be used as "tobacco cessation tools" much like nicotine gum or patches -- both of which are regulated as drugs or medical devices by the FDA. Essentially, the FDA doesn't want a tobacco product to be making therapeutic-type claims without being regulated like a medical device.

The new proposed tobacco and e-cigarette rules may allow the FDA to put a stop to those claims.

Proposed Rules

The FDA's proposed rules are scheduled to be published in the Federal Register on Friday, but are available online now.

One of the biggest proposed changes is requiring all tobacco products, including e-cigarettes and cigars, to be registered with the FDA and subject to FDA inspections. David B. Abrams of the Schroeder National Institute for Tobacco Research and Policy Studies told the Times these new rules may shutter unsafe production in the tobacco market. "You won't be able to mix nicotine in your bathtub and sell it anymore," Abrams quipped.

E-cigarettes would also be required to come with cigarette-style warning labels about their nicotine content. Somewhat strangely, the rules do not contain mention of banning candy-like flavors in e-cigs or cigars or banning e-cig marketing from television. The rules may also exempt hand-rolled cigars from any new regulation.

The FDA's proposed e-cigarette regulations will be available for public comment on Regulations.gov beginning Friday (it's Docket No. FDA-2014-N-0189). Comments will be accepted for 75 days.

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