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BREAKING: FDA announcement means strict regulation of most e-cigarettes

May 5, 2016
by Gary A. Enos, Editor
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The Food and Drug Administration (FDA) today formally extended its authority to all tobacco products, including electronic cigarettes, leading to immediate speculation on whether new federal requirements on the makers of e-cigs could drive many of these companies out of business.

Despite claims by some that e-cigarettes help smokers quit and that restrictions on their marketing and sale will drive people back to more harmful conventional cigarettes, federal officials clearly believe e-cigs carry their own serious risks.

“As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap,” Health and Human Services (HHS) Secretary Sylvia Burwell said in a news release from the FDA. “All of this is creating a new generation of Americans who are at risk of addiction.”

The FDA cited in its announcement of the final rule a study showing that the prevalence of e-cigarette use among high school students increased from 1.5% in 2011 to a striking 16% in 2015.

The final rule that was issued today establishes an important cutoff date for manufacturers of newly regulated products such as e-cigarettes, cigars and hookah tobacco: Feb. 15, 2007. Makers of any such products that were not on the market as of that date (the date was set out in the 2009 Family Smoking Prevention and Tobacco Control Act adopted by Congress) will have to submit new tobacco product applications and demonstrate that their products meet public health standards.

Given that there were virtually no e-cig products on the market before 2007, USA Today reported that some industry advocates believe many companies will choose not to go through a costly application process. Members of the U.S. House are considering an amendment to budget legislation that would subject fewer e-cigarette makers to the application requirements.

Greater disclosure

The FDA rule, which was issued in proposed fashion in 2014, will also subject manufacturers of newly regulated products to requirements to disclose the ingredients in their products and to place health warnings on packaging and advertising.

Manufacturers will have two years to submit new product applications and the FDA will have another year to review them, but retailers will have to begin complying with provisions such as prohibiting sales to minors as soon as the regulations take effect in 90 days.

The final rule does not include a ban on flavored products, which some health advocates supported as a way to lessen the products' appeal to young users.

“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated,” said Mitch Zeller, who directs the FDA's Center for Tobacco Products. “The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced.”

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