FDA to Start Regulating E-Cigarettes

FDA to Start Regulating E-Cigarettes

A man uses an electronic cigarette in this undated file photo. Martina Paraninfi/Getty Images

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E-cigarettes will face new regulations by the U.S. Food and Drug Administration, including requirements that affect manufacturing, ingredient labeling and not selling the product to those under the age of 18, the agency announced today.

The FDA announced a plan to regulate e-cigarettes two years ago, but these are the first concrete regulations issued. The new rules affect not only e-cigarettes but more traditional tobacco products, including cigars, pipe tobacco and hookah tobacco.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” U.S. Department of Health and Human Services Secretary Sylvia Burwell said in a statement today.

“Today’s announcement is an important step in the fight for a tobacco-free generation — it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions,” Burwell said.

The various new regulations affect the selling, marketing and manufacturing of e-cigarettes and other tobacco products.

Newly announced prohibitions on selling e-cigarettes, hookah tobacco and cigars to people under 18 or giving free samples will start to be enforced within 90 days, according to the FDA.

Health officials have been concerned that teens and other young adults may view e-cigarettes as an alternative to cigarettes with a rising number of teens using e-cigarettes. A recent survey found current e-cigarette use among high school students has risen sharply, from 1.5 percent in 2011 to 16 percent in 2015, according to the FDA and the U.S. Centers for Disease Control and Prevention. An estimated 3 million middle and high school students were current e-cigarette users in 2015, according to the FDA. Data also showed high school boys smoked cigars at about the same rate as cigarettes.

To ensure compliance with new regulations, manufacturers of e-cigarettes will have to present their products to the FDA to meet public health standards. The new regulations include new requirements to report ingredients and any potentially harmful aspect of the product. Health warnings will be required on e-cigarette packages and ads and e-cigarette makers must register the places where their products are manufactured. The new regulations will likely take time to be implemented, as the FDA expects that manufacturers will sell their products for up to two years before they submit their product for FDA review. It will take another year for the FDA to review the product the application.

“As a physician, I’ve seen first-hand the devastating health effects of tobacco use,” FDA Commissioner Robert M. Califf, said in a statement. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”

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