FDA to regulate e-cigs: ban sales to minors, require warning signs, require federal approval; did not address advertising issues

In a long-anticipated move, the U.S. Food and Drug Administration announced May 5 that it is assuming regulatory authority over all tobacco products, including electronic cigarettes, cigars, hookah, tobacco and pipe tobacco that include banning sales to anyone under 18.

“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,” Health and Human Services Secretary Sylvia Burwell said in a news release.

FDA’s new tobacco regulations will prohibit sales of e-cigarettes and all tobacco products to anyone under 18, both in person and online, and buyers must now show photo ID.

Health warnings will also be placed on packages and in advertisements, saying, “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” It also bans free samples and the sale of covered products in vending machines not located in adult-only facilities.

The regulation also requires manufacturers of all newly-regulated products introduced to the market after Feb. 15, 2007, a date that is set by the Tobacco Control Act of 2009, to require federal approval. An amendment to the legislation has been submitted to change the date so more e-cigarettes would be grandfathered in, Jayne O’Donnell and Laura Ungar report for USA Today.


The e-cigarette industry is pushing back on these regulations.

“Industry experts say treating e-cigarettes, which don’t contain tobacco, the same as cigarettes could lead to such onerous and costly approval that all but the largest tobacco companies would be forced out of the market — and possibly those companies, too,” USA Today writes. Jeff Stier, an e-cigarette advocate with the National Center for Public Policy Research and industry officials, told USA Today that it could cost $1 million or more per application.

Vapers also argue that e-cigs help people quit, but studies on that conflict.

Ellen Hahn, a professor at the University of Kentucky College of Nursing and co-chair of the UK Tobacco-free Task Force, told USA Today that the new rule is a good first step toward controlling e-cigarettes, noting “vaping” can get youth addicted to nicotine and threatens to prolong “the tobacco epidemic.”

“From a health perspective, to reduce the social acceptance of them is good because frankly, it’s the wild, wild West out there,” she told the newspaper. “Vape stores are everywhere.”

The Robert Wood Johnson Foundation commended the FDA for these regulations, noting the use among high school students has “rocketed from 1.5 percent in 2011 to 16 percent in 2015, an increase of more than 900 percent.” But it also said the regulation did not go far enough.

“Studies have proven that tobacco advertising directly influences youth, and that such sweet e-cigarette flavors as gummy bear and cotton candy play a role in children trying these products,” Dr. Risa Lavizzo-Mourey, CEO of the RWJF, said in the statement “Today’s final rule did not address these issues, and we strongly urge the FDA to take aggressive regulatory and enforcement actions to prevent and reduce youth tobacco use, in any form it takes.”

The regulation goes into effect Aug. 8, and gives affected industries two years to comply. The original proposal was introduced in 2014.

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