Monday, October 10, 2016

FDA Proposes Warning Labels on Liquid Nicotine Bottles

Federal, state lawmakers have urged the agency to accelerate its push to regulate e-cigarette

The Food and Drug Administration is expected to complete its April 2014 rules regulating e-cigarettes within the next two months.ENLARGE
The Food and Drug Administration is expected to complete its April 2014 rules regulating e-cigarettes within the next two months. PHOTO: TONY GENTILE/REUTERS
A proposal introduced on Tuesday by the Food and Drug Administration could result in warning labels and child-resistant packaging on bottles of liquid nicotine used in electronic cigarettes.
It is the first regulatory action on e-cigarettes the U.S. agency has announced since proposing regulations in April 2014 that would allow it to assume oversight of the $3.5 billion industry. The FDA is expected to complete those rules within the next two months. As part of the rules, it is also expected to restrict sales of battery-powered devices to anyone under 18 years old and require manufacturers to submit their products for federal approval.
The agency said on Tuesday that it would seek public comment for 60 days about whether bottles of liquid nicotine should require warning labels and childproof packaging in light of a recent increase in nicotine exposure and poisoning incidents. A January report by the California Department of Public Health said that reports of e-cigarette-related nicotine poisonings in young children in the state of California rose to 154 in 2014 from seven cases in 2012.

Federal and state lawmakers have urged the FDA this year to accelerate its push to regulate e-cigarettes. They have expressed alarm about nicotine poisonings and a report by the federal Centers for Disease Control and Prevention in April that e-cigarette use among teenagers tripled between 2013 and 2014.
The FDA will weigh comments on its proposal to put warning labels on liquid nicotine used in e-cigarettes before potentially proposing a rule.ENLARGE
The FDA will weigh comments on its proposal to put warning labels on liquid nicotine used in e-cigarettes before potentially proposing a rule. PHOTO: LUCAS JACKSON/REUTERS
In the absence of federal regulations, many states and cities have pushed forward with their own rules. More than 40 states have banned e-cigarette sales to minors and more than 100 cities have banned e-cigarette use indoors.
The FDA said earlier this year that it needed time to complete rules because e-cigarettes involve “complicated rule making.” The agency gained regulatory authority over cigarettes through the 2009 Family Smoking Prevention and Tobacco Control Act, but the act didn’t cover e-cigarettes and liquid nicotine products because they were just being introduced to the market.
The e-cigarette industry isn’t opposed to child-resistant packaging or warning labels, but e-cigarette advocates criticized the timing of the proposal because it came before the FDA has taken oversight of the industry. 
E-cigarette advocates oppose the FDA treating e-cigarettes as tobacco products because they say e-cigarettes don’t contain tobacco leaf and they believe e-cigarettes can be used to help smokers quit cigarettes.
“This seems premature,” said Gregory Conley, president of the American Vaping Association, an industry funded advocacy group. “There are still numerous problems the FDA should be working out with their proposed regulations from last year before they contemplate new regulatory actions.”
Write to Tripp Mickle at Tripp.Mickle@wsj.com
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