FDA weighs warning labels for liquid nicotine

The Food and Drug Administration is asking the public to weigh in on what warning labels and child-resistant packaging should look like for liquid nicotine used in electronic cigarettes.

In a notice in the Federal Register, the agency said it’s specifically looking for comments, data and research results that could help the FDA regulate how manufacturers label and package liquid nicotine.

Industry and health groups are still waiting for the FDA to finalize its tobacco deeming regulations and, for the first time, regulate e-cigarettes. The rule, first proposed in April 2014, would limit sales to people age 18 or older, and force manufactures to display health warning labels on packaging and in advertisements.

The FDA said it’s considering additional rules that would force manufacturers to create childproof packaging in response to growing public concern about liquid nicotine poisonings and exposures.

In November, poison control centers reported that calls related to e-cigarettes had nearly doubled in 2014 from the 1,543 exposures reported in 2013, with the majority of cases involving children younger than six. 

In December, a toddler reportedly died after swallowing liquid nicotine, pushing Sen. Bill Nelson (D-Fla.) to introduce the Child Nicotine Poisoning Prevention Act, which would direct the Consumer Product Safety Commission to issue new rules requiring safer, child-resistant packaging for liquid nicotine containers.

That bill might not be needed if the FDA includes rules for childproof packaging when it finalizes its tobacco deeming regulations, which are due out this summer.

The agency is asking if it were to require nicotine exposure warning labels on liquid nicotine, what issues should the warning labels address and what wording should be used, and if the FDA were to require child-resistant packaging for liquid nicotine, how the requirement should be articulated, among other questions.

In a statement, the American Academy of Pediatrics (AAP) said FDA is taking an important step forward in protecting children from liquid nicotine poisoning that’s become a preventable health crisis.

“The FDA has clear authority to keep children safe from liquid nicotine poisoning, and we urge the agency to issue the strongest possible safety standards for liquid nicotine refills as soon as possible,” AAP said. “Barring urgent action from the FDA, legislation is necessary to prevent more harm to children from these products.”

The public has 60 days to send comments to FDA.

— This story was updated at 1:18 p.m.