FDA Seeking More E-cigarette Data After Poisonings Spike

The U.S. Food and Drug Administration is seeking additional data and comments on liquid nicotine as if considers whether to add exposure warning labels and child-resistant packaging.

In a post on it’s website Tuesday, the agency issued a “Notice of proposed rulemaking“. The notice requests “comments, data, research results or other information that may inform regulatory actions FDA might take” on the matter. A 60 day window is open for the public respond, either by email or post mail.

Last year the Centers for Disease Control and Prevention (CDC) reported that calls to poison centers across the country involving e-cigarettes had risen significantly.

Between September 2010 and February 2014, the agency said, calls involving e-cigarettes rose nationally from about one per month to 215 per month.

Liquid nicotine is the active “ingredient” in electronic cigarettes (or e-cigarettes). The devices deliver nicotine to the user as a vapor.

The FDA writes in the notice:

“The continuing rise in popularity of electronic nicotine devices (ENDS), such as e-cigarettes, which often use liquid nicotine and nicotine-containing e-liquids, has coincided with an increase in calls to poison control centers and visits to emergency rooms related to liquid nicotine poisoning and other nicotine exposure risks.”

Sandra Hassink, American Association of Poison Control Centers‘ president, comments:

“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”.

Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products
21 CFR Parts 1100, 1140, and 1143 June 2015