FDA seeks further information on liquid nicotine

The US Food and Drug Administration is looking for further information to help it decide what action it might take in respect of nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing e-liquids.

The FDA said that recent increases in calls and visits to both poison control centers and emergency rooms in the US involving liquid nicotine poisonings and exposures had increased the public health concerns of these exposure risks.

In an ‘advance notice of proposed rulemaking’ (ANPRM) issued today, the FDA said it was ‘…seeking comments, data, research results, or other information that may inform regulatory actions FDA might take with respect to nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing e-liquid(s) that are made or derived from tobacco and intended for human consumption, and potentially for other tobacco products including, but not limited to, novel tobacco products such as dissolvables, lotions, gels, and drinks’.

The FDA said it had evaluated data and science related to the risks, especially to infants and children, from accidental exposure to nicotine, including exposure to liquid nicotine and nicotine-containing e-liquids primarily used with electronic nicotine delivery systems, such as electronic cigarettes.

And it said that it was considering whether, based on the acute toxicity of nicotine (up to and including nicotine poisoning), it would be appropriate for the protection of the public health to warn the public about the dangers of nicotine exposure, especially due to inadvertent nicotine exposure in infants and children, and/or require that some tobacco products be sold in child-resistant packaging.

In its ANPRM, the FDA poses 16 questions under the heading, Nicotine exposure warnings; nine questions under the heading, Child-resistant packaging; and five under the heading Other actions and considerations.

The FDA’s ANPRM with details of how to respond is at: http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM453226.pdf