Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products; Request for Comments

The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of ``tobacco products'' subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and restrictions regarding the sale and distribution of such tobacco products. Specifically, this ANPRM is 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. In April 2014, FDA published a proposed rule seeking to deem products meeting the statutory definition of ``tobacco product,'' except accessories to proposed deemed tobacco products, to be subject to the FD&C Act, as amended by the Tobacco Control Act. Specifically, the proposed rule seeks to extend the Agency's ``tobacco product'' authorities to those products that meet the statutory definition of ``tobacco product,'' prohibiting the sale of ``covered tobacco products'' to individuals under the age of 18, and requiring the display of health warnings on certain tobacco product packages and in advertisements. The deeming rulemaking does not address the issues raised in this ANPRM.