FDA publishes an advance notice of proposed rulemaking for products containing liquid nicotine.
On July 1, the Food and Drug Administration (FDA) published an advance notice of proposed rulemaking (ANPRM) to obtain feedback regarding the potential requirement for nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing e-liquids made or derived from tobacco, including dissolvables, lotions, gels, and drinks. The FDA has authority over tobacco products under the Tobacco Control Act (Pub. L. 111-31) that added Section 901 [21 U.S.C. § 387a] to the Food, Drug, and Cosmetic Act (FD&C Act).
The ANPRM comes over a year after the FDA proposed a rule to deem all products meeting the statutory definition of “tobacco products” (including liquid nicotine used in e-cigarettes) as being regulated under the Tobacco Control Act. “Liquid nicotine” is defined in the ANPRM as “made or derived from tobacco and intended for human consumption.” The FDA cites the increase in calls to poison control centers and visits to emergency rooms due to accidental infant and child exposure to nicotine as a motivation for the proposed exposure warnings and child-resistant packaging.
The FDA is requesting comment on the following aspects of nicotine exposure warnings:
Regarding child-resistant packaging, the FDA seeks comment on the following:
The FDA did not address whether it has authority to mandate child-resistant packaging for tobacco products notwithstanding the fact that such authority to require special packaging generally lies with the Consumer Product Safety Commission under the Position Prevention Packaging Act.
Electronic and written comments will be accepted until August 31, 2015. All submissions must include Docket No. FDA-2015-N-1514. See the FDA’s ANPRM for more information on submissions.
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 FD&C Act § 201(rr) [21 U.S.C. § 321(rr)].
 See 79 Fed. Reg. 23142 (Apr. 25, 2014).
 See, e.g., Centers for Disease Control, Notes from the Field: Calls to Poison Centers for Exposure to Electronic Cigarettes – United States, September 2010 – February 2014, CDC.gov (Apr. 4, 2014); Robert A Bassett, et al., Nicotine Poisoning in an Infant, 23 N Engl. J Med. 2249 (June 5, 2014).
 16 U.S.C. §§ 1700-1702.