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.[1] 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”[2] (including liquid nicotine used in e-cigarettes) as being regulated under the Tobacco Control Act.[3] “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.[4]

The FDA is requesting comment on the following aspects of nicotine exposure warnings: 

• The scope of potential exposure warnings with respect to oral, ocular, and dermal exposure
• The presentation of the warnings, including novel textual and graphic warnings
• The types of abbreviated warnings
• Whether the warnings should include the American Association of Poison Control Centers’ telephone number

Regarding child-resistant packaging, the FDA seeks comment on the following:

• The need for child-resistant packaging for liquid nicotine products for consumer and non-consumer-packages
• What types of child-resistant packaging should be used
• Whether the child-resistant packaging should be performance-based (e.g., based on the percentage of five-year-olds who cannot open the package versus the percentage of adults who can open the package) or have mandated physical characteristics (e.g., a squeeze-and-turn lid)
• Whether the FDA should minimize steps users may take to disable the child-resistant packaging.

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.[5]

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.

[1] Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products; Request for Comment, 80 Fed. Reg. 37555 (July 1, 2015).

[2] FD&C Act § 201(rr) [21 U.S.C. § 321(rr)].

[3] See 79 Fed. Reg. 23142 (Apr. 25, 2014). 

[4] 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).

[5] 16 U.S.C. §§ 1700-1702.