Aug 24, 2015

FDA Extends Comment Period on ANPRM Regarding Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, E-Liquids and Novel Tobacco Products

Alert | FDA Alert

As Roetzel & Andress reported in July, the Food and Drug Administration (FDA) issued an advance notice of proposed rulemaking (ANPRM) seeking comments, data, research results, or other information to inform the agency’s thinking about options for issuing potential regulations related to requiring nicotine exposure warnings and/or child-resistant packaging for liquid nicotine and nicotine-containing e-liquids 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.  80 Fed. Reg. 37555-37559 (July 1, 2015).

The original deadline for submitting comments to the ANPRM was August 31, 2015, however, the FDA has extended the comment period to September 30, 2015. 80 Fed. Reg. 51146-51147 (August 24, 2015).

Please contact Craig A. Koenigs for further information on this Alert or if you would like assistance in preparing comments or responding to the ANPRM.

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