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FDA Issues Nicotine Exposure Warnings and Child-Resistant Packaging ANPRM

THIS WEEK IN CTP

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FDA Issues Nicotine Exposure Warnings and Child-Resistant Packaging ANPRM

Today, FDA issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking comments, data, research, and/or other information related to nicotine exposure warnings and child-resistant packaging for liquid nicotine, nicotine-containing e-liquid(s), and potentially for other tobacco products including, but not limited to novel tobacco products such as dissolvables, lotions, gels, and drinks.

FDA has 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-liquid (s). The continuing rise in popularity of electronic nicotine devices (ENDS), such as e-cigarettes, which often use liquid nicotine and nicotine-containing e-liquids, has coincided with an increase in calls to poison control centers and visits to emergency rooms related to liquid nicotine poisoning and other nicotine exposure risks. FDAs assessment of these recent trends has led the agency to seek additional information on 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 some tobacco products be sold in child-resistant packaging.

FDA values the publics input through the comment process and will consider all input, data, research, and other information submitted to the docket to help the agency make the best decisions about possible regulatory actions. If FDA decides to issue a rule, the first step in that process would be to issue a Notice of Proposed Rulemaking in the Federal Register, which would give the public an opportunity to comment on the proposal.

This ANPRM will be available for comment for 60 days, beginning tomorrow, July 1, 2015.


REMINDER: A Public Workshop on Biomarkers of Tobacco Exposure

Dont forget to register for the Biomarkers of Tobacco Exposure Public Workshop! This workshop, designed to discuss how to identify and use of biomarkers for the purpose of tobacco product regulation, will be held August 3-4.  Those interested in participating can attend in person at the FDA White Oak Conference Center or watch a live webcast, but everyone must register online or in writing by July 10.  For those attending the workshop in person, FDA will hold a public comment session on August 4. If you would like to present during the public comment session, please indicate this at the time of registration and provide your presentations topic. 

The workshop will focus on gathering information on identifying potential biomarkers that may be currently appropriate for regulatory use, as well as identify biomarkers for which more data is required, but may be used in the near future. For more information, including how to get involved, important deadlines, and topic areas for this workshop, read the full notice online.  


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