FDA: Advance Notice of Proposed Rulemaking (ANPRM)!
Thursday, July 9, 2015
Posted by: Natalia Gromov
DEADLINE: This ANPRM will be available for comment for 60 days, beginning July 1, 2015.
FDA is 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. FDA’s 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:
FDA values the public’s 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.
- 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.