By Emily Krulewitz & Kristen Booth
The Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009 amended the Food, Drug, & Cosmetic (FD&C) Act, giving FDA the authority to regulate the manufacturing, marketing, and sale of tobacco products, including cigarettes, roll-your-own tobacco, and smokeless tobacco. Because the FSPTCA does not include other products such as electronic cigarettes, cigars, pipe tobacco, nicotine gels, and dissolvables, FDA proposed a rule in April 2014 to “deem” these products to be tobacco products so that they can be regulated under the FSPTCA (for more information about the products covered by and the implications of this proposed rule, see our blog).
On July 1, 2015, FDA published an Advance Notice of a Proposed Rulemaking (ANPRM) regarding the regulation of products containing liquid nicotine. This ANPRM concerns whether the Agency should “warn the public about the dangers of nicotine exposure, especially due to inadvertent nicotine exposure in infants and children, and/or require that some tobacco products be sold in child-resistant packaging.” The recent increase in calls to poison control centers as well as emergency room visits involving liquid nicotine exposure and poisoning prompted FDA to begin this rulemaking process.
The term “liquid nicotine” generally refers to liquid nicotine that is made or derived from tobacco and intended for human consumption, including nicotine-containing e-liquids. These e-liquids are found in electronic cigarettes. The e-liquids come either pre-packaged in the e-cigarette, such as in a disposable product, or separately so they can be used to fill the reservoir of the tank of a larger, non-disposable e-cigarettes. While the ANPRM is worded such that it could also apply to other novel tobacco products (e.g., dissolvables, lotions, gels, drinks), it seems to be design especially in response to the emergence of electronic cigarettes.
E-cigarettes are controversial products, with proponents touting harm reduction and possible efficacy for smoking cessation and opponents warning of a new gateway product for children and a renormalization of smoking behaviors. The April 2014 proposed rule received many comments to the docket from a wide range of individuals and organizations advocating for or against increased regulation of electronic cigarettes.
The ANPRM asks for “comments, data, research results, or other information” to help inform FDA as the Agency begins the rulemaking process. FDA lists a number of specific questions surrounding two general categories:
- Nicotine Exposure Warning(s)
- Should they be required?
- What specific risks should be addressed and what wording is appropriate?
- What products should carry this warning?
- Should they be directed at specific populations (e.g., children or pregnant women)?
- Should they contain information regarding when to contact a Poison Control Center?
- Child-Resistant Packaging
- Should this be required?
- What type of child-resistant packaging should be used?
- What products should this apply to (e.g., to all products or only those intended to be opened by the consumer)?
- How should FDA define “child-resistant”?
The original announcement stated that the comment period on the ANPRM would close on August 31, 2015, which has already passed. However, FDA recently announced that the comment period would be extended until September 30, 2015. Although that does not allow an abundance of time for Sponsors to prepare comments, there is still enough time left. The ANPRM provides instructions on how to file a comment to the docket in Section III. Clients with questions on the effects of the AMPRM, submitting comments to the docket, or any other tobacco-related questions should call us to assist.
Do you have a liquid tobacco product that is either developed or still in the process of being developed? Ensuring you are compliant with the FDA regulation on these products can be tricky, but that is why we are here to help. We have a history of working with various tobacco and e-cigarette products, and using our unique approach that combines scientific knowledge with regulatory expertise, we have been able to successfully help our clients get through FDA. To learn more about our tobacco and e-cigarette services or for more information on how we can help you, email us here.
Written by: Emily Krulewitz, Consultant, and Kristen Booth, Marketing Associate, at The Weinberg Group, the world’s leading food and drug regulatory consulting firm and a leading expert on tobacco regulation. If you have any questions or thoughts on this blog post or others, please reach out to us by email or telephone (202.833.8077).