Potential Major Changes for Liquid Nicotine and Novel Tobacco Product Firms on the Horizon
Prompted by increases in both calls and visits to poison control centers and hospitals related to liquid nicotine ingestion and exposure—and in response to pressure from some on Capitol Hill and several health and medical organizations—the U.S. Food and Drug Administration (FDA or the Agency) yesterday issued an advance notice of proposed rulemaking (ANPRM) regarding nicotine exposure warnings and child-resistant packaging.
FDA poses a series of questions seeking information that may inform regulatory actions regarding nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing e-liquid(s) that are made or derived from tobacco and intended for human consumption, and potentially for novel tobacco products (e.g., dissolvables, lotions, gels, and drinks). Publication of the ANPRM in the Federal Register opens a 60-day public comment period, after which a Proposed Rule could be issued.
In April 2014, FDA published a proposed rule seeking to deem products meeting the statutory definition of "tobacco product" (e.g., e-cigarettes, liquid nicotine, nicotine-containing e-liquid) to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). For more information on the "deeming rule," please see the following article. FDA has yet to finalize the deeming rule, despite the pendency of the proposed rule for over 14 months.
In issuing the ANPRM, FDA is signaling that it is considering going beyond the proposed "deeming rule" and issuing regulations requiring package or other warnings about the dangers of nicotine exposure, particularly regarding accidental exposure of infants and children to nicotine, and requiring that e-liquids be sold in child-resistant packaging. Whether the Agency has the authority to issue any regulations related to vapor products remains an open question and will likely be the subject of legal challenges moving forward. However, the ANPRM provides some insight into how FDA intends to proceed with regulating this product category.
With respect to nicotine exposure warnings, some of FDA's questions include:
- Should FDA consider requiring nicotine exposure warning(s) text on liquid nicotine and novel tobacco products?
- Should there be multiple textual warnings that randomly display to convey different dangers, or should there be a single, consistent textual warning that covers all of the different dangers?
- Should FDA consider requiring color(s) or graphic elements, such as symbols, as part of the warning(s)?
- Should FDA adopt a different nicotine exposure warning(s) requirement based on the packaging/containers (e.g., a brief/abbreviated warning(s) for liquid nicotine in small packaging/containers, omit the warning(s) if the tobacco product is in a child-resistant package)?
- Should FDA require the inclusion of the American Association of Poison Control Centers’ telephone number on the container labeling and/or packaging of liquid nicotine and tobacco products other than liquid nicotine?
With respect to child-resistant packaging requirements, some of FDA's questions include:
- Should FDA require child-resistant packaging for liquid nicotine and novel tobacco products?
- Should FDA require child-resistant packaging for liquid nicotine if the liquid nicotine product is not intended to be opened by the consumer (e.g., liquid nicotine in permanently sealed, prefilled, and/or disposable cartridges)?
- If FDA were to require child-resistant packaging for liquid nicotine (including for those products that are not intended to be opened by the consumer) and novel tobacco products, what type of exposure risks (e.g., oral, ocular, dermal) should FDA seek to mitigate with the requirement?
- If FDA were to require child-resistant packaging for liquid nicotine and novel tobacco products, how should the requirement be articulated ((a) whether the requirement should be based on mandated physical characteristics of the packaging (e.g., must have a squeeze-to-turn lid, flow restrictor); (b) whether the requirement should be performance based (e.g., unable to be opened by 80 percent or more of 5-year-olds who try to open the package, and more than 90 percent of adults on average between the ages of 50-70 can successfully open the package); or (c) some combination of (a) and (b))?
The performance testing standards suggested by FDA are based largely on the United States Consumer Product Safety Commission's (CPSC) testing requirements promulgated under the Poison Prevention Packaging Act (PPPA).
While the requirements being considered in the ANPRM are only the start of the regulatory process, rules in this area, if adopted, would have a major impact on liquid nicotine and novel tobacco product firms.