Reynolds American Inc. is asking the Food and Drug Administration to adopt a new enforcement policy directed at illegally marketed disposable electronic nicotine delivery system (ENDS) products, calling out companies like Puff Bar and Elf Bar that market to youth.
Such a policy would close a loophole in the FDA’s current tobacco enforcement efforts, Reynolds said.
“The action requested will better protect the public health and ensure a level playing field by discouraging illicit products and maintaining the availability of legally marketed, potentially less harmful options for current and former adult smokers who have transitioned or wish to transition from combustible cigarettes,” the Winston-Salem, North Carolina-based tobacco company said in its citizen petition, submitted Feb. 6.
Enforcement action should occur at both retail establishments and ports of entry, Reynolds said. It asked the FDA to prioritize enforcement for:
- Any flavored disposable ENDS, except for tobacco- or menthol-flavored products.
- Any disposable ENDS containing nicotine derived from any source other than tobacco that lacks premarket authorization.
- Disposable products containing nicotine derived from tobacco that were not on the market as of Aug. 8, 2016, or that failed to submit a timely premarket tobacco product applications (PMTA).
- Any disposable ENDS for which the manufacturer failed to take adequate measure to prevent minors’ access.
- ENDS targeted to minors, or whose marketing is likely to promote use by minors.
The National Youth Tobacco Survey showed that youth use of disposable ENDS products increased significantly between 2019 and 2022, Reynolds said in the petition. In 2019, among current ENDS users, only 2.4% of high-school students used disposable ENDS. But in 2022, among current ENDS users, 57.2% used disposable products.
Many manufacturers of disposable ENDS use child-friendly flavors or youth-targeted social media marketing in ways associated with a greater risk of vaping uptake by youth, Reynolds said. It gave the example of Puff Bar running an ad in April 2020, encouraging people to “stay sane” and stating that Puff Bar is the “perfect escape from the…parental texts.” Elf Bar, a Chinese manufacturer, marketed its products to young people via social media platform TikTok, Reynolds said.
Disposable ENDS manufacturers also were able to evade FDA’s tobacco authority by using non-tobacco-derived or synthetic nicotine in their devices before President Joe Biden granted the FDA explicit authority over synthetic nicotine products. After that, manufacturers of tobacco products with synthetic nicotine had to file a PMTA by May 14 to remain legally on the market.
When a citizen petition, or request for a policy change, is submitted to the FDA, the agency usually has 150 to 180 days to provide the initial response.
RAI Services Co. submitted the citizens petition on behalf of its affiliated tobacco companies including Reynolds American Inc., and its subsidiaries including R.J. Reynolds Tobacco Co., American Snuff Co., Santa FE Natural Tobacco Co., R.J. Reynolds Vapor Co. and Modoral Brands. The FDA issued a marketing denial order to two of R.J. Reynolds Vapor Co.’s products—the Vuse Vibe Tank Menthol 3% and Ciro Cartridge Menthol 1.5% in January. However, a stay was later issued on the Vuse Vibe Tank Menthol 3%.
Elf Bar and Puff Bar representatives could not immediately be reached by CSP Daily News.
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