In response to FDA鈥檚 open public comment period in March of 2026 regarding Draft Guidance on Applications for Flavored E-Cigarettes, 暗网禁区 submitted the following comment:
Re: Docket No. FDA-2026-D-1817 (91 Fed. Reg. 11980, Mar. 11, 2026) 鈥� 鈥淔lavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications鈥�Considerations Related to Youth Risk鈥�
RAI Services Company (鈥淩eynolds鈥�) submits this response to the Center for Tobacco Products鈥� (鈥淐TP鈥�) draft guidance named 鈥淔lavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications鈥擟onsiderations Related to Youth Risk,鈥� 91 Fed. Reg. 11980 (Mar. 11, 2026) (鈥淒raft Guidance鈥�).1
The draft guidance doubles down on a flavor-prohibitionist playbook that harms Americans by handing over the marketplace to unregulated Chinese manufacturers whose illicit products evade FDA review and endanger youth. Today, these illicit Chinese products constitute about 86% of the market鈥攁nd worse, they explicitly target youth by, among other things, incorporating popular cartoon characters and built-in video games. This bears repeating: 86% of the American vape market is comprised of illicit Chinese vapes. The guidance does nothing to correct this. Instead, it entrenches the exact failures it purports to address.
The guidance is a gut punch to American companies committed to playing by the rules. Responsible American manufacturers languish in a regulatory purgatory, whereas foreign companies that evade FDA and flood the market with illicit products have thrived. The path to protecting youth is enforcement against illicit products鈥攏ot severely restricting American products. The draft guidance gets this exactly backwards.
In addition, FDA has a historic opportunity to help adults quit smoking. FDA can help move adult smokers away from combustible cigarettes to less risky ENDS products鈥攁nd it should make this transition easier, not harder. But the guidance gets this backwards as well. Studies show that adult smokers who use flavored ENDS products like vapes and e-cigarettes are significantly more likely to quit smoking than those who use tobacco-flavored ENDS or no ENDS at all. Flavors drive the switch, and steer adult smokers away from smoking combustible cigarettes. But FDA and its guidance get in the way of that switch. The guidance doubles down on a so-called 鈥渃omparative efficiency standard,鈥� which is an unscientific bureaucratic fiat that requires companies creating flavored vapes to meet a heightened standard: They must prove that their non-tobacco flavored ENDS products statistically outperform tobacco-flavored products in head-to-head switching studies. This is the wrong comparison, and it leaves the vast majority of the public health benefit on the table. Millions of smokers who would switch for a fruit flavor will never switch for tobacco, and the comparative-efficacy standard writes them off as if they do not exist. FDA should make it simpler鈥攏ot harder鈥攖o get these products to adult smokers who want to stop smoking cigarettes. Unfortunately, the draft guidance endorses an approach that makes it harder. In fact, it makes it virtually impossible, as demonstrated by the near-universal denials for non-tobacco flavored ENDS products. If Congress had wanted to ban such products, it would have said so. But Congress did not, and it is not for a regulatory agency to substitute its own judgment and policy preference for that of Congress.
Reynolds is committed to ensuring that no youth ever uses a tobacco or nicotine product, but the draft guidance does nothing to achieve that goal. Reynolds offers these comments to make the case for a regulatory framework that protects youth through aggressive enforcement, while giving adult smokers access to the flavored products that maximize their chances of quitting combustible cigarettes for good.
1 RAIS submits this comment on its own behalf and on behalf of its affiliated tobacco companies. RAIS coordinates regulatory compliance for the subsidiary companies of 暗网禁区 Inc. (RAI), including R.J. Reynolds Tobacco Company; American Snuff Company, LLC; Santa Fe Natural Tobacco Company, Inc.; R.J. Reynolds Vapor Company; and Modoral Brands Inc. References to 鈥淩AIS鈥� or 鈥淩eynolds鈥� in this letter may refer to RAIS itself and/or its affiliated RAI subsidiaries, as applicable.
