FDA Backs Rule Requiring Vape Makers to Prove Flavors Aid Smoking Cessation
FDA requires vape makers to prove flavored products better aid smoking cessation than tobacco flavor.
Why it matters: This FDA rule shapes compliance and enforcement for vape manufacturers, directly influencing litigation risks and regulatory approaches in the tobacco and vaping sectors.
- FDA mandates manufacturers show flavored vapes are more effective than tobacco-flavored vapes for smoking cessation.
- Only six e-cigarette products approved by FDA out of hundreds of thousands of applications since 2020.
- Fifth Circuit is reviewing challenges from vape makers against FDA’s denial of marketing for flavored products.
- Supreme Court unanimously upheld FDA's denial of some flavored e-liquid marketing authorizations in April 2025.
The FDA is defending its stringent new rule requiring vape manufacturers to demonstrate that flavored e-cigarettes are more effective than tobacco-flavored ones in helping smokers switch from traditional cigarettes. This rule directly affects manufacturers seeking marketing authorization for flavored electronic nicotine delivery systems.
Since the 2020 Pre-Market Tobacco Application (PMTA) deadline, the FDA has approved only six e-cigarette products out of hundreds of thousands of submissions. This approval rate has raised concerns about a de facto ban on flavored, especially open-system, vape products. As noted by Gregory Troutman, counsel for VDX Distro, "None of the open-system bottled or tank devices have been approved. So it is a de facto ban on open system products." Meanwhile, Justice Department Attorney Ben Lewis highlighted that "There have been approvals."
The heightened enforcement and denial rates have sparked legal challenges, including a notable case currently before a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit. The panel heard arguments from seven small vape-liquid companies contesting the FDA's refusal to authorize marketing for flavored e-cigarette products. Judge Cory T. Wilson noted the practical effect, stating, "If you're effectively at 100% denial on a certain class of products, then it is a de facto ban." The case underscores the tension between regulatory scrutiny and industry demands.
Earlier, in April 2025, the U.S. Supreme Court unanimously upheld the FDA's denial of marketing authorization for select flavored e-liquids, affirming the agency's authority to apply rigorous standards aimed at protecting public health.
Overall, the FDA's position reflects ongoing concerns about youth usage and public health risks, justifying the higher evidentiary bar for flavored vape products. Legal battles continue to shape how these regulatory policies will impact the vaping landscape moving forward.
By the numbers:
- 6 — e-cigarette products approved by FDA out of hundreds of thousands since 2020
- April 2025 — U.S. Supreme Court upheld FDA's denial of flavored e-liquid marketing authorizations
Yes, but: While the FDA has approved some e-cigarette products, none of the open-system flavored vaping products have been authorized, leading to claims of an effective ban for those devices.
What's next: The Fifth Circuit court is expected to issue a ruling on the challenges to the FDA's denial of flavored vape product marketing authorizations, which may further clarify the regulatory landscape.