The U.S. FDA’s Center for Tobacco Products (CTP) has released a draft for public comment. The document reiterates that flavored e-cigarettes, especially fruit-flavored and candy/dessert/other sweetened products, face higher review thresholds due to their greater appeal to teenagers. Companies applying for market approval must demonstrate additional adult public health benefits compared to tobacco-flavored products. Simultaneously, the FDA explicitly proposes a “risk-proportional” assessment approach, meaning that the risks to teenagers from different non-tobacco flavors are not entirely the same, and the required adult benefit margin may vary accordingly.
Key Points at a Glance
- FDA Releases New Draft for Flavored E-cigarette Review: This draft document outlines how the FDA will assess the risks associated with flavored e-cigarettes for teenagers during PMTA reviews.
- Basic Stance Unchanged: Flavored e-cigarettes generally pose a higher risk to teenagers than tobacco-flavored products; applicants must demonstrate benefits not only to adult smokers but also additional public health benefits compared to tobacco flavors.
FDA Introduces “Risk-Stratified Assessment by Flavor”
Explicitly Proposes “Risk-Stratified Assessment by Flavor”:
The FDA states that the appeal of different non-tobacco flavors to teenagers varies, and the required adult benefit margin will also differ. The higher the risk, the higher the burden of proof.
Flavor Risk: Fruit and candy/sweet flavors remain high-risk flavors, facing the highest evidentiary threshold; while menthol, mint, and some coffee, tea, and spice flavors are left with limited room for argumentation.
Technology Alone Cannot Offset Youth Risk
Technological Limitations Insufficient to Replace Substantive Evidence:
Companies can demonstrate the relatively low appeal of a flavor through sensory perception studies and consumer response studies, but relying solely on device access restriction technologies such as fingerprint recognition and geofencing is usually insufficient to offset the risks to adolescents posed by high-risk flavors.
FDA Releases Draft PMTA Guidance for Flavored E-cigarettes
On March 10, 2026, the U.S. Food and Drug Administration (FDA) released a draft industry document regarding Premarket Tobacco Product Applications (PMTAs) for flavored electronic cigarettes, reiterating that fruit flavors and sweet flavors such as candy and desserts pose a “significant public health risk” to adolescents. Products seeking market authorization in this area will face a correspondingly high burden of evidence.
Public Comment Draft Aims to Clarify Review Standards
This draft, titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk,” was released by the FDA’s Center for Tobacco Products in March 2026 and is a public comment period; it is not legally binding. The document states that its purpose is to help applicants submit and refine their PMTA applications for e-cigarette products more efficiently and to reflect the FDA’s current review approach.
Core Public Health Standard Remains Unchanged
According to the document, the FDA’s core review standards for e-cigarette products remain unchanged. Applicants must demonstrate that the product is “fit to protect public health,” meaning its potential benefits to adult cigarette users must outweigh the potential risks to non-users such as adolescents.
Flavored Products Must Show Additional Public Health Benefits
The FDA states that flavored e-cigarettes pose a higher risk to adolescents than tobacco-flavored products. Therefore, applicants must not only demonstrate that flavored products are beneficial to adults but also that they provide additional public health benefits compared to tobacco-flavored products. This practice “remains unchanged” and has been affirmed by the U.S. Supreme Court in FDA v. Wages and White Lion.
Adult Benefit Requirements Will Vary by Flavor Risk
However, this draft further addresses a more specific question: what level of additional adult benefit needs to be demonstrated for different flavored products to pass review? The FDA states that in the future, the required adult benefit will be measured proportionally based on the risk of different flavors initiating and continuing use by adolescents. The document states that the higher the risk to adolescents, the higher the adult benefit that needs to be demonstrated.
Fruit and Sweet Flavors Remain High-Risk Categories
Within this framework, fruit flavors, as well as candy, desserts, and other sweet flavors, remain classified as high-risk.
The FDA notes that these products pose significant public health risks to U.S. adolescents and therefore continue to face a high burden of proof. The document also states that while the FDA has granted marketing authorization to tobacco-flavored and menthol-flavored e-cigarette products, it has not yet found any flavors that are “highly appealing to adolescents” and can provide sufficient evidence of public health benefits to overcome the risks to adolescents.
Some Non-Sweet Flavors May Present Lower Youth Appeal
Meanwhile, the FDA states that some flavors may show relatively low appeal to adolescents. The draft mentions that menthol, peppermint, and certain “novel flavors” such as spices may have lower risks to adolescent initiation and use than fruit-flavored and sweet flavors.
Coffee, Tea, and Spice Flavors May Have Lower Evidence Requirements
The document also states that flavors such as coffee, tea, or spices, if they show lower appeal to adolescents, may theoretically meet the review criteria even if their additional adult benefits compared to tobacco-flavored products are “relatively small.”
FDA Cautious About Evidence of Adult Smoking Benefits
Regarding potential adult benefits, the FDA maintains cautious wording in the document. The draft states that flavored e-cigarettes may, in certain circumstances, help adult smokers switch away from combustible cigarettes, increase attempts to quit, maintain a complete switch, or reduce cigarette consumption. However, the document also points out that existing research evidence has methodological limitations, and the FDA will evaluate “all scientific evidence,” rather than drawing conclusions based on a single study or preference survey.
Scientific Evidence Required in PMTA Applications
Regarding the method of evidence, the FDA recommends that applicants submit scientifically valid evidence demonstrating the relative appeal of the proposed product among adolescents, young adults, and adults.
Sensory and Consumer Studies Recommended
The document specifically mentions the use of sensory perception and consumer response studies, including blinded sensory panels, to assess the relative appeal of different flavor formulations without actual product use. The FDA also recommends that such studies include benchmark flavors such as tobacco, fruit, and candy for comparison.
Role and Limits of Device Access Restriction Technologies
The draft also discusses device access restriction technologies (DAR), such as fingerprint recognition, biometric unlocking, and geofencing.
The FDA states that these technologies can be part of adolescent prevention strategies, but relying solely on such technologies is generally insufficient to mitigate the risks posed by flavors highly appealing to adolescents.
High-Risk Flavors Face an Exceptionally High Evidence Burden
For high-risk flavors such as fruit, candy, and desserts, applicants who rely primarily on DAR to mitigate the risk to minors will face an “exceptionally high” burden of proof.
