New Draft Guidance From FDA On Flavored Vape Products

On March 9, 2026, the FDA's Center for Tobacco Products (FDA) released a draft guidance,  Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk; Draft Guidance for Industry, outlining how manufacturers must evaluate and submit premarket tobacco applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS).

The guidance emphasizes FDA's regulatory stance on flavored vape products, especially fruit, candy, and dessert flavors, is that they pose significant public health risks to youth and will continue to face a higher evidentiary burden for approval through the PMTA process.

In the draft guidance, FDA sets forth how it will evaluate PMTA submissions for flavored ENDS products, with a specific focus on flavorings that appeal to youth. The draft guidance aims to clarify CTP's current thinking regarding the potential risks flavored ENDS pose to youth populations, as well as the benefits these products may offer to adult smokers seeking alternatives to combustible cigarettes.

As noted in the Draft Guidance, prior to marketing a new vape products manufacturers must obtain FDA authorization and demonstrate their product marketing aligns with FDA consideration as to whether the marketing and sale of the products is “appropriate for the protection of the public health”. The FDA's PMTA review process remains unchanged, requiring applicants to clear a very high evidentiary burden and must show the benefits (i.e., aiding adult smoking cessation) outweigh potential risks to the population as a whole, particularly the risk of youth initiation. As was recently upheld by the U.S. Supreme Court in FDA v. Wages and White Lion Investments, since flavored vape products pose higher youth risks than tobacco-flavored ones, companies must prove an additional public health benefit to justify approval.

As has been discussed in prior articles, nearly all ENDS products have not received a marketing granted order from FDA. At present, FDA has only approved 39  ENDS products in tobacco menthol flavors from large tobacco manufacturers. FDA further indicates it hopes the non-binding Draft Guidance will improve the efficiency of the PMTA submission and review process.

Below are the Key Considerations Addressed in the Draft Guidance

• Youth Appeal and Initiation:
  Flavored ENDS, especially those with fruit, candy, dessert, or other sweet flavors, are identified by CTP as particularly appealing to youth, raising concerns about increased initiation among minors. The FDA emphasizes the importance of assessing whether marketing, product design, and flavor profiles disproportionately attract youth.
• Risk-Benefit Analysis:
  While flavored ENDS may provide adult smokers with a less harmful alternative to cigarettes or assist in smoking cessation, their appeal to youth complicates the risk assessment. The FDA considers whether the potential benefits for adult smokers outweigh the risks associated with youth initiation and long-term use.
• Flavor Criteria:
  The guidance discusses the need for considering the nature and strength of flavors, including whether flavors are overwhelmingly appealing to youth or serve a specific adult purpose, such as aiding cessation.
• Marketing and Access Controls:
  The document underscores the importance of marketing restrictions and access controls to minimize youth exposure, including restrictions on sales channels, advertising, and youth-targeted marketing strategies.
• Regulatory Approach:
  The FDA indicates a risk-based approach, where products with flavors that are highly appealing to youth face a higher level of scrutiny. The agency advocates balanced regulations that seek to prevent youth initiation while allowing adult smokers access to potentially beneficial products.
• Pre-market Authorization Requirements:
  Applicants seeking approval must demonstrate that their flavored ENDS formulations do not unduly promote youth use and that their marketing and distribution strategies are adequately controlled to minimize youth exposure.

Conclusion:

The Draft Guidance reflects the FDA's ongoing efforts to regulate flavored ENDS by evaluating the specific risks related to youth appeal alongside potential benefits for adult smokers. The Draft Guidance also underscores the FDA's importance for manufacturers and reiterates that when submitting PMTAs to provide transparent, science-based assessments and the need for stringent marketing and access controls to protect youth while accommodating adult harm reduction needs. This Draft Guidance does not represent a dramatic change from FDA's past approach to flavored vape products. It remains to be seen if FDA will publish new rules or regulations for comment in light of the Draft Guidance, and if flavored vape product manufacturers will be able to obtain FDA authorization to legally market and sell their products in the United States.

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