FDA’s New Enforcement Priorities Signal a Shift for the Electronic Nicotine Delivery Systems (ENDS) Industry

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In May 2026, the U.S. Food and Drug Administration (FDA) issued final guidance titled Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization. While the guidance also addresses oral nicotine pouch products, its most significant impact is on the Electronic Nicotine Delivery Systems (ENDS) industry. The policy reflects a notable shift in how FDA intends to allocate enforcement resources and may have important consequences for manufacturers, retailers, and other stakeholders in the vaping market.

Statutory Background and Regulatory Framework

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), all “new tobacco products,” including ENDS products, must receive FDA premarket authorization before they may be legally marketed in the United States. Historically, FDA has taken a broad enforcement approach against unauthorized vaping products, particularly flavored products associated with youth use concerns. The new guidance signals a more targeted enforcement framework, rather than a uniform approach across all unauthorized products.

Shift Toward Enforcement Priorities Based on PMTA Status

FDA generally does not intend to prioritize enforcement against certain unauthorized ENDS products that are the subject of a pending Premarket Tobacco Product Application (PMTA), provided the application has successfully passed acceptance and filing review.

For non-tobacco-flavored ENDS products, FDA further requires that applications contain sufficient scientific evidence to allow FDA to determine whether the product is “appropriate for the protection of public health” (APPH). This approach effectively distinguishes between products based on the completeness and quality of their regulatory submissions, rather than solely on market presence.

Implications for Manufacturers and Regulatory Compliance

One of the most significant practical effects of the guidance is the increased clarity it provides to manufacturers with pending PMTAs. Companies that meet FDA’s criteria may face a reduced risk of enforcement action while their applications remain under review.

However, the guidance does not create a blanket exemption. Products that appeal to youth remain a continued enforcement priority. FDA specifically highlights characteristics such as cartoon imagery, toy-like designs, or disguised vaping devices as factors that may trigger enforcement regardless of application status.

Evolving Enforcement Focus and Youth Usage Trends

The guidance also reflects FDA’s acknowledgment of shifting youth usage trends. Prior enforcement actions often focused on flavored cartridge-based products due to their prevalence among younger users. More recent data indicate that disposable ENDS products are now the most commonly used device type among youth. In response, FDA is moving toward a broader, risk-based enforcement framework rather than one defined primarily by device category.

Incentives for Stronger PMTA Submissions

FDA also emphasizes that many PMTAs fail during the acceptance or filing stages due to insufficient information. Common deficiencies include incomplete manufacturing details, inadequate ingredient disclosures, limited testing data, and insufficient information on harmful constituents. By signaling that products supported by complete and scientifically robust applications may be less likely to face enforcement, the guidance incentivizes manufacturers to improve the quality and completeness of their submissions.

Consumer and Market Transparency Considerations

FDA intends to maintain a public-facing webpage identifying manufacturers and products that generally fall within the agency’s enforcement discretion policy. Importantly, inclusion on this list does not indicate that a product has received or is likely to receive authorization. Nevertheless, this development may improve transparency for consumers, retailers, and other market participants seeking to understand the regulatory status of products currently in distribution.

How We Can Help

FDA’s evolving enforcement approach to ENDS products underscores the importance of careful regulatory strategy, particularly for manufacturers, importers, and distributors operating in this space. Companies should ensure that their PMTAs are complete, scientifically supported, and aligned with FDA’s current enforcement priorities.

Our firm assists clients in navigating FDA tobacco regulations, including PMTA strategy and compliance, import and admissibility issues, and enforcement risk assessments. We also advise clients on responding to FDA enforcement actions and structuring regulatory submissions to reduce exposure under shifting policy frameworks.

If your business is impacted by FDA’s updated guidance or you are uncertain about your compliance status, our firm can help evaluate your regulatory position and develop a strategy tailored to your operations.

Have questions? Give our office a call today at (917) 546-6997 or schedule an intake meeting, we would be happy to speak with you.

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