On May 8, the U.S. Food and Drug Administration (FDA) issued guidance that clarifies how the agency enforces premarket review requirements for certain electronic nicotine delivery system (ENDS) products and nicotine pouches with pending premarket tobacco applications (PMTAs).

Until this announcement, FDA had emphasized that the mere pendency of a PMTA does not create a legal safe harbor for marketing new tobacco products. In the new guidance, however, FDA adopted an enforcement discretion policy that, in practice, provides a measure of “cover” for some ENDS and nicotine pouch products vis-à-vis the Federal Food, Drug, and Cosmetic Act (FDCA) while their PMTAs are under review.

Under the FDCA, only those new tobacco products that have received FDA marketing authorization may be lawfully marketed in the U.S. Any new tobacco product that lacks FDA premarket authorization is considered adulterated and cannot be legally sold. To date, only 45 ENDS products and 26 nicotine pouch products have received FDA marketing authorization in the form of a marketing granted order (MGO).

Now, FDA’s new enforcement discretion policy will allow many ENDS and nicotine pouch products to be sold while the agency considers their PMTAs. Although “all new tobacco products on the market without authorization are illegally marketed products,” FDA stated that the agency “generally does not intend to prioritize enforcement of the premarket authorization requirement” where a product satisfies the following requirements:

1. The product is subject to an application that is pending, and the application has been accepted and filed, or is subject to a supplemental application (for modifications to a previously authorized product) that has been accepted and pending for more than 180 days.
2. For ENDS with flavors other than tobacco, FDA has determined that the application also includes data necessary to evaluate whether such product is appropriate for the protection of the public health (APPH).

For the second requirement for non-tobacco flavors, FDA’s guidance does not specify how the agency will document its determination that the product has the “data necessary” to evaluate whether such product is APPH. FDA regulations provide that the agency’s issuance of a notice of filing means that “the application contains sufficient information to permit a substantive review,” so the “data necessary” standard presumably goes beyond the usual filing threshold to support an APPH finding. In prior applications for flavored ENDS pouch products, for example, FDA has insisted that applicants must provide comparative efficacy data that shows that flavored products offer a greater benefit than their tobacco-flavored counterparts in facilitating cigarette smoking cessation and switching. FDA might insist on seeing this additional data for purposes of satisfying the “data necessary” standard.

FDA emphasizes that it may still pursue enforcement “on a case-by-case basis,” and the guidance identifies two categories of products that generally will not be eligible for enforcement discretion, including:

1. Youth-appealing products, such as those “depicting a cartoon-like fictional character, disguising its nature as a vaping product, or resembling a children’s toy, phone, or gaming platform,” and
2. Products presenting heightened public health or safety concerns that are “greater than generally presented by ENDS or nicotine pouch products or other tobacco products.” Examples include: “a product that has high nicotine content,” “serious adverse experiences or a larger number of unexpected associated adverse experiences compared with authorized ENDS or nicotine pouch products,” a lack of “child-resistant packaging (CRP) in accordance with Child Nicotine Poisoning Prevention Act of 2015,” and a ”potential fire hazard.”

FDA stated that it intends to publish a public list of companies that are eligible for enforcement discretion (although such companies must request to be listed). The timing of this process remains unclear.

For now, the new enforcement guidance clarifies what has long been an area of uncertainty. When FDA first extended its tobacco product authorities to cover e-cigarettes with tobacco-derived nicotine, the agency indicated that it generally intended not to enforce the premarket review requirement against e-cigarette products that were on the U.S. market as of August 8, 2016, and that had a timely submitted PMTA by September 9, 2020, that was still undergoing review. Although that original policy had a one-year sunset, it appeared in practice that FDA was exercising enforcement discretion to not prioritize action against such products while their PMTAs were pending.

The agency’s stance on enforcement was even more cloudy with respect to nontobacco-derived (a/k/a synthetic) nicotine products. When FDA’s tobacco product authorities were extended to cover such products in 2022, Congress allowed companies that had products on the market as of April 14, 2022 to continue to sell their products if they submitted PMTAs by May 14, 2022; however, Congress made clear that any such products that remained on the market after July 13, 2022, must have an MGO to be sold. FDA never issued guidance suggesting there would be an exercise of enforcement discretion for nontobacco-derived nicotine products, but in practice it again seemed like FDA was not enforcing the premarket authorization requirement for such products subject to timely submitted PMTAs.  

FDA’s de facto enforcement discretion policy has been evident in warning letters and civil money penalty complaints. In a 2022 warning letter to SV3, LLC, for example, FDA targeted certain unauthorized ENDS products, but did not include in its letter products that were subject to the companies’ pending PMTAs. In the past, FDA warning letters have also stated that the agency’s “highest enforcement priorities” include those “[p]roducts for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted.” In addition, a review of FDA’s civil money penalty complaints to date suggests that no such complaints have involved products subject to a pending PMTA.

Over the past several years, however, FDA increasingly distanced itself from the notion that it maintained any such enforcement discretion policy. For example, in September 2025, FDA launched a widely publicized seizure of more than 2.1 million ENDS products, which purportedly included tobacco-derived ENDS products with pending PMTAs that were submitted by the September 9, 2020 deadline for such products. Last fall, FDA quietly shuttered a webpage that contained lists of deemed new tobacco products with timely applications submitted by September 9, 2020, that FDA previously said “may fall outside of FDA’s stated enforcement priorities.” According to the Internet WayBack Machine, this site was available as of September 18, 2025, but was no longer found as of November 27, 2025. And FDA’s Advisory and Enforcement Actions website, last updated as recently as May 6, 2026, states that “FDA has not adopted a broad policy of enforcement discretion regarding tobacco products without marketing authorization,” and “[t]he pendency of an application does not create a legal safe harbor to sell that product.” Yet, just two days later, FDA released this new guidance, which effectively adopts a broad enforcement discretion framework for certain products.

Even if FDA’s new policy provides some cover from FDA enforcement, we anticipate that some state AGs may continue to try to clear market shelves of certain unauthorized ENDS and nicotine pouch products. Just three days after FDA published the new guidance, a bipartisan group of 21 state AGs sent a letter to FDA expressing “serious concerns” that the guidance will increase access to flavored, youth-appealing ENDS products and urging FDA to reconsider. And, as we have seen recently, state AGs are increasingly creative in using existing tools to target unauthorized ENDS. For example, state AGs have recently focused their attention on payment processors, asserting that the payment platforms have legal obligations “to identify, investigate, and remove merchants engaged in the unlawful sales of illicit e-cigarettes from their networks.”

If you have questions about how FDA’s new enforcement guidance affects your company or specific products — or how to navigate overlapping federal and state requirements — please contact Troutman Pepper Locke’s Tobacco + Nicotine team. We regularly advise on PMTA strategies, enforcement risk assessment, state registry laws, and related litigation and regulatory matters.