The U.S. Food and Drug Administration (FDA) has adjusted the rules for Import Alert 98-07 (regarding vapes), incorporating the May 2026 enforcement priority policy—which targets certain unauthorized Electronic Nicotine Delivery Systems (ENDS)—into the import detention process. While Import Alert 98-07 still allows the FDA to implement Detention Without Physical Examination (DWPE) for ENDS lacking required marketing authorization, field offices must now handle relevant products in accordance with the May risk-based prioritization policy; when necessary, decisions to detain or refuse entry require review by the FDA’s Center for Tobacco Products (CTP). Products lacking marketing authorization, such as PACHA and Vuse Pro, have already been affected by the May policy; however, enforcement prioritization is not equivalent to FDA marketing authorization.
Key Summary
The FDA adjusted the rules for Import Alert 98-07 to incorporate the May risk-based enforcement prioritization policy for certain unauthorized ENDS into the import detention process.
Import Alert 98-07 continues to authorize DWPE; when necessary, detention or refusal of entry requires review by the FDA’s Center for Tobacco Products.
The FDA’s May policy does not cover all products with pending Premarket Tobacco Product Applications (PMTAs); applicability depends on application status, data conditions, and product risk characteristics.
PACHA and Vuse Pro serve as corporate examples following the implementation of the May policy, though the products in question have not thereby obtained FDA marketing authorization.
September 28, 2026. The U.S. Food and Drug Administration (FDA) recently adjusted the rules for Import Alert 98-07 (regarding e-cigarettes), incorporating the May 2026 enforcement priority policy—which targets certain unauthorized Electronic Nicotine Delivery Systems (ENDS)—into the import detention process.
FDA Revises Import Alert 98-07 for ENDS Imports
The FDA’s current webpage indicates an issuance date of September 18 for Import Alert 98-07 and explicitly notes that the “Reason for Alert” and “Guidance” sections were revised on September 4. Import Alert 98-07 continues to utilize the Detention Without Physical Examination (DWPE) mechanism. For ENDS lacking the required FDA marketing authorization, field offices may implement DWPE based on the FDA’s enforcement priority framework; where necessary, cases must be submitted to the FDA’s Center for Tobacco Products (CTP) for review prior to a decision on detention or refusal of admission.
Incorporation of the May Enforcement Policy into Import Alert 98-07
In May, the FDA issued a final guidance titled Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization, establishing new enforcement priority policies for specific ENDS and oral nicotine pouches that have not yet received premarket authorization.
This revision to Import Alert 98-07 directly references that guidance.
The FDA has clarified that field offices should handle import cases involving ENDS that lack the required marketing authorization in accordance with the current enforcement priority framework.
For cases requiring confirmation at the Center level, FDA compliance officers must initiate a case file and submit it to the relevant CTP enforcement and manufacturing division for review under the process of “Center Review of Detained Shipment for Refusal.”
The CTP will verify whether the ENDS in question fall under the scope of the May guidance or if they should not be detained or refused admission for other reasons, such as court orders.
Pending PMTA Does Not Automatically Preclude Enforcement Priority
The FDA’s May policy targets specific unauthorized products meeting certain criteria, rather than all ENDS for which a Premarket Tobacco Product Application (PMTA) has been submitted.
The FDA has previously indicated that it may defer enforcement of premarket authorization requirements for certain products that have successfully passed the application acceptance and filing stages, as well as for supplemental PMTA products meeting relevant conditions.
For non-tobacco-flavored ENDS, the FDA also requires applications to contain sufficient data to support an assessment of whether the product meets the “Appropriate for the Protection of the Public Health” (APPH) standard.
Even if a product meets certain application criteria, it may still be subject to enforcement priority due to other factors, including product design or marketing features deemed by the FDA to be clearly appealing to minors. The policy announced in May concerns the allocation of FDA enforcement resources; it does not alter the legal status of products regarding whether they have obtained marketing authorization.
PACHA and Vuse Pro Cases Show the Policy in Practice
PACHA and Vuse Pro have become examples of the policy in practice.
Following the announcement of the FDA’s May policy, the resulting changes have begun to impact specific companies and products.
2Firsts previously reported that the U.S. e-cigarette company Charlie’s Holdings stated the FDA notified it on June 23 that 30 of its PACHA e-cigarette SKUs—for which PMTAs had been submitted—were preliminarily identified for inclusion on a public product webpage the FDA plans to establish.
This webpage is intended to list certain unauthorized products against which the FDA does not generally intend to prioritize enforcement of premarket authorization requirements.
The 30 PACHA SKUs disclosed by Charlie’s were merely “preliminarily identified for inclusion” and did not thereby obtain FDA marketing authorization.
Another case involves R.J. Reynolds Vapor Company, a subsidiary of British American Tobacco (BAT).
The company has launched four flavored Vuse Pro pods in select U.S. markets: Peach, Berry, Watermelon, and Fresh Mint. The company informed 2Firsts that these products are undergoing FDA scientific review and are being sold in accordance with the FDA’s May 2026 enforcement guidance.
As of the time of disclosure, none of the four Vuse Pro pods had received FDA marketing authorization.
BAT previously stated plans to expand Vuse Pro distribution to approximately 25,000 U.S. retail outlets in the third quarter of 2026, with an additional 25,000 outlets added in the fourth quarter.
These cases demonstrate that the May enforcement policy is already influencing corporate decisions regarding product launches and distribution channels; the recent adjustment to the “98-07” rule further incorporates this same set of enforcement priorities into import detention operations.
Import Alert 98-07 Continues to Use DWPE
“98-07” continues to utilize DWPE as its core import enforcement tool.
The “98-07” rule targets ENDS (Electronic Nicotine Delivery Systems) that lack the required premarket authorization, including devices that deliver atomized e-liquids via inhalation, as well as related components and parts.
Under the DWPE (Detention Without Physical Examination) mechanism, the FDA can detain products based on import alerts and relevant information without the need for a prior physical inspection of each shipment. The primary grounds for refusal of entry listed under 98-07 include: the product appears to lack a valid FDA marketing order and may therefore be considered “adulterated” under the Federal Food, Drug, and Cosmetic Act; or the product failed to submit required notifications and information and may therefore be considered “misbranded.”
Corresponding OASIS codes include:
TP NO PMTA: Lacks required premarket tobacco product marketing authorization;
TP NO SE: Failed to meet requirements for Substantial Equivalence (SE) notifications or information.
The FDA lists the countries subject to 98-07 as “MULTIPLE COUNTRIES.” This rule is not a measure specifically targeting China or any other single nation.
Legal Status of Products Without Marketing Authorization Remains Unchanged
The adjustment to rule 98-07 does not alter the FDA’s legal determination regarding unauthorized new tobacco products.
Under the Federal Food, Drug, and Cosmetic Act, new tobacco products requiring premarket review must, in principle, obtain the appropriate FDA marketing authorization.
The FDA’s decision to defer enforcement action against certain products does not mean those products have received marketing authorization, nor does it imply FDA approval of their safety or compliance status.
This boundary applies equally to PACHA, Vuse Pro, and other products that may fall under the scope of the May enforcement policy.
Import Procedures Begin to Align with the May Risk-Based Enforcement Policy
The May guidance initially shifted the FDA’s enforcement priorities regarding certain unauthorized ENDS (Electronic Nicotine Delivery Systems) and nicotine pouches.
Subsequently, companies began adjusting product launches and distribution channel arrangements in light of this policy. The FDA also established a public webpage allowing retailers, distributors, and other stakeholders to identify products for which premarket authorization requirements are generally not being prioritized for enforcement.
The revision to 98-07 further clarifies how this policy is implemented regarding ENDS imports: unauthorized products may still be detained under DWPE (Detention Without Physical Examination), but field offices must make determinations based on the May enforcement priorities, with some cases requiring further review by the Center for Tobacco Products (CTP).
For ENDS companies relying on overseas manufacturing and importation into the U.S. market, factors such as marketing authorization status, PMTA application status, product characteristics, and current FDA enforcement priorities will collectively determine how products are handled at the point of import.
