Updated: September 30, 2026 

The FDA has updated its import alerts for unauthorized tobacco products, including Import Alert 98-07 for electronic nicotine delivery systems (ENDS). The update matters to manufacturers, importers and distributors because it tells FDA field staff how to handle ENDS shipments that lack a marketing authorization while accounting for the agency's newer enforcement priorities. 

There is a crucial distinction for businesses planning inventory: a pending PMTA is not FDA authorization. Under certain conditions, however, FDA says it generally does not intend to prioritize enforcement against some unauthorized products while their applications are under review. The revised import alert instructs field staff to consider that policy before detention or refusal. It does not promise that a shipment will clear customs. 

 

What changed in Import Alert 98-07? 

Import Alert 98-07, published in its current form on September 18, 2026, covers ENDS lacking premarket authorization. FDA says the revision dated September 4 updates its explanation and instructions to field staff to reflect its May 2026 enforcement-priorities guidance. 

Under the alert, FDA divisions may detain an ENDS shipment without physically examining it if the product lacks the required marketing authorization, in accordance with FDA's enforcement-prioritization framework. Where necessary, the Center for Tobacco Products must concur before detention or refusal to determine whether the May guidance applies or another reason, such as a court order, means the product should not be detained or refused. 

“Detention without physical examination” (DWPE) means FDA can hold an entry based on the alert without first testing or inspecting every unit. It is an import enforcement mechanism, not a blanket declaration that every product with a pending application will be stopped. 

 

Which products are covered? 

For this alert, FDA describes ENDS as products that deliver aerosolized e-liquid when inhaled, including components and parts. That makes it risky to assume a device, pod, e-liquid or component falls outside import scrutiny simply because it is shipped separately or contains no e-liquid at the time of shipment. Product classification and its intended use still matter. 

FDA maintains a separate Import Alert 98-06 for new tobacco products other than ENDS that lack required authorization. It includes products such as nicotine pouches. Unlike the wording of 98-07, 98-06 directs field staff to detain products identified on its Red List and describes a process to request removal from that list. Both alerts were revised to refer to the May enforcement policy; they should not be treated as the same alert. 

 

Does a pending PMTA protect a shipment? 

Not automatically. FDA's May guidance says it generally does not intend to prioritize enforcement of the premarket authorization requirement for an unauthorized ENDS or nicotine pouch product if it is covered by a pending application that has been accepted and filed, or by an accepted supplemental PMTA pending for more than 180 days. For a non-tobacco-flavored ENDS product, FDA must also have determined that the application contains data needed to evaluate whether the product is appropriate for the protection of public health. 

Those details matter. A submission receipt or acceptance letter alone should not be presented as proof that an original PMTA has passed both acceptance and filing review. The 180-day provision in this guidance applies to an accepted supplemental PMTA; it is not a general 180-day safe harbor for every pending application. FDA can still prioritize a product with child-appealing features or an elevated safety concern, and it can act on other violations. 

FDA expressly says unauthorized products remain illegally marketed under federal law, even when they fall within a lower enforcement priority. An enforcement policy is discretionary; it is not a marketing order, import license or guarantee against enforcement. State directory, licensing and sales rules also require separate review. 

 

What should importers and distributors do now? 

• Identify each SKU precisely. Match the manufacturer, product name, flavor, strength, device configuration and component to the relevant application and shipment documents. 

• Verify the actual FDA status. Check FDA's searchable tobacco products database for marketing authorization. For a pending PMTA, obtain documentation showing the application status, including filing review where relevant. Do not label a pending product “FDA approved.” 

• Check the right alert before placing orders. Review 98-07 for ENDS and 98-06 for other tobacco products. The alerts and Red List can change. 

• Coordinate with the manufacturer, customs broker and counsel before shipment. Confirm the product description and entry paperwork accurately describe what is being imported. If FDA detains an entry, respond through the established admissibility process with product-specific records rather than assuming a PMTA number alone resolves the issue. 

• Plan for interruptions. Build possible detention, storage expense and missed delivery dates into purchasing and customer communications. Retailers should ask suppliers for status information before promising incoming stock. 

For import questions, FDA lists Imports@fda.hhs.gov; for tobacco-product questions concerning these alerts, it lists CTP-ComplianceImports@fda.hhs.gov. 

 

The takeaway for vape businesses 

The revised alert brings border instructions into line with FDA's May 2026 enforcement policy. It provides a route for FDA staff to consider whether a qualifying pending product should be a lower priority before detention or refusal. It does not turn pending PMTAs into authorizations or eliminate the risk of a hold at the border. 

For B2B buyers, the practical move is to verify the specific product and application status, keep supporting records ready, and check both federal import rules and the states where the inventory will be sold. When the paperwork and the product do not match, the cost of sorting it out can land on the entire supply chain. 

This article is general industry information, not legal advice. Import decisions depend on the particular product, entry and FDA's current assessment. 

Primary sources 

• FDA Import Alert 98-07: ENDS Lacking Premarket Authorization 

• FDA Import Alert 98-06: New Tobacco Products Other Than ENDS 

• FDA May 2026 Enforcement Priorities Guidance (PDF) 

• FDA announcement of the May 2026 guidance