FDA Updates Import Alert: All Unauthorized Vapes May Be Seized Without Physical Inspection

With the rise in popularity of vapes and the expansion of the global tobacco product market, more and more countries and regions have begun to implement stringent regulatory policies for vape products. The U.S. Food and Drug Administration (FDA), as a key regulatory authority for vapes, has drawn widespread attention with its latest update to the import alert policies. In particular, at the beginning of 2025, the FDA announced updates to Import Alerts 98-07 and 98-06, and further refined its management of vape products. This article will delve into the key points of these updates and provide readers with a more comprehensive understanding, combining relevant vape knowledge.

1. Key Points of FDA Import Alert 98-07 Update

The update to Import Alert 98-07 marks a significant adjustment in the import management of vape products. The FDA has clearly stated that any vape product imported into the U.S. without authorization may be subject to seizure, and this can happen without the need for a physical inspection. This policy means that the FDA can determine whether a vape product complies with U.S. laws and regulations based solely on relevant documents and information, rather than waiting for the actual product to arrive in the U.S. for further inspection. This change greatly improves the FDA’s efficiency in regulating Nexa vape products, reducing the chances of non-compliant products entering the market.

1.1 Streamlined Import Alert 98-07

The updated Import Alert 98-07 not only strengthens the FDA’s regulatory efforts but also simplifies related procedures. The FDA has launched a searchable tobacco product database on its website, where importers, customs brokers, and other stakeholders can check which vape products have received FDA authorization and can be legally imported into the U.S. The release of this database undoubtedly provides more convenience for the trade community, allowing them to know in advance which products meet U.S. regulatory requirements, thus avoiding unnecessary risks.

Additionally, the FDA has provided a list of authorized vape products. This list includes all vape products that have been reviewed and approved by the FDA. Importers can refer to this list to verify whether their products are in compliance with the regulations. It is important to note that unauthorized vape products, regardless of whether they are in the approval process, are not allowed to be sold in the U.S. This means that simply submitting an application does not create a legal path for a product to be sold.

1.2 Legal Requirements for Vape Products

According to the FDA, all new tobacco products, including vapes, must receive FDA authorization before they can be legally sold in the U.S. This policy has had a significant impact on the entire vape industry. In recent years, with the rapid growth of the vape market, many brands and products have failed to obtain timely FDA approval, preventing them from entering the U.S. market. For products that have already been authorized, the FDA will continue to enforce strict regulations to ensure their safety and legality.

The updated Import Alert 98-07 also emphasizes that the FDA will continue to take stringent enforcement actions against unauthorized vapes. Although the FDA does not have broad discretionary enforcement power over all unauthorized vape products, this does not mean that regulation has been relaxed. Any vape product that has not been approved by the FDA faces the risk of being denied entry.

2. Key Points of FDA Import Alert 98-06 Update

Unlike Import Alert 98-07, which focuses on vape products, Import Alert 98-06 primarily targets other tobacco products, such as smokeless tobacco, nicotine pouches, and other similar tobacco products. In recent years, with the rise of "heat-not-burn" tobacco products, the FDA's regulatory focus has also expanded to include these new types of tobacco products.

2.1 Newly Added Tobacco Product Types

In the update to Import Alert 98-06, the FDA specifically mentioned several brands of nicotine pouch products, such as NOIS, LYFT, and SKRUF. These nicotine pouches have become a popular alternative to traditional smoking in recent years. Like vapes, nicotine pouches provide a smoking-like experience through the absorption of nicotine, but unlike traditional cigarettes, they involve placing nicotine in a small pouch that is held in the mouth.

These products are generally considered a safer alternative to smoking, but the FDA has not relaxed its regulation of them. According to the latest import alert, any unauthorized nicotine pouches also face the risk of being seized and denied entry by the FDA. This shows that the FDA is not only concerned with the compliance of vape products but also with the compliance of other new tobacco products.

2.2 Strengthened Regulatory Efforts

With the update to Import Alert 98-06, the FDA has strengthened its regulatory efforts, particularly against unauthorized products. Whether it’s vapes or nicotine pouches, any product that has not been approved by the FDA faces the risk of seizure, which could occur before the product even reaches the U.S. The FDA has enhanced its monitoring and control of illegal tobacco products, further protecting consumer health.

3. Multi-Agency Cooperation to Combat Illegal Tobacco Products

To more effectively combat illegal tobacco products, the FDA not only relies on its own regulatory capacity but also collaborates closely with multiple federal partners. Through cooperation with U.S. Customs and Border Protection (CBP), the FDA is able to more efficiently detect and intercept illegally imported tobacco products.

3.1 Successful Joint Operations

In October 2024, the FDA and U.S. Customs and Border Protection successfully completed a joint operation that resulted in the administrative seizure of approximately 3 million unauthorized vape products, with an estimated retail value of $76 million. This operation demonstrates that the FDA has not only strengthened domestic regulation of tobacco products but also, through cooperation with Customs and other agencies, intensified efforts to combat the illegal importation of tobacco products.

Through multi-agency cooperation, the FDA can better coordinate resources to combat the transnational trade of illegal tobacco products. Whether it’s vapes or other tobacco products, this inter-departmental collaboration strengthens regulatory efforts, making it easier to detect and prevent illegal activities.

3.2 Combating False Declarations

The FDA is also particularly concerned with the issue of false declarations of tobacco products. Some importers attempt to bypass regulations by falsifying documents or altering product labels, allowing unauthorized products to enter the market illegally. To address this, the FDA has strengthened cooperation with Customs and other law enforcement agencies to implement stricter inspection and verification procedures, aiming to curb this illegal behavior.

4. Future Regulatory Trends for Vape Products

As the market for vape products continues to grow, the FDA’s regulatory measures will continue to evolve. In the future, in addition to existing import alert policies, the FDA may introduce more regulations and requirements for vape products. For example, the FDA may implement more detailed regulations regarding the ingredients, nicotine content, and safety of vapes. Additionally, as the technology behind vapes advances, the FDA may conduct specialized reviews of new vape technologies.

Furthermore, with the growing global concern over the health effects of vapes, countries may further strengthen their regulations on vape products. International cooperation will also become a key tool in combating the illegal trade of tobacco products. Regulatory agencies around the world may share data and information to better identify and combat the illegal trade of cross-border tobacco products.

5. Conclusion

The FDA’s updates to the import alert policies for vape products reflect the agency's determination and actions to strengthen the regulation of new tobacco products. From the updates to Import Alerts 98-07 and 98-06, it is evident that the FDA has not only intensified its crackdown on unauthorized products but also implemented several innovative measures to improve regulatory efficiency. These policies will help reduce the influx of illegal vape products, protect consumer health, and create a fairer competitive environment for legitimate businesses.

For consumers, understanding the safety and legality of vape products is particularly important. While vapes are considered by many as an alternative to traditional smoking, they still carry certain health risks. Therefore, consumers should choose vape products within the framework of legality and compliance, avoiding the purchase of unauthorized illegal products to protect their health.