
Effective January 3, 2025, the U.S. Food and Drug Administration (FDA) announced updates to two import alerts: 98-07 and 98-06 which U.S. Customs and Border Protection (CBP) will be enforcing. These reinforce FDA’s policies regarding unauthorized e-cigarette products and other tobacco products entering the United States.
Import Alert 98-07: Unauthorized E-Cigarette Products
FDA has strengthened its policies regarding unauthorized e-cigarette products to help prevent their importation into the United States. These changes provide additional clarity and resources for importers and federal enforcement agencies to identify and address unauthorized products. Key updates include:
All unauthorized e-cigarette products may be detained without physical examination and refused admission by FDA.
Links to FDA’s Searchable Tobacco Products Database and a downloadable list of authorized e-cigarette products are now available for guidance.
Pending Premarket Tobacco Production Applications (PMTAs) do not provide a legal safe harbor for unauthorized products.
Import Alert 98-06: Other Tobacco Products
In addition to e-cigarettes, FDA has updated its import policies for other tobacco products, including smokeless tobacco and nicotine pouches. These updates aim to ensure that only authorized products enter the U.S. market. Key updates include:
A focus on smokeless tobacco and nicotine pouches, including NOIS, LYFT, and SKRUF brands.
These products may also be detained without physical examination and refused admission by FDA.
Key Considerations
Compliance is critical to avoid penalties and enforcement actions. Ensure that all imported tobacco products have FDA authorization and that your operations align with federal regulations. Regularly consult FDA’s Searchable Tobacco Products Database for the most up-to-date information on authorized products and guidance for importers.
Accurate and complete declarations are essential. Work closely with your trade partners, including customs brokers, to review and confirm that all information submitted to regulatory agencies is precise and adheres to FDA requirements. Taking these steps can help prevent costly delays or enforcement actions.
We are always here to help. Our team is available to provide guidance and support in navigating these regulatory updates and ensuring compliance. If you have any questions or need assistance developing effective compliance strategies, please don’t hesitate to reach out to us. Your proactive approach to regulatory compliance helps protect your business and ensures smooth import operations.
Have questions? Give our office a call today at (917) 546-6997 or schedule an introductory call, we would be happy to speak with you.
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