The FDA recently updated Import Alerts 98-07 and 98-06. Import Alert 98-07 now focuses specifically on unauthorized e-cigarette products while Import Alert 98-06 targets other unauthorized tobacco products like smokeless tobacco and nicotine pouches. Some of the key details are:
- Detention Without Physical Examination:
- Unauthorized e-cigarette products may be detained without physical examination and refused admission by the FDA.
- This policy aims to prevent unauthorized products from entering the U.S. market.
- Enforcement and Compliance:
- All new tobacco products, including e-cigarettes, must have FDA authorization to be marketed legally in the U.S.
- Pending applications do not provide a legal safe harbor for distributing or selling unauthorized products.
- Collaboration with Federal Partners:
- FDA works with U.S. Customs and Border Protection to address mis-declared products.
- A recent joint operation resulted in the seizure of approximately three million units of unauthorized e-cigarettes.
- Resources and Information:
- FDA provides a searchable database and a downloadable list of authorized e-cigarette products.
- The agency’s website outlines tobacco product enforcement priorities and import alerts.
You can view the original notice here.
