What is Prior Notice?
Prior Notice is a mandatory notification to the U.S. Food and Drug Administration (“FDA”) that a food shipment is entering the United States. This requirement applies to all commercial imports of food and beverages, including alcohol beverages and samples.
For alcohol beverage importers, filing Prior Notice is a crucial step that must be completed before the shipment arrives in the U.S. This requirement is part of a broader regulatory framework, which includes obtaining a federal importer permit, state licenses, paying taxes and duties, and securing Certificate of Label Approval (“COLA”) and formula approvals. Additionally, importers must ensure their foreign suppliers are registered with the FDA.
If you need assistance with federal or state permits, COLA and formula approvals, or filing Prior Notice, Lindsey Zahn P.C. is here to help. Contact us at info@zahnlawpc.com to schedule an introductory consultation.
When and How to File Prior Notice
Prior Notice must be filed before the shipment arrives in the U.S. If submitting via the FDA’s Prior Notice System Interface, you can file up to 15 calendar days before the shipment’s expected arrival. If filing through U.S. Customs and Border Protection’s Automated Broker Interface (ABI) system, you can file up to 30 days in advance.
Filing is done electronically through the FDA website, which requires an FDA account and potentially the FDA registration number of the foreign supplier. While anyone can file Prior Notice, it is typically done by the overseas supplier, U.S. importer, or a third party, such as a customs broker.
Required Information for Prior Notice Filing
The following information is generally required for filing Prior Notice (this list is not exhaustive):
- Shipment date
- FDA registration number of the shipper
- Contact details of the shipper and consignee
- FDA registration number of the consignee
- Commodity description, including the common name of the food or beverage
- Quantity and packaging details
- FDA product code, Harmonized Tariff Schedule code, country of origin, manufacturer information, and registration number.
What is Prior Notice?
Prior Notice is a mandatory notification to the U.S. Food and Drug Administration (FDA) that a food shipment is entering the United States. This requirement applies to all commercial imports of food and beverages, including alcohol, as well as samples.
For alcohol beverage importers, filing Prior Notice is a crucial step that must be completed before the shipment arrives in the U.S. This requirement is part of a broader regulatory framework, which includes obtaining a federal importer permit, state licenses, paying taxes and duties, and securing label (COLA) and formula approvals. Additionally, importers must ensure their foreign suppliers are registered with the FDA.
If you need assistance with federal or state permits, COLA and formula approvals, or filing Prior Notice, Lindsey Zahn P.C. is here to help. Contact us at [insert contact info].
When and How to File Prior Notice
Prior Notice must be filed before the shipment arrives in the U.S. If submitting via the FDA’s Prior Notice System Interface, you can file up to 15 calendar days before the shipment’s expected arrival. If filing through U.S. Customs and Border Protection’s Automated Broker Interface (ABI) system, you can file up to 30 days in advance.
Filing is done electronically through the FDA website, which requires an FDA account and potentially the FDA registration number of the foreign supplier. While anyone can file Prior Notice, it is typically done by the overseas supplier, U.S. importer, or a third party, such as a consultant or customs broker.
Required Information for Prior Notice Filing
The following information is generally required for filing Prior Notice (this list is not exhaustive):
- Shipment date
- FDA registration number of the shipper
- Contact details of the shipper and consignee
- FDA registration number of the consignee
- Commodity description, including the common name of the food or beverage
- Quantity and packaging details
- FDA product code, Harmonized Tariff Schedule code, country of origin, manufacturer information, and registration number.
Additional Customs Requirements for Alcohol Shipments
To clear alcohol shipments at U.S. Customs after filing Prior Notice, the waybill must include the Prior Notice number and the statement, “Contains Alcohol – Signature of a Person Age 21 or Older Required for Delivery.” The commercial invoice should also have the FDA Prior Notice document attached.
Consequences of Failing to File Prior Notice
If Prior Notice is not filed or is inadequately completed, the shipment may be refused entry or held at the port. This could lead to storage fees, shipment destruction, and penalties or fines for non-compliance.
How Lindsey Zahn P.C. Can Assist
At Lindsey Zahn P.C., we help food and beverage importers navigate complex FDA regulations, including filing Prior Notice. Our firm also assists with reviewing product labels to ensure compliance before entering the U.S. market. Whether you’re an importer or a foreign supplier, we can guide you through the regulatory process and help ensure full compliance with the FDA’s Federal Food, Drug, and Cosmetic Act or the Alcohol and Tobacco Tax and Trade Bureau’s Federal Alcohol Administration Act and/or corresponding regulations.
For more information about how we can assist your business, please contact us at info@zahnlawpc.com to schedule an introductory consultation.