US Import Alerts and Exporting from Canada
Avoid product detention at the border by knowing about these FDA requirements for countries and industries.
What is an Import Alert?
An import alert is a notification the FDA places on products at the border awaiting shipment into the United States. Due to a prior violation found, products from a particular country or industry are placed on hold to be tested or examined. The shipment is refused entry until the importer can demonstrate that the product is not in violation of the import alert. The FDA has specific protocols for a business to follow to remove an FDA detention and release the product for distribution[1].
What is the Yellow or Red List?
The FDA maintains the Yellow or Red List, which consists of companies and products subject to an Import Alert from a specific country and must be detained at the border without examination (DWPE). Those on this list cannot enter the United States without testing or inspection[1].
What is the Green List?
Companies and products on the FDA’s Green List are not required to be held at the border for mandatory examination. They are considered exempt from verification against the specific Import Alert[1].
What is an FDA Detention?
Also known as detention without physical examination (DWPE), an FDA detention occurs when a violation of the Federal Food, Drug, and Cosmetic (FD&C) Act is identified at the border[1]. The product is detained and held until the importer or responsible party can demonstrate compliance. The requirements to lift the FDA hold vary depending on the violation and the product involved.
What Import Alerts Exist for Food Products Exported from Canada to the US?
Several import alerts are in effect for foods from Canada exported to the United States. Below are a few of the most recent alerts for various food products, such as dietary supplements, pet treats, processed foods, and grains. This is not an exhaustive list and is intended to demonstrate the variety of alerts in place[1].
- 23-14, DWPE of Food Products Due to the Presence of Mycotoxins
- 54-14, DWPE of Dietary Supplement Products from Firms that have not met Dietary Supplement GMP
- 71-04, DWPE of Animal Foods, Other Pet Treats, Due to Presence of Salmonella
- 99-08, DWPE of Processed Human and Animal Foods for Pesticides
How to Avoid Detention
Be familiar with what import alerts are in place for your origin country and product type when exporting to the United States. By including these alert topics in a risk assessment or supplier compliance program that includes vendor validation and verification, as well as the export program criteria, an organization can prevent the shipment of non-compliant products to the U.S. as well as have increased confidence if a product is seized and tested at the border, knowing checks and balances are monitoring those import risks[2].
Navigating Import Alerts & FDA Detentions? Get Expert Regulatory Compliance Assistance
Need help to determine what Import Alerts may affect your product? Is your shipment currently under FDA detention and needs assistance? Are there other regulatory considerations for your food product being exported from Canada? Contact the regulatory compliance team to find out how they or others at Mérieux NutriSciences help you with your labeling needs.
References
[1] U.S. Food and Drug Administration. (n.d.). Import alerts. https://www.fda.gov/industry/actions-enforcement/import-alerts
[2] U.S. Food and Drug Administration. (n.d.). Import alerts by country/area: Canada. https://www.accessdata.fda.gov/cms_ia/country_CA.html