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FDA Import Alerts: Red & Green Lists

There are two types of FDA Import Alerts. The most common type is a Red List Import Alert. In this case, FDA notices a pattern of non-compliance from a specific company and adds the company to a red list. For example, a company may be on a red list for attempting to import seeds contaminated with salmonella. Once added to the red list, any seeds that the company imports to the United States will be detained without physical examination (DWPE) by FDA.

The other type of Import Alert is a Country-Wide Import Alert. This type of alert occurs when FDA notices a pattern of non-compliance from a specific country. For example, in 1979, FDA noticed a high rate of filth and decomposition in shipments of raw and cooked shrimp from India. So, FDA created an Import Alert to increase surveillance of Indian shrimp shipments. Any raw or cooked shrimp shipped from India is subject to DWPE, unless the exporter is on the Green List.

A Green List is a list of companies that are exempt from a particular Country-Wide Import Alert. Following the example above, shrimp exported by an Indian company that is on the Green List is not subject to DWPE.

Petitioning FDA for Exemption from an Import Alert (Removal from a Red List or Addition to a Green List)

If you find your shipments detained due to an Import Alert, there are procedures by which you may petition FDA to be removed from a Red List or added to a Green List. Typically, this process has three phases:

  • An analysis by your firm of the violation that caused FDA to issue the Import Alert, as well determining the corrective actions or preventive measures your firm must undertake in response.
  • Once your corrective actions have been implemented, FDA will require evidence that these actions were successful in resolving the issue, including (but not limited to) proof of five to twelve cleared, non-violative shipments of the product to the United States. Registrar Corp can assist with the detentions of these shipments and in obtaining and properly organizing the necessary documentation.
  • Upon completion of steps 1 and 2 above, evidence must be gathered and organized into a petition to be submitted and reviewed by FDA’s Division of Import Operations.

According to FDA, in 2013 fewer than 3% of the approximate 13,000 companies that were on an FDA import alert red list petitioned to be removed and only 165 companies petitioned to be added to a green list. Many are intimidated by the petitioning process. Import alert petitions are often extensive and complicated, requiring hundreds of pages of supporting documents.

Registrar Corp makes the petitioning process easier by helping draft your petition to FDA, including certified statements by appropriate personnel at your firm, required documentation and other evidence. Registrar Corp will also help you draft a written explanation to FDA concerning how the petition justifies removal from the FDA Red List or addition to the FDA Green List.

If you are interested in having a company added to an FDA Green List or removed from an FDA Red List, click here.

To see if your company, a competitor, or your U.S. importer is on an Import Alert, click here.