Industry FAQs for Import Alerts
Administrative Questions about Import Alerts
What is a red, green and yellow list?
Firms, products and/or countries which have met the criteria for Detention without Physical Examination (DWPE) under an import alert.
Firms, products and/or countries subject to intensified surveillance; or firms that may have satisfied GMP issues but where the nature of violations may warrant further field examinations of individual entries and/or additional analyses.
Firms, products and/or countries that have met criteria for exemption from Detention without Physical Examination (DWPE) under an import alert.
Per RPM 9-8, in most cases the publication of a firm/product on an import alert or removing the product/firm serves as notification to firm.
Import alerts can be deactivated if it is found that they are no longer applicable. Import alerts can also be replaced by new alerts and the manufacturer/product combination would be moved to that alert if still applicable. To request historical copies of import alerts, you may submit a Freedom of Information Act (FOIA) request here:
- For Detained Shipments: Contact the Compliance Officer listed on the Notice of FDA Action showing the product has been detained. You can find this information on the last page on the bottom right side.
- For Import Alert Policy Questions: If you have questions about DWPE, how to submit a petition for removal from import alert, email the FDA’s Division of Import Operations (DIO) at fdaimportsinquiry@fda.hhs.gov
- For Sampling-related Questions: If you have questions about sample size, sample methods, deviations from a method listed, alternative methods, you should provide this information in detail to the Compliance Officer (CO). The CO may need to consult with the appropriate Center(s).
- For Import Alert Petition Status: Please contact the reviewer assigned to your case for status. This information can be found on the Acknowledgement Letter you should have received after submitting your petition to importalerts2@fda.hhs.gov.
Questions about Products/Firms on Import Alerts
It is recommended that importers use the search function (link here) prior to importing products to determine if their product is subject to any alerts. Importers should perform multiple search criteria (i.e., manufacturer name, product name, country of origin) to ensure all possible reasons for DWPE are explored.
The Guidance Section of the alert will provide specific instructions on how to secure a release of a shipment subject to the alert. It will also be noted in the Guidance Section if the violation associated with the alert precludes release of shipments subject to the alert.
Each import alert will contain specific instructions on if and how a firm can overcome the violations when importing products. Knowing the options prior to importing can help importers determine if (1) importing the product is still feasible and (2) what evidence should be provided in an attempt to overcome the appearance of a violation.
No, not all detentions are due to Import Alert violations. The Detention Notice of Action will detail the reason the product is detained. Visit the Detention and Hearing page for more information.
Products/firms subject to DWPE have been found to be in violation of the FDA’s Food, Drug, and Cosmetic Act (FDCA). Manufacturers, distributors, exporters, importers, etc. can ensure that any FDA-regulated products offered for import into the U.S. are compliant with all applicable requirements and not in violation of the FDCA.
If the firm/product combination is no longer listed on the Red List of the import alert, the appearance of the violation has been overcome and the firm/product are NOT subject to Detention Without Physical Examination (DWPE).
If a firm/product combination is no longer listed on the Green List of the import alert, then the appearance of the violation has no longer been overcome and the firm/product ARE SUBJECT to DWPE.
Any change in the conditions that were used as evidence to subject or exempt a product/firm from DWPE, MAY result in the firm/product no longer being subject to or exempt from DWPE. A change in conditions MAY include, but not limited to, a change in company name, company ownership, physical location/facilities, equipment, procedures, products, labeling, etc.
Examples of information that may demonstrate these conditions can be found in the FDA’s Regulatory Procedures Manual (RPM), specifically, Chapter 9-8-15: Import Operations and Actions.
The firm listed on the import alert should notify the FDA of any changes in conditions that may impact the firm’s status on an import alert by submitting a notification and documentation of the change to the FDA’s DIO at importalerts2@fda.hhs.gov. Please refer to guidance in the import alert for petitions for removal from the import alert. Some petitions should go directly to the compliance officer working on your case, for example for import alert 99-41 cases.
Questions about Removal from Import Alerts
Please see Removal from Import Alert page.
When a shipment is DWPE, the importer or consignee has the right to introduce testimony and/or evidence to demonstrate that the product does not have the violation listed on the import alert. The “Guidance” section of the import alert should contain information regarding how to secure the release of an individual shipment.
Please note that some import alerts list violations that may require corrective action and removal from DWPE to secure a release of the shipment. Refer to the “Guidance” section of each alert for more information.
Additional questions should be directed to the Compliance Officer listed on the Notice of FDA Action.
There is no specific requirement identifying what constitutes a quantity that may be considered “routine commercial entries” or an exact timeframe that represents a “reasonable time period”, however, the FDA’s Regulatory Procedures Manual (RPM) does state that the articles offered for importation should be over the course of a reasonable time and should reflect their normal shipping patterns.
For example, if historically the firm always shipped 100 pails per shipment every other week, and then suddenly start shipping 5 pails per shipment every day, and then after the petition resumes shipping 100 pails per shipment every other week, those nonroutine shipments/timeframes would not likely represent “routine commercial entry” or “over a reasonable time period”.
A firm may consider submitting a petition for removal from DWPE (import alert) to importalerts2@fda.hhs.gov. It is not appropriate to submit a petition for products temporarily not in production. There is no specific evidence required to be provided. The FDA will consider the totality of evidence presented in the petition to make a decision.
Firms listed on a red list of an import alert were declared to be a responsible party for the product on the entry of the shipment where the product was found to be in violation of the FDCA or was found to be the responsible party for the product via an inspection, historical data, product label/labeling, etc.
The FDA does not get involved in business practices of companies. If you did not intend to have a product you manufacture exported to the U.S., you may consider investigating your supply chain. You may also consider submitting a petition for removal from DWPE demonstrating that your product is compliant with all applicable FDA laws and regulations.
If you believe your firm is incorrectly listed as the responsible party for a product subject to DWPE (import alert), you may consider submitting a Freedom of Information Act (FOIA) request to identify if your firm was incorrectly transmitted to the FDA as the manufacturer, shipper, or importer of the product. If you have evidence that your firm was incorrectly declared, you may consider submitting a petition for removal from DWPE to importalerts2@fda.hhs.gov with all available evidence for consideration.