U.S. Food and Drug Administration (FDA)-regulated products that are imported into the U.S. must comply with the same laws and regulations that apply to domestic products. When products are found to not be in compliance, they will be refused entry to the US and the entity exporting the product to the US may be placed on an import alert. At the end of February 2023, there were more than 2,000 active Import Alerts from 170 countries, with the greatest number of shipments being from China, Mexico, Canada and India. Just what does it mean to be on Import Alert – and what does it take to be removed from the “Red List”?
What is an Import Alert?
When FDA has evidence that an imported product appears to be in violation of regulations, the agency recommends that the product and/or company be placed on an Import Alert. If the recommendation is deemed valid, the product/company is placed on an Import Alert “Red List” resulting in the automatic Detention Without Physical Examination (DWPE) of all future shipments until the import alert is resolved. Each import alert relates to a specific type of violation. For example, pesticides in a product or Salmonella in a product.
What does a DWPE mean?
When a company is on an import alert they are still allowed to submit the product for entry into the U.S. But each shipment will be held at the port of entry and will not be allowed to enter unless the product has been tested by an approved laboratory for the agent of concern (e.g., Salmonella) using a testing protocol and laboratory that FDA will review. Once the testing is done, the results are sent to FDA, and if FDA accepts the results and the product is compliant it will be allowed to enter the U.S. The entire cost of this process (testing, holding of product etc.) is borne by the company trying to import the product into the U.S. For each shipment, the process can take many weeks, so it is a complex and costly process.
How does a company get off the Import Alert?
In very simple terms, getting off an Import Alert requires that the conditions that caused the violation be resolved, and the company submit a petition for removal with sufficient evidence to give FDA confidence that future entries will be in regulatory compliance. Unfortunately, the process to do so is not quite as simple as this sounds.
While FDA provides general requirements for removal, the evidence required by FDA will differ depending upon the nature of the violation, the reason for the DWPE, and the specific requirements included in the “Guidance” section of the Import Alert. This evidence required in the petition will likely include a root cause analysis to determine the source of the violation, a description of the corrective actions and/or preventive measures put in place to prevent the violation from occurring in the future, verification that they are effective, and FDA acceptance of five consecutive compliant shipments into the U.S. Each one of those five shipments will have to go through the hold-and-testing process described earlier.
When can the petition be submitted?
A company should never submit the petition to FDA until it has conducted a complete, well-developed root cause analysis (which can take weeks or even months), implemented corrective action, and verified that the corrective actions address the root cause and will prevent future occurrence.
As this process is occurring, the company can begin to write up the root cause analysis, corrections and verification that will be submitted as evidence of future compliance in the petition. The recommendation is that once the corrective actions have been made with appropriate verification the company also can begin the process of shipping compliant product to fulfill the five consecutive shipment requirement. When these shipments arrive at the U.S. port, the importer of record will receive an FDA notice that they had been DWPE. The company can then hire a third-party lab in the U.S. to conduct sampling to demonstrate the goods are in compliance. If accepted as such by FDA, the shipment will be released and the company can use the compliant shipment as evidence in the petition for removal.
Clearance of each shipment typically takes three to four weeks, and to be used as evidence in the petition, five consecutive shipments must be deemed compliant. Once all four factors are completed (root cause analysis, corrective action, verification, consecutive shipment release), the petition can be submitted. In some cases, the petition can be submitted before showing five consecutive shipments, for example to enable an importer to attain customers for the five shipments. In such cases, if FDA accepts the root cause analysis and corrective action plan, they may accept the petition, with the condition that five consecutive shipments be sent with the new controls in place.
What needs to be included in the petition?
The specific items to be included in a petition for removal include:
- Cover letter. This is the statement requesting that the firm/product be removed from DWPE. It must prominently note the Import Alert number, name and address of the firm petitioning for removal, the products requesting to be removed, and the entry numbers of released shipments.
- Supporting evidence. This section provides FDA with root cause analysis, description of corrective actions/preventive measures and their verification. As applicable, it also may include proof of registration or listing, third-party laboratory analyses, third-party audits, copies of product labeling, training records, certificates of analysis, etc.
- Other information. As required by the Guidance section of the Import Alert.
How will I know if the petition is accepted?
Once FDA’s review is complete, the agency will issue a letter indicating whether the petition met the criteria for removal from DWPE. If met, the letter will indicate the removal. If not met, the letter will indicate the reasons that the request did not meet the criteria. Some causes of denial include:
- Failure to submit the steps the company took to correct the violations.
- Failure to present evidence giving FDA confidence that future shipments will be in compliance.
- Failure to submit entry documentation for five (5) consecutive, compliant shipments.
- Failure to submit other information required by the Import Alert.
- Reoccurrence of the violation.
Once the letter is issued, the case is considered closed. For subsequent requests, a new petition would need to be submitted.
How can TAG help?
Import alerts are costly for the impacted business, and the process for getting off an import alert is complex and challenging. If a company has a petition rejected, it may be looking at many more months of business disruption. So it is very important to get the petition for removal from the import alert right the first time. This is where TAG can help. TAG’s regulatory expertise and experience in company and product removal from Import Alert can assist you in both the root cause assessment and corrective verification to help you successfully petition for and achieve removal from Import Alert. TAG manages this process by reviewing communications and documentation to provide a gap analysis and recommendations on next steps and further documentation required to address the concerns. In the resolution phase, TAG assists in addressing and resolving the open case, writing the petition, and liaising with the FDA as needed, to help the company be moved to a Green Light Status with the FDA.
TAG is ready to assist in your Import Alert Removal. Give us a call today!