by Gunster
The Food and Drug Administration (FDA) has the responsibility under the Federal Food, Drug and Cosmetics (FD&C) Act to stop any adulterated or mislabeled food products from entering the United States. Foreign companies that attempt to ship to the United States products not in compliance with FDA’s laws and regulations often get listed on an FDA Import Alert.
Companies located as close as Mexico and Canada, and as far away as China and Australia are on FDA Import Alert lists because their products were found to contain illegal pesticide residues, contaminants, salmonella, or other hazards to consumers. Even products from certain Italian suppliers such as cheese, fish, honey, and confectionary products are on the FDA Import Alert List. Once listed, any future shipments of the same product from the same foreign company will automatically be detained without physical examination (DWPE), and not allowed to proceed into the commerce of the United States unless time consuming and expensive laboratory analysis for that particular, refused shipment is conducted in the United States by specific laboratories, and the negative laboratory report is accepted by the FDA.
To get off an FDA Import Alert, a company must prepare and submit a persuasive petition to FDA’s Division of Import Operations (DIO) that the problem has been permanently remedied. Petitions to the DIO are usually done through an attorney familiar with the policies and procedures of the FDA. Chapter 9 (Import Operations and Actions) of the FDA’s Regulatory Procedures Manual provides some guidance on “Removal From Detention Without Physical Examination”. FDA decisions to remove a product, manufacturer, packer, shipper, grower, country, or importer from DWPE should be based on evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved, and the FDA has confidence that future entries will be in compliance with U.S. law. The most important point to keep in mind – and to avoid potential delays in the review of a petition – is that all requisite documentary information must been initially submitted with the petition. A minimum of five (5) consecutive non-violative commercial shipments of that product is required from that manufacturer, supplier, country, etc. Each of the five (5) shipments should include a U.S. Customs and Border Protection entry number, date of entry, and port of entry.
In many cases, not only must documentation of compliance for at least five consecutive, commercial-size shipments be submitted to the FDA, but also documentation that the manufacturer or supplier of the product has eliminated the source of contamination or adulteration that caused the product to be listed. The FDA may require a foreign establishment inspection which demonstrates the company has adequately addressed its violative conditions before removal from DWPE. The Petition for Removal from Import Alert is submitted electronically to the FDA, should always be accompanied by a cover letter addressed to the FDA, a letter of authorization from the company to the submitting attorney, and include numerous exhibits of supporting evidence. The supporting evidence is typically one or more of the following:
- Third-party laboratory analyses
- Manufacturing or processing records
- FDA establishment inspections
- Proof of registration and/or listing
- Proof of certification by a foreign government or certified body
- Evidence that labeling violations have been corrected
- Evidence that the product is in compliance
The FDA will promptly respond by email to acknowledge the receipt of the Petition. The file is then assigned to an FDA analyst who will review the submission. Too often, such Petitions are rejected because they did not contain the information required by the FDA. That delays the entire process as a new Petition must be submitted, and the Petitioner will have to wait until the next FDA analyst is available. Hopefully, when properly submitted the first time, it is analyzed, and a letter from the FDA granting the request for removal from the FDA Import Alert is granted and would be immediately effective.
Please call or email me with any questions or comments at PQuinter@Gunster.com or mobile (954) 270-1864. Mr. Quinter has been recognized by “Best Lawyers in America” legal directory in the area of FDA Law from 2009 to 2023. He is also one of very few attorneys to be heralded by the Chambers Global legal directory as one of the best attorneys in the area of International Trade in 2020, 2021, and 2022.
