Getting off an A-List No One Wants to Be on: FDA Import Alerts
by Peter Quinter, guest columnist
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 US products not in compliance with FDA’s laws and regulations often wind up an FDA Import Alert list.
Companies located as close as Mexico and Canada and as far away as China and Australia are on Import Alert lists because their products were found to contain illegal pesticide residues, contaminants, salmonella, or other hazards to consumers. Once listed, any future shipments of the same product from the same foreign company will be detained without physical examination (DWPE) and not allowed to proceed into the commerce of the United States.
To get off an Import Alert list, 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. But you can find helpful information on the process on the FDA website. The FDA Regulatory Procedures Manual supplies guidance on “Removal from Detention without Physical Examination” (Chapter 9, Section 6). 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 submitted with the petition.
1. The following documents should be provided for each compliant shipment cited in support of a petition:
- US Customs Form 3461 or US Customs Form 7501
- Commercial Invoice
- Packing List
- Bill of Lading
2. For the FDA to consider removing a firm and/or product from DWPE, the agency must have evidence establishing that the conditions that gave rise to the apparent violation have been resolved and that the FDA can be confident that future entries will be in compliance with the FD&C Act. Information outlining the steps that have been taken to prevent violations in future shipments is expected.
3. Individual Import Alerts may also set specific requirements for removal from DWPE – these should be carefully reviewed to ensure that all documentation called for has been submitted.
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.
Please call or email me with any questions or comments at [email protected] or (954) 270-1864.
Copyright © 2013 GrayRobinson
This column is based on material that originally appeared in the GrayRobinson Customs and International Law Blog, which is edited by Peter Quinter and covers a range of legal and regulatory issues related to trade. Subscribe at http://www.grcustomslaw.com/
About Peter Quinter
The Datamyne Blog’s legal contributor is a shareholder in GrayRobinson’s Miami and Ft. Lauderdale offices, and chair of the firm’s Customs & International Trade Law Group. Appointed by the Secretary of Commerce to the Florida District Export Council, Quinter is a recognized expert in international and trade law, and has been listed in “Best Lawyers in America” in the area of FDA Law each year since 2009.
The opinions expressed in this article are those of its author and do not purport to reflect the opinions or views or Descartes Datamyne. In addition, this article is for general information purposes only and it’s not intended to provide legal advice or opinions of any kind and my not be used for professional or commercial purposes. No one should act, or refrain from acting, based solely on this article without first seeking appropriate legal or other professional advice.
Date posted: November 29, 2013