Thursday, October 17, 2013

How to Successfully Petition FDA to Remove a Company from an FDA Import Alert List

The U.S. Food and Drug Administration (FDA) has the responsibility to stop any adulterated or mislabeled food products from entering the United States. Foreign companies which have attempted to ship to the United States such contaminated products not in compliance with FDA'a laws and regulations are often put on a Import Alert list. Many companies located as close as Mexico and Canada and as far away as China and Australia are on Import Alert lists because of the use of illegal pesticides or other contaminants. 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 any particular Import Alert list, such companies with this problem 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 of FDA in Rockville, Maryland for the removal of a company from an Import Alert list are usually done through an attorney.

The FDA website has helpful information, especially in its Regulatory Procedures Manual, which provides some guidance on "Removal from Detention Withouth Physical Examination". The important points to keep in mind and help avoid potential delays in the review of a petition is by ensuring the following information has been provided:

1. The following documents should be submitted for each entry you supplied in support of your petition:

US Customs Form 3461 or US Customs Form 7501
Commercial Invoice
Packing List
Bill of Lading

2. In order for FDA to consider removing a firm and/or product from detention without physical examination, FDA must have evidence which establishes the conditions that gave rise to the apparent violation have been resolved and which gives FDA confidence that future entries will be in compliance with the Act. Therefore, it is expected you will submit information outlining the steps that have been taken to prevent violations in future shipments.

3. Individual Import Alerts may also have specific information regarding removal from detention without physical examination. You should review the import alert specific to your request, and ensure any and all documentation called for has been submitted.
Often, not only must documentation from at least five (5) consecutive, commercial sized shipments be provided to the FDA, but also documentation from the manufacturer or supplier of the product shipped to the United States which explains that the source of contamination or other adulteration has been eliminated.

Peter Quinter*, Shareholder
Customs and International Trade Law Group
GrayRobinson law firm
Miami, Florida
Direct: (305) 416-6960
Mobile: (954) 270-1864

*Mr. Quinter has been selected as one of the Best Lawyers in America in the area of FDA Law 2009-2013.

For any questions or comments about this Blog post or related import FDA matters, please write below.

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