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How To Get Off The FDA ‘Black List’

Posted in Food, Import, Import Alert

What is the FDA ‘Black List’?

The United States Food and Drug Administration (FDA) has authority to put an importer, manufacturer, shipper, grower, geographic area of a country, or an entire country on a “detention without physical examination” (DWPE) list  (a/k/a the FDA’s ‘Black List’).  To check if a company you are doing business with is on such a list, check FDA’s Import Alert page.   You can search by country, company, etc.  If your company is on this list, any merchandise you attempt to import into the United States may be detained by the FDA as soon as it is offered for entry into the United States.  An importer will have to prove to the FDA that the merchandise should be allowed to enter the U.S., otherwise, it will be refused entry and must be exported or destroyed within 90 days.  The company/country, etc. will remain on this ‘Black List’ until sufficient information is presented to the FDA that proves the merchandise complies with the FDA requirement.

How to Get Off the Black List

FDA’s Regulatory Procedures Manual provides guidance to those who wish to get off the ‘Black List’.  The specific method to use to get off the ‘Black List’ is directly related to why you were placed on the ‘Black List’ in the first place.  For example, if a food product was placed on the ‘Black List’ because it was deemed “adulterated” or “misbranded” by the FDA, a minimum of five consecutive non-violative commercial shipments must thereafter enter the U.S., and at least one of the five non-violative entries should be audited by the FDA to ensure compliance.  The five shipments must be over a reasonable time period, not one day.  Separately, a Petition must be filed with the FDA requesting that the importer be removed from the ‘Black List’.  The Petition must include the specific products being automatically detained, the Entry Numbers, and any other relevant documentation to detail steps taken to prevent entry into the U.S. of merchandise that violates the FDA’s many requirements. 

It is wise to know whether you or your company are on the FDA ‘Black List’, to know the FDA requirements to get off the list as soon as possible, and to take action, so that you too, can get off the FDA ‘Black List’.

  • Terry

    Hi I would like to know if you could help us to get off black list from FDA . If you could do, i need to know how we do this

    pls comment this

    thanks

  • Jen Diaz

    Of course, have successfully assisted many companies in being removed from the Black List. As stated above, its a detailed process. We need to discuss why the company was placed on the list and the steps that have been taken by the company to remove the original issue (FDA wants assurance the issue the company had will not re-occur). Feel free to email me with the company name, a synopsis of the original issue, and I can work on these types of matters on alternative fee arrangements. I look forward to discussing your Import Alert issue.