FoodImportImport AlertU.S. Food and Drug Administration (FDA)

How To Get Off The FDA ‘Black List’

posted by Jennifer Diaz August 3, 2009 6 Comments

What is the FDA ‘Black List’ (Also Referred to as the Red List/Green 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  or FDA’s Data Dashboard. You can search the Import Alert page 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 under very specific guidelines (each port follows their own process).  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’.

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6 Comments

Terry November 21, 2012 at 5:56 am

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

Reply
Jen Diaz November 21, 2012 at 10:10 am

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.

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steve Freedman June 1, 2017 at 9:09 am

how do you put someone on the black list

Reply
Jennifer Diaz June 1, 2017 at 9:37 am

Only FDA has the ability to add to the “black list”. If you have specific questions or concerns about a company and want to report them to the FDA, contact me at info@diaztradelaw.com.

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steve b freedman October 27, 2017 at 11:46 pm

i have questions and possible may need assitance

Reply
LUCIA VALERA February 19, 2020 at 10:43 pm

Hola, nosotros somos exportadores hacia EEUU y hemos ingresado a lista, como podríamos hacer para salir de ella?

Reply

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