HOW TO GET OFF THE FDA BLACK LIST (Import Alert List)

What is the Black List?

The United States Food and Drug Administration (FDA) has authority from Congress to place an importer, manufacturer, shipper, grower, geographic area, or country on a “detention without physical examination” (DWPE) list (aka 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 import may be detained as soon as it is offered for entry into the United States. You 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 information is presented to the FDA that proves the merchandise is no longer violative.

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 automatic detention list because it was deemed “adulterated” or “misbranded” by the FDA, a minimum of five consecutive non-violative commercial shipments must 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 automatic detention 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 violative merchandise.

It is wise to consult an experienced attorney in this area to find out exactly what procedure applies to your case, so that you too, can get off the FDA Black List.

For example, I recently assisted a company who was listed on the Import Alert because of a labeling violation. I assisted the company with amending their labeling so it was compliant with FDA regulations, and a detailed Import Alert removal request, and within ONE MONTH we had a successful response from the FDA and the company was in fact removed from the Import Alert List.

If your company is listed on the FDA's IMPORT ALERT page, contact me today at jdiaz@bplegal.com - and we will discuss why you are listed and how I can assist you in getting off of the list.