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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 […]

By Jennifer Diaz|2022-08-09T10:33:12-04:00February 14, 2012|Import Alert, U.S. Food and Drug Administration (FDA)|0 Comments

International Boston Seafood Show – LIVE!

I am at the final day of the annual International Boston Seafood Show held at the Boston Convention Center. With record attendance and a record number of exhibitors filling the convention center floor with extravagant booths overflowing with shrimp, fish, crab, lobster, and other seafood delectables from all over the world, the Show is a success. After all, this is the largest seafood show in North and South America. Perennial exhibitors Pescanova, Inc. and Preferred Freezer Services had the largest and most memorable displays. In addition to my speaking on the topic of “Food Safety”, my law firm exhibited at the Show for the first time, and shared a booth with food testing laboratory, ABC Research Corp.

Serious topics for the educational seminars included “Rebuilding Consumer Confidence in Gulf Seafood,” and “Food Safety”. There was significant discussion of aquaculture. For pure fun, the Show included a new Game Lounge, the 5th Annual Oyster Shucking Competition, the 2nd Annual Tweet & Meet Tweetup, and a keynote address from Wayne Rogers, the actor from the hit series M*A*S*H.

By Jennifer Diaz|2021-04-09T12:54:01-04:00March 22, 2011|Events, FDA Issues, Food, Import Alert, U.S. Customs and Border Protection (CBP)|0 Comments

FDA Import Alerts for Seafood

Americans are constantly bombarded with warnings that the seafood we eat is contaminated with salmonella, listeria, or some other antibiotic, fungicide, or microorganism that will make us sick. The U.S. Food and Drug Administration (FDA) is taking more samples of imported seafood, holding more seafood for laboratory analysis, and rejecting more seafood than in past years. That is true of basa from Vietnam, crabmeat from Indonesia, and a variety of seafood from countries as far away as China, or as close to the United States as the Bahamas.

The FDA issues ‘Import Alerts’ to attempt to prevent contaminated seafood (or specific products) from certain overseas suppliers from entering the food supply chain in the United States. Seafood importers should be very familiar with Import Alert 16-81 – “Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella”.

The Obama Administration’s Import Safety Working Group Food Protection Plan encourages the FDA to issue more Import Alerts. An Import Alert is an order to all FDA district officials to detain and examine imported seafood that is identified on an Import Alert, or to detain and examine any seafood shipped by an overseas company that is listed on the Import Alert (i.e. the “Red List”).

Import Alerts are issued on an almost daily basis by the FDA. For Import Alert 16-81, the “Charge” reads as follows:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to contain salmonella, a poisonous and deleterious substance, which may render it […]

By Jennifer Diaz|2015-12-01T01:40:19-05:00August 23, 2010|Import, Import Alert|0 Comments

Made in China, Sold in America

This weekend, I visited both Lowe’s and Home Depot looking for some new plants for my backyard. As I walked by all the newly arrived Christmas merchandise, I casually picked up a few to see where they were made. You guessed it, from Santa to Rudolph, one by one they all clearly stated “Made in China”. I finally did find one item that stated “Assembled in USA from foreign and domestic components.” I was getting frustrated. After all, as a customs and international trade attorney for the past 20 years, including the first 5 as an attorney for U.S. Customs, I have made a living doing international trade. I wondered, what happened to our balance in international trade? What happened to “Made in America”?

Everyone knows that mountains of Chinese goods are daily shipped to and sold in the United States, but what about the reverse. Fortunately, I also have that perspective, as I visit the People’s Republic of China (PRC) at least once a year for U.S. based clients importing from China or Chinese companies selling to the United States. I travel to China on an airplane, am transported to the hotel by car, and sometimes go down to the bar to have a drink. The plane is made by Boeing, the car is a Ford, the hotel is a Sheraton, and the drink is a rum and Coke (Bacardi and Coca-Cola). All of those iconic names are pure Americana.

With 1.4 billion people in China, no wonder American companies,and the rest of […]

By Jennifer Diaz|2019-08-26T20:02:23-04:00October 22, 2009|China, China Trade War, Import, Import Alert, International Business, International Law, International Trade, Supply Chain|0 Comments

How To Get Off The FDA ‘Black List’

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 […]

By Jennifer Diaz|2015-11-30T19:25:55-05:00August 3, 2009|Food, Import, Import Alert|0 Comments

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