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Q: United States FDA Consent Decree Question ( Answered,   0 Comments )
Subject: United States FDA Consent Decree Question
Category: Business and Money
Asked by: aox-ga
List Price: $200.00
Posted: 29 Oct 2005 08:33 PDT
Expires: 28 Nov 2005 07:33 PST
Question ID: 586391
I would like a list of US food manufacturers who have signed "consent
decrees" with the FDA in the last 10 years.

I would like to know how many of these companies are still in business
and how many are now out of business.

Spreadsheet format would be great, if possible.

Request for Question Clarification by pafalafa-ga on 29 Oct 2005 11:53 PDT
There appear to be only a handful of actual consent decrees issued by
FDA that directly involve traditional food companies.

Most FDA enforcement action involves drug companies.  

A smaller number involve companies tangentially related to food
manufacturing.  These might include slaughter houses and feedlots, 
For instance, this recent action was taken against a "dairy", but it
was, in actuality, an operation selling animals for slaughter:
Consent Decree Filed in Tissue Residue Case at Alvin Souza Dairy

Consent decrees have also been issued to companies that manufacture
food supplements that are being marketed as if they were drugs. An
example of this would be the food supplement Laetrile, which was sold
as a cure for cancer.

A few consent decrees do involve food manufacturers, such as this one from 1997:
Royal Baltic Ltd

"The defendants introduced into interstate commerce adulterated
fish...The fish was adulterated in that it was prepared, packed and
held under insanitary conditions whereby it might have been rendered
injurious to health...A consent decree of permanent injunction was

From a preliminary look, I'd be surprised if there were more than a
handful of such consent decrees issued against true food companies in
the past ten years.

Should I continue my research and post the few consent decrees that I
find?   Or would you prefer some other sort of approach to this topic?

Let me know your thoughts.


Clarification of Question by aox-ga on 29 Oct 2005 13:00 PDT
I am only interested in companies that make foods.

I believe there have only been a few that have signed consent decrees,
but I would like to know who they are, if possible.

Especially if they have gone out of business as a result.

Please continue your research.

I appreciate your timely response.
Subject: Re: United States FDA Consent Decree Question
Answered By: pafalafa-ga on 29 Oct 2005 16:52 PDT

Thank you for your prompt follow-up to my earlier clarification request.

As we both expected, there are only a handful of cases in the FDA
files that appear to meet your criteria -- consent decrees imposed on
actual food manufacturing companies.

Since the numbers involved are so small, I took the liberty of
summarizing the information below, rather than formatting it for a
spreadsheet file.  However, if a spreadsheet format is preferred, just
let me know, and I'll be glad to reformat the answer for you.

I trust this information fully answers your question.  

However, please don't rate this answer until you have everything you
need.  If you would like any additional information, just post a
Request for Clarification to let me know how I can assist you further,
and I'm at your service.

All the best,



The following items are about Consent Decrees imposed on actual food manufacturers.

Conte?s Pasta...On April 24, 2001, FDA investigators accompanied the
U.S. Marshals Service in a seizure at Conte?s Pasta located at
Vineland, New Jersey. The firm manufactures a variety of products
including Shrimp Ravioli, Crabmeat Ravioli, Seafood Manicotti, Shrimp
Pasta, and other products...The Consent Decree of Condemnation was
entered on August 20, 2001.

Status -- Company is still in business:
Consent Decree of Permanent Injunction Against Jensen?s Old Fashioned Smokehouse 

Jensen?s Old Fashioned Smokehouse...In January 2001, the owner of
Jensen?s Old Fashioned Smokehouse, Inc., Seattle, Washington, signed a
Consent Decree of Permanent Injunction for violating the Seafood HACCP
Regulations...FDA also found Listeria monocytogenes (L. mono) in 3 of
4 finished product samples of the firm?s vacuum-packaged hot smoked

Status -- Company is still in business:
Seafood International, Inc. Found in Civil Contempt 

Seafood International...On October 24, 2000, U.S. District Court Judge
Richard Haik granted the government's Motion for an Order to Show
Cause why Defendants should not be held in civil contempt for
violation of the Consent Decree of Permanent Injunction...The
government sought to hold the defendants, a seafood processing plant
and its president and manager, in contempt for continuing to process
seafood that was contaminated with filth...

Status -- Company is still in business:

There is also the Royal Baltic consent decree, that I mentioned earlier:

Status -- Company appears to still be in business, based on a current
listing in the Yello Pages, along with this recent mention of a


These dairies produced milk, which puts them pretty close to the
business of "food manufacturing"
August 29, 2001 

Joe Sozinho Dairy...Consent Decree of Permanent Injunction between the
United States, and Joe Sozinho Sr., Danny Sozinho, and Dimas M.
Sozinho.   These individuals were doing business as Joe Sozinho Dairy
#1 and Joe Sozinho Dairy #2 in Hanford, California.  The Dairy #1
milks approximately 650 dairy cows daily, which yields approximately
5,500 gallons of fluid milk per day.  The Dairy #2 milks approximately
450 dairy cows daily, which yields approximately 2,800 gallons of
fluid milk per day.

Status -- Company appears to still be in business, based on this 2004
mention in a newspaper article:
January 2004
REASON Listeria monocytogenes contamination based on FDA's samplings & analyses.


The following Consent Decrees involved food items, but did not appear
to involve food manufacturers.
November 6, 2002

New Choice Food Inc....The Food and Drug Administration (FDA) and New
Choice Food Inc., a distributor of conjac gel candies, have entered
into a consent decree which will lead to the FDA-supervised
destruction of 13,000 cases of mini-cup gel candies containing the
ingredient conjac. This is the latest in a series of actions the
agency has taken to protect the public against conjac gel candies,
which pose an unacceptable choking hazard.

Appellate Court Backs FDA In Contested Seizure

First Phoenix...A federal appeals court in Louisiana reversed a 1994
district court ruling, paving the way for FDA to oversee destruction
of 216,000 cans of adulterated and misbranded mushrooms detained in
New Orleans since 1992...On Jan. 22, 1996, First Phoenix signed a
consent decree that released the mushrooms into FDA's custody...Last
September, the Court of Appeals for the Fifth Circuit overturned a
decision by the U.S. District Court for the Eastern District of
Louisiana that barred FDA from destroying the mushrooms, which were
processed in China.

PRODUCT: Lobster Tails,

National Freezers, Inc...While held for sale after shipment in
interstate commerce at National Freezers, Inc., in Miami, Fla., the
articles were adulterated in that they consisted in whole or in part
of decomposed lobster...Pursuant to a consent decree of condemnation,
the articles were reexported under bond
Seizure at Boyd Bluford, Norfolk, Virginia 

Boyd Bluford...The firm is a distributor of candy, snack foods, and
beverages to firms in the Tidewater, Virginia area. Two previous
inspections revealed live mice and insects, rodent excreta, and rodent
gnawed foods in the retail store and throughout the warehouse...On
July 19, 2001, the owner of Boyd Bluford signed a consent decree
concerning food in susceptible containers seized on June 14, 2001.


Again, let me know if there's anything more I can do for you on this one.


search strategy -- Searched several newspaper databases, along with a
Google search for:  "consent decree" -pharmaceutical -pharmaceuticals
-abbott -schering -"red cross" -glaxo -supplement -implant -medical
-dairy -dairies
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