FDA Import Alert - Detaining ALL Vegetable Protein - 1950 cats 2200 dogs reported dead to FDA

Added 9pm: USA Today reports on this here

The Food and Drug Administration is enforcing a new import alert that greatly expands its curtailment of some food ingredients imported from China, authorizing border inspectors to detain ingredients used in everything from noodles to breakfast bars.

The new restriction is likely to cause delays in the delivery of raw ingredients for the production of many commonly used products.

The FDA has issued the following Import Alert... - all vegetable protein products from China are being held. There is a ton of additional information in this, read it all at the link or down below. (Many thanks to Mike for sending the information!)

And for the first time we have real numbers from the FDA, from below:

As of April 26, 2007, FDA had received over 17,000 consumer complaints relating to this outbreak, and those complaints included reports of approximately 1950 deaths of cats and 2200 deaths of dogs.

(Note how similar these numbers are to those reported over on petconnection.com)

Here are numbers reported by pet owners into the Pet Connection database, updated just a few minutes ago:

• Total reports of illness or death: 14,228
• Total cats reported dead: 2,334 cats
• Total dogs reported dead: 2,249

• 
  

http://www.fda.gov/ora/fiars/ora_import_ia9929.html

IA #99-29, 4/27/07, IMPORT ALERT #99-29, "DETENTION WITHOUT PHYSICAL EXAMINATION OF ALL VEGETABLE PROTEIN PRODUCTS FROM CHINA FOR ANIMAL OR HUMAN FOOD USE DUE TO THE PRESENCE OF MELAMINE AND/OR MELAMINE ANALOGS"

TYPE OF ALERT: Detention Without Physical Examination (Countrywide)

(Note: This import alert represents the Agency's current guidance
to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue.  
It does not create or confer any rights for or on any person, and does not operate
to bind FDA or the public).

PRODUCTS:   Wheat Gluten
  Rice Gluten
  Rice Protein
  Rice Protein Concentrate
  Corn Gluten
  Corn Gluten Meal
  Corn By-Products
  Soy Protein
  Soy Gluten
  Proteins (includes amino acids and protein hydrosylates)
  Mung Bean Protein

PRODUCT     02G[][]08 - Soy Bean Meal/Powder/Gluten/Protein Isolate
CODES:      18E[][]03   Soy Protein Powder
  02F[][]08   Wheat Gluten
  02E[][]06 - Wheat Flour Gluten
  71M[][]01   Wheat Gluten
  02D[][]12   Rice Protein
  02D[][]13   Rice Gluten
  71I[][]03   Rice Protein
  71G[][]02 - Corn Gluten
  02B[][][][]   Milled Rice Products
  54[][][][][]- Amino acids and protein hydrosylates

PROBLEM:   Poisonous or Deleterious Substance
Unfit For Food
Unsafe Food Additive
...
MANUFACTURER/SHIPPER:     All

In recent weeks, there has been an outbreak of cat and dog deaths

and illness associated with pet food manufactured with vegetable

proteins contaminated with melamine and melamine related

compounds. In response to this outbreak, FDA has been conducting

an aggressive and intensive investigation. Pet food manufacturers

and others have recalled dog and cat food and other suspect

products and ingredients. This has been one of the largest pet

food recalls in history, a recall that continues to expand. Thus

far, 18 firms have recalled product, 17 Class I and 1 class II,

covering over 5,300 product lines. As of April 26, 2007, FDA had

received over 17,000 consumer complaints relating to this

outbreak, and those complaints included reports of approximately

1950 deaths of cats and 2200 deaths of dogs. The Agency is

working with federal, state, and local governments, academia, and

industry to assess the extent of the outbreak, better understand

how melamine and melamine related compounds contributed to the pet

deaths and illnesses, and to determine the underlying cause of the

contamination.

As of April 26, 2007, FDA had collected approximately 750 samples

of wheat gluten and products made with wheat gluten and, of those

tested thus far, 330 were positive for melamine and/or melamine

related compounds. FDA had also collected approximately 85

samples of rice protein concentrate and products made with rice

protein concentrate and, of those tested thus far, 27 were

positive for melamine and/or melamine related compounds. FDA's

investigation has traced all of the positive samples as having

been imported from China.

Although FDA's investigation is ongoing, the Agency has learned

the following about the outbreak and its association with

contaminated vegetable proteins from China:

1. For the vegetable proteins and finished products that have

been found to be contaminated, it is unknown who the actual

manufacturers are, how many manufacturers there are, or

where in China they may be located.

The samples of vegetable proteins that have tested positive

for the presence of melamine and melamine analogs have, thus

far, been traced to two Chinese firms, Xuzhou Anying

Biologic Technology Development Co. Ltd. and Binzhou Futian

Biology Technology Co. Ltd. Records relating to the

importation of these products indicate that these two firms

had manufactured the ingredients in question. There is

strong evidence, however, that these firms are not the

actual manufacturers. Moreover, despite many weeks of

investigation, it is still unknown who the actual

manufacturer or manufacturers of the contaminated products

imported from China are.

All of the contaminated wheat gluten has thus far been

traced to Xuzhou Anying. According to the General

Administration of Quality Supervision, Inspection and

Quarantine (AQSIQ) of the Chinese government, Xuzhou Anying

purchased its wheat gluten from 25 different manufacturers

and Xuzhou Anying may just be a supplier. Press statements

by Xuzhou Anying state that it did not manufacturer the

wheat gluten it had shipped to United States that has been

associated with the outbreak, but that it received that

wheat gluten from other sources not named in the press

statements.

Despite its investigation into the matter, FDA has been

unable to determine who, in fact, the actual manufacturer(s)

are.

2. The source of the contamination problem is currently unknown

and FDA has been unable to isolate the scope of the problem.

Melamine is a molecule that has a number of commercial and

industrial uses. Other than a few limited authorizations

for use in food contact materials for human food, melamine

has no approved use as an ingredient in human or animal food

in the United States. FDA is continuing its investigation

into how the melamine and melamine related compounds may

have gotten into the vegetable protein, and has asked the

Chinese government to help with this investigation.

In addition, FDA does not know how widespread the problem in

China might be. For example, FDA does not know which

regions of the country may or may not be impacted by the

problem, which firms are the major manufacturers and

exporters of vegetable proteins to the United States, where

these vegetable proteins are grown in China, and what

controls are currently in place to prevent against

contamination.

According to the Chinese government, Xuzhou Anying did not

declare the contaminated wheat gluten it shipped to the

United States as a raw material for feed or food. Rather,

according to the Chinese government, it was declared to them

as non-food product, meaning that it was not subject to

mandatory inspection by the Chinese government. In

addition, in a communication to the U.S. government, the

Chinese government has requested that FDA either request or

require that U.S. importers of plant protein products insist

on AQSIQ certification, based on AQSIQ testing, as part of

the import contract. According to a media report, China's

Foreign Ministry issued a statement that the contaminated

vegetable protein managed to get past Chinese customs

without inspection because it had not been declared for use

in pet food. The news report said the contamination problem

has prompted China to step up inspections of plant-based

proteins and to list melamine as a banned substance for food

exports and domestic sales.

This information indicates that there are manufacturing

control issues that cannot be linked to specific sources in

China, but instead require country-wide monitoring.

3. On April 17, 2007, pet food manufacturers in South Africa

recalled dry cat and dog food due to formulation with a

contaminated corn gluten, a vegetable protein. FDA has

learned that the corn gluten was contaminated with melamine

and that the corn gluten had been imported from a third-

party supplier in China. According to news reports, the

contaminated pet food has been linked to the deaths of

approximately 30 dogs in South Africa.

GUIDANCE:    Districts may detain without physical examination, all Vegetable
protein products from China.

****************
Definition from the FDA site http://www.cfsan.fda.gov/~lrd/imp-info.html

DETENTION WITHOUT PHYSICAL EXAMINATION

In some instances a product may be detained as soon as it is offered for entry into the United States. This procedure is the administrative act of detaining a product without physical examination and is based on past history and/or other information indicating the product may be violative. A product may be subject to a detention without physical examination (DWPE) recommendation until the shipper or importer proves that the product meets FDA guidelines or standards.

Occasionally, FDA identifies products from an entire country or geographic region for DWPE when the violative conditions appear to be geographically widespread. Detention recommendations of this breadth are rare and are initiated only after other avenues for resolving the problem have been exhausted. (See FDA Regulatory Procedures Manual (RPM), Chapter 9-25-00 for details on Detention Without Physical Examination - formerly known as Automatic Detention)