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.htmlIA #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)
