News / Extended Coverage With Audio
FDA Finds Previously Unnamed Chemical In Wheat Gluten From China In Recalled Pet Food, Says It Can't Confirm Different Chemical Claimed By NY State Agency; We Post Audio Of FDA Teleconference
On-Demand Audio of March 30 FDA Teleconference
Pet Food Maker Exec. Holds News Conference, Delivers Statement
(March 30, 2007, with updates) -- U.S. Food and Drug Administration (FDA) officials held a Mar. 30 media teleconference in which they said Melamine, a chemical that isn't supposed to be in pet food, was found in wheat gluten imported from China and used in certain now-recalled lots of "cuts and gravy" style wet pet foods manufactured by Canada-based Menu Foods for firms that sold them under various brand names in the U.S.
FDA also announced that Cornell University was unable to confirm the presence of Aminopterin (a rodenticide not authorized in the U.S. and occasional anti-cancer drug) as contended March 23 by the NY State Dept. of Agriculture...which subsequently issued a statement standing by its findings.
In the public interest, LBReport.com posts below audio of the FDA teleconference on links below.
Following the FDA teleconference, Menu Foods of Canada held a press conference in which President/CEO Paul Henderson said in opening remarks that "other top scientists" had been unable to validate the findings" [of NY's Dept. of Agriculture] that aminopterin was in Menu Foods' pet foods or in any of the component ingredients. "It was also brought to our attention that some veterinary experts held the view that aminopterin was inconsistent with what was being observed in dogs and cats," Mr. Henderson said.
Menu Foods also posted a release on its web site titled Menu Foods Clears Non-Recalled Food for Pet Consumption, stating that the company "expressed confidence that its 'cuts and gravy' style pet food outside the recalled period is safe and healthy for consumption by North America’s cats and dogs."
The company release noted that U.S. FDA had "identified that melamine has been found in wheat gluten imported from China. This is the wheat gluten in the recalled pet food that caused illnesses and deaths. Melamine has not been found in other Menu Foods pet food, nor is it present in the wheat gluten from the other suppliers used by Menu Foods.
Mr. Henderson's opening remarks also stated in part:
The pet food that we have manufactured after March 6 is safe and healthy. How do we know this? First, it contains no melamine. Secondly, it contains none of the suspect wheat gluten. Thirdly, all of the testing that has been conducted, including the routine taste tests that were underway prior to the discovery of this problem, have demonstrated that those products not associated with the suspect wheat gluten performed very well and in a manner consistent with historic norms...
Following the FDA teleconference, the NY State Dept. of Agriculture released on its web site a Statement by NY State Agriculture Commissioner Patrick Hooker, stating in part:
...While we have no doubt that Melamine is present in the recalled pet food, there is not enough known data on the mammalian toxicity levels of Melamine to conclude it could cause illness and deaths in cats. With little existing data, many questions still remain as to the connection between the illnesses and what has caused them.
Last Friday [Mar. 23], we announced that the New York State Food Laboratory identified Aminopterin as a toxin present in cat food samples from Menu Foods. We stand confident in our finding of Aminopterin and know of at least one other laboratory that has confirmed its presence, the University of Guelph’s Animal Health Laboratory in Canada. Since, neither Aminopterin nor Melamine are compounds that should be found in pet food, it is important for full public disclosure.
We believe the laboratories involved in this investigation should continue to maintain an open forum to definitively identify the one or more agents that are causing the deaths and illnesses of cats and dogs so that they do not enter the animal or human food chain in the future. We are committed to continuing to work closely with FDA and collaborating laboratories in sharing testing protocols and samples to ensure all possibilities are explored with the hope for a timely outcome to this situation.
During the FDA teleconference, Dr. Sundlof indicated that his agency believes one company that makes dry pet food may have received a shipment of that wheat gluten from that Chinese source...and FDA is working with the firm to determine whether or not they used that product in the manufacture of their dry food. "As we learn anything, we will alert the public," Dr. Sundlof said.
[update Mar. 30] On March 30, Hill's Pet Nutrition, Inc. announced it is voluntarily recalling a single product -- Prescription Diet™ m/d™ Feline Dry Food -- its only product containing wheat gluten.
In a March 30 company release, Hill's said it is doing so as a "precautionary action because during a two-month period in early 2007, wheat gluten for this product was provided by a company that also supplied wheat gluten to Menu Foods. U.S. Food and Drug Administration tests of wheat gluten samples from this period show the presence of a small amount of melamine." The release continued:
Prescription Diet m/d Feline Dry represents less than one half of one percent of all Hill's products. This is the only product Hill's currently sells in the United States and Canada that contains wheat gluten from any supplier. No other Hill's Prescription Diet® or Science Diet® products are affected by this voluntary recall. Hill's Science Diet Savory Cuts Feline canned cat foods, manufactured by Menu Foods, were previously withdrawn from the market as a precaution. Together with this earlier withdrawal, less than 1% of all Hill's products have been affected." [end update]
[further update] On March 30, Nestle Purina PetCare voluntarily recalled all sizes and varieties of its ALPO Prime Cuts in Gracy wet dog food in cans with specific date codes. In a company release, the firm said:
Nestlé Purina PetCare Company today [March 30] it is voluntarily recalling all sizes and varieties of its ALPO® Prime Cuts in Gravy wet dog food with specific date codes. The Company is taking this voluntary action after learning [March 30] that wheat gluten containing melamine, a substance not approved for use in food, was provided to Purina by the same company that also supplied Menu Foods. The contamination occurred in a limited production quantity at only one of Purina's 17 pet food manufacturing facilities. Consumers should immediately stop feeding their dogs ALPO Prime Cuts products with the date codes listed below and consult with a veterinarian if they have any health concerns with their pet.
The recalled 13.2-ounce and 22-ounce ALPO Prime Cuts cans and 6-, 8-, 12- and 24-can ALPO Prime Cuts Variety Packs have four-digit code dates of 7037 through 7053, followed by the plant code 1159. Those codes follow a "Best Before Feb. 2009" date. This information should be checked on the bottom of the can or the top or side of the multi-pack cartons.
Importantly, no Purina brand dry pet foods are affected by the recall - including ALPO Prime Cuts dry. In addition, no other Purina dog food products, no Purina cat food products, Purina treat products or Purina Veterinary Diet products are included in this recall, nor have been impacted by the contaminated wheat gluten supply.
FDA's Sundlof indicated that his agency had to date received roughly 8,800 phone calls from concerned owners and veterinarian who believe their animals may have been affected by the recalled product...but for the moment the agency couldn't confirm links, if any, to any suspected food or manufacturer (beyond roughly a dozen cases that FDA previously confirmed).
The FDA further indicated that wheat glunten from China wasn't known to be used in any human food...but all wheat gluten from China is now being reviewed.
In the public interest, LBReport.com has posted the FDA teleconference on links below. The original audio quality was marginal; while the telephone feed was fine, someone thought it would be adequate to have the participants off-mike [not wise].
LBReport.com has posted the event un the "real audio" format that should "stream" into your computer (minimizing download time for the large audio files).
The participants in the FDA teleconference were Stephen F. Sundlof, D.V.M., Ph.D., Director of FDA's Center for Veterinary Medicine; Donald F. Smith, D.V.M.. Dean, College of Veterinary Medicine at Cornell University; David Elder, Director, of FDA's Office of Enforcement in its Office of Regulatory Affairs; and Neal Bataller, D.V.M., Director of FDA's Division of Compliance in its Center for Veterinary Medicine, FDA.
To launch the audio, click the following links:
FDA Teleconference Statements, March 30, 2007 (The first voice heard is Dr. Sundlof. Total running time for this segment is 13:56)
Q & A for FDA March 30 Teleconference (Running time 26:17)
[The "real audio" format is played via software many people already have on their computer. If you don't have the player software, you can download it free [caveat: check your system requirements and make sure the link on the page indicates it's free] at: RealOne player download]
Remarks of Menu Foods President/CEO Paul Henderson at March 30 company news conference
Mr. Henderson: ...One week ago, some of the dedicated researchers who had been investigating this matter reported the discovery of a single, toxic compound in our pet food. That, seemingly, cleared the way for us to address the problem, deal fairly with the pet-owners who had been injured, put our business back together, and move on.
In the intervening week, other top scientists have been unable to validate the findings. That is, they were unable to find the toxin -- called aminopterin -- in our pet food, or in any of the component ingredients. It was also brought to our attention that some veterinary experts held the view that aminopterin was inconsistent with what was being observed in dogs and cats.
There is an entirely different story today.
As you heard earlier from the FDA and Cornell University, a compound called melamine has been identified as being present in the food that caused the pet illnesses and deaths.
Melamine has been found in the finished product that was the subject of recall and has not been found in other Menu Foods pet food outside of the recall. Menu Foods only manufactures wet pet food.
Melamine has been found in the wheat gluten from a new supplier in the United States, who sourced this wheat gluten in China. This is the same ingredient that Menu Foods made reference to in its recall press release of March 16. Melamine has not been found in the wheat gluten that we obtain from our other suppliers.
The recalled product is unfit for consumption by pets. It contains melamine.
The pet food that we have manufactured after March 6 is safe and healthy. How do we know this?
First, it contains no melamine. Secondly, it contains none of the suspect wheat gluten.
Thirdly, all of the testing that has been conducted, including the routine taste tests that were underway prior to the discovery of this problem, have demonstrated that those products not associated with the suspect wheat gluten performed very well and in a manner consistent with historic norms.
Menu Foods has been in operation for more than 35 years. Our plants are modern, run by dedicated, experienced and well-trained employees. We operated with good manufacturing practices and are routinely audited by well recognized, independent experts on food safety and sanitation. It’s clear from our customer base that we must meet the most rigorous quality standards in the industry in order to be allowed to produce these products for some of the world’s largest brands. That is how we have confidence in our abilities to produce quality products.
With all of these quality standards, how did this happen? Quite simply, one supplier’s product was adulterated with a material that is not part of any known screening procedure for wheat gluten. The important point today is that the source of the adulteration has been identified and removed from our system.
Needless to say, we have a great deal of interest in finding out why we were supplied with this kind of product. This is a subject of very great interest to us and our lawyers and you can expect that we will be following up. For litigation purposes, we cannot elaborate at this time.
Let me be clear on this - we have removed that problem from our system. Our recall is well underway and products produced today are being made with known, quality and tested raw materials.
As a result, I can say with complete confidence today – to consumers, to our customers, to governments – that Menu Foods continues to uphold the high standards for which we have been known since 1971.
Our products are safe. We continue to engage in the highest levels of monitoring and testing in the pet food industry. These tests will be expanded as a result of this experience.
A final word on melamine. We have had correspondence with the FDA and we know that they are diligently following-up on the supply of the suspect wheat gluten. It is not our place to name the supplier as we do not want to interfere in any way with the important investigation they are conducting.
What we know today is that the products made by Menu Foods are of the highest quality, are safe, and will be returning to store shelves across North America in the coming weeks and months.
Now, as we did last time, I think we can anticipate some of your questions.
Does Menu have something it wants to say to any pet owners who have suffered a loss?
All of us at Menu Foods want to express our sympathy to those people who have suffered with sickness and loss of pets.
We are pet-people and we have almost 1,000 caring employees who are dedicated to making food that is safe, nutritious and palatable.
We are proud of our employees and the hard work, loyalty and diligence they have demonstrated in these trying times
We are angered that a source outside of the company has apparently adulterated the product causing this regrettable loss.
We are grateful to our customers and retailers who have been so responsible in the quick removal of affected product from the market and ask their continued diligence to assure that affected product is not accidentally restocked in their systems.
What is your reaction to the FDA’s Announcement earlier today?
We believe the announcement today by the FDA supports the products and the procedures used by Menu Foods in the recall. We are pleased that they have acknowledged that the nature of the adulteration could not have been identified by detection methods used by the industry and by their acknowledgement that no violations occurred.
One area that has made this recall particularly confusing is that Menu Foods executed the recall before there was a known scientific cause for the illness experienced by pets and with very few reported incidents from the field. We believe today’s press announcement by the FDA again supports our actions. The actions we took out of an abundance of caution undoubtedly saved many lives.
The FDA has reported that the adulterant found in the wheat gluten has only been found in wheat gluten from one specific supplier of that ingredient. This is the ingredient referenced in our recall announcement of March 16.
What is the immediate priority for Menu Foods?
Our first priority is the recall. We have implemented procedures to work with our retail customers to effectively clear all recalled product from the supply chain before each customer can receive new products. These new products have ingredients that we know are clear of the adulterant that was found in the single source of wheat gluten.
In light of the FDA’s findings, what are Menu’s next steps for getting back to business?
We look forward to returning to supplying safe, palatable “cuts and gravy” product for consumers. Our traditional loaf products do not contain any of the suspect ingredients and only two of Menu’s four plants have ever had the suspect ingredient in use at any time. All of our products produced after March 6 have been clear of the suspect wheat gluten.
We are working with our partners to help make it easy for consumers to know that they are purchasing only products that are clear of the suspect wheat gluten, in order to ease their mind and provide assurance of safety.
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