http://www.fda.gov/AnimalVeterinary/New ... 166265.htm
FDA Suspends Temporary Emergency Permit of Pet Food Maker
June 12, 2009
The U.S. Food and Drug Administration announced today it was suspending the temporary Emergency Permit issued to Evanger's Dog & Cat Food Co., Inc.
Evanger's, operating in Wheeling, Illinois, deviated from the prescribed process, equipment, product shipment, and recordkeeping requirements in the production of the company's thermally processed low acid canned food (LACF) products. The deviations in their processes and documentation could result in under-processed pet foods, which can allow the survival and growth of Clostridium botulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans.
In April 2008, Evanger’s was issued an “Order of Need for Emergency Permit” after the agency determined that the company had failed to meet the regulatory requirements to process a product that does not present a health risk. In June, 2008, FDA issued Evanger’s a temporary Emergency Permit. During inspections conducted between March 2009 and April 2009, FDA determined Evanger’s was not operating in compliance with the mandatory requirements and conditions of the Temporary Emergency Permit.
“The FDA is stopping Evanger's ability to ship pet food in interstate commerce,” said Dr. Bernadette Dunham. “Today’s enforcement action sends a strong message to manufacturers of pet food that we will take whatever action necessary to keep unsafe products from reaching consumers.”
In order for Evanger's to resume shipping in interstate commerce, the company must document that corrective actions and processing procedures have been implemented to ensure that the finished product will not present a health hazard.
Botulism is a powerful toxin that affects the nervous system and can be fatal. The disease has been documented in dogs and cats. Signs of botulism in animals are progressive muscle paralysis, disturbed vision, difficulty in chewing and swallowing, and progressive weakness to the body. Death is usually due to paralysis of the heart or the muscles used in breathing.
While FDA’s Center for Food Safety and Applied Nutrition is responsible for regulating all human and animal LACF processing, FDA's Center for Veterinary Medicine has authority over animal feed and foods. The two centers are collaborating on this enforcement action.
Evanger’s Dog & Cat Food Company Responds to FDA News Release
June 14, 2009
To All Valued EVANGER’S DOG AND CAT FOOD CO., INC. Customers,
As you may be aware, the United States Food and Drug Administration has taken action against our company. Although there are no recalls, or any allegations of unsafe foods manufactured by Evanger’s, we feel that we must respond to this situation with a detailed report to you, our customers.
The main reason for the suspension of our permit involves confusion while updating the FILED SCHEDULED PROCESSES as required by F.D.A. rules 21 CFR 108.35(2) and 21 CFR 113.83. The rules dictate that all “STYLES” of food must be studied for adequate heat penetration to achieve “commercial sterility”. This procedure usually involves the understanding that heat penetrates different consistencies of product at different rates. For example, heat penetrates Evanger’s 100% ALL MEAT COOKED CHICKEN at a different rate than Evanger’s ALL FRESH VEGETARIAN style formula.
Our “Process Authority” (F.D.A. recognized expert) communicated to the F.D.A. that he intended to file a single SCHEDULED PROCESS that would cover ALL loaf style foods that are manufactured at Evanger’s using the “MOST RIGOROUS” process (VEGETARIAN). The intention being, that applying this process to all of our loaf style products would add an additional layer of safety. At the same time, our Process Authority indicated that he would “CLEAN UP” our file by deleting older processes.
In August of 2008, our process authority completed the update of our file.
During a regularly scheduled inspection by the F.D.A. earlier this year, the FDA inspector informed us that the FILED PROCESSES that we normally use were deleted from our file. Furthermore, the only FILED PROCESS that remained only allowed us to manufacture “VEGETARIAN” foods. To give you a complete picture of the facts, here is the actual explanation that was sent to us by the F.D.A. as cited for the reason for taking action (SEE ATTACHED)
[FDA STATEMENT FOLLOWS]
Your firm’s processing authority’s response stated it had replaced two older filings with a new filing, Submission Identifier (SID) 2008-03-21/003, to cover all variations of “Loaf Style” pet food produced by Evanger’s in the 300 x 400 can size including “Vegetarian Style Loaf”. However, documentation on all formula types that your firm intended to include under this filing was not provided. Compliance with 21 CFR 108.35(c)(2) will require your firm to submit a filing for each of the above products, including the ingredients for the various formulations. The additional products that can be called “loafs” using the same process will need their own SID unless they can be included in the existing filing (SID 2008-03-21/003) in which case your processing authority will have to show that these additional products heat the same or faster than the product originally filed as SID 2008-03-21/003 and that the filed minimum scheduled process is sufficient for the safety of all the various product formulations.
Your firm failed to submit to FDA, within 30 days after first use, a complete description of the modification made and utilized and a copy of the file record showing prior substantiation by a qualified scientific authority for the following products as required by 21 CFR 108.35(c)(2)(ii):
· On 8/12/08, TechniCAL (your contracted process authority) cancelled SID# 1996-03-15/001 and SID# 1977-08-23/001, Loaf Style Dog and Cat Food Ground Meat & Grain Blends in tinplate steel 300 x 405 and 300 x 407 cans, respectively. FDA was not notified of the change from the can size filed to 300 x 400 for Loaf Style Dog and Cat Food Ground Meat & Grain Blends.
In short, Evanger’s and its Process Authority believe the processes filed with F.D.A. cover all its products, though FDA appears to disagree.
The management of EVANGER’S is working closely with the F.D.A and our Process Authority to resolve this matter quickly.
PLEASE KEEP IN MIND THESE IMPORTANT FACTS:
· The issue involves only canned food products.
· THERE ARE NO RECALLS OR SAFETY ISSUES ASSOCIATED WITH THIS SITUATION.
· All Evanger’s products that are currently on store shelves are safe as they always have been.
· Evanger’s Dog and Cat Food Co., Inc. continues and will continue to manufacture the highest quality, nutritious, wholesome, innovative and safe pet foods and treats as it has done for over 75 years.
We hope this response addresses the confusion that has been in the marketplace as of recently. For all additional inquiries, please contact EVANGER’S DOG AND CAT FOOD CO., INC. at 1800 288-6796.
To Our Valued Customers,
Evanger’s Dog & Cat Food hopes that the following statement will alleviate the concerns about the safety of our products that are being fueled by inaccurate information and rumor.
As we have indicated, the FDA Action does not call into question the safety of any of Evanger’s products.
Evanger’s voluntarily conducts internal testing on all of its production batches. These tests are not required by the FDA, but are part of European Union and USDA protocol. These tests detect any bacterial presence, including that of Botulin bacteria.
There has never been any detection of any bacteria in any of our products. As part of the FDA inspection, every can in our warehouse was inspected by the FDA for signs of bacterial contamination. The result: NO contamination was found.
Individual incubation test results are available to our customers upon request. Requests must include product name and production code.
We thank you for your understanding.
Evanger’s Dog & Cat Food Co., Inc.