FDA Suspends Evanger's Emergency Permit
The following is not a recall, the FDA has suspended Evanger's emergency permit so they can no longer ship their food interstate.
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 record keeping 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.
Joel Sher, the VP of Evanger Dog & Cat Food Company, has issued a response.
Evanger's Dog & Cat Food Company Responds to FDA News Release
June 12, 2009
To our valued customers:
In August of 2008, while updating required process information to the FDA our "process authority" (processing expert) inadvertently deleted pertinent filings. Evanger's has been working with the FDA to resolve this issue quickly. This situation does not call into question the safety of any Evanger's products.
No Evanger's product are involved in any recall, nor is there any indication that any Evanger's product is unsafe. Evanger's Dog and Cat Food Co. continues to manufacture the highest quality, wholesome, nutritious and safe products as it has done for 75 years.
"As our customers, retailers and distributors know, Evanger's takes the quality and safety of its pet foods very seriously," said Holly Sher, president of Evanger's. "Evanger's has a long history of using only human-grade ingredients in our products. The FDA has not called into question the wholesomeness of any ingredient we use. We are confident Evanger's products continue to be safe, wholesome and natural, so confident that we continue to feed them daily to our own pets."
All ingredients in Evanger's products are sourced in the United States and all manufacturing is done in its suburban Chicago facility. The routine FDA inspection was related only to Evanger's canned foods and is not affiliated with of production its dry pet food or treat products.
As the United States' oldest natural pet food company, Evanger's products are known for their human-grade ingredients, including hand-packed meats, fish and poultry, and 100% meat and organic meals.
Consumers and distributors may contact Evanger's customer service department at US +1 8002886796 Call for further information. In addition, all new or updated information will be immediately posted to our Website, http://www.evangersdogfood.com/
Evanger's Dog & Cat Food Co., Inc