Evangers Vs FDA Timeline of Events and Related Press Releases
The U.S. Food and Drug Administration releases a press release, announcing they have issued an order requiring that Evanger's obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce.
“A recent inspection revealed significant deviations from prescribed documentation of processes, equipment, and recordkeeping in the production of the company's thermally processed low acid canned food (LACF) products. These problems 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.
“The FDA issues an 'Order of Need for Emergency Permit' if the agency determines that a company fails to meet the regulatory requirements to process a product that does not present a health risk. For Evanger's to resume business, 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."
The U.S. Food and Drug Administration announces it is suspending the temporary Emergency Permit issued to Evanger's Dog & Cat Food Co., Inc.
“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.”
“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 products 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 manufacturer the highest quality, wholesome, nutritious and safe products as it has done for 75 years.”
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 Press Release).
“Evanger’s Dog & Cat Food hopes that the following statement will alleviate the concern 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.”
The U.S. Food and Drug Administration sends another Warning Letter to Evanger's, claiming that samples of two of their dog food products had been analyzed and found to be 'adulterated' and 'misbranded'.
“From December 2, 2010 through February 10, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your low-acid canned food manufacturing facility located at 221 Wheeling Road, Wheeling, Illinois. In addition, on August 19, 2010, FDA received samples of (b)(4) Lamb and Rice Dog Food from the distributor, (b)(4). This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our inspection and from the samples we received from the distributor. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.
We found that you offered for sale (b)(4) Lamb and Rice Dog Food which was adulterated. Under Section 402(b)(2) of the FD&C Act, 21 U.S.C. § 342(b)(2), a food is deemed to be adulterated if any substance has been substituted wholly or in part therefore. Our analytical sample results of this product revealed that a substance (lamb) was not detected in the product and another ingredient (bovine material) detected in the product was substituted therefore. Furthermore, this product was misbranded. Under Section 403(b) of the FD&C Act, 21 U.S.C. § 343(b), a food is deemed to be misbranded if it is offered for sale under the name of another food. This product was offered for sale under the name of “(b)(4) Lamb and Rice Dog Food.” However, the analytical sample results did not detect the presence of lamb, but detected the presence of bovine material.
On December 14, 2010, FDA collected samples of your Evanger’s Grain-free Duck Pet Food during the inspection of your facility. We found that the Evanger’s Grain-free Duck Pet Food product was adulterated. Under Section 402(b)(1) of the FD&C Act, 21 U.S.C. § 342(b)(1), a food is deemed to be adulterated if any valuable constituent has been in whole or in part omitted or abstracted therefrom. Our investigation revealed that a valuable constituent (duck) was not detected in the product and had been omitted or abstracted therefrom. Furthermore, this product was misbranded. Under Section 403(a)(1) of the FD&C Act, 21 U.S.C. § 343(a)(1), a food is deemed to be misbranded if its labeling is false or misleading in any particular. The labeling indicates that Evanger’s Grain-free Duck Pet Food contains duck, but the analytical sample results did not detect the presence of duck in the product.
In addition, your firm was not able to provide processing and production records upon written demand, as required by 21 C.F.R. 108.35(h), for products manufactured in 2009.”
Evanger's responds to this latest FDA Warning Letter by informing customers that they retained an independent company to conduct their own lab tests. The test results for the Duck Pet Food opposes the FDA's lab findings. No word yet on the outcome of the Lamb and Rice Dog Food tests. Additionally, Evanger's denies the FDA's allegation that they were unable to provide 'certain required records'.
"To that end, The Burdock Group contacted distributors that had received the Evanger’s Duck product, Lot #2401E02DK2, and instructed them to forward samples to a reputable independent third party laboratory. At no time was Evanger’s in control of the sample product sent out for independent testing and analysis. The firm's DNA test results confirmed that there was Duck DNA present in Duck Lot #2401E02DK2."
"The FDA letter also referenced that our firm “could not provide certain required records.” Evanger’s flatly denies this allegation and maintains that all required records have always been, and remain at our facility for inspection."