Update on FDA’s Warning Letter to Evanger’s Pet Food
This is certainly an interesting twist. Phyllis Entis, food safety microbiologist, the author of numerous books and the blog efoodalert.wordpress.com, is one sharp cookie! Ms. Entis spotted something in Evanger’s Pet Food response to their recent FDA Warning letter that I didn’t catch – most didn’t catch. Here’s what she found.
Phyllis Entis couldn’t figure out how the FDA found no duck meat in Evanger’s Grain Free dog food testing, and a third-party lab used by Evanger’s Pet Food found duck DNA in the sample provided. Her thoughts were, perhaps the lab methods used by the FDA and the private lab were significantly different. However, “Even a slight difference in technique would not be enough to explain a total lack of positive duck meat reaction in FDA’s hands” says Phyllis Entis.
I’ve copied the rest of Phyllis Entis’s post…I think her exact words are the best to describe this situation…
“I was stymied until I revisited the wording of the FDA warning letter and compared it to the wording of the information released by Evanger.
Here’s the relevant portion of the Evanger statement:
“Our results show that, in fact, Evanger’s brand Super Premium Duck was detected positive for duck…”
And here’s the relevant statement from the FDA warning letter:
“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.”
A quick review of Evanger’s website brought everything into focus. Super Premium Duck and Grain-Free Duck are two VERY different products!
I challenge Evanger’s to submit samples of the same batch of Grain-Free Duck dog food analyzed by FDA to a third-party lab for testing.
Anyone care to speculate on the outcome?”
Wow! Just to look at this one more time, below is the FDA Warning letter to Evanger’s Pet food…Bold added…
May 5, 2011
RETURN RECEIPT REQUESTED
Ms. Holly N. Sher, President
Mr. Joel A. Sher, Vice President
Evanger’s Dog & Cat Food Company, Inc.
221 Wheeling Road
Wheeling, Illinois 60090
Dear Mr. and Ms. Sher:
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.gov1.
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.
The above is not intended to be an all-inclusive list of violations. As a processor of animal food, you are responsible for ensuring that your overall operation and the food you distribute are in compliance with the law. You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Rosemary Sexton, Compliance Officer, U.S. Food and Drug Administration, 550 West Jackson Boulevard, Suite 15, Chicago, Illinois 60661. If you have any questions about this letter, please contact Compliance Officer Rosemary Sexton at 312-596-4225
Scott J. MacIntire
Below is the Evanger’s Pet Food response, posted on their website, to the FDA Warning letter…Bold added…
Evanger’s Responds to FDA Warning Letter
May 6, 2011
Dear valued customers and distributors,
Recently the FDA notified Evanger’s Dog & Cat Food Company that out of 300 different types of products, two production runs consisting of a total of four pallets of finished product manufactured in 2010, may have been misbranded by the FDA’s definition. Evanger’s has supplied information to FDA which supports their assentation to be inaccurate. A product is considered misbranded “if a component has been omitted in part or in whole.” The products in question are: Evanger’s brand Super Premium Duck, Lot #2401E02DK2, and a private label customer’s Lamb & Rice formula whose Lot number was not provided by FDA.
While the FDA was at our facility conducting a regular inspection in December of 2010, Evanger’s manufactured the Super Premium Duck in their presence. The inspectors took a sample of the food that was manufactured during their inspection for analysis. FDA analysis of each product suggested that Duck and Lamb, respectively, were not detected in product samples.
We, at Evanger’s Dog & Cat Food Company Inc., would like to assure our valued customers, distributors, and constituents that there is ABSOLUTELY NO HEALTH OR SAFETY ISSUE associated with this inquiry.
All of Evanger’s manufactured products, as always, remain safe, nutritious, and of the highest quality.
Evanger’s has retained The Burdock Group, a full service Food Safety and Regulatory Compliance Consulting Firm, to conduct an independent review of this matter.
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. Please see the lab results below:
At this time, our formal response is still being drafted by the Burdock Group, and has not yet been sent to the FDA. Our results show that, in fact, Evanger’s brand Super Premium Duck was detected positive for duck and, as of this date, we are awaiting the complete laboratory analysis for the lamb product.
Although Evanger’s has evidence that contradicts FDA findings, it is the policy of FDA to issue warning letters first while they continue their investigation. Therefore, we expect that there will be a warning letter posted on the FDA website in the near future.
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.
All of this information has been forwarded to the FDA and we are confident that the enclosed information should resolve this matter.
The management of Evanger’s Dog & Cat Food Company, Inc. looks forward to continuing to working closely with the FDA, and we are confident that the resolution will be favorable for Evanger’s.
The Evanger’s Family
As of today (5/22/11) the Evanger’s website has not posted the results from the Lamb Pet Food testing. However I do appreciate that this Warning Letter issue is out front, linked on the homepage of their website.
So, what do you think?
Wishing you and your pet(s) the best,
What’s in Your Pet’s Food?
Is your dog or cat eating risk ingredients? Chinese imports? Petsumer Report tells the ‘rest of the story’ on over 2500 cat foods, dog foods, and pet treats. 30 Day Satisfaction Guarantee. www.PetsumerReport.com
Are you subscribed to Truth About Pet Food Newsletter? Click Here to subscribe
Follow Truth about Pet Food on Twitter
Find Healthy Pet Foods in Your Area Click Here