FDA weekly list of Warning Letters included an old familiar name this morning – Evanger’s Dog & Cat Food Company, Inc. (Wheeling, IL).
Readers of eFoodAlert who have been following the adventures of Joel and Holly Sher will remember that the company has been in and out of trouble with FDA since April 2008.
The latest problems revolve around misbranding and record keeping.
On August 19, 2010, FDA obtained samples of Lamb and Rice Dog Food from the company’s distributor. FDA’s analysis of the food failed to detect any lamb. Instead, the Lamb and Rice Dog Food contained beef.
On December 14, 2010, during its inspection of the company’s low acid-canned food manufacturing facility, FDA collected samples of Evanger’s Grain-free Duck Pet Food. Analysis of the food failed to detect any duck.
According to the Federal Food, Drug, and Cosmetic Act, “…a food is deemed to be adulterated if any substance has been substituted wholly or in part therefore.” Also, offering a product for sale under the name of another food constitutes misbranding.
In addition to the adulteration/misbranding issue, Evanger’s still has not fixed its processing documentation problem. FDA’s warning letter states that the “…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 period during which Evanger’s was operating under a suspended “Emergency Operating Permit” while it was supposed to be correcting its processing documentation flaws.
The company has been given fifteen (15) working days to bring its operations into full compliance, or to provide a time frame within which the corrections will be completed.
In a letter to its “Dear valued customers and distributors” dated Friday, May 6, 2011, Evanger’s disputed FDA’s lab findings on the Duck Pet Food, but made no comment on the absence of processing and production records mentioned in the agency’s warning letter.
Evanger’s letter goes on to claim that there is “…ABSOLUTELY NO HEALTH OR SAFETY ISSUE…” associated with the misbranding. I beg to differ. Some dogs are allergic or sensitive to particular sources of protein. If my dog was allergic to beef, I would be very upset to learn that the premium lamb-based product I had chosen for him contained beef instead – or in addition to – lamb.
In my post of June 17, 2009, I wondered whether Evanger’s was being singled out by FDA in order to “send a message” to the pet food industry. If this was the case, I suggested that we might owe Evanger’s an apology.
Instead, I am now convinced that Evanger’s owes its customers an apology.