Evangers and the FDA – Everything Old is New Again

The recent FDA letter isn’t the first time that Illinois pet food company Evangers has tangled with the Food and Drug Administration. Back in 2008, the FDA issued an “Order of Need for Emergency Permit”, after Evangers failed to follow the prescribed method of production for their canned raw pet food products.

Then, as now, Evangers handled it pretty much exactly how you do NOT want to see a pet food company deal with a recall.

The FDA warning stated:

“As outlined in the Food Protection Plan, the FDA uses a risk-based approach to locate the areas of greatest risk for foods, and targets preventive controls and inspections to those areas, ” said Dr. Stephen Sundlof, director, Center for Food Safety and Applied Nutrition. “The FDA’s authority to issue an order requiring an emergency permit is an enforcement tool designed to prevent unsafe foods from reaching consumers.”

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.”

Essentially, Evangers was then told that they had to stop producing their canned food, and would have to obtain a ‘special permit’ before they were allowed to continue processing and distribution.

The specific issue that the FDA found with the food was:

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 Clostridiumbotulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans.

What’s most telling is that, even back in 2008, Evangers was taking a sort of high handed, “We’re right and you’re wrong” approach to FDA warnings. Instead of saying something along the lines of “We found the problem, we’re addressing the problem, we’re sorry about the problem”, Evangers said:

“Contrary to a news release issued by the FDA Thursday, April 24, 2008, Evanger’s continues to make and distribute its products with FDA approval. Evanger’s is working closely with the FDA and already has addressed many of the FDA’s questions. Evanger’s expects to have the few remaining FDA queries fully satisfied shortly.”

Source

Additional information provided by the FDA post Evangers detailed more about the infractions:

The firm had serious deviations form the mandatory provisions of 21 CFR parts 108 and 113, including lack of documentation of process adequacy and lack of processing filing with FDA for most of their processes. The firm was operating the retorts improperly (not venting), failing to record critical process information including initial temperatures, temperature recording devices were recording temperatures higher than the mercury-in glass thermometers. The firm’s retort supervisors had not attended the required training schools.

As correctly stated in the press release, the firm is operating under an Order of Need for Emergency Permit, which means it cannot introduce or deliver for introduction in interstate commerce any of its low–acid canned pet food. The regulation does allow the firm to have a processing authority evaluate the processing of each lot for adequacy and to submit release requests in writing to FDA for specific lots.

There was no ‘oops, we made a mistake’ letter on the FDA website in regard to this matter, but Evangers in 2008 tried the same tactic they’re using today – insinuating to the public that the FDA issued their letters in error.

In other words “Silly FDA, stop picking on us. We’re holistic, and holistic is magically healthy”.