Ohio company gets FDA warning for selling adulterated feed additives

The Ohio-based company recently received a warning letter​ regarding practices that included the use of certain products that were labeled unfit for use in animal feed when making some of its dairy feed ingredients.

“Our inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), causing the animal food distributed by your firm to be adulterated,”​ said officials with the FDA. “The introduction or delivery for introduction into interstate commerce of any food that is adulterated or misbranded is prohibited according to section 301(a) of the FD&C Act.”​

Warning details​

The company reportedly received three separate shipments of products on August 17, August 19 and August 21 all of which included items that were not to be fed to animals, said officials with the FDA.

An industrial brown grease contained a warning that it was not to feed to animals, they said. “You stated in a signed affidavit this product was off-loaded into your facility and you processed this into Energy Booster 100, a dried dairy feed ingredient, lot #082015-34 that you subsequently sold as animal feed,” ​they added.  

A sludge oil product that also was identified as being non-edible, was still used to make a liquid animal feed ingredient, they said. And a vegetable fatty acid product was labeled as containing pesticides.

“The invoice contains a pesticide clause stating the material is not intended or suitable for human or animal consumption and certifies that the product will not be used for such purposes,” ​said officials. “You stated in a signed affidavit, this product was off-loaded into your facility and you processed this into Dairy Feed 165 a liquid dairy feed ingredient, lot numbers 082018-30 and 082015-31, that you subsequently sold as animal feed.”​

As all three additives were not to be used in animal feed, products containing them are considered adulterated and unsafe, they said. The company also does not have a ‘validated or approved’ process established to remove contaminants from animal feed ingredients.

“The above is not intended to be an all-inclusive list of violations,”​ added officials. “You are responsible for assuring that your overall operation and any products you distribute comply with the law.”​

What’s next?​

The inspections took place in September and October, and the company was asked to respond in writing as to how it has, or plans, to address the issues mentioned and prevent their happening again, said officials.

Additionally, the company was warned that the FDA may assess fees needed to re-inspect the facility as the violations are related to food safety, they said. 

Hardy Animal Nutrition did not return our requests for comment.