Regulatory Focus™ > News Articles > Warning Letter Analysis: Animal Food Manufacturer Cited for Marketing Violations

Warning Letter Analysis: Animal Food Manufacturer Cited for Marketing Violations

Posted 24 May 2012 | By Alexander Gaffney, RAC 

A warning letter released by the US Food and Drug Administration (FDA) on 24 May cites a manufacturer of animal food products for promoting its products using claims restricted by law to animal drugs approved by the agency.


Process Managers, LLC (Veterinary Pharmaceuticals)


A warning letter sent to a Kentucky-based manufacturer of animal health products, Process Managers, LLC, alleges two of the company's food products are marketed using claims reserved for approved animal drug products.

In FDA's  18 May 2012 letter to Process Managers' owner, James Criggall, the agency states that an inspection of the company's website found two products claiming to mitigate, treat or prevent diseases in animals.

These claims included statements purporting the products prevented bone disease, offered protection against joint damage brought on by orthopedic disease, alleviate acidosis-dehydration, prevents arthritis, benefited cardiovascular health and several other benefits.

FDA noted the claims offered by Process Managersfor the two products brought them under the definition of new animal drugs, making them adulterated under the Federal Food, Drug and Cosmetic Act.

While FDA said Process Managers has responded to an earlier letter, the agency sent the warning letter after the company's website continued "to contain claims that establish that the intended use of [its] products is to mitigate, treat or prevent disease in animals."


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