FDA WARNING_LETTER - Douglas Bennett Farm - August 15, 2008

On August 11 and 15, 2008, the FDA inspected Douglas Bennett Farm in Johnson, Vermont, and found violations of the Federal Food, Drug, and Cosmetic Act. An adult dairy cow sold for slaughter on February 18, 2008, was found to have sulfamethazine at 0.66 ppm in the liver and 32.91 ppm in the muscle, and detectable gentamicin in the kidney. These drug levels are above the zero tolerance for uncooked edible tissue in adult dairy cows, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The farm also failed to maintain treatment records, indicating insanitary conditions where medicated animals with harmful drug residues could enter the food supply, violating section 402(a)(4). Furthermore, sulfamethazine was used extralabelly, specifically administered to a lactating dairy cow, which is prohibited by 21 C.F.R. 530.41(a)(9), and resulted in illegal drug residues, violating 21 C.F.R. 530.11(c). This extralabel use, not conforming to approved labeling or 21 C.F.R. Part 530, caused the drug to be unsafe and adulterated under sections 512(a) and 501(a)(