FDA WARNING_LETTER - Newell Farms - May 14, 2014

On May 6, 8, and 14, 2014, the FDA conducted an investigation of Newell Farms' dairy operation, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated cow for slaughter on October 21, 2013. Tissue analysis revealed desfuroylceftiofur residues at 6.28 ppm in the kidney (tolerance 0.4 ppm) and flunixin residues at 0.879 ppm in the liver (tolerance 0.125 ppm), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The investigation also found that Newell Farms holds animals under inadequate conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, violating 21 U.S.C. § 342(a)(4). This was supported by findings of incomplete treatment records and expired drugs. Furthermore, the firm adulterated new animal drugs, Naxcel and Prevail, through extralabel use not directed by approved labeling or a veterinarian's prescription. This extralabel use was not under the supervision of a licensed veterinarian (21 C.F.R. 530.11(a)) and resulted in illegal drug residues (21 C.F.R. 530.11(d)), causing the drugs to be unsafe and adulterated under 21 U.S.C. § 351(a)(5). Newell Farms must take prompt corrective actions and establish preventative procedures, responding to the FDA within 15 working days to avoid potential regulatory actions like seizure or injunction.