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FDA Sends Warning to Two Dairies and a Candy Manufacturer

Dec 9, 2015

The Food and Drug Administration (FDA) has recently sent warning letters to two dairies and a candy manufacturer, notifying them of a variety of violations of food safety regulations that could result in enforcement actions if not acted on promptly.

Oomsview Holsteins of Constable, New York and Swiss Hill Farms of West Winfield, New York, each sold a cow to be slaughtered for food that had drug residues in its tissue in excess of what the law allows, Food Safety News reports. In both cases, the presence of the drug residues in edible tissue of the animals caused the food to be considered adulterated, according to the FDA letter.

The candy manufacturer, Chris A. Papas and Sons Co. of Covington, Kentucky, was cited for "significant violations" of FDA's Current Good Manufacturing Practice (CGMP) regulations for manufacturing, packing, or holding human food. Violations included use of the same equipment for nut- and non-nut-containing products, employees' failure to wash their hands, and failure to use a detergent or surfactant to properly wash, rinse, and sanitize food contact surfaces, the warning letter states.

According to its manual, the FDA warning letters "give individuals and firms an opportunity to take voluntary and prompt corrective action before [the FDA] initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice."

The cow sold by Oomsview Holsteins had 8.25 parts per million (ppm) of desfuroylceftiofur (marker residue for the antibiotic ceftiofur) in its kidney tissue. The FDA tolerance is 0.4 ppm for residues of desfuroylceftiofur in the uncooked edible kidney tissue of cattle. The cow from Swiss Hill Farm had 13.06 ppm of neomycin in its kidney tissue, though the established tolerance for neomycin residues is 7.2 ppm uncooked edible tissues of cattle. There is no acceptable level of residue associated with the use of the drug in veal calves, according to Food Safety News.

The FDA warned the Papas and Sons candy company about misbranding violations, including failure to declare on the label all major food allergens present in Papa's Chocolate Covered Easter Eggs, failure to list all the ingredients by common or usual name, and failure to include nutrition information in the correct format. The company's failure to properly clean equipment after batches of nut-containing products could result in the presence of nuts-an allergen-in products that do not have declared nut ingredients.

Recipients of FDA warning letters have 15 working days from receipt of the letter inform the agency of specific steps they have taken to come into compliance with the law. If the recipient fails to do so, the FDA can take enforcement actions, which may include seizure of the adulterated or misbranded food.

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