FDA Issues Warnings to Three Food Firms for Food Safety Violations

The Food and Drug Administration (FDA) has warned three food businesses—two dairies and a candy company—of violations of food safety regulations that could result in enforcement actions.

The dairies, 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 deemed adulterated under FDA regulations, according to the warning letter.

Chris A. Papas and Sons Co., a candy manufacturer in Covington, Kentucky, was cited for “significant violations” of Current Good Manufacturing Practice (CGMP) regulations for manufacturing, packing, or holding human food. Among the violations noted in the warning letter were the 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 clean and sanitize food contact surfaces, Food Safety News reports.

According to its policies, the FDA sends warning letters “to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice.”

In the cow sold by Oomsview Holsteins, FDA testing showed 8.25 parts per million (ppm) of desfuroylceftiofur (marker residue for the antibiotic ceftiofur) in the cow’s 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 the antibiotic neomycin in its kidney tissue. The established tolerance for neomycin residues is 7.2 ppm in uncooked edible tissues of cattle and there is no acceptable level of residue for the drug in veal calves, according to Food Safety News.

The Papas and Sons warning letter cited the candy company for misbranding violations, including failure to declare all major food allergens present in Papa’s Chocolate Covered Easter Eggs on the label, failure to list all the ingredients by common or usual name, and failure to include nutrition information in the correct format. In addition, 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. Undeclared nuts could cause a serious allergic reaction in an individual with a nut allergy.

A firm that receives an FDA warning letter has 15 working days from receipt of the letter to inform the agency of specific steps it has taken to come into compliance with the law, Food Safety News reports. If the recipient fails to do so, the FDA can move to enforcement actions, which may include seizure of the adulterated or misbranded food.

from Parker Waichman http://www.yourlawyer.com/blog/fda-issues-warnings-to-three-food-firms-for-food-safety-violations/