The latest round of warning letters from the U.S. Food and Drug Administration (FDA) went to a well-known manufacturer of snack bars, plus a Detroit bakery, a California seafood processor and two dairies. FDA WarningOn March 17, 2015, FDA sent a warning letter to Kind LLC of New York, NY, notifying the company that four of its snack bar products carry nutrient content claims on their labels not supported by the product ingredients. The agency’s letter asserted that the products (Kind Fruit & Nut Almond & Apricot, Kind Fruit & Nut Almond & Coconut, Kind Plus Peanut Butter Dark Chocolate + Protein, and Kind Plus Dark Chocolate Cherry Cashew + Antioxidants) were therefore in violation of the Federal Food, Drug, and Cosmetic Act. Specifically, FDA stated that the labels on the four snack bars suggest the product “may be useful in maintaining healthy dietary practices, and those statements are made in connection with claims or statements about nutrients.” These claims include, “Healthy and tasty, convenient and wholesome,” along with “good source of fiber,” “no trans fats,” “very low sodium,” among others. Because of information provided in the Nutrition Facts panels on the product labels, FDA’s letter states that the four snack bar products do not meet the requirements of being “antioxidant-rich,” “healthy,” or “low saturated fat” and other claims made. Mexicantown Bakery in Detroit, MI, was told March 18 that an inspection of its bakery facility from Oct. 24-Nov. 4, 2014, revealed “serious violations” of Current Good Manufacturing Practice regulations. FDA’s letter stated that inspectors observed that bakery employees were not adequately washing their hands, there were signs of rodent and insect activity inside the facility, and there were undeclared allergens and artificial colors in the company’s products despite several related recalls. “We acknowledge you recalling and correcting the labels each time; however, the recalls are repeatedly involving the same products. For example, the Concha Blancas bakery product was recalled in 2011, 2012, and again in 2014 for undeclared FD&C Yellow No. 5. Your current preventative actions appear to inadequately control your finished product labeling declarations to comply with [federal regulations],” the agency stated. FDA sent a letter March 31 to Culinary Specialties Inc. of San Marcos, CA, alleging that the company’s Hazard Analysis and Critical Control Points (HACCP) plans were inadequate to ensure the safety of its seafood products (brochettes, canapés, burritos, and other appetizers containing crab, tuna, shrimp, and lobster). Further, the agency told the company that it had no HACCP plan for “sushi roll products, including California Rolls, Spicy Tuna Rolls, Salmon Rolls, and Crunchy Crab Rolls, to control the food safety hazards of histamines, pathogen growth/toxin formation, and allergens.” The company buys these sushi roll products from other manufacturers and sells or distributes them to its customers, the letter stated. Issues regarding sanitation and cleanliness were also raised in the FDA letter following a Jan. 10-11, 2015, inspection of the company’s facility. Drug residue found in the tissues of a slaughtered dairy cow prompted an April 2, 2015, letter to Silva Dairy in Laton, CA. The agency noted that an analysis of tissue samples collected from the animal showed the presence of sulfadimethoxine at 0.891 parts per million (ppm) in the liver. “FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the uncooked edible tissues of cattle …” the letter stated. FDA sent a letter dated April 6, 2015, to Joseph Timothy Smart Dairy in Clyde, NC, stating that a dairy cow slaughtered on or about July 1, 2014, was found to have 16.54 parts per million (ppm) desfuroylceftiofur (marker residue for ceftiofur) in the kidney tissue. However, FDA’s tolerance level for residues of desfuroylceftiofur in the kidney tissue of cattle is 0.4 ppm, the letter noted. In each letter, FDA requested that the companies provide written responses detailing steps taken to bring the facilities into compliance with food-safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence. Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.