In its most recent round of posted warning letters, the U.S. Food and Drug Administration (FDA) focused some regulatory attention on pesticide residues in imported produce. Two warning letters went to produce exporters in Puerto Rico: Supermercados Encono Inc. of Carolina, PR, and Richies Produce Inc. of San Juan, PR. FDA’s Sept 8, 2015, warning letter to Supermercados Encono stated that the agency had refused a shipment this past spring of Dasheen (Yautía Lila), a root vegetable, because lab tests had identified the presence of Trifloxystrobin and Cyprocozole. These are two pesticides for which the tolerance limit is zero or is not established in the U.S., thereby rendering the imported produce adulterated under federal law, FDA stated. Despite this import refusal, the agency’s letter stated that the company distributed the shipment into U.S. commerce for consumption without an agency release, which is a violation of the law. Further, the agency stated, the U.S. Customs Border Protection (CBP) issued a Notice to Redeliver the shipment and the company did not comply, which is subject to a penalty action from CBP. If this situation is not prompted corrected, future such shipments could be held in a secure CBP warehouse, with all costs paid for by the company, FDA’s warning letter noted. FDA told Richies Produce in a Sept. 9 letter that its shipment of the same product from the same grower was detained in June 2015 because of unacceptable residues of Trifloxystrobin and Cyprocozole. That shipment was also refused and a CBP Notice to Redeliver issued, with which the company failed to comply, according to the agency. “On July 16, 2015, despite this refusal, you partially distributed the shipment into U.S. commerce for consumption without an FDA release. This was confirmed by you during our visit to witness product line destruction,” the letter stated. FDA told Ruby’s Quail Farm of Gordonville, TX, in a Sept. 17 letter that an inspection of the facility in May 2015 revealed significant violations of the acidified foods regulations during processing of the company’s Hot and Mild Pickled Quail Eggs. Specifically, scheduled processes for heat processing and control of pH, salt, sugar and preservative level, among other items, were not shared with FDA within set timelines and in sufficient detail to ensure a safe product. Also, adequate processing and production records were not being kept, FDA stated. On Sept. 18, 2015, FDA sent Double A Dairy of Wendell, ID, a warning letter stating that an investigation of the operation in Jerome, ID, found that a dairy cow had been sold for slaughter as food in May 2015. An analysis of tissue samples from this animal showed the presence of sulfadimethoxine at 0.334 parts per million (ppm) in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the uncooked edible tissues of cattle, the letter added. The agency also informed Double A Dairy that it did not maintain complete treatment records and that a new animal drug, Albon (sulfadimethoxine, NADA 31-715), was not being used as directed by approved labeling or by veterinarian order, which constitutes an unlawful “extralabel use.” East Oceanic International Co. Ltd. of Brooklyn, NY, was sent a warning letter Sept. 21, 2015, indicating the FDA had inspected the company’s seafood importing facility and found serious violations of the seafood HACCP regulations. Specifically, FDA stated that the ready-to-eat anchovy fish snacks packaged in hermetically sealed pouches were adulterated because the firm did not perform an affirmative step to ensure the product was processed in accordance with those regulations. FDA sent an amended warning letter to New Dawn Nutrition Inc. of Omaha, NE, on Sept. 24, 2015, to say that two of the company’s dietary supplement products — NDN Ares Battle Ready Pre Workout (Warpath Watermelon), and NDN Ares Black (Orange Overdose) — contain dimethylbutylamine (also known as DMBA), which is not only not declared on the label but also, under federal regulations, cannot reasonably be expected to be safe. “To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that DMBA will reasonably be expected to be safe as a dietary ingredient,” the letter stated. That also applies to synthetically produced DMBA, the agency added. FDA’s warning letter to the company also noted problems relating to packaging and labeling operations, misbranding, and misuse of the FDA logo. 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.

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