The bulk of the nine warning letters released last week by the U.S. Food and Drug Administration were addressed to seafood processing facilities for violations of seafood Hazard Analysis and Critical Control Points (HACCP) regulation. HACCP failures at Portland Fish Exchange of Portland, ME, led FDA to declare the company’s seafood products – including histamine-producing seafood such as mackerel, bluefish and tuna – adulterated because “they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.” FDA cited the Whole Foods Market Denver Distribution Center of Aurora, CO, for not having a HACCP plan for scombroid/histamine-forming species fish such as tuna, sardines, anchovy, mackerel, bluefish, mahi-mahi and wahoo to control the food safety hazard of histamine. Josephson’s Smokehouse of Astoria, OR, Britto Seafoods Exports of Tamil Nadu, India, Seorak Clean Food in Sokcho, Republic of Korea, and Royal Foods of Bangkok, Thailand, were all cited for inadequate responses to HACCP failures noted by FDA’s inspectional observations. In addition, there were some misbranding issues with certain products from Josephson’s Smokehouse, FDA stated. The Hot Smoked Wine-Maple is fabricated from two or more ingredients, but the labeling fails to bear a complete list of all of the ingredients. The Hot Smoked Garlic Pepper Salmon, Hot Smoked Wine-Maple Salmon, Hot Smoked Spring Chinook Salmon and Hot Smoked Peppered Atlantic Salmon products failed to bear nutrition information on the package. Wagner Dairy Operations of Middleton, WI, and Jernigan Dairy of Fallon, NV, received warning letters after selling cows for slaughter that FDA officials considered adulterated because of unacceptable levels of desfuroylceftiofur and penicillin residues in their tissues. FDA also came down on Dewmar International for including melatonin in its “Lean Slow Motion…Potion” beverage product. Because the product is “represented for use as conventional foods, and accordingly are not dietary supplements,” the melatonin is considered an unapproved food additive and the agency is “not aware of any basis” to conclude that melatonin is General Recognized As Safe (GRAS) for use in conventional foods. Furthermore, FDA considers the products misbranded because the products are represented for use as conventional foods, but below the Nutrition Facts panel, their labels state: “DIETARY SUPPLEMENT.” In each letter, FDA requested that the facilities and farms provide written responses detailing steps taken to bring the firms into compliance with food safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence.