The U.S. Food and Drug Administration recently published warning letters issued to a dairy farm, a seafood company and two dietary supplement makers. R Style Holsteins of Edison, OH, received a warning letter after selling a cow for slaughter that was considered adulterated because of unacceptable levels of drug residues in its liver. FDA cited Stock Island Lobster Company of Key West, FL, for “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.” These violations were failing to list critical points and critical limits in the company’s HACCP plan and failing to follow monitoring procedures for King Mackerel, FDA stated. These include determining the location of harvest for each lot at the time of receipt, determining the adequacy of ice surrounding the product twice daily, and making and keeping an accurate record for the internal temperature of the fish at time of receipt. Big Easy Confections of Covington, LA, received a warning letter about “serious violations of the Current Good Manufacturing Practice (CGMP) regulations” for dietary supplements. Most of the letter states that the company’s response to the issues from May 27 failed to include supporting documentation for changes made. The facility also failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use, according to the agency. One of the company’s products was also considered misbranded because its label did not identify it with the term “dietary supplement” or include the name and place of business of the manufacturer, packer or distributor. Another dietary supplement manufacturer, EnerHealth Botanicals of Longmont, CO, faced “serious violations of the Federal Food, Drug, and Cosmetic Act.” FDA determined that five of the company’s products — including “Parasite Purge Herbal Remedy” and “Daily Immune Support” — are “promoted for conditions that cause them to be drugs” and are “not generally recognized as safe and effective for the … referenced uses.” FDA goes on to state that even if the products did not have therapeutic claims that make them “unapproved new drugs,” they would still be considered adulterated because they were not prepared, packed or held under conditions that meet CGMP regulations. After inspecting the facility in July 2013, FDA found that EnerHealth, among other things, failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, failed to prepare and follow a written master manufacturing record (MMR), and failed to establish and follow written procedures for packing and labeling, holding and distributing, handling returned dietary supplements, and review and investigation of product complaints. Also, FDA found parts of the responses provided by the company in August and October 2012 to be inadequate. In the 2014 letter, FDA added that two products are misbranded and that even if the “Daily Immune Support” and “Lung Renewal Herbal Remedy” products were not “unapproved new drugs, they would still be misbranded foods.” All four products failed to have the term “dietary supplement” on their labels. “Lung Renewal Herbal Remedy,” “EchinOsha,” and “Liver Cleanse” also failed to have nutrition labeling. And the “Daily Immune Support” label faced some issues with ingredient declaration, namely that it included botanical ingredients, but not the part of the plant from which each is derived, the agency stated. In each letter, FDA requested that the farms and companies provide written responses detailing steps taken to bring them into compliance with food safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence. Recipients of the warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.