A federal court in New York has entered a consent decree of permanent injunction against Kabco Pharmaceuticals, Inc. and its CEO to enjoin them from violating the federal Food, Drug, and Cosmetic Act in manufacturing, packing and distributing dietary supplements. United States v. Kabco Pharms., Inc., No. 12-3468 (U.S. Dist. Ct., E.D.N.Y., entered April 4, 2013). Food and Drug Administration (FDA) inspectors apparently found that the company distributed products, including Brewers Yeast Tablets®, Dandelion Root Capsules®, Night-Time Herb Capsules®, Inositol Calcium & Magnesium Capsules®, Vitamin C-500 with Rose Hips Time Released Tablets®, and Joint All Capsules®, “that did not meet product specifications.”
FDA found that the company did not investigate product complaints, failed to prevent product mix-ups and included unlabeled raw ingredients in their supplements, including whey polio, an undeclared allergen that can cause a reaction in those allergic to milk. Previous inspections had apparently uncovered a history of violations and warnings. The company has agreed to stop manufacturing and distributing dietary supplements until it demonstrates to FDA “that it is meeting the quality, safety and labeling standards required by law.” Kabco must also engage independent third-party oversight to ensure compliance. See U.S. Department of Justice News Release, April 8, 2013.