U.S. District Court Judge Joseph F. Bianco entered a consent decree of permanent injunction between the United States, Kabco Pharmaceuticals Inc. and its CEO and President. The consent decree entered by the court enjoins the defendants from violating the Federal Food, Drug and Cosmetic Act (FDCA) in connection with their manufacturing, packing and distributing of dietary supplements.
In a complaint filed with the court, the United States alleged that FDA inspections found that Kabco distributed dietary supplements, 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. As alleged in the complaint, during inspections of the defendants’ manufacturing facilities, FDA investigators found numerous current good manufacturing practice (CGMP) violations. Among other violations, Kabco did not review and investigate product complaints, failed to hold dietary supplements under conditions designed to prevent product mix-ups and included unlabeled raw ingredients in their dietary supplements, including whey polio, an unlabeled allergen. Individuals who are allergic to milk could have a serious adverse health reaction from consuming any product with an unlabeled milk allergen like whey polio.
“When consumers purchase dietary supplements, they are entitled to know that they got what they paid for,” said Stuart F. Delery, Acting Assistant Attorney General of the Justice Department’s Civil Division. “When supplement manufacturers fail to ensure that their products contain their labeled ingredients – especially when the labels do not warn consumers that the products may contain allergens dangerous to them – they put consumers at risk. We stand ready to take appropriate enforcement steps against the manufacturers who cannot comply with their good manufacturing practice obligations.”
According to the government’s complaint, the FDA previously inspected the defendants’ facility and noted a history of violations and warnings. As a result of the defendants’ most recent violations, as well as a history of unheeded warnings, the Justice Department filed this injunction. Under the consent decree, the defendants agreed to stop manufacturing and distributing dietary supplements until, among other corrective actions, the company demonstrates to the FDA that it is meeting the quality, safety and labeling standards required by law. The consent decree further requires the defendants to engage in appropriate, independent outside oversight to ensure compliance.
See the DOJ Announcement