A federal court permanently enjoined a Chandler, Arizona company from making and selling adulterated and misbranded dietary supplements, the Department of Justice announced today.
In a complaint filed on Oct. 12, 2022, the United States alleged that Global Vitality Inc., doing business as Enzyme Process International, along with company owner Steven D. Roderick, and the company’s corporate secretary Gorica Blagojevic, violated the Federal Food, Drug, and Cosmetic Act by distributing adulterated and misbranded dietary supplements. The government alleged that despite several Food and Drug Administration inspections over eight years and an FDA warning of non-compliance, the defendants continued to manufacture dietary supplements that were adulterated and misbranded in violation of current good manufacturing practice regulations, relevant food safety standards, and hazard prevention measures.
According to the complaint, which was filed in the U.S. District Court for the District of Arizona, FDA inspected the Global Vitality facility multiple times, in 2012, 2014, 2016, 2019 and most recently in June and July 2021. The complaint alleged that FDA inspections found violations of regulatory requirements meant to control the risk of hazards in dietary supplements, and failures to follow current good manufacturing practices for dietary supplements. The complaint also alleged that a quality control failure at Global Vitality led to a positive test for the bacteria E. coli in one of its products.
“Dietary supplement makers must abide by federal health and safety requirements,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will work with FDA to vigorously enforce laws meant to protect consumers.”
“Protecting the American public’s access to safe and quality-made products is a core function of the FDA’s public health work,” said the FDA’s Associate Commissioner for Regulatory Affairs Judith McMeekin, Pharm.D. “To do so, the agency will continue to use all of the regulatory tools available and work with our federal law enforcement partners at the Department of Justice to ensure firms meet acceptable regulatory requirements for quality. Today, these standards were again upheld. Global Vitality Inc. (doing business as Enzyme Process International), along with company owner Steven D. Roderick and company corporate secretary Gorica Blagojevic, will be required to comply with federal law.”
The defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The order entered by the court permanently enjoins the defendants from violating the Food, Drug, and Cosmetic Act. Among other measures, the order requires the defendants to come into compliance with the law and to retain independent experts in labeling and current good manufacturing practices.
Trial Attorney Ellen Bowden McIntyre of the Justice Department’s Consumer Protection Branch is handling the case with the assistance of Associate Chief Counsel Roselle Oberstein of the Food and Drug Administration’s Office of the Chief Counsel.
The claims resolved by the resolution announced today are allegations only and there has been no determination of liability.
