12.01.14
The U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Scilabs Nutraceuticals Inc. of Irvine, CA, and its board chairman and CEO, Paul Edalat in November to prevent the distribution of adulterated dietary supplements, according to the Department of Justice. SciLabs is a contract manufacturer of dietary supplements distributed under the brand All Pro Science, including Complete Immune + capsules and various flavored powders called Complete, Recovery and Precharge. The department filed a complaint in the U.S. District Court for the Central District of California at FDA’s request, alleging the company’s dietary supplements are manufactured under conditions that are inadequate to ensure quality.
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from committing violations of the Federal Food, Drug, and Cosmetic Act. The consent decree requires the manufacturer to cease all operations; in order for defendants to resume manufacturing dietary supplements, the FDA first must determine that manufacturing practices have come into compliance with the law. “The failure to comply with current good manufacturing practice requirements by a maker of dietary supplements can pose a risk to the public health,” said Acting Assistant Attorney General Joyce Branda, of the Justice Department’s Civil Division. “The Department of Justice will continue to bring enforcement actions against those who do not follow the necessary procedures to comply with the safety laws for dietary supplements.”
According to the complaint, FDA inspections performed in 2012, 2013 and 2014 revealed adulterated products within the meaning of the Food, Drug, and Cosmetic Act. For example, the company allegedly failed to verify the identity of its dietary ingredients, and failed to establish product specifications for the identity, purity, strength and composition of finished batches of dietary supplements. Defendants also allegedly failed to document equipment use, maintenance, cleaning and sanitization in individual equipment logs.
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from committing violations of the Federal Food, Drug, and Cosmetic Act. The consent decree requires the manufacturer to cease all operations; in order for defendants to resume manufacturing dietary supplements, the FDA first must determine that manufacturing practices have come into compliance with the law. “The failure to comply with current good manufacturing practice requirements by a maker of dietary supplements can pose a risk to the public health,” said Acting Assistant Attorney General Joyce Branda, of the Justice Department’s Civil Division. “The Department of Justice will continue to bring enforcement actions against those who do not follow the necessary procedures to comply with the safety laws for dietary supplements.”
According to the complaint, FDA inspections performed in 2012, 2013 and 2014 revealed adulterated products within the meaning of the Food, Drug, and Cosmetic Act. For example, the company allegedly failed to verify the identity of its dietary ingredients, and failed to establish product specifications for the identity, purity, strength and composition of finished batches of dietary supplements. Defendants also allegedly failed to document equipment use, maintenance, cleaning and sanitization in individual equipment logs.