Washington, DC—(ENEWSPF)—November 13, 2014. The U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Scilabs Nutraceuticals Inc. of Irvine, California, and its board chairman and chief executive officer (CEO), Paul P. Edalat, to prevent the distribution of adulterated dietary supplements, the Department of Justice announced today.
SciLabs Nutraceuticals Inc. is a contract manufacturer of dietary supplements distributed under the brand name 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 the request of the U.S. Food and Drug Administration (FDA), alleging that the company’s dietary supplements are manufactured under conditions that are inadequate to ensure the quality of its products.
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 dietary supplement manufacturer to cease all operations and requires that, in order for defendants to resume manufacturing dietary supplements, the FDA first must determine that Scilabs’ 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 R. 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 that the company’s dietary supplements are adulterated within the meaning of the Food, Drug, and Cosmetic Act. The complaint alleges, for example, that the company failed to conduct at least one appropriate test or examination to verify the identity of every dietary ingredient before using them. The complaint also alleges that the company failed to establish product specifications for the identity, purity, strength and composition of finished batches of dietary supplements. In addition, as alleged in the complaint, defendants failed to document equipment use, maintenance, cleaning and sanitization in individual equipment logs as required by law.
The government is represented by Trial Attorney Heide L. Herrmann of the Civil Division’s Consumer Protection Branch, with the assistance of Senior Counsel Claudia Zuckerman of the Food and Drug Division of the U.S. Department of Health and Human Services’ Office of General Counsel.
Source: justice.gov
