A California federal court entered a consent decree permanently prohibiting Custompax Inc. of Fremont, California, and owner and Chief Executive Officer Cedric P. Ling from distributing adulterated dietary supplements, the Department of Justice announced today. Under the terms of the injunction, the defendants must stop manufacturing such products until remedial steps are taken.
The Department also filed a complaint in the U.S. District Court for the Northern District of California on Sept. 12, at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, the company did not manufacture its dietary supplements in conformity with current good manufacturing practices. For example, the complaint alleged that the defendants failed to establish and maintain adequate specifications and testing procedures for the purity, strength, and composition of its dietary supplements, and failed to adequately test the identities of the ingredients used to make those supplements.
“Dietary supplement manufacturers that fail to comply with basic manufacturing requirements risk the health and well-being of consumers in the United States and abroad,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department's Civil Division. “The Department of Justice and FDA remain vigilant against the dangers posed by such adulterated products.”
The consent decree entered today resolves the litigation, requiring that the defendants adhere to the law's current good manufacturing practices for dietary supplements. The decree also directs Custompax to stop manufacturing dietary supplements until the company implements specified remedial measures. The measures include, among other things, retaining an expert to inspect Custompax's facilities and certifying that the company's manufacturing methods, facilities and controls are in conformity with current good manufacturing practices for dietary supplements.
This matter was handled by Trial Attorney Gabriel H. Scannapieco of the Civil Division's Consumer Protection Branch, with the assistance of Associate Chief Counsel for Enforcement Tara Boland of the FDA's Office of General Counsel, Department of Health and Human Services.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney's Office for the Northern District of California, visit its website at https://www.justice.gov/usao-ndca.
Attachment(s): Download Custompax Consent Decree of Permanent Injunction
Topic(s): Consumer Protection
Component(s): Civil Division
Press Release Number: 17-1145 Updated October 13, 2017
Northern District of California DOJ / 17-1145 / October 13, 2017