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The War on Adulterated Drugs: Federal Court Issues Permanent Injunction Against California Dietary Supplement Manufacturer 

Nov 30, 2017 | Posted by Elizabeth Chiba Rein | Topic: Business Litigation

In September 2017, Federal prosecutors filed a lawsuit under the Federal Food, Drug, and Cosmetic Act for a permanent injunction against Custompax, Inc. and its owner Cedric Ling (“Defendants”) in the United States of America v. Custompax Inc. et al., No. 5:17-cv-05269-SVK.  (N.D. Cal. Sep. 12, 2017)  The lawsuit alleged that the Defendants manufactured and distributed adulterated customized dietary supplements online.  The lawsuit further alleged that Defendants failed to adequately identify the dietary ingredients, failed to ensure the finished product met federal guidelines, and failed to conduct appropriate tests, among other allegations.

On October 12, 2017, U.S. Magistrate Judge Susan van Keulen entered a consent decree of permanent injunction between the federal government and Defendants.  According to the consent decree, Defendants manufactured and distributed adulterated dietary supplements, given that they were prepared, packed, and held under conditions that do not comply with current good manufacturing practices.  Pursuant to the consent decree, Defendants agreed to stop manufacturing and distributing any dietary supplements.  Defendants also agreed not to resume operations until they retained an independent expert to ensure they are following federal regulations and received written authorization from the FDA.  In addition, under the consent decree, the FDA is allowed to conduct random inspections—at the Defendants’ expense—to ensure that the Defendants are complying with the consent decree. 

Since these types of permanent injunctions can cripple a company, companies would be well served to review their own policies and procedures to ensure that they are complying with the applicable federal and/or state rules and regulations.