Federal court issues permanent injunction against customized supplement maker Custompax
CustomPax was founded in 2005, according to its company LinkedIn profile. Its website was not active as of the writing of this article.
It specializes in manufacturing and selling “customized dietary supplements directly to websites where physicians and health care practitioners created and ordered their own unique dietary supplements by selecting the type and quantity of ingredients as well as custom labels or unique names,” according to the release issued by the FDA.
According to the complaint filed by the US District Court for the Northern District of California, the company was found to violate current good manufacturing (cGMP) regulations for dietary supplements, “including the failure to adequately establish identity specifications for each component used in the manufacture of finished dietary supplements,” among other things, FDA’s release stated.
In addition, the company failed to establish component specifications to ensure that the product meets specifications for purity, strength, and composition.
Cedric Ling, listed in the consent decree of permanent injunction as the chief executive officer, secretary, chief financial officer, and owner of CustomPax, received an FDA warning letter back in 2012 for his company Vitagenic for many of the same reasons CustomPax received its permanent injunction.
“Companies that repeatedly violate cGMP regulations put consumers at risk for harm, as well as mislead consumers regarding product ingredients which they think they are paying for,” said Melinda Plaisier, FDA’s associate commissioner for regulatory affairs. “While voluntary compliance is something that the agency strives for, actions like these are necessary for those that simply cannot adhere to regulations.”
FDA’s issued statement said that, should CustomPax wish to begin manufacturing again, the company must hire an expert to ensure that they are following all cGMP regulations, and following an inspection, receive FDA approval to resume operations.
