Verdure Sciences

Editor's Note: FDA announced this consent decree of permanent injunction entered against Custompax, which manufactured and sold customized dietary supplements to websites that physicians used to create custom dietary supplements by selecting the type and quantity of ingredients. According to the complaint filed with the consent decree, the company failed to adequately establish: identity specifications for each component used in finished dietary supplements; component specifications; product specifications for the identity, purity, strength, composition of the finished batch; appropriate testing to determine compliance with specifications.

Food and Drug Administration
Oct. 13, 2017

A California dietary supplement manufacturer recently was ordered by a federal court to stop selling its products until the company comes into compliance with the U.S. Food and Drug Administration's dietary supplement manufacturing regulations and other requirements listed in a consent decree.

Magistrate Judge Susan van Keulen for the U.S. District Court for the Northern District of California entered a consent decree of permanent injunction between the United States and Custompax Inc. of Freemont, California, and its Chief Executive Officer, Secretary, Chief Financial Officer and owner Cedric Ling.

According to the complaint filed with the consent decree, Custompax manufactured and sold 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.

The complaint, filed by the U.S. Department of Justice on behalf of the FDA, sought a permanent injunction against Custompax for multiple violations of the current good manufacturing practices (cGMP) regulations for dietary supplements, including the failure to adequately establish identity specifications for each component used in the manufacture of finished dietary supplements; the failure to establish component specifications to ensure the finished product meets specifications for purity, strength, and composition; the failure to establish product specifications for the identity, purity, strength, composition of the finished batch of dietary supplement; and the failure to conduct appropriate tests or examinations to determine compliance with specifications for identity, purity, strength, and composition.

"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."
  
Custompax is not currently manufacturing any dietary supplements. Should they wish to begin manufacturing again, the consent decree prohibits Custompax from receiving, processing, manufacturing, preparing, packing, holding and distributing dietary supplements until they hire an expert to ensure that they are following all cGMP regulations and following an inspection, receive FDA approval to resume operations.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 
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