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FDA Obtains Court Order to Shut Down Dietary Supplement Maker
A federal court ordered a California dietary supplement manufacturer to stop selling its products until the company comes into compliance with the FDA’s dietary supplement manufacturing regulations and other requirements listed in a consent decree.
U.S. District Judge Beverly Reid O’Connell of the Central District of California signed a consent decree of permanent injunction against Health One Pharmaceuticals, Inc., of City of Industry, California, and Richard S. Yeh, the firm’s president and owner. Health One is a private label and contract manufacturer of dietary supplements.
As part of the decree, Health One and Yeh told the court that they have already ceased manufacturing and distributing all articles of food, drugs, and dietary supplements.
The decree requires Health One, under FDA supervision, to recall and destroy all dietary supplements that were manufactured, prepared, packed, labeled, held, or distributed between September 1, 2011, and January 15, 2015.
“When a company puts consumers at risk, the FDA will take action to protect public health,” said Melinda K. Plaisier, FDA associate commissioner for regulatory affairs. “Our goal is to ensure that consumers have access to dietary supplements that meet federal standards for safety and quality.”
The FDA issued Health One a warning letter on March 28, 2012, that outlined serious violations of FDA’s current good manufacturing practice (cGMP) requirements. The violations included failure to perform tests to verify the identity of dietary ingredients used to manufacture the supplements; failure to establish appropriate manufacturing controls; and failure to maintain, clean, and sanitize equipment.
Despite assurances from Health One that it was correcting the violations noted in the warning letter, follow-up inspections showed that the company failed to correct all of the manufacturing violations. Failure to follow cGMP requirements made the firm’s products adulterated under the Federal Food, Drug, and Cosmetic Act.
According to the complaint filed with the court, certain dietary supplements manufactured by Health One Pharmaceuticals also were not properly labeled because the labels did not list the common or usual names of all product ingredients.
In order to resume operations, Health One needs to receive permission from the FDA and hire an independent expert to assess whether the firm is in compliance with cGMP requirements. Audit reports documenting compliance with FDA manufacturing regulations then need to be filed with the agency biannually for at least five years.
Source: FDA; January 16, 2015.