A California dietary supplement manufacturer was ordered by a federal court to stop selling its products until the company comes into compliance with the FDA’s dietary supplement manufacturing regulations and other requirements listed in the 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 the firm’s president and owner on January 15, 2015.
Health One Pharmaceuticals, Inc. is a private label and contract manufacturer of dietary supplements. As part of the decree, Health One Pharmaceuticals and the owner represented to the court that they have already ceased manufacturing and distributing all articles of food, drugs, and dietary supplements.
The decree requires Health One Pharmaceuticals, 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.
The FDA issued Health One Pharmaceuticals 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 Pharmaceuticals 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 Pharmaceuticals 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.
See the FDA Announcement
See also Medical Law Perspectives, April 2013 Report: Complementary and Alternative Medicine: Practitioner Liability
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication