• FDA Shuts Down Supplement Manufacturer
  • March 12, 2015 | Author: Stephen J. Burg
  • Law Firm: Burg Simpson Eldredge Hersh & Jardine, P.C. - Englewood Office
  • A federal court ordered a California-based dietary supplement manufacturer to stop selling its products because it failed to comply with regulations set forth by the U.S. Food and Drug Administration. U.S. District Judge Beverly Reid O'Connell of California's Central District signed a permanent injunction against Health One Pharmaceuticals, Inc.

    "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."

    Not the first time
    Health One has been on the FDA's radar for some time following prior regulatory violations. The FDA issued a warning letter to the private supplement manufacturer in 2012, which listed manufacturing violations, including failure to identify all ingredients as well as not listing all steps in the manufacturing process. However, when the FDA conducted a follow-up investigation, Health One had not corrected all of the problems, according to Medical Daily.

    The court ordered the company to cease distribution of products and destroy them all as the FDA supervises. Products to be destroyed include all supplements manufactured from Sep. 1, 2011, through Jan. 12, 2015.

    Health One can resume operations as soon as the FDA approves new manufacturing methods are in compliance with production regulations.

    Dietary supplements
    Most adults in the U.S. take one or more dietary supplements a day, according to the National Institutes of Health. Consumers purchase supplements at an increasing rate, as many adults don't get the complete vitamins and minerals from their daily diets. However, as the expansion of purchasing and manufacturing supplements continues, it is important for regulations and safety practices to be followed to keep consumers safe.