SE HABLA ESPAÑOL | MAP
312-739-4200
Contact Us

Contact Us

Archives

  • April 2017
  • March 2017
  • February 2017
  • January 2017
  • December 2016
  • November 2016
  • October 2016
  • September 2016
  • August 2016
  • July 2016
  • June 2016
  • May 2016
  • April 2016
  • March 2016
  • February 2016
  • January 2016
  • December 2015
  • November 2015
  • October 2015
  • September 2015
  • August 2015
  • July 2015
  • June 2015
  • May 2015
  • April 2015
  • March 2015
  • February 2015
  • January 2015
  • December 2014
  • November 2014
  • October 2014
  • September 2014
  • August 2014
  • July 2014
  • June 2014
  • May 2014
  • April 2014
  • March 2014
  • February 2014
  • January 2014
  • December 2013
  • November 2013
  • October 2013
  • September 2013
  • August 2013
  • July 2013
  • June 2013

  • Areas & Topics

    Frquently Asked Questions

    Our Office Location

    Edelman, Combs, Latturner, & Goodwin, LLC

    20 South Clark Street
    Suite 1500
    Chicago, IL 60603

    info@edcombs.com
    Phone: 312-739-4200
    Fax: 312-419-0379


    E-mail Us  |  Chicago Law Office

    Edelman Combs Latturner Goodwin's facebook page   Edelman Combs Latturner Goodwin's Twitter Page   Edelman Combs Latturner Goodwin's Google Plus Page

    Louisiana drug and dietary supplement maker ordered to cease operations due to federal violations

    FDA News Release

    Louisiana drug and dietary supplement maker ordered to cease operations due to federal violations

    For Immediate Release

    February 21, 2017

    Release

    On Friday, U.S. District Judge Robert G. James for the U.S. District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a manufacturer and distributor of drugs and dietary supplements, and its owner, Anton S. Botha, requiring the business to immediately cease operations until it comes into compliance with federal laws.

    The complaint, filed by the U.S. Department of Justice, sought a permanent injunction against the company and its owners for unlawfully manufacturing and distributing unapproved new drugs, misbranded drugs, adulterated dietary supplements and misbranded dietary supplements.

    The company and its owner marketed their products online at www.ciliminerals.com, www.cilihealthstore.com and www.cil-ergy.com. They also sold their products through a retail location in Lafayette, Louisiana.

    “The FDA works with companies to ensure their processes comply with the public health requirements in our laws and regulations,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “But when a company refuses to comply, we will take enforcement action.”

    The FDA inspected Pick and Pay Inc./Cili Minerals four times since 2012. During the inspections, the FDA found Pick and Pay Inc./Cili Minerals was manufacturing and distributing misbranded and unapproved new drugs as well as misbranded and adulterated dietary supplements. The defendants marketed their products with claims that they could treat medical conditions such as cancer, cardiovascular disease, multiple sclerosis, autism, bipolar disorder, brain injury and epilepsy. The FDA has not approved Pick and Pay Inc./Cili Minerals’ drugs for any use.

    During the inspection, FDA investigators also found numerous violations of the agency’s current Good Manufacturing Practice (cGMP) regulations for dietary supplements, including failing to establish specifications for dietary supplement components and failure to test or verify that components and finished products meet product specifications for identity, purity, strength or composition. Because the defendants failed to follow cGMP regulations, their dietary supplements are adulterated under the Federal Food, Drug, and Cosmetic Act.

    In May 2015, the FDA issued a Warning Letter to Pick and Pay Inc./Cili Minerals for similar violations.

    The consent decree prohibits the company and its owner from marketing and distributing misbranded or unapproved new drugs and adulterated or misbranded dietary supplements. Before the company and its owners can resume operations, they must, among other things, recall and destroy their existing stock of drugs and dietary supplements, hire labeling and good manufacturing practices experts, and receive written permission from the FDA to resume operations.

    Pick and Pay Inc./Cili Minerals is based in Lafayette, Louisiana.