FDA orders drug, dietary supplement maker to immediately cease operations

United States District Judge Robert G. James for the District Court for the Western District of Louisiana issued a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals for unlawfully manufacturing and distributing unapproved new and misbranded drugs, as well as adulterated and misbranded dietary supplements, according to a press release issued by the FDA.

Since 2012, the FDA inspected Pick and Pay Inc./Cili Minerals four times. FDA investigators found that the company claimed that their products could treat medical conditions such as cancer, cardiovascular disease, multiple sclerosis, autism, bipolar disorder, brain injury and epilepsy; however, the company’s drugs have not been approved by the FDA for any use. Pick and Pay Inc./Cili Minerals marketed their products through a retail location in Lafayette, La., and various online sites, including www.ciliminerals.com, www.cilihealthstore.com and www.cil-ergy.com.

Also during the inspection, the FDA discovered that Pick and Pay Inc./Cili Minerals had committed several violations of the current Good Manufacturing Practice regulations for dietary supplements. Specifications for dietary supplement components were not established by the company and components and finished products were not tested or verified to ensure that they meet identity, purity, strength or composition specifications, according to the FDA.

The FDA sent a warning letter to Pick and Pay Inc./Cili Minerals in May 2015 for similar violations.

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

The consent decree requires that all of Pick and Pay Inc./Cili Minerals’ products be destroyed. The company must hire manufacturing practice and labeling experts and fulfill labeling requirements, as well as obtain written FDA permission before it can resume operations, according to the FDA.

The FDA also recently shut down another dietary supplement distributor, Regeneca Worldwide, for unlawfully distributing unapproved new drugs and adulterated and misbranded dietary supplements.

For more information:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm542520.htm

Disclosure: Healio Internal Medicine was not able to confirm relevant financial disclosures at the time of publication.