FDA Orders Drug and Dietary Supplement Maker to Cease Manufacture and Distribution

A Louisiana drug and dietary supplement maker was ordered to cease operations for failing to comply with federal laws, according to a press release from the FDA.

The US Department of Justice filed a complaint requesting a permanent injunction against Pick and Pay Inc./Cili Minerals and its owner, Anton S. Botha, for unlawful manufacturing and distributing unapproved new drugs, misbranded drugs, adulterated dietary supplements and misbranded dietary supplements. The defendants claimed their products could treat medical conditions such as cancer, cardiovascular disease, multiple sclerosis, autism, bipolar disorder, brain injury, and epilepsy.

FDA officials inspected the company 4 times in 2012, when they reported that the company failed to comply with federal regulations. FDA investigators also noted several violations of the agency’s current Good Manufacturing Practice regulations for dietary supplements, such as failing to establish specifications for dietary supplement components. The FDA has not approved any of the company’s drugs for use.

The company and its owner have been prohibited from marketing and distributing misbranded or unapproved drugs and adulterated or misbranded dietary supplements. Additionally, they must recall and destroy their existing stock of drugs and supplements, hire labeling and good manufacturing practice experts, and receive written permission from the FDA before they resume operations.

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

Reference

Louisiana drug and dietary supplement maker ordered to cease operations due to federal violations [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm542520.htm. Accessed Feb. 22, 2017.