A Tuesday release from the Food and Drug Administration:
On Friday [2/17], 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.
Lydia Ramsey and Skye Gould report at Business Insider:
At least one of President Trump's possible picks to head the Food and Drug Administration has a radical idea for when drugs should come to market.
Jim O'Neill, managing director at Mithril Capital, has said that he is in favor of approving drugs that are proven to be safe, even before they're shown to be actually effective.
Regardless of who Trump picks in the end, his interest in cutting regulation at the FDA is clear.
"We're going to be cutting regulations at a level that nobody's ever seen before," Trump said in a meeting with pharma executives on January 31. He estimated up to 80% of regulations will be slashed.
