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Monday, February 27, 2017

Company Peddling Unproven Autism Treatments Forced to Close

From DisabilityScoop

By Shaun Heasley
February 24, 2017

A drug and dietary supplement maker has been ordered to cease operations after the U.S. Food and Drug Administration found that it was falsely marketing products as being able to treat autism and other conditions.

Louisiana-based Pick and Pay Inc./Cili Minerals must immediately halt business under a consent decree entered this month by U.S. District Judge Robert G. James.

The move comes after the FDA found that the company improperly manufactured and distributed drugs and dietary supplements and marketed products claiming that they could treat everything from autism to epilepsy, brain injury, bipolar disorder and cancer, despite having no drugs approved by the agency for any use.

“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 said it inspected Pick and Pay Inc./Cili Minerals four times since 2012. The agency sent a warning letter in 2015 indicating that the company violated the Federal Food, Drug and Cosmetic Act by hawking unapproved drugs on its website. The letter included examples from the company’s website of claims that PoLith and Lithium could address autism.

Subsequently, the U.S. Department of Justice stepped in, filing a complaint seeking a permanent injunction against the company.

Websites for Pick and Pay Inc./Cili Minerals have been disabled. The company is not permitted to resume further operations without written permission from the FDA, among other steps, the agency said.

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