The consent decree prohibits the defendants from manufacturing or distributing dietary supplements until they hire a labeling expert, pull violative labeling, and receive written permission from FDA to resume operations.
A U.S. District Court for the District of Utah has entered a consent decree of permanent injunction between the U.S., Grandma’s Herbs Inc. (St. George, UT), and the company’s owners Kevin R. Parr and Tracey Parr, prohibiting the defendants from directly or indirectly manufacturing or distributing dietary supplement products. The decree comes after FDA issued a warning letter to the company in 2017 for selling misbranded dietary supplements that made claims to cure, mitigate, treat, or prevent disease.
“The FDA’s action is aimed at protecting consumers who unknowingly put their health at risk by using products with claims to cure, treat or prevent a serious illness. We urge consumers to seek proven treatments recommended by licensed health care professionals,” said Judy McMeekin, PharmD, FDA’s associate commissioner for regulatory affairs, in a press release. “We previously warned this manufacturer, but they continued to make claims that their products could treat or prevent serious diseases. We took action to protect consumers.”
Under the consent decree, Grandma’s Herbs will not be able to sell dietary supplement products until the company, among other things, hires a labeling expert, removes its products’ violative labeling, and received written permission from the FDA to resume operations. The complaint was filed by the U.S. Department of Justice on behalf of the FDA.