Utah-based dietary supplement manufacturer ordered to stop selling products

WASHINGTON, D.C. (ABC4) – A federal court has ordered a Utah-based dietary supplement manufacturer to stop selling products until they come into compliance with federal regulations and requirements. The company is accused of claiming the products have been approved by the FDA even though they have not.

A consent decree of permanent injunction between the U.S., Grandma’s Herbs of St. George, and its owners. According to the Food and Drug Administration, Grandma’s Herbs has manufactured and distributed products that are being marketed as dietary supplements with labels rendering them unapproved new drugs and misbranded drugs.

According to the FDA, Grandma’s Herbs’ products have not been approved for any use despite the company’s claims that its products could be used to diagnose, cure, mitigate, treat, or prevent conditions such as respiratory tract infections, ulcers, heart disease, autoimmune disorders, and epilepsy.

Under the consent decree from a federal court, Grandma’s Herbs cannot directly or indirectly manufacture or sell such products until certain requirements are met.

“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,” says Judy McMeekin, Pharm.D., FDA’s associate commissioner for regulatory affairs. “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.”

Four years ago, in 2017, the FDA issued a warning letter to Grandma’s Herbs after reviewing the company’s website. The letter informs the company many of the products being sold are not dietary supplements as they are being marketed. Instead, the FDA says they are unapproved new and misbranded drugs.

The U.S. Department of Justice filed the complaint on behalf of the FDA. As of Thursday afternoon, Grandma’s Herbs website is still accessible and products can be purchased.