WASHINGTON, DC (ABC4) – A federal court has ordered a Utah-based supplement manufacturer to stop selling products until they meet federal regulations and requirements. The company is accused of claiming the products were FDA approved when they were not.
A permanent injunction consent decree between the United States, 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 marketed as dietary supplements with labels making them unapproved new drugs and mislabelled drugs.
According to FDA, Grandma’s Herbs products have not been approved for use despite the company’s claims that its products could be used to diagnose, cure, alleviate, treat or prevent conditions such as respiratory tract infections, ulcers, heart disease, autoimmune disorders and epilepsy. .
Under the consent decree of 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 claiming to cure, treat or prevent serious illness. We urge consumers to seek proven treatments recommended by licensed healthcare professionals, ”said Judy McMeekin, Pharm.D., Associate Commissioner of Regulatory Affairs, FDA. “We previously alerted this manufacturer, but they continued to claim that their products could treat or prevent serious illnesses. We have taken steps to protect consumers.
Four years ago, in 2017, the FDA sent a warning letter to Grandma’s Herbs after reviewing the company’s website. The letter informs the company that many of the products sold are not dietary supplements as they are marketed. Instead, the FDA says these are new, mislabeled, unapproved drugs.
The US Department of Justice filed the complaint on behalf of the FDA. As of Thursday afternoon, the Grandma’s Herbs website is still open and products can be purchased.