A consent decree of permanent injunction has been entered between U.S. Grandma’s Herbs, Inc. of St. George, Utah, and the company’s owners. The company allegedly marketed products as dietary supplements, with labeling that rendered them unapproved new drugs and misbranded drugs, according to an FDA news release. The U.S. District Court for the District of Utah entered the consent decree on behalf of the FDA.
The FDA has not approved Grandma’s Herbs products for any use. The company has claimed that the products could be used to “diagnose, cure, mitigate, treat, or prevent conditions such as respiratory tract infections, ulcers, heart disease, autoimmune disorders, and epilepsy.”
Judy McMeekin, Pharm.D., FDA’s associate commissioner for regulatory affairs said in a statement, “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. 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.”
The FDA issued a warning letter to Grandma’s Herbs after conducting a review of the company’s website in 2017. The warning letter said that many of the products they were selling were not dietary supplements as they were marketed, but were unapproved new and misbranded drugs because they were “intended to cure, mitigate, treat, or prevent diseases.”
The consent decree prohibits the company from marketing these products until the company, among other things, hires a labeling expert and removes its products’ violative labeling. It must also receive written permission from the FDA to resume operations.
