A dietary supplement manufacturer and its two owners have been ordered by a federal court to stop selling products until they come into compliance with federal regulations and requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The 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., of St. George, Utah, and the company’s owners Kevin R. Parr and Tracey Parr. Grandma’s Herbs, Inc. manufactured and distributed products, which the company marketed as dietary supplements, with labeling that rendered them unapproved new drugs and misbranded drugs. The FDA has not approved Grandma’s Herbs’ products 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. The consent decree prohibits the defendants from, among other things, directly or indirectly manufacturing or distributing 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,” said 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.”
In 2017, the FDA issued a warning letter to Grandma’s Herbs, Inc., after conducting a review of the company’s website. The warning letter informed the company that many of the products being sold are not dietary supplements as they are being marketed, but instead unapproved new and misbranded drugs because they are intended to cure, mitigate, treat, or prevent disease.
The consent decree prohibits Grandma’s Herbs, Inc. from marketing such products until the company, among other things, hires a labeling expert, removes its products’ violative labeling and receives written permission from the FDA to resume operations.
The U.S. Department of Justice filed the complaint on behalf of the FDA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.