Silver Spring, MD—A dietary supplement manufacturer and its owners have been ordered to stop selling products until they come into compliance with the FD&C Act, according to an announcement from FDA.
The U.S. Department of Justice filed the complaint on behalf of FDA, and the U.S. District Court for the District of Utah entered a consent decree of permanent injunction between the U.S. and Grandma’s Herbs, Inc., and company owners Kevin and Tracey Parr.
Grandma’s Herbs manufactured and distributed products marketed as supplements with labeling that rendered them unapproved new drugs and misbranded drugs, according to FDA. The decree prevents the defendants from directly or indirectly manufacturing or distributing products until certain requirements are met.
FDA previously issued a warning in 2017, after FDA conducted a review of the company’s website. Claims listed in that warning letter included:
- “This tincture is effective at preventing and eliminating the common cold and the flu viruses.”
- “It is also good for cuts, bruises, fevers, burns and plagues. We have testimonial after testimonial of it’s [sic] effective results.”
- “BRIGHT EYES has also been used for pink eye …”
- “[R]ebuild the tissue in the stomach and aid in the healing stomach and intestinal ulcers.”
- “In case of a heart attack cayenne will stimulate the heart… “
- “Cayenne will stabilize blood pressure, stop internal bleeding and help to stop a stomach ulcer from bleeding”
- “There is a lot of scientific data around the world indicating that the anti-inflammatory properties of resin oils (frankincense is a resin oil) are useful to inflammatory diseases such as Crohn’s disease.”
The letter also pointed towards multiple testimonials.
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“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.”