Consent decree shuts down Utah herbal firm

Regulatory NewsRegulatory News | 20 October 2021 |  By 

A Utah-based manufacturer and seller of herbal remedies and nutritional supplements has agreed not to market or sell its wares until products and labeling are compliant with federal drug regulations. Acting on behalf of the US Food and Drug Administration (FDA), the Department of Justice filed the complaint that triggered the consent degree of permanent injunction between Grandma’s Herbs, Inc., its owners, and the US government. The consent decree was entered by the US District Court for the District of Utah.
The filing came after FDA issued a 2017 warning letter to the supplement manufacturer, which then continued marketing and selling its products with claims that made them unapproved and misbranded drugs, rather than the dietary supplements which Grandma’s Herbs marketing claims made them out to be.
The 2017 letter details the claims that Grandma’s Herbs made at the time about its products, including a blog entry maintaining that “In case of a heart attack cayenne will stimulate the heart,” and another claim made for an essential oil called Deliverance that it “is one of the most potent antiviral, antibacterial, antifungal combinations available.” The website claimed that the uses of Deliverance included treating respiratory infections, dental diseases, strep throat and general infections, among others.
Since then, Grandma’s Herbs has made some adjustments to its product line and website, but at press time, consumers could still visit the firm’s website and shop for such items as “Immune Enhancer,” “Nature’s Biotic,” and “Heart Plus – Sustains a Healthy Heart.”
"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, FDA's associate commissioner for regulatory affairs, in the agency’s announcement of the consent decree. "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."
FDA has stepped up the pace of its warning letters for misbranded dietary supplements in 2020 and 2021 amid the pandemic, as many supplement sellers included claims that their products would have some effect against COVID-19. (RELATED: Current status and future FDA enforcement of dietary supplements, Regulatory Focus 25 June 2021; ‘Immune’ claims and COVID-19, Regulatory Focus 27 August 2021)


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