Balance of Nature ordered to stop sales of supplements after FDA lawsuits
A popular brand of dietary supplements must stop production and sales under the terms of a federal court order announced by the Food and Drug Administration.
The U.S. District Court for the Central District of Utah entered the orders against Balance of Nature maker Evig LLC and company CEO, Douglas Lex Howard and Premium Production LLC and its manager. Ryan Peterson. The action comes after Food and Drug Administration court filings that accused the Utah-based companies of continued violations of the Federal Food, Drug, and Cosmetic Act.
“This FDA action ensures that dietary supplements distributed to American consumers are appropriately labeled, lawfully manufactured, and prevents products that potentially put people’s health at risk with unproven claims to cure, treat or prevent a serious illness,” said Michael C. Rogers, the FDA’s Acting Associate Commissioner for Regulatory Affairs. “We previously warned Evig LLC and Premium Production LLC, but they have demonstrated repeated violations of manufacturing requirements, and the public cannot have confidence that their products are what they purport to be.”
Balance of Nature is sold through Amazon, Walmart and its own online store.
In its statement, the FDA said Balance of Nature products are marketed as dietary supplements but are not approved by the agency – despite the maker’s claims – to prevent or treat cancer, heart disease, cirrhosis, diabetes, asthma or COVID-19. The companies also failed to “establish ingredient and finished products specifications for identity, purity, strength, and composition, which rendered them adulterated dietary supplements.”
Under the terms of the order, Evig and Premium Production must stop producing and selling the supplements until the companies are in compliance with federal manufacturing and labeling requirements, hire outside experts to audit compliance and receive FDA approval to restart operations.
Evig and Premium Production are not challenging the orders and, in a statement, said the companies “are committed to full compliance with FDA regulations.”