A federal court has mandated that the brand Balance of Nature cease the production and sale of its dietary supplements this week, following allegations from the Food and Drug Administration (FDA) that the two Utah-based companies behind it consistently violated laws in the production and marketing of their supplements.
Evig LLC, the company responsible for marketing Balance of Nature, and its CEO Lex Howard, are accused of disregarding years of federal warnings regarding inappropriate claims about the diseases their supplements could treat or prevent.
Meanwhile, Premium Productions LLC and its CEO Ryan Petersen, responsible for manufacturing the supplements, are accused of insufficient efforts to ensure that their products actually contain the claimed ingredients.
Michael Rogers, the FDA’s acting associate commissioner for regulatory affairs, expressed concern, stating, “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.”
To rectify the issues, Balance of Nature must engage external experts to audit the companies before resuming supplement sales.
Evig and Premium Production are not contesting the orders, opting to resolve FDA lawsuits with these “consent decree” orders instead of going to trial.
Balance of Nature and its attorney have not immediately responded to requests for comment. The FDA reported that approximately 85% of Balance of Nature sales are to customers outside Utah, spanning from Pennsylvania to California. The brand has faced scrutiny for claims made in its advertising on talk radio, television, and social media.
The FDA and the Justice Department accused Evig of making numerous unsupported claims about Balance of Nature’s benefits, including referencing a Russian study on its website that suggested health benefits on cancer and cirrhosis.
In a video, now removed, someone claimed, “for myself, the two years I’ve been on it, I don’t even think I’ve had a cold, never mind the flu,” according to the FDA.
Apart from marketing issues, the FDA alleges that the company failed to enhance procedures for investigating complaints about product quality.
A separate filing against Premium Productions criticized the manufacturer for insufficient measures to verify the authenticity of ingredients used in its supplements, as federal regulations mandate.
The court order is the latest legal setback for Balance of Nature, which faced a lawsuit by California prosecutors over false claims and violations of state law regarding subscription warnings.
Balance of Nature has been under scrutiny from outside groups, including a 2020 complaint by Truth in Advertising to the FTC and FDA, citing claims made on talk radio shows. The Council of Better Business Bureaus challenged advertising claims in 2017.
FDA attorneys emphasized that seeking new orders became necessary after Balance of Nature failed to address years of warnings regarding violations of the Federal Food, Drug, and Cosmetic Act.