Balance of Nature Ordered to Stop Selling Dietary Supplements
A federal court has issued a cease and desist order against the brand Balance of Nature, prohibiting them from producing and selling their dietary supplement products. This action comes after the Food and Drug Administration (FDA) accused the two Utah-based companies responsible for the brand, Evig LLC and its CEO Lex Howard, of repeatedly violating the law in the manufacturing and marketing of their supplements.
The FDA claims that Evig LLC has disregarded numerous federal warnings regarding the claims made about the ability of their supplements to cure or prevent diseases. Meanwhile, Premium Productions LLC, the company responsible for manufacturing the supplements, and its CEO Ryan Petersen, have been accused of failing to ensure that the products contain the ingredients they claim to have.
Michael Rogers, the FDA's acting associate commissioner for regulatory affairs, expressed concern over the repeated violations by Evig LLC and Premium Productions LLC. He stated, "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."
As a result of the court order, Balance of Nature will be required to hire external experts to conduct audits of the companies. These audits will ensure that the marketing and manufacturing issues are addressed and resolved before the supplements can be sold again.
Evig and Premium Production have accepted the orders without contesting them. Both companies have agreed to resolve FDA lawsuits filed last month with these "consent decree" orders, thus avoiding trials.
Balance of Nature and an attorney for the brand did not immediately respond to a request for comment.
The FDA stated that approximately 85% of Balance of Nature sales are made to customers outside of Utah, ranging from Pennsylvania to California. The brand has previously faced scrutiny over claims made in its advertising across talk radio, television, and social media platforms.
In a court filing, lawyers from the FDA and the Justice Department accused Evig of making numerous unsupported claims about the benefits of Balance of Nature, despite repeated warnings from authorities.
These claims included statements on the company's website, such as one stating that a Russian study had discovered "health benefits" of its supplements on cancer and cirrhosis.
A video, which has since been removed by the company, featured an individual claiming that "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 agency.
Aside from its marketing practices, the FDA stated that the company had failed to fulfill its promises to improve its procedures for investigating complaints about product quality issues.
"To date, Evig has not shown that it has conducted any complaint investigations," wrote the FDA's attorneys.
A recent court filing against Premium Productions has criticized the supplement manufacturer for not adequately ensuring the accuracy of the ingredients used in its products. The filing states that federal regulations require supplement manufacturers to establish procedures for analyzing and testing ingredients from suppliers to confirm their authenticity.
The FDA has revealed that approximately 95% of the raw materials used in Balance of Nature supplements are sourced from outside Utah, with suppliers located in Illinois, Wisconsin, California, and India.
According to the FDA's complaint, Premium informed the agency that it relies on organoleptic characteristics, such as smell, to identify the powdered ingredients used in the three Balance of Nature products.
This court order represents the latest legal setback for Balance of Nature, as the company was previously sued by local prosecutors in California. The lawsuit accused Balance of Nature, marketed by Utah-based company Evig, of making false claims about its products through extensive advertising across the state.
Prosecutors also alleged that Evig violated state law by failing to provide customers with adequate warning before enrolling them into automatically renewing subscriptions and failing to offer a convenient online cancellation process for recurring fees.
In July, Evig settled the lawsuit for $1 million.
Balance of Nature has faced ongoing scrutiny from external organizations for several years.
Balance of Nature Faces Complaints
The nonprofit Truth in Advertising filed complaints in 2020 against Balance of Nature with the FTC and FDA, citing claims made across a number of talk radio shows including "The Joe Piscopo Show," "Kevin McCullough Radio" and "America First with Sebastian Gorka" episodes.
In 2017, the Council of Better Business Bureaus challenged multiple advertising claims made about the health benefits of the products.
FDA's attorneys said they had little choice but to seek the new orders against the companies, after Balance of Nature had failed to address years of warnings that they had run afoul of the Federal Food, Drug and Cosmetic Act.
"Defendants have a long history of failing to comply with the Act. FDA has documented a pattern of continued violative conduct during multiple inspections of Defendants' Establishment and have repeatedly warned Defendants that such conduct could lead to enforcement action," they wrote.
