Rekubit Exchange:Court orders Balance of Nature to stop sales of supplements after FDA lawsuits

A federal court ordered the brand Balance of Nature to stop producing and Rekubit Exchangeselling its dietary supplement products this week, after the Food and Drug Administration accused the two Utah-based companies behind it of repeatedly breaking the law in how they made and marketed their supplements.

The FDA says the company marketing Balance of Nature, Evig LLC, and its CEO Lex Howard had flouted years of federal warnings about overstepping limits in what they could claim about diseases their supplements could cure or prevent.

Meanwhile, those responsible for manufacturing the supplements, Premium Productions LLC and its CEO Ryan Petersen, were accused of not doing enough to ensure their products actually contained the ingredients they claimed to. 

"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," Michael Rogers, FDA's acting associate commissioner for regulatory affairs, said in a release Thursday. 

Balance of Nature will now need to hire outside experts to audit the companies, ensuring their marketing and manufacturing issues are fixed, before resuming sales of the supplements.

Evig and Premium Production are not challenging the orders. Both companies agreed to resolve FDA lawsuits filed last month with these "consent decree" orders, avoiding trials.

Balance of Nature and an attorney for the brand did not immediately respond to a request for comment.

Around 85% of Balance of Nature sales are to customers outside its home state of Utah, the FDA said, ranging from Pennsylvania to California. The brand has previously drawn scrutiny over claims in its advertising across talk radio, television and social media.

In a court filing, FDA and Justice Department lawyers had accused Evig of making dozens of unsupported claims about Balance of Nature's benefits despite repeated warnings from authorities.

These included several statements on the company's website, like one saying that a Russian study had found "health benefits" of its supplements on cancer and cirrhosis.

A video, now taken down by the company, featured someone 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," the agency said.

Beyond its marketing, the FDA says the company had fallen short of pledges to step up its procedures for investigating complaints about issues with the quality of its products. 

"To date, Evig has not demonstrated that it has conducted any complaint investigations," the FDA's attorneys wrote.

A separate court filing against Premium Productions faulted the supplement manufacturer for not doing enough to ensure that the ingredients it was using in its supplements were actually what they claimed to be. 

Federal regulations require supplement manufacturers to draw up procedures to analyze and test ingredients from their suppliers to verify that they are what they claim to be.

Around 95% of the raw materials used in Balance of Nature supplements come from outside Utah, the FDA says, from suppliers in Illinois, Wisconsin, California and India.

"Following the inspection, Defendant Premium informed FDA that it uses organoleptic characteristics, i.e., smell, as the specification to identify the powdered ingredients that comprise the three Balance of Nature products," the FDA's complaint says.

The court order marks the latest legal setback for Balance of Nature, which also faced a lawsuit over the summer by local prosecutors in California.

Evig, the Utah-based company which markets Balance of Nature, had been accused of making false claims about its products in "extensive radio, television, and internet advertising" across the state. 

Prosecutors also accused the firm of violating state law requiring companies to warn customers before enrolling them into automatically renewing subscriptions and provide them with ways to cancel the recurring fees online.

Evig settled the lawsuit for $1 million in July.

Balance of Nature has also drawn scrutiny for years from outside groups. 

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.

Alexander Tin

Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers the Biden administration's public health agencies, including the federal response to infectious disease outbreaks like COVID-19.

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