Court orders Balance of Nature to stop selling dietary supplements after FDA lawsuits

A federal court ordered the brand Balance of Nature to stop making and selling 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 manufactured and marketed their nutritional supplements.

The FDA says the company that markets Balance of Nature, Evig LLC, and its CEO Lex Howard had ignored years of federal warnings about exceeding limits on 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 that their products actually contained the ingredients they claimed to have.

“We have previously warned Evig LLC and Premium Production LLC, but they have demonstrated repeated violations of manufacturing requirements and the public cannot trust that their products are what they claim to be,” said Michael Rogers, the FDA’s acting associate Commissioner for Regulatory Affairs. in a release Thursday.

Balance of Nature will now have to hire outside experts to audit the companies to ensure their marketing and manufacturing issues are resolved before sales of the supplements resume.

Evig and Premium Production do not challenge the orders. Both companies agreed to settle FDA lawsuits filed last month with those “consent decree” orders and avoid litigation.

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

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

In a lawsuitFDA and Justice Department lawyers had accused Evig of making dozens of unsubstantiated claims about Balance of Nature’s benefits despite repeated warnings from authorities.

These included several statements on the company’s website, such as one that said a Russian study had found “health benefits” of its supplements on cancer and cirrhosis.

A video now taken down by the company featured one person claiming that “for myself, the two years I’ve been on it, I don’t think I’ve even had a cold, never mind the flu,” said the agency.

In addition to its marketing, the FDA says the company had not followed through on promises to step up its procedures to investigate complaints about problems with the quality of its products.

“To date, Evig has not demonstrated that it has conducted any complaint investigations,” FDA attorneys wrote.

A separate one lawsuit v. Premium Productions accused the supplement manufacturer of not doing enough to ensure that the ingredients it used in its supplements were actually what they claimed to be.

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

About 95% of the raw materials used in Balance of Nature supplements come from outside of 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 make up the three Balance of Nature products,” the FDA’s complaint states.

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.

Everlasting, the Utah-based company that markets Balance of Nature, had been accused of making false claims about its products in “extensive radio, television and Internet advertisements” across the state.

Prosecutors also accused the firm of violating state law that requires companies to warn customers before signing them up for auto-renewing subscriptions and provide them with ways to cancel the recurring charges online.

Eternal settled the lawsuit for 1 million dollars in July.

Balance of Nature has also received oversight from outside groups for years.

The nonprofit organization Truth in Advertising filed complaints in 2020 against Balance of Nature with the FTC and FDA, citing allegations made across a number of talk radio programs, including “The Joe Piscopo Show,” “Kevin McCullough Radio” and “America First with Sebastian Gorka” episodes.

In 2017, the Council of Better Business Bureaus challenged numerous advertising claims about the products’ health benefits.

FDA lawyers said they had no choice but to seek the new orders against the companies after Balance of Nature failed to address years of warnings that they had run afoul of the federal Food, Drug and Cosmetic Act.

“Defendant has a long history of failing to comply with the law. FDA has documented a pattern of continued infringing conduct during multiple inspections of Defendant’s establishment and has repeatedly warned Defendant that such conduct may lead to enforcement action,” they wrote.

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