Court Orders Balance of Nature to Halt Supplement Sales

UPDATE 11/29/23: Balance of Nature is currently taking supplement orders on its website less than two weeks after a federal court ordered the company to stop sales. The FDA declined to comment on a report that it approved Balance of Nature to resume operations, as required by a consent decree. Our original article follows.

A federal court has ordered Balance of Nature and its CEO to halt production and sales of its supplements, including its “Fruits” and “Veggies” capsules, following a lawsuit filed by the U.S. Department of Justice on behalf of the FDA last month.

The lawsuit accused Balance of Nature of selling misbranded and unapproved drugs by advertising the supplements as able to prevent, treat or cure diseases including cancer, COVID-19, diabetes, heart disease, asthma and cirrhosis. It also cited repeat violations of current good manufacturing practice (CGMP) requirements at the company’s distribution facility in Utah, with the most recent inspection by the FDA in May 2022 revealing a failure to adequately investigate product complaints.

The court order comes more than four years after the FDA sent Balance of Nature a warning letter regarding its unapproved disease-treatment claims and CGMP violations. It also comes more than three years after TINA.org filed a complaint with the FDA against Balance of Nature for deceptively claiming that its supplements can prevent and help treat COVID-19 by boosting a person’s immune system. TINA.org also filed a complaint with the FTC. A clip that TINA.org provided to regulators where Balance of Nature CEO Douglas Howard claims on his “Reinventing your Health” podcast that his supplements help ward off COVID-19 is cited as evidence in the government’s complaint.

In a separate consent decree issued the same day last week, the court also ordered the manufacturer of Balance of Nature, Premium Production LLC, and its CEO, to stop production and sales. Premium Production was also the subject of an FDA warning letter regarding CGMP violations in 2019. Its latest FDA inspection, also conducted in May 2022, revealed that the company uses smell alone as the specification to identify the powdered ingredients in Balance of Nature’s products, according to the government’s complaint.

Michael Rogers, the FDA’s acting associate commissioner for regulatory affairs, said in a release that the companies “have demonstrated repeated violations of manufacturing requirements, and the public cannot have confidence that their products are what they purport to be.”

The consent decrees prohibit the companies from distributing or manufacturing products until they are in compliance with CGMP and labeling regulations. To that end, both companies must hire CGMP experts, submit documents demonstrating compliance and receive the FDA’s approval to resume operations. In addition, Balance of Nature must hire an independent labeling expert to ensure its products are no longer considered new and/or misbranded drugs.

In July, Balance of Nature agreed to pay $1.1 million to settle a lawsuit filed by consumer protection officials in California alleging the company falsely advertised that its supplements could prevent, treat or cure serious diseases. But only $250,000 of the settlement amount went toward customer restitution — and only California residents were eligible for refunds. And unfortunately for consumers, who have continued to file complaints with TINA.org over Balance of Nature’s false health claims, this latest action doesn’t provide any restitution for customers who have already been harmed by the company’s deceptive marketing.

Find more of our coverage on Balance of Nature here.