The U.S. Food and Drug Administration (FDA) announced that a federal court ordered a dietary supplement distributor, manufacturer, and two executives to stop selling Balance of Nature branded products, due to alleged disease claims.
 
The consent decrees of permanent injunction entered by the U.S. District Court of Utah were against Evig LLC of St. George, Utah, and that company’s CEO, Douglas Lex Howard, as well as Premium Production LLC, of St. George, Utah, and its manager, Ryan Petersen.
 
Balance of Nature products are marketed as dietary supplements, but, in accordance with the Food, Drug, and Cosmetic Act, FDA alleges that their labeling renders them as unapproved new drugs and misbranded drugs due to disease related claims.
 
FDA accused Balance of Nature of claiming that its products could be used to diagnose, cure, mitigate, treat, or prevent diseases including cancer, heart disease, cirrhosis, diabetes, asthma, and COVID-19.
 
Evig LLC was also charged with violating current good manufacturing practices (cGMP) requirements, which rendered its products adulterated. Evig distributes Balance of Nature products through Amazon, Walmart, and the brand’s online store.
 
Premium Production LLC and Petersen were charged with manufacturing Balance of Nature products in violation of multiple cGMP requirements, such as failing to establish ingredient and finished product specifications for purity, strength, and composition, which rendered them adulterated.
 
“This FDA action ensures that dietary supplements distributed to American consumers are appropriately labeled, lawfully manufactured, and prevents products that potentially put people’s health at risk with unproven claims to cure, treat or prevent a serious illness,” said Michael C. Rogers, the FDA’s acting associate commissioner for regulatory affairs. “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. The FDA will continue to protect the U.S. public health by taking appropriate actions when companies violate the law.”
 
In 2019, FDA issued warning letters to both Evig LLC and Premium Production LLC after inspectors identified cGMP violations at both companies’ facilities.
 
At the time, the warning letter to Evig LLC also said to the company that its Balance of Nature website contained disease related claims.
 
FDA inspections which followed the two warning letters found that the firms failed to address the issues within the letters, and were still not in compliance with FDA requirements, the agency said.
 
“Products intended to treat or cure diseases require FDA approval,” said Brian M. Boynton, principal deputy assistant attorney general and head of the Department of Justice’s Civil Division. “Dietary supplement maker must also abide by federal health and safety requirements. The department will continue to work closely with FDA to stop the distribution of unapproved, adulterated, and misbranded dietary supplements.”
 
Unde the consent decrees, both firms are required to hire cGMP experts, submit documents demonstrating compliance, and receive FDA’s approval to resume operations. Evig LLC is also required to hire a labeling expert to ensure their products no longer contain disease related claims.