A consent decree of permanent injunction has been entered against Evig LLC, a dietary supplement manufacturer and distributor, along with the company’s CEO, and Premium Production LLC and its manager, according to the FDA. These companies produce and market Balance of Nature Products, with false label claims. Those corporations are located in St. George, Utah.
The U.S. District Court for the District of Utah, Central Division entered the consent decrees. The FDA has not approved the Balance of Nature products for any use. The company has made claims that its products could be used to diagnose, cure, mitigate, treat, or prevent diseases such as cancer, heart disease, cirrhosis, diabetes, asthma, and COVID-19.
And Evig LLC violated current good manufacturing practice (CGMP) requirements, which make these dietary supplements adulterated. The products were sold through Amazon, Walmart, and the company’s online store.
In addition, the company did not establish ingredient and finished products specifications for identify, purity’s strength, and composition. These errors also render the items adulterated dietary supplements.
Michael C. Rogers, the FDA’s Acting Associate Commissioner for Regulatory Affairs said in a statement, “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. 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.”
The FDA issued warning letters to both companies in 2019 after inspectors found the violations at both company’s facilities. After the letters were sent, inspections showed that the firms did not address the devisions and come into compliance.
Until the corporations are in compliance with CGMP and labeling regulations, they may not distribute or manufacture products. The firms must hire CGMP experts, submit documents that demonstrate compliance, and get the FDA’s approval to resume operations.
