FDA Policy/General

2 Consent Decrees Against Supplement Marketers

The central Utah federal court has entered two consent decrees of permanent injunction against Evig LLC and Premium Production LLC, both of St. George, UT, over their distribution and marketing of Balance of Nature products. An FDA release says the products are marketed as dietary supplements, but their labeling “rendered them unapproved new drugs and misbranded drugs.” Additionally, Evig violated current good manufacturing practice (CGMP) requirements, making its products adulterated. Evig distributes Balance of Nature products through Amazon, Walmart, and its own online store at www.balanceofnature.com.

The agency says that Premium Production manufactured Balance of Nature products in violation of multiple CGMP requirements, such as “failing to establish ingredient and finished products specifications for identity, purity, strength, and composition, which rendered them adulterated dietary supplements.”

FDA in 2019 issued Warning Letters to Evig LLC and Premium Production LLC after facility inspections identified manufacturing violations at both companies' facilities. “Following the 2019 warning letters, FDA inspections showed that the firms failed to address the deviations and come into compliance with the FDA's requirements,” the agency says. “Based on the firms' continued violations, the FDA pursued injunctions against the firms.”

The consent decrees prohibit Evig and Premium Production from distributing or manufacturing products until they are in compliance with CGMP and labeling regulations. The firms must also hire CGMP experts, submit documents demonstrating compliance, and receive the agency’s approval to resume manufacturing operations. In addition, Evig must hire an expert on labeling make sure marketed products are no longer considered new or misbranded drugs.

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