Consent Decrees Entered Against Utah Supplement Manufacturer and Distributors
Consent decrees were issued against Evig LLC, of St. George, Utah, and Premium Production LLC, of St. George, Utah, for unapproved dietary supplements.
FDA announced on Nov. 16, 2023 that the US District Court for the District of Utah, Central Division, entered into consent decrees of permanent injunction with two dietary supplement companies, Evig LLC and Premium Production LLC, both based in St. George, Utah, and their chief operating officers.
Evig LLC and the company’s CEO, Douglas Lex Howard, distributes Balance of Nature products, which are marketed as dietary supplements that include labeling that renders them unapproved and misbranded drugs. “[FDA] has not approved Balance of Nature products for any use, despite the company’s 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,” FDA stated in a press release. The agency says the company also violated current good manufacturing practice (CGMP) requirements.
The products were manufactured by Premium Production in violation of CGMPs, according to FDA, including “failing to establish ingredient and finished products specifications for identity, purity, strength, and composition, which rendered them adulterated dietary supplements.”
FDA sent both companies warning letters in 2019 after agency inspectors found CGMP violations during facility inspections at both companies’ facilities. Evig was warned Balance of Nature products were unapproved new and misbranded drugs. According to the agency, the companies failed to address the deviations, resulting in the injunctions.
“Products intended to treat or cure diseases require FDA approval,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, in a press release. “Dietary supplement makers also must 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.”
The two companies are prohibited from distributing or manufacturing products until they comply with CGMP and labeling regulations. Both companies must hire CGMP experts and submit documents to the agency demonstrating compliance and get FDA approval before resuming operations. Evig must also hire a labeling expert.
Source: FDA
