Evig, LLC dba Balance of Nature Finalizes Terms of Consent Decree with the U.S. FDA
For Immediate Release:
ST. GEORGE, Utah — Evig, LLC dba Balance of Nature (“Evig” or the “company”), a dietary supplement company based in St. George, Utah, announced today that the company has entered into a Consent Decree of Permanent Injunction (Consent Decree) with the U.S. Food and Drug Administration (FDA) to resolve allegations related to the marketing of the company’s Balance of Nature dietary supplements, as well as the company’s system for handling product complaints. Evig voluntarily entered into the Consent Decree without admitting to the allegations. As the Department of Justice stated, “[t]he claims resolved by the injunctions are allegations only. There has been no determination of liability.” Continuing to put our customers and quality first, we believe Balance of Nature has an exciting future ahead of it.
Evig is committed to full compliance with FDA regulations. Earlier this year, Evig began implementing a comprehensive Action Plan that has improved compliance with respect to product labeling, promotional materials and complaint handling. The Action Plan, which was submitted to FDA, includes assistance and input from independent third-party experts. Prior to the Action Plan, Evig had already been updating product labels, company websites and promotional materials.
Evig believes that the terms of the Consent Decree recognize the progress made in remediation efforts to date. The Consent Decree allows Evig to continue the work already initiated under the Action Plan, and provides additional assurance of the company’s adherence to FDA regulations.
Under the terms of the Consent Decree, the company will continue to work with independent experts who will regularly assess the Company’s compliance with relevant regulations and issue recommendations. Based upon these findings, the company will develop and implement additional actions as needed and will update the FDA accordingly.
Evig is dedicating the personnel and financial resources necessary to improve and enhance operations. Evig remains committed to providing the same formulas consisting of high quality ingredients to help consumers supplement their diet with fruits, vegetables and fiber in dietary supplement form.