ST. GEORGE — The U.S. Food and Drug Administration announced Thursday that St. George-based Balance of Nature has been ordered by a federal court to stop producing and selling its products until it comes into compliance with federal regulations and requirements under the Federal Food, Drug, and Cosmetic Act.
Evig LLC CEO Lex Howard appears in a video statement, date and location not specified | Photo courtesy of Balance of Nature, St. George News
In a complaint filed Oct. 11 in the U.S. District Court for the District of Utah at the request of the U.S. Food and Drug Administration, the U.S. Department of Justice alleged that Evig LLC and the company’s CEO, Douglas Lex Howard, violated the Federal Food, Drug and Cosmetic Act by distributing adulterated and misbranded dietary supplements.
In a separate complaint filed the same day, the Justice Department alleged that Premium Productions LLC and the company manager’s, Ryan Petersen, violated the act by manufacturing adulterated dietary supplements. The dietary supplements involved are marketed throughout the United States under the brand name Balance of Nature.
The complaint against Evig LLC alleges that the defendants claimed their dietary supplements can cure, treat and prevent a variety of diseases and health conditions. According to the complaint, the supplements were neither approved by FDA nor exempt from approval, making them unapproved new drugs and misbranded under the terms of the Federal Food, Drug, and Cosmetic Act.
The complaint further alleges that FDA inspections showed the defendants had no system in place to handle customer complaints after they received reports asserting that their products may have caused allergic reactions from ingredients not identified on the label.
The FDA sent both companies warning letters in August 2019 explaining that their conduct did not comply with the Federal Food, Drug, and Cosmetic Act. According to the government’s complaints, the defendants failed to take appropriate steps to come into compliance after receiving those letters.
“Products intended to treat or cure diseases require FDA approval,” Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, said in a news release issued by the Justice Department. “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.”
Lex Howard, Balance of Nature President and Founder of United of Pledge congratulating the newest American citizens at the nationalization ceremony in Zion National Park, Springdale, Utah, Oct. 18, 2022 | Photo courtesy of the Color Country Chapter of the Daughters of the American Revolution, St. George News
In both cases, the defendants agreed to settle the suits and be bound by consent decrees of permanent injunction. The consent decrees prohibit Evig LLC and Premium Production LLC from distributing or manufacturing products until they are in compliance with current good manufacturing practice requirements and labeling regulations.
Under the consent decrees, both firms must hire current good manufacturing practice experts, submit documents demonstrating compliance and receive the FDA’s approval to resume operations. In addition, Evig LLC must hire a labeling expert to ensure their products are no longer considered new and/or misbranded drugs.
A press release issued by Balance of Nature on Thursday states that Evig LLC 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,” the company said in the news release.
In the press release, Evig LLC states that it 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,” the release states. “Prior to the Action Plan, Evig had already been updating product labels, company websites and promotional materials.”
In a video statement posted to the Balance of Nature website, Howard said the company is working with the FDA to resume normal operations as quickly as possible. View the video in its entirety below:
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