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.
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.
In both cases, the defendants agreed to settle the suits and be bound by consent decrees of permanent injunction. The consent decrees prohibit Evig and Premium Productions from distributing or manufacturing products until they are in compliance with current good manufacturing practice requirements and labeling regulations.
A press release issued by Balance of Nature on Thursday states that 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,” the company said in the news release.
“Evig believes that the terms of the Consent Decree recognize the progress made in remediation efforts to date,” the company said. “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.”
In the complaint filed by the Justice Department, “adulterated ingredients” are defined by federal law as having been prepared, packed or held in violation of the current good manufacturing practice regulations for dietary supplements.
In Evig’s case, the Justice Department alleged that the products are adulterated after the FDA reviewed Evig’s consumer complaint log and determined that it did not demonstrate that the listed complaints were being adequately investigated.
The complaint notes that Evig did produce a record of complaints, but the federal agency reportedly found the records to be lacking.
In the complaint filed against Premium Productions, the Justice Department alleged that the products are adulterated after it was determined the company had not established adequate Standard Operation Procedures for their quality control operations. Additionally, it was alleged that the company had not established identity specifications for the components used to manufacture the dietary supplements nor established specifications for finished product identity and strength.
The complaint notes that in all cases, Premium Productions did produce documentation to show compliance, but the FDA inspectors reportedly found it to be inadequate.
The complaint against Evig alleged that the defendants claimed their dietary supplements can treat a variety of diseases and health conditions.
In some examples in the complaint, the Justice Department cited several online customer reviews from people with various ailments talking about how they feel better after using Balance of Nature’s products. The reviews include responses from Balance of Nature thanking the users and saying they are glad the customers are feeling healthier, but Balance of Nature did not appear to endorse the health-related claims of those consumer reviews.
Evig said in its press statement that it is dedicating 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,” the company said.
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 must hire a labeling expert to ensure their products are no longer considered new and/or misbranded drugs.
In its press release, Evig states that it has already been working toward improvement and 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:
Ed. note: This article was updated to include specific definitions and examples related to the alleged violations.
Copyright St. George News, SaintGeorgeUtah.com LLC, 2023, all rights reserved.