Balance of Nature ordered to stop production after claiming supplements cure cancer and COVID-19

20 Nov 2023 --- The US Federal Court has ordered Evig and Premium Production, the Utah-based dietary supplement distributor behind the Balance of Nature supplement brand, to cease operations after making false promises not backed by the FDA.

According to the FDA’s official press release, the District Court for the District of Utah has entered two content decrees of permanent injunction against the two companies’ executives, Evig CEO Douglas Lex Howard and Premium Production CEO Ryan Petersen.

The Federal Court has ordered the halt of manufacturing and sale of the Balance of Nature products until they comply with federal regulations and requirements under the Federal Food, Drug, and Cosmetics Act.

“We previously warned Evig and Premium Production, but they have demonstrated repeated violations of manufacturing requirements and the public cannot have confidence that their products are what they purport to be. The FDA will continue to protect the US public health by taking appropriate actions when companies violate the law,” says Michael Rogers, the FDA’s acting associate commissioner for Regulatory Affairs.

The US Federal Court has ordered the halt of manufacturing and sale of all Balance of Nature products.Misbranding violations
The companies’ infringements include the use of inaccurate labeling, due to which the supplements were found to be “unapproved new drugs” and “misbranded drugs.”

The health concerns that the supplement brand promised to alleviate include cancer, heart disease, cirrhosis, diabetes, asthma and COVID-19.

“This FDA action ensures that dietary supplements distributed to American consumers are appropriately labeled, lawfully manufactured and prevents products that potentially put people’s health at risk with unproven claims to cure, treat or prevent a serious illness,” Rogers comments.

Premium Production has further been found to be manufacturing the Balance of Nature products in violation of multiple Current Good Manufacturing Practice (CGMP) regulations enforced by the FDA, including failing to establish ingredient and final product specifications for identity, purity, strength and composition, rendering them ‘adulterated dietary supplements.

Evig CEO Douglas Lex asserts that according to the Department of Justice, “The claims resolved by the injunctions are allegations only. There has been no determination of liability.”

“We are working with the FDA to resume normal operations as quickly as possible,” he further states in a video on the Balance of Nature official website, where the supplements are still being sold.

“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, comments.

Previous breaches
Evig LLC and Premium Production were issued a warning by the FDA in 2019 following a facility inspection that found CGMP violations at both locations. The same warning letter to Evig outlined that a review of the Balance of Nature website has concluded that its products are mislabeled. The US Department of Justice reminds dietary supplements must abide by federal health and safety requirements.

An FDA investigation following the warning letters found that the companies failed to address the issues and remained not in compliance with FDA requirements.

The FDA states it is continuing its injunctions against the two firms based on their continued violations.

“Dietary supplement makers 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,” Boynton highlights.

According to the consent decrees, Evig and Premium Production are now banned from distributing or manufacturing products until they comply with CGMP and labeling regulations.

Both companies are expected to hire CGMP experts, submit documents proving compliance and achieve FDA approval in order to resume operations. Evig has further been asked to employ a labeling expert.

By Milana Nikolova

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