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On Nov. 15, the U.S. Food and Drug Administration (FDA) blocked the sales of Evig LLC’s Balance for Nature dietary supplements following repeated violations of federal regulations.
According to the FDA, Balance of Nature advertised is products as “treatment for a variety of ailments without approval” and sold them through Amazon, Walmart and its private distributor, Premium Production LLC.
Some of the claims include a Russian study demonstrating the health benefits on cancer and cirrhosis and a now-deleted video featuring a customer claiming they never had a cold or the flu in the two years they took the supplements, according to CBS News.
“The 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 said in a statement.
A federal court has now ordered both Evig’s CEO Lex Howard and Premium Production’s CEO Ryan Petersen to stop making and selling their products.
According to FDA, Howard flouted years of federal warnings and overstepped the limits of supplement claims whereas Petersen didn’t do enough to ensure the products contained the proper ingredients.
“We previously warned Evig LLC and Premium Production LLC, but they have demonstrated repeated violations of manufacturing requirements, and the public cannot have confidence that their products are what they purport to be,” said Michael Rogers, the acting associate commissioner for regulatory affairs at FDA.
Balance for Nature will now need to hire third-party experts to audit the company and ensure the violations are resolved before resuming sales.
On Nov. 16, Balance of Nature responded to the allegations. In both a video statement and a press release, Evig said it is committed to following FDA regulations and implemented a “comprehensive action plan” focusing on product labeling, promotional materials, complaint handling and third-party auditing.
“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,” the company said. “Based upon these findings, the company will develop and implement additional actions as needed and will update the FDA accordingly.”
On Nov. 15, the U.S. Food and Drug Administration (FDA) blocked the sales of Evig LLC’s Balance for Nature dietary supplements following repeated violations of federal regulations.
According to the FDA, Balance of Nature advertised is products as “treatment for a variety of ailments without approval” and sold them through Amazon, Walmart and its private distributor, Premium Production LLC.
Some of the claims include a Russian study demonstrating the health benefits on cancer and cirrhosis and a now-deleted video featuring a customer claiming they never had a cold or the flu in the two years they took the supplements, according to CBS News.
“The 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 said in a statement.
A federal court has now ordered both Evig’s CEO Lex Howard and Premium Production’s CEO Ryan Petersen to stop making and selling their products.
According to FDA, Howard flouted years of federal warnings and overstepped the limits of supplement claims whereas Petersen didn’t do enough to ensure the products contained the proper ingredients.
“We previously warned Evig LLC and Premium Production LLC, but they have demonstrated repeated violations of manufacturing requirements, and the public cannot have confidence that their products are what they purport to be,” said Michael Rogers, the acting associate commissioner for regulatory affairs at FDA.
Balance for Nature will now need to hire third-party experts to audit the company and ensure the violations are resolved before resuming sales.
On Nov. 16, Balance of Nature responded to the allegations. In both a video statement and a press release, Evig said it is committed to following FDA regulations and implemented a “comprehensive action plan” focusing on product labeling, promotional materials, complaint handling and third-party auditing.
“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,” the company said. “Based upon these findings, the company will develop and implement additional actions as needed and will update the FDA accordingly.”
