Nov. 16 (UPI) — The Food and Drug Administration on Wednesday entered a consent decree to block the Utah-based manufacturers and distributors of Balance of Nature dietary supplements from producing their products until they comply with the Federal Food, Drug and Cosmetic Act.
The FDA says that Balance of Nature products, which were available from their primary distributor, as well as through Amazon and Walmart, have been advertised as treatment for a variety of ailments without approval.
“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,” the FDA said in a press release Thursday.
A federal court has now ordered Evig LLC, and its CEO, Douglas Lex Howard, and Premium Production LLC, and its CEO, Ryan Petersen, to stop making and selling their product.
“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 FDA Acting Associate Commissioner for Regulatory Affairs Michel Rogers.
The FDA says warning letters were sent to Evig LLC and Premium Production LLC in 2019 indicating that the product’s website was in violation of regulations.
Additionally, the FDA says the companies were unwilling to provide crucial information about the contents and purity of its products.
