Court orders Balance of Nature to stop production & sale of non-compliant supplements
In a complaint filed on Oct. 11 in the U.S. District Court for the District of Utah, the FDA alleged that Evig LLC of St. George, Utah and its CEO Douglas Lex Howard violated the federal law by distributing adulterated and misbranded dietary supplements.
The complaint alleged that the defendants claimed their dietary supplements can cure, treat and prevent a variety of diseases and health conditions, including cancer, heart disease, diabetes and coronavirus. Such claims would make the products unapproved new drugs and misbranded under the terms of the Food, Drug and Cosmetic Act (FDCA).
The FDA also alleged that federal inspections showed the defendants had no system in place to handle customer complaints despite receiving reports asserting that their products may have caused allergic reactions from ingredients not identified on the label.
“Products intended to treat or cure diseases require FDA approval,” said Brian Boynton, principal deputy assistant attorney general and head of the Justice Department’s Civil Division. “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.”
cGMP violations
In a separate complaint, the company responsible for manufacturing the supplements, Premium Productions LLC of St. George, Utah, and its CEO Ryan Petersen were accused of failing to comply with current Good Manufacturing Practices (cGMPs) and failing to develop good operating procedures and adequate quality controls, making their products adulterated under the FDCA.
Both companies were sent warning letters in August 2019 by the FDA explaining that their conduct did not comply with the FDCA. According to the complaints, neither defendant took the appropriate steps to come into compliance after receiving those letters.
"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," Michael Rogers, FDA's acting associate commissioner for regulatory affairs, said in a release Thursday.
“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,” he added.
The defendants have now agreed to be bound by consent decrees, requiring them to hire outside experts to audit the companies, ensuring their marketing and manufacturing issues are fixed, before resuming sales of the supplements.
Howard and Peterson were contacted by NutraIngredients-USA for comment, but no response was received prior to publication.
Serious enforcement action
Commenting independently on the action, Marc Ullman, of counsel for Rivkin Radler LLP, told NutraIngredients-USA that it was “gratifying to see the FDA district in Utah bring a serious enforcement action like this. It sends a message,” he said.
Ullman added that while this a relatively basic injunction, it is “very hard to come out from under an injunction like this. These things are onerous. They’re expensive to cope with”.
He also noted with surprise that there is no recall language for product that is currently on the market (the decree does state that FDA may order a future recall, at the defendants’ expense, of any product that is adulterated or violates the decree in any way).
“Generally, when you have violations for this length of time, and FDA and DoJ seek a remedy for that non-compliance, there’s a product recall. So, FDA believes the conditions are so serious that this kind of action is required but doesn’t initiate an immediate recall. That is surprising,” said Ullman.
