Balance of Nature says it is back in business after FDA shutdown
Balance of Nature says it has resumed selling and shipping its dietary supplements, following a court-ordered pause of its operations earlier this month over concerns raised by the Food and Drug Administration.
The FDA had asked a federal judge to block the two Utah-based companies behind Balance of Nature – Evig LLC and Premium Productions LLC – from the market in October.
At the time, the agency cited “repeated violations of manufacturing requirements,” unfounded claims by the brand in marketing its products and concerns that Balance of Nature supplements may not actually contain what they claimed to.
release.
In a letter shared with CBS News by Daryl Farnsworth of Balance of Nature, an FDA official told the company that it had appeared to now be “in compliance” with supplement regulations and that it would be allowed to resume manufacturing and distributing its supplements.
The FDA warned Evig in the letter it would need to “maintain compliance” with the consent decree it had agreed on with the agency in order to keep selling its Balance of Nature product.
That agreement had included a pledge to take steps to improve how it handled customer complaints about its products and to take down any marketing about Balance of Nature’s supplements that had run afoul of federal law.
An FDA spokesperson did not immediately respond to a request for comment.
The FDA had previously accused the brand of making dozens of unsupported claims about the benefits of taking its supplements, despite repeated warnings from health authorities.
It came after Balance of Nature also settled a lawsuit by local prosecutors in California, alleging it had overstepped in advertising its supplements.
Balance of Nature’s manufacturer had also been accused by the FDA of not doing enough to verify that the ingredients it was using in its products were what they claimed to be.
In a Nov. 16 statement after the court-ordered pause, Evig said it had “voluntarily entered into the Consent Decree without admitting to the allegations” and had already been working to implement a plan to address the FDA’s concerns.
Under the agreement, the company said it was working with independent experts to “regularly assess” its compliance with FDA regulations.
“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.
Alexander Tin
Source: cbsnews.com