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US court orders Balance of Nature to stop sales of supplements after FDA lawsuits

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  1. skybrian
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    From the article: ...

    From the article:

    A federal court ordered the brand Balance of Nature to stop producing and selling its dietary supplement products this week, after the Food and Drug Administration accused the two Utah-based companies behind it of repeatedly breaking the law in how they made and marketed their supplements.

    The FDA says the company marketing Balance of Nature, Evig LLC, and its CEO Lex Howard had flouted years of federal warnings about overstepping limits in what they could claim about diseases their supplements could cure or prevent.

    Meanwhile, those responsible for manufacturing the supplements, Premium Productions LLC and its CEO Ryan Petersen, were accused of not doing enough to ensure their products actually contained the ingredients they claimed to.

    "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.

    Balance of Nature will now need to hire outside experts to audit the companies, ensuring their marketing and manufacturing issues are fixed, before resuming sales of the supplements.

    ...

    FDA's attorneys said they had little choice but to seek the new orders against the companies, after Balance of Nature had failed to address years of warnings that they had run afoul of the Federal Food, Drug and Cosmetic Act.

    "Defendants have a long history of failing to comply with the Act. FDA has documented a pattern of continued violative conduct during multiple inspections of Defendants' Establishment and have repeatedly warned Defendants that such conduct could lead to enforcement action," they wrote.

    5 votes