“Mender” Supplement Firm Hopes To Reopen After Mending Its Violations
This article was originally published in The Tan Sheet
BioAnue Labs says it temporarily stopped selling its products, which FDA warned are unapproved new drugs due to claims the firm made. BioAnue’s website and others associated with the firm continue to advertise supplements under brands that include a common disease name and terms that refer to treating the condition.
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“There is no bright-line requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements,” CRN states in petition. FTC, however, says it “makes no bright-line distinctions between categories of health-related products or claims.”