Federal Agencies Shut Down Church Group's Sales Of Bleach Mixture Promoted As COVID-19 Cure
The combination of Genesis II Church's rejection of FDA's warning, the potential for serious adverse events linked to its chlorine dioxide formulation and its claims the product treats COVID-19 led FDA to seek an injunction to stop sales of the product a week after it warned the group.
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Previous businesses FDA warned about COVID-19 claims for chlorine dioxide, a bleach solution, were marketing dietary supplements unlawfully. But Pro Breath MD's oral rinses available under the Dentist Select and OraCare brands are allowed and FDA isn’t asking the firm to discontinue distribution.
FDA’s latest COVID-19 warnings note fewer violative claims than identified in previous warnings to consumer health firms. One had a single noncompliant claim on its website, while another’s violations included identifying potential symptoms of COVID-19. Four men associated with a Florida church face counts of conspiracy to defraud the US and of contempt of court stemming from COVID-1 claims for a bleach solution.
FDA faces unprecedented challenges responding to pandemic, needing to balance urgency, speed, safety and transparency against a fast-moving background. Hahn, who spoke at a recent medical device industry conference and will testify at a congressional hearing on 23 June, says he has focused on making decisions supported by data and science, and updating those decisions as more information became available.