Seattle Biologics Firm Offers COVID-19 ‘Vaccine’ OTC Before Warnings By State, Federal Agencies
When businesses rapidly pivot to offering consumer health products and services, they’re likely not contemplating compliance with FDA regulations. Recent warning letters are more proof COVID-19 represents opportunities for numerous businesses that aren’t prepared to follow or simply aren’t aware of FDA regulations.
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FDA's COVID-19 Naughty List Now Includes Marketers Of Copper Germ Stoppers, ‘24-Hour’ Hand Sanitizer
Warning letters issued by the US FDA on 28 May target two companies using COVID-19 and other disease-prevention claims to market purported germ-killing products, including a rub touted as 24-hour protection and a line of copper rollers and other implements to disinfect hands and personal items.
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.
Pataday Once Daily Relief Extra Strength is the same formulation as Novartis' Rx Pazeo. It will be the first OTC eye drop indicated for allergy itch with 24-hour efficacy, available online in September and through retailers in early 2021.