Malcolm Spicer, Managing Editor – US
Latest From Malcolm Spicer
Series C investment of an undisclosed amount announced in early May follows $20m funding for the Los Angeles company from Volition Capital and angel investors.
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.
Latest warning to Humaworm notes findings that FDA inspectors made in July 2019. FDA officials apparently have been in Humaworm’s facility since then, executing a search warrant in October and confiscating encapsulating machines, herbs, capsules, computers, and records.
“Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says. Warning submitted in March said falsifying data was found in making batch release decisions related to whether certain sterile ophthalmic drugs contained viable microorganisms.
Recent US consumer health and beauty product recalls also include three shades of lip moisturizer with sunscreen, made by Pfizer and marketed by GSK due to a packaging problem. A Florida firm recalled one lot of a CBD oil tincture after a state agency’s test found high lead levels.
FTC nearly doubles its total of warnings on false and misleading COVID-19 claims for consumer health products with 50 announced on 21 May. WHO reported the same day that the largest number of COVID-19 cases, more than 106,000, were recorded in any 24-hour period during the pandemic.