FDA warns Purell to STOP claiming its hand sanitizer can kill flu and Ebola
- Purell makes suggestions on its ‘frequently asked questions’ page that its hand sanitizers can kill viruses like the flu and Ebola
- The FDA this month said that its claims that the hand sanitizers are antiseptics make them unapproved drugs
- Purell formulas are made of about 70% ethyl alcohol
- While this alcohol content can kill many bacteria, a 90% alcohol formula is needed to kill most viruses
- The FDA has demanded that Purell stop making unproven claims about its products
- The agency said Purell’s hand sanitizers qualify as ‘drugs’ but have not been approved
US regulators are demanding that Purell stop telling consumers that its hand sanitizers can kill viruses like flu and Ebola.
The Food and Drug Administration (FDA) issued an an exhaustive warning letter to GOJO Industries, the maker of Purell products.
In addition to its insistence that Purell stop making ‘false claims’ about its products, the FDA said that Purell’s alcohol products qualify as drugs – but have not been approved for their advertised uses by the FDA.
Purell is far and away the most popular brand-name hand sanitizer in the US – but so long as it claims to use alcohol for the ‘mitigation…or prevention of disease,’ it is also distributing a drug illegally.
The FDA has hit out at Purell for claiming its hand sanitizer can kill viruses like flu and Ebola, uses that the popular disinfectant is not approved for in the US
The claim is all over Purell’s bottles, branding, website, and product descriptions: ‘Proven to kill 99.9% of germs on the hands.’
It’s a bold and reassuring claim – especially in the midst of disease outbreaks like the ongoing global spread of coronavirus.
Even the Centers for Disease Control and Prevention (CDC) recommend using hand sanitizer if soap and water are not available.
But being better than using nothing to get rid of illness-causing germs on your hands is not the same thing as being proven to kill them.
In a delicate attempt to suggest that Purell can kill viruses without stating it as fact, Purell has a carefully worded section in its FAQs, and pits the FDA against the CDC.
‘The FDA does not allow hand sanitizer brands to make viral claims,’ Purell’s website says.
It then makes a maneuver that makes a step-wise justification
‘But from a scientific perspective, influenza is an enveloped virus. Enveloped viruses in general are easily killed or inactivated by alcohol.
‘The World Health Organization (WHO) and the Center for Disease Control and Prevention (CDC) are recommending the use of alcohol-based hand sanitizer as a preventive measure for flu prevention.’
The CDC’s website says that disinfectants with concentrations between 60 and 80 percent are ‘potent’ at ‘inactivating all the [enveloped] viruses,’ and lists influenza as an example of these viruses.
However, that’s not a claim that’s proven in the FDA’s eyes, so advertising it presents a problem for the regulatory body.
And, if that weren’t reason enough to hit out at Purell, ethanol alcohol is designated a drug under one of the FDA’s ‘Pharmacopia’ compendiums of ingredients and compounds that require regulation.
So now, Purell is facing a one-two punch in the warning letter.
Its parent company, GOJO, has 15 days from when the January 17 letter was sent to explain to the FDA what actions its going to take to make sure that it complies with the agency’s regulations and isn’t making false claims.