A nasal spray claiming to provide up to eight hours of protection from diseases including COVID-19 has stepped back from the assertion after being warned by regulators.
Bottles of CofixRX Nasal Spray — sold in 800 U.S. pharmacies for $24.95 each —made the bold suggestion when they first went on sale.
They quickly caught the attention of local media, with some outlets reporting the drug could be a potential defense against the virus.
But the company quietly removed the claim this month after the Food and Drug Administration (FDA) accused it of selling a ‘mislabeled’ and ‘unauthorized’ product.
These types of sprays have emerged are marketed as a potential way to avoid a Covid infection, although none have been proven to work.
The above pictures show the spray on the website before the FDA threatened to pull it from shelves (left) and afterwards (right). It reveals that the up to eight hour protection claim has been removed, and a phrase added at the top saying the spray may not prevent an infection
CofixRX is sold at more than 800 pharmacies across the US (pictured) for about $24.95 each. Pharmacists say it is a best-seller locally
Nasal sprays for preventing infections with respiratory viruses — including Covid — are gaining popularity in the U.S. as a quick way to protect someone for infection.
But the FDA is yet to have authorized a single one for use in preventing a Covid infection.
Unapproved nasal sprays are allowed to be sold, though, as long as they do not make false claims or use drugs that are only available via prescription.
The CofixRX Nasal Spray was developed by eight doctors in Detroit, Michigan, who claimed it was ‘highly effective’ against Covid.
One pharmacist in the state told local news that over the first three months he stocked the spray it became a ‘best-seller’.
Bill Lemanski, owner of Notre Dame Pharmacy in Grosse Pointe, Michigan, less than ten miles east of Detroit, told ABC: ‘I’ve got repeat buyers, especially the grandmothers and the mothers who are buying it for their kids at school.’
Do nasal sprays work against Covid?
A number of nasal sprays are currently being developed to treat people who test positive for Covid.
Some are also being looked at as a way of preventing an infection.
However, none have been approved for stopping a Covid infection by the FDA at present.
Evidence on how well they work has been patchy, with few subjected to rigorous trials.
One trial on a nasal spray in Tel Aviv, Israel, last year however suggested that they could protect people from catching Covid.
Scientists monitored more than 250 Orthodox Jews at a religious gathering.
Of the 81 attendees who used the spray every five hours, none caught Covid. But of the rest 16 did, including two who failed to follow the proper dosing regimen for the product.
Manufacturers claim the nasal spray can kill Covid because it contains povidone-iodine, commonly used in hospital wipes to prevent infections.
But it was never tested in human trials before being rolled out in pharmacies, and there is no evidence to suggest it can stop someone catching the virus.
The FDA warned the company earlier this month to ‘cease the sale’ of its nasal spray claiming to help protect against Covid.
They said the nasal spray may give users the ‘false impression that they need not rigorously adhere to interventions such as social distancing… that have been demonstrated to curb the spread of Covid’.
They added: ‘Users who do not follow these interventions are at increased risk for contracting Covid and for spreading disease if they have been exposed to the virus, thereby prolonging the pandemic and increasing its associated morbidity and mortality.’
Since receiving the letter CofixRX has removed the up to eight hour claim from its product packaging and website.
However, one picture displayed online still carries the claim.
CofixRX has also removed a phrase stating: ‘The active ingredient in CofixRX, Povidone-iodine, is FDA approved to be used in over the counter products.’
And they have taken down another sentence saying the product uses ‘patent-pending technology’ that is ‘effective 45 second after application’.
A newly-added notice on the CofixRX website above a picture of the nasal spray reads: ‘Not intended to mitigate, prevent, treat, diagnose, or cure COVID-19 or other viruses.
‘Not intended to be a substitute for vaccines or other approved therapeutics.’
Infectious disease experts have previously raised concerns over CofixRX’s claims that its spray could prevent a Covid infection.
Dr Luis Ostrosky, who specializes in diseases at UTHealth Houston in Texas previously told Fox News 26: ‘I don’t think there’s any data to recommend (this product) as a primary prevention measure (for Covid).’
‘The ingredient that they list is Povidone-iodine which is a very common antiseptic used in healthcare.
‘There’s laboratory evidence that this antiseptic kills Covid and other viruses, but there’s no clinical data that is in patients that have been exposed to Covid to show that it actually prevents it.’
The above show the website before (left) and after (right) the FDA got in touch. The green box on the website has been removed
The company has also removed a sentence saying that the product contains an ingredient that is FDA-approved. The regulator warned this could give the impression that the product had been approved by them, which was not the case
This is not the first time nasal sprays claiming to protect people from Covid have fallen foul of US authorities.
Last year Xlear was accused of promoting its nasal spray as an effective treatment for Covid without any evidence by the Federal Trade Commission.
They said the company had used unsubstantiated claims to promote the product on its website, social media and in magazines.
This included a claim that it could protect people against Covid for up to four hours.
The FDA told DailyMail.com that it was not able to comment on discussions it was having with companies.
CofixRX said it took the FDA’s warning ‘very seriously’, and was ready to work with all parties to make sure its packaging was ‘never misleading’.
A spokesman said: ‘CofixRX Nasal Spray is a safe and scientifically proven over-the-counter povidone-iodine nasal spray developed by a team of eight board-certified doctors determined to provide an easily accessible way to combat germs and pathogens.
‘CofixRX Nasal Spray is designed to provide an additional layer of protection against exposures to reduce the likelihood of infection or transmission.’
They added: ‘Independent research from Utah State University’s Institute for Antiviral Research tested the CofixRX Nasal Spray and the scientific results proved the product to be highly effective at inactivating the SARS-CoV-2, the flu and common cold viruses.’