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FDA sends warning letter to hand sanitizer company over coronavirus claims following I-Team investigation

FDA says Durisan falsely claimed its product prevents COVID-19
Durisan-hand-sanitizer.jpg
Posted at 10:16 PM, May 11, 2020
and last updated 2020-05-11 22:19:18-04

SARASOTA, Fla. -- An I-Team Investigation has prompted federal action against a Sarasota-based hand sanitizer company.

Two days after I-Team Investigator Kylie McGivern’s report last month, questioning Durisan about its alcohol-free hand sanitizer, the FDA started looking into the company.

PREVIOUS COVERAGE: Governor DeSantis touted alcohol-free hand sanitizer not recommended by the CDC

The feds now say Durisan falsely claimed its hand sanitizer prevents the spread of coronavirus.

The CDC recommends hand sanitizers with at least 60 percent alcohol to be effective against the coronavirus. But Durisan’s hand sanitizer has no alcohol.

After reviewing Durisan’s website and social media, the FDA issued a warning letter on Thursday, ordering the company to take immediate action to stop selling its “unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis or cure of COVID-19.”

Back in March, Governor Ron DeSantis plugged Durisan’s hand sanitizer during a news conference, saying he keeps the product on his desk.

“I think because these aren't what people look for and so Amazon was able to deliver these. So Durisan -- I don't know where it comes from -- but it's pretty good stuff,” said DeSantis in the news conference.

The I-Team asked the the governor’s office for comment about whether he still uses Durisan.

A spokesperson would only say, “Governor DeSantis uses various alcohol-based products and hand hygiene practices recommended by the CDC to combat COVID-19. The most effective is hand washing with soap and water for 20 seconds. The DeSantis administration respects and follows the guidelines and recommendations made by the CDC and Food and Drug Administration.”

In its warning letter, the FDA said time-specific extended efficacy claims, like Durisan’s claim to kill 99.9% of illness causing germs for up to 24 hours, “endanger the public health by creating a false sense of security for the general public.”

On Thursday, the FDA gave Durisan 48 hours to take corrective action.

A spokesperson for Durisan sent the following response to the I-Team:

“We have reviewed the FDA’s official letter dated May 7, 2020 and immediately took action to remove the sections on both our website and in our social media cited by the administration. We completely support our valued customers during this time – and at all times – and therefore take seriously our responsibility to inform the public in a consistent and factual manner.

We do believe in our product and the science behind it, and should note that we have been around for nearly half a decade, and the active ingredient in our products, BZK, is used in dozens of household brands for both cleaning and hand sanitizing.

Moreover, we comply with all FDA labeling guidelines for our products – every label we use has been previously reviewed by the FDA. We manufacture all of our products in an FDA-compliant facility and comply with all EPA testing and regulations for our sanitation products. Finally, we regularly and routinely ship samples of our products to external labs to ensure quality control is met and that the products we sell are maintaining both safety and efficacy at compliant levels.

Finally, we should note that no hand sanitizer or surface disinfectant on the market today can truthfully claim to kill novel coronavirus SARS-CoV-2, as both virus samples and test protocols are currently being developed and have not yet been made available to the industry.”

We’ve included a full list of companies that have received warning letters from the FDA for selling fraudulent products claiming to prevent or cure COVID-19 here.