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Germstar Hand Sanitizer

Company takes down some infection prevention claims in wake of FDA warning letter.

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Germstar Hand Sanitizer

Who needs a doctor when you have Germstar hand sanitizer, advertised, until recently, as an effective method to prevent infection from norovirus, swine flu and other illnesses?

The answer is you (so don’t break up with your doctor just yet) because as a recent FDA warning letter to Germstar’s parent company, Soaptronic, shows, the company lacks the required FDA approval to make such drug claims. Which is why the infection prevention claims cited in the warning letter no longer appear on the website.

Before (claims at issue shown in underlined text):

After:

More evidence of the impact of the FDA warning letter can be found on an FAQ page where, in response to whether Germstar can kill “99.99% of harmful germs,” the company confusingly says (emphasis added):

Yes! Germstar Hand Sanitizer products are tested against a broad range of micro-organisms and have resulted in 99.99% reduction of those organisms. It is prohibited by the Food and Drug Administration for manufacturers to make viral reduction claims.

So, on the one hand, Germstar can kill virtually all harmful germs, but on the other hand, the company can’t tell you Germstar reduces viruses caused by harmful germs.

Back on the homepage, instead of explicitly claiming its product can prevent the coronavirus, Germstar shares links to learn more about the virus from the FDA and CDC, arguably implying a connection between its products and the deadly disease.

So has the company learned its lesson? That may remain to be seen.

The FDA has also sent a warning letter to hand sanitizer giant Purell citing some of the same types of infection prevention claims. Purell also faces a class-action lawsuit.

Find more of our health coverage here.


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