Hand Sanitizer Claims Flagged by FDA via Happi

The US FDA has sent Prefense LLC, Muscatine, IA, a warning letter for offering Prefense Hand Sanitizers for sale in the United States that it said were intended to mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases in people.

The agency reviewed the company’s website (www.prefense.com) on April 6, 2020 and its social media sites (Twitter and LinkedIn) as well as links from other websites (www.safety-med.com, www.mdsassociates.com, and www.apollosafetyproducts.net).

Based on that review, FDA said the products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).

Some of the laims that were flagged by FDA included:

• “We hate to say it, but coronavirus is in the U.S. and close to home in Chicago. Nasty stuff but that’s why the best defense is Prefense!” [from a January 24, 2020 post on your Twitter webpage at https://twitter.com/prefense]
• “Coronavirus now a global emergency! . . . Be safe out there – the best defense is Prefense hand sanitizer – up to 24 hour protection from one application – it works when it dries!” [from a January 30, 2020 post on your Twitter webpage at https://twitter.com/prefense]
• …

Based on the above claims, FDA says Prefense Hand Sanitizers are drugs and that Prefense Hand Sanitizers are intended for use as both consumer and health care personnel antiseptic rubs.

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Published the 30 April 2020