The U.S. Food and Drug Administration cleared an Iowa hand sanitizer company of making misleading claims about its product’s ability to “mitigate, prevent, treat, diagnose, or cure COVID-19.”
Prefense LLC, of Muscatine, faced an April 23 FDA complaint that made the company the nation’s first manufacturer to get an FDA warning letter claiming the firm marketed a hand sanitizer with unproven COVID-19-related claims.
“We appreciate the steps Prefense has taken to bring its products into compliance,” Carolyn Becker, of the FDA, wrote in a Monday, May 18, letter to the company. Becker is director of the Office of Unapproved Drugs and Labeling Compliance.
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“Based on a review performed on May 15, 2020 of the Prefense website www.prefense.com and social media sites, it appears that your previous claims that the Prefense Hand Sanitizer product line is effective in preventing infection or disease from specific pathogens such as the novel coronavirus that causes COVID-19, as well as your previous time-specific extended efficacy claims, have been removed,” the one-page letter stated.
Prefense had told the FDA that it had seen distributors of its product making some claims that Prefense ordered taken down in mid-March. The FDA cited Prefense for illegal labeling of its sanitizer because it had links to the distributors’ websites. Additionally, the FDA cited Prefense for social media posts that the company took down, although it disputed whether or not the posts made false claims.
“Prefense is certainly pleased – and relieved – that the FDA acknowledges we are in full compliance,” Prefense board member and secretary John Patchett said. “We’re moving full-steam ahead with the same formula and same pricing since we launched our product in 2009, and look forward to meeting our customers’ needs in the U.S. and globally as well.”
Prefense is a small, private company founded in 2008. It has seven employees.
The FDA complaint had said people using the company’s sanitizer might get a false impression that they don’t have to rely on measures like social distancing or good hygiene that curb COVID-19’s spread.
Prefense’s attorney had requested that the FDA post an April 24 company response on the agency’s website alongside a link to the complaint. The FDA will not do that but will note on the website that Prefense has taken appropriate corrective action, Becker wrote in the May 18 letter to the company. FDA procedures give it the right to determine whether or not to post warning letter responses, Becker wrote.
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This story was published by The Gazette (Cedar Rapids, IA) and Des Moines Register under IowaWatch’s mission of sharing stories with media partners.