FDA Warns Imprimis for False and Misleading Website and Twitter Promotions

Posted 16 January 2018 | By Zachary Brennan 

FDA Warns Imprimis for False and Misleading Website and Twitter Promotions

The US Food and Drug Administration (FDA) late last month sent a warning letter to San Diego-based Imprimis Pharmaceuticals for false and misleading claims made on the company’s website and Twitter account, among other violations.

FDA said that for two products – "Simple Drops" and "Klarity C-Drops" – the company claims they are made with FDA approved components or are FDA-approved, "when that is not the case." 

In addition, FDA said Imprimis' website makes false or misleading claims about its "Dropless," "LessDrops" and "Simple Drops" products by "omitting important risk information, including side effects, contraindications, or consequences that may result from their use, and by presenting efficacy claims about your ‘Simple Drops’ products while omitting material information."

FDA said in the letter released Tuesday: "These violations are concerning from a public health perspective because they create a false or misleading impression about the safety and effectiveness of these products.  This is especially concerning in light of the many known risks associated with several of the active ingredients in these products, as reflected in the prescribing information for FDA-approved products containing the same active ingredients."

Imprimis Founder and CEO Mark Baum, whose Twitter account appears to no longer exist, is also called out in the letter for tweeting a suggestion that the company’s compounded cyclosporine product – "Klarity-C drops" -- is FDA approved, but the product is not approved.

The company did not respond to a request for comment.

Warning Letter

Categories: Regulatory News

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