Michael Todd, ‘Where Science Meets Nature,’ Meets FDA Warning Letter
This article was originally published in The Rose Sheet
Port St. Lucie, Fla.-based firm’s Intensive Eye Treatment and Knu Anti-Aging Face Lift Serum are unapproved drugs based on claims featured online, FDA says. The July 18 warning letter, posted to the agency’s website Aug. 16, was one of at least 10 that issued to skin-care companies in July.
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Add Menscience Androceuticals, La Bella Figura and Healing Scents to the list of skin-care marketers hit with FDA warning letters in July. The agency’s policy is to wait for warning letter recipients to acknowledge receipt before posting the communications to its website.
At least nine skin-care marketers received FDA warning letters in July for unapproved drug claims. In the month’s final two weeks, recipients included companies behind the Freeze 24-7 Instant Targeted Wrinkle Treatment and a Resurgent Stem Cell Firming Activator, among others.
The Committee on Energy and Commerce of the US House of Representatives has requested a set of documents from the FDA in order to assess whether the agency is doing enough to address the challenge of approving complex generics within its existing authorities, or whether additional authority is needed.