Wednesday, December 12, 2007

$2 Million of Potentially Harmful Cosmetic Eye Product Seized by FDA

In mid-November the FDA issued a press release announcing the agency's seizure of Age Intervention Eyelash, which is sold and distributed by Jan Marini Skin Research, Inc. The FDA stated that it considered the product a misbranded drug for which a prior showing of safety and efficacy must be shown to- and approval obtained by- the FDA BEFORE marketing. The FDA also considered the product to be an adulterated cosmetic, as it contains a nasty thing called "bimatoprost."

These guys apparently didn't do what they were supposed to, instead calling the product a "cosmetic" for which prior FDA approval before marketing is not required; however, the company was still charged with adequately substantiating for safety before selling the product as a cosmetic.

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