FDA says product mislabeled, misleading

November 20, 2007

U.S. regulators seized about $2 million of potentially harmful eye products that contain a drug ingredient officials said could lead to decreased vision.

At the request of the U.S. Food and Drug Administration, federal marshals seized 12,682 tubes of Age Intervention Eyelash, a product that may, in some users, lead to decreased vision, the FDA said in a news release. Authorities said the seized tubes could have generated about $2 million in sales.

The FDA said it considered Age Intervention Eyelash an unapproved and improperly branded drug because Jan Marini Skin Research promoted the product to increase eyelash growth. The regulator said it also considered the product to be an adulterated cosmetic because it contains bimatoprost, an active ingredient in an FDA-approved drug used to treat elevated pressure inside the eye.

The FDA said patients taking the prescription drug may have an increased risk of optic nerve damage if they use Age Intervention Eyelash. Because it contains bimatoprost, Age Intervention Eyelash also may cause adverse effects in some people, including macular edema and uveitis.

The FDA recommended that consumers, dermatologists and estheticians discontinue using Age Intervention Eyelash and discard the product.

Copyright 2007 by United Press International

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