'Cosmeceuticals': The Fine (Regulatory) Line Between Cosmetics and Drugs

In January 2008, Jan Marini Skin Research suspended U.S. sales of its product, Age Intervention Eyelash Conditioner, which had been marketed as a cosmetic product that could be used to make eyelashes look longer and increase eyelash growth. The suspension came in the wake of a November 2007 seizure of approximately $2 million worth of the product by U.S. Marshals at the request of the U.S. Food and Drug Administration ('FDA'). According to the FDA, Age Intervention Eyelash Conditioner was an 'unapproved and misbranded drug,' not a cosmetic. The product contained bimatoprost, an active ingredient in Lumigan', an FDA-approved prescription drug for glaucoma that is manufactured by Allergan. (Allergan filed a related patent-infringement lawsuit against Jan Marini Skin Research in November 2007.) Eyelash growth is a reported side effect of Lumigan. See Press Release, 'Approximately $2 Million of Potentially Harmful 'Cosmetic' Eye Product Seized,' U.S. Food and Drug Administration, Nov. 16, 2007, available at www.fda.gov/bbs/topics/NEWS/2007/NEW01746.html; Rhonda L. Rundle, 'Drug That Lengthens Eyelashes Sets Off Flutter,' The Wall Street Journal, Nov. 19, 2007, Page B1; Rhonda L. Rundle, 'Jan Marini Eyelash Product Is Taken Off the U.S. Market,' The Wall Street Journal, Jan. 7, 2008, Page B7.