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'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.
The seized product is just one example of a fast-growing group of products known in the cosmetics industry as 'cosmeceuticals' ' cosmetic products that have medicinal or drug-like benefits. The market for cosmeceuticals is huge. According to Datamonitor, the total European and U.S. market for cosmeceuticals stands at $8.2 billion. The United States is the largest cosmeceutical market, reaching $4.2 billion in 2006 after strong annual growth of 6.7% between 2001 and 2006. Similar growth is expected between 2006-2001. See 'Meeting Beauty and Wellness Needs Through Cosmeceuticals: Solving Specific Beauty and Personal Care Problems for Premium Consumers,' April 4, 2007, available at www.datamonitor.com. Search for 'Cosmeceuticals' to find the article.
Manufacturers that try to capitalize on the U.S. market for cosmeceuticals, however, face regulatory challenges and uncertainty. While the FDA has the authority to regulate cosmetics and drugs in interstate commerce under the Federal Food, Drug and Cosmetic Act of 1938, 21 U.S.C. '301, et seq., ('FDCA'), it does not recognize the term 'cosmeceutical.' See Fact Sheet, 'Cosmeceutical,' U.S. Food and Drug Administration, Feb. 3, 1995, revised Feb. 24, 2000, available at www.cfsan.fda.gov/~dms/cos-217.html. According to FDA, '[a] product can be a drug, a cosmetic, or a combination of both, but the term 'cosmeceutical' has no meaning under the law.' See Fact Sheet, 'Is It a Cosmetic, a Drug, or Both?' United States Food and Drug Administration, July 8, 2002, available at www.cfsan.fda.gov/~dms/cos-218.html.
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