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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.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.