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The Expanding “Cosmeceutical” Conundrum: The Growing Need for Heightened FDA Regulations in the Face of Modern Day Cosmeceuticals

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2011

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Minsun Lee, The Expandin “Cosmeceutical” Conundrum: The Growing Need for Heightened FDA Regulations in the Face of Modern Day Cosmeceuticals (April 2011).

Abstract

The popularity and prevalence of cosmeceutical products is growing at an unprecedented rate both domestically and abroad. In the United States, cosmeceuticals are typically regulated as cosmetics even though these products often offer drug-like benefits. As the efficacy claims, technology and science used in these products continues to advance, the application of the pure cosmetics regulatory scheme under the FDCA grows increasingly problematic. This paper aims to discuss why the existing legal system is ill equipped to properly monitor the modern cosmeceutical industry and it attempts to suggest possible ways to improve the oversight of these products. Part I sets the stage by examining the current cosmeceutical industry. Part II reviews the historical and current regulatory framework of both cosmetics and drugs. Part III looks at two modern day cosmeceuticals, eyelash growth products and anti-age creams with stem-cell technology, to further analyze why existing regulations are insufficient to protect consumers. Part IV proposes several possible modifications to the current regulation of cosmeceuticals, ultimately recommending the creation of a new cosmeceuticals category under the FDCA. Part V concludes.

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cosmetics

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