Stem Cells Intended for Cosmetic Use Only: Regulation in Belgium, Europe and the United States
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CitationSarah Panis, Stem Cells Intended for Cosmetic Use Only: Regulation in Belgium, Europe and the United States (April 2011).
AbstractThe central question in this paper is whether it is wise to assume that cosmetics are not hazardous, especially in the light of the stem cell hype. Some cosmetics contain stem cell extracts or claim to influence the stem cells in the skin. This paper examines the issue of these “stem cell creams” in three jurisdictions: Belgium, Europe and the United States.
The paper approaches the issues raised by the advent of such products in the following manner: first, the classification problem is discussed. Stem cell creams sometimes fall in a grey area between cosmetics and drugs. When the categorization is only based on claims made of the products, manufacturers can easily evade their responsibilities by manipulating the claims.
The applicable regulations are then analyzed. Although the requirements for drugs are similar in the three jurisdictions, this is not the case with respect to cosmetics. Cosmetics are clearly regulated more strictly in Europe. Finally, a clear overview of the loopholes in the current regulations is offered and some recommendations for change are proposed. The conclusion of the paper is that the discussed stem cell creams might be hazardous and therefore, should be rigorously regulated. Moreover, something as superficial as claims by manufacturer should not be determinative so as to alter the classification of a product. The European model could thus arguably be an inspiration for FDA to base future reforms upon.
Citable link to this pagehttp://nrs.harvard.edu/urn-3:HUL.InstRepos:8784344
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