Chris White - Comment

Document ID: FDA-2011-N-0770-0005
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: January 23 2012, at 12:00 AM Eastern Standard Time
Date Posted: February 1 2012, at 12:00 AM Eastern Standard Time
Comment Start Date: November 1 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: January 30 2012, at 11:59 PM Eastern Standard Time
Tracking Number: 80fa1d6f
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Thank you for the opportunity to provide feedback to “Cosmetic Microbiological Safety Issues; Public Meeting” [regulations.gov Docket No.: FDA-2011-N-0770, FR Doc No.: 2011-28238]. This response document shall briefly address some of the ethical and safety issues associated with utilitising foreskin-derived ingredients in cosmetic products. Ethical and safety concerns associated with utilitising foreskin-derived ingredients in cosmetic products Circumcision of male minors, in the absence of a clear and present immediate medical indication, is a controversial practice within the medical profession (KNMG 2010; Smith 2011). Foreskins excised from minors in the absence of a clear and present immediate medical indication, almost invariably present in a normal healthy state, and as such their excision and preservation contributes little to the study of the pathology of disease. Further, the most promising advances in the field of cellular regeneration research, are to be found in cell lines derived from adult sources including dental pulp cells (Authur et al 2008), uterine cells (Bock 2011) and bone marrow cells (Wada et al 2011); diagnostic and therapeutic application of patient-derived cells (HHS 2011; Pasca et al 2011); and fetal cells (Hirt-Burri et al 2008; Ramelet et al 2009), rather than cell lines derived from the excised healthy foreskins of minors. Products derived from foreskins excised en masse from minors in the absence of clear and present immediate medical indications, are frequently utilised in the commercial medical product, and more especially cosmetics industries. Sources: http://www.scientificamerican.com/article.cfm?id=a-cut-above-the-rest-wrin http://www.dermagraft.com/about/overview/ http://www.ncbi.nlm.nih.gov/pubmed/18638304

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