The distinction between a cosmetic and a drug is important from a regulatory and safety perspective because, among other things, a cosmetic should not contain pharmaceutical active ingredients (AIs). Otherwise they are classified as a drug according to European Commission’s No. 1223/2009 and the U.S. FDA’s regulations on Cosmetics.
In this webinar, we describe a study of several cosmetic products that contained prohibited pharmaceutical AIs such as corticosteroids. Several samples tested positive for prohibited skin lightening agents. Packaging labels were often misleading, and in some cases, the skin lightening agent was not listed on the enclosed product information increasing the potential of improper long-term use and adverse side effects to consumers.
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Selected samples were first screened using a DART source coupled with mass detection. Results observed were confirmed using UHPLC with MS and PDA detection. In addition a workflow for component identification using a database is demonstrated using high resolution mass spectrometry and comprehensive informatics tools. This method could be used in the routine analysis of cosmetics to screen for skin lightening agents to ensure that they meet regulatory and safety standards.
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