Cosmetics Adverse Events Under Spotlight In FDA Transparency Push
This article was originally published in The Rose Sheet
FDA’s release of AER data removes some secrecy surrounding cosmetic product adverse events but could create a false alarm about the industry. The data dump comes as Congress is considering legislation that would mandate that cosmetics firms provide FDA with reports of serious adverse events they receive.
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The agency will accept public comment for 60 days on its proposed survey to gain insight into “consumer use of cosmetic products, the frequency of adverse events believed to be caused by allergens in cosmetics, consumer awareness of the problem, and actions (if any) taken to avoid the allergens.”
Interested parties capable of conducting in vivo and in vitro tests "to study alopecia that may be associated with the use of commercially available cosmetic hair products and individual ingredients in these products" must respond to FDA's Sources Sought Notice by Feb. 26.
The Rose Sheet’s coverage of FDA’s warning letter crackdown and data sharing produced some of its most-read stories of 2016, based on online analytics. Legislative proposals and cosmetic safety issues in the US mainstream factored in the agency’s transparency work, a situation that may not repeat in the new year.