If mandatory reporting of serious adverse events is in the cosmetics industry's future, the dietary supplement industry's experience in recent years offers a preview of what companies could be in for.
Mandatory AE Reporting In Supplement Space Offers Glimpse Of Possible Cosmetic Future
Reports of serious adverse events in the dietary supplement industry have increased exponentially since reporting was made mandatory in 2008, and FDA warning letters citing failures to report have been on the rise as companies labor to keep up with investigations and reporting duties. Similar challenges could lie ahead for the cosmetics industry under proposed bills in the US House and Senate.
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The Washington State Department of Ecology publishes ‘Interim Policy on Lead in Cosmetics’ which provides safe harbor options for cosmetic products struggling with the 1ppm limit under the state’s Toxic Free Cosmetics Act, while the department gathers information under a newly opened rulemaking to ‘identify a feasible approach to regulating lead in cosmetic products.’
The Washington Department of Ecology hasn’t backed down on its targeting of formaldehyde-releasing preservatives under the state’s Toxic-Free Cosmetics Act, as industry still awaits a draft final rule. In a recent webinar, attorney Angela Deisch of Amin Wasserman Gurnani, LLP said the department has also not provided clarity on penalties under the law, which goes into effect 1 January.
The FDA's current leader, whose term will end with Donald Trump’s second inauguration, also described three qualities the agency’s next commissioner will need to succeed, including "believing that there is such a thing as expertise."
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