Sen. Feinstein’s Cosmetics Safety Bill Launches With GOP Cosponsor
This article was originally published in The Rose Sheet
The Personal Care Products Safety Act would preempt duplicative state-level requirements for ingredient use and manufacturer responsibilities, addressing what has become one of the foremost banes of industry in recent years, while increasing FDA’s authority over the sector and giving it new responsibilities with regard to ingredient safety review. Additional compliance requirements for industry could prove challenging, but the positive PR likely to result from the legislation could help soften the blow.
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With the release of an atypically lean, clean FDA user-fee reauthorization draft bill, it’s doubtful that cosmetics regulatory reform language will get tacked onto the must-pass legislation. Stakeholders likely will refocus their efforts on standalone cosmetics legislation to modernize FDA’s oversight of the industry.
Compared with the Cosmetic Ingredient Review, FDA could consider a wider selection of data in its ingredient safety evaluations under the Personal Care Products Safety Act, an FDA official says. Further, industry would have the burden of demonstrating reasonable certainty of no harm, a high bar to clear.
In a letter to FDA leadership, Sen. Lamar Alexander, R-Tenn., asks the agency to explain its current regulatory authorities over cosmetics and limitations under current law, as well as how it handles adverse-event reports and takes action against non-compliant products. Alexander chairs the Senate HELP Committee and raised concerns at a recent hearing about FDA’s response to WEN.