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FDA Divulges Cosmetics Enforcement Data, Notes Hair Loss As ‘Serious’ AE

 
• By Lauren Nardella

Momentum this year behind legislative proposals for cosmetics regulatory reform has prompted key Congress members to question FDA about the current oversight system. In a response to the Senate HELP Committee’s chairman, FDA provides a wealth of data on its enforcement activities and confirms hair loss as an adverse event it considers “serious,” if not one currently identified as such by MedWatch’s definition.

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FDA says 30% of the 2,128 cosmetic adverse events reported to the agency from FY 2011 through FY 2015 were “serious” – a classification that covers hair loss, it notes amid abiding concerns over WEN safety issues.

AE numbers are included in a bonanza of statistics provided by FDA in a letter responding to questions posed by...

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More from Regulation

ECHA Adds Two Cosmetic/Personal Care Silicones To REACH Candidate List

 
• By Eileen Francis

ECHA has added two silicone ingredients used in cosmetics and personal care products to the REACH Candidate List as they are persistent and have bioaccumulative properties, requiring companies to notify customers and update safety data sheets if concentrations exceed 0.1%.

MoCRA Implementation Delay Creates More Legal Exposure For Stakeholders – Attorney

 
• By Eileen Francis

The delay in implementation of MoCRA is seen by many companies as a temporary reprieve, but it does create more legal uncertainty, says attorney Marissa Alkhazov of law firm Buchalter.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

Animal Studies Would Not Provide ‘Meaningful Insights’ Into UV Filter Safety - Study

 
• By Lauren Nardella

A new study on the safety of sunscreen filters relies on an alternative assessment methodology and concludes that six sunscreen UV filters are unlikely to be carcinogenic.

More from Policy & Regulation

MoCRA Implementation Delay Creates More Legal Exposure For Stakeholders – Attorney

 
• By Eileen Francis

The delay in implementation of MoCRA is seen by many companies as a temporary reprieve, but it does create more legal uncertainty, says attorney Marissa Alkhazov of law firm Buchalter.

California Legislators Advance Bill To Ban Plastic Glitter, Abrasive Microbeads In Personal Care

 
• By Lauren Nardella

Lawmakers in California heeded calls from industry to change proposed legislation to avoid a wider ban on microplastics in personal care products.

EPR Alert! Unregistered Producers In Colorado No Longer Permitted To Sell 1 July

 
• By Eileen Francis

Packaging producers subject to Colorado’s Extended Producer Responsibility program that have not registered with the organization running the program will no longer be able to sell in the state starting 1 July.