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.
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 Sen. Lamar Alexander, R-Tenn., chair of the Senate Health, Education,...