FDA's Sunscreen Data Guidance Lacks Risk/Benefit Balance

FDA's Sunscreen Data Guidance Lacks Risk/Benefit Balance – Stakeholders

25 Feb 2016

FDA's proposal that sunscreen ingredient sponsors seeking GRASE status conduct maximal usage trials to assess potential for systemic absorption will delay consumer access to new broad-spectrum sunscreens without a sound scientific basis, PASS says in comments on FDA draft guidance. The American Cancer Society and American Academy of Dermatology Association express similar concerns.

Industry, physician and public health advocates agree that FDA's draft guidance on data needs for sunscreen ingredient GRASE determinations is overly focused on risks relative to benefits, potentially shortchanging consumers at a time of soaring skin-cancer rates.

FDA extended the comment deadline and was pointed about soliciting feedback regarding its draft guidance “Over-the-Counter Sunscreens: Safety...