Sunscreen Data Guidance Risk/Benefit Balance Uneven – Comments

FDA's suggestion of maximal use trials to assess the systemic absorption potential for proposed sunscreen ingredients will delay consumer access to new broad-spectrum sunscreens without a sound scientific basis, say PASS, the American Cancer Society and American Academy of Dermatology Association.

FDA's draft guidance on data for sunscreen ingredient GRASE determinations overly focuses on risks relative to benefits, potentially shortchanging consumers at a time of soaring skin cancer rates, according to manufacturers, physicians and public health advocates.

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