On April 18, 2019, the Food and Drug Administration (FDA) published a Federal Register notice announcing that it is extending the comment period for its February 26, 2019, proposed rule that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. As reported in our February 21, 2019, blog item, “FDA Proposed Rule for OTC Sunscreen Drug Products Addresses Sunscreens Containing Nanomaterials,” FDA invites comment on the following topics:

  • Specific nanomaterials or types of nanomaterials that have been used or proposed for use in OTC sunscreen products;
  • Concerns about sunscreen product safety, effectiveness, or quality associated with the use of nanomaterials in OTC sunscreen products, with supporting data;
  • Need for, and proposals of, specifications or limitations for particular nanomaterials for use in OTC sunscreen products;
  • Any particular nanomaterials that you believe should not be permitted for use in OTC sunscreen products, along with supporting scientific information; and
  • FDA’s proposed regulatory approach and/or alternative regulatory approaches to the use of nanomaterials in OTC sunscreen products.

Comments are now due on June 27, 2019.