CU comments on sunscreen drug products for over-the-counter human use

November 26, 2007

Division of Dockets Management (HFA-305)
U.S. Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Via: http://www.regulations.gov
Via fax: (301) 827-6870
Comments of Consumers Union of America
to the Food and Drug Administration
21 CFR Parts 347 and 352
“Sunscreen Drug Products for Over-the-Counter Human Use; Proposed
Amendment of Final Monograph”
Proposed Rule
Docket No. 1978N-0038
RIN 0910-AF43

Introduction

Consumers Union (CU), non-profit publisher of Consumer Reports and Consumer Reports Online, submits the following comments in response to the Food and Drug Administration’s (“FDA” or “Agency”) proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph” (Proposed Rule).

Summary

In general, CU supports the Proposed Rule, and the potential for many of the proposed changes to spur better-informed and safer use of sunscreens by consumers. We urge the FDA to act quickly to finalize the proposed changes, and we strongly urge the agency to take a proactive approach, and require labeling (i.e., disclosure when
products contain nano-sized particles) and testing of sunscreens that use nano-sized ingredients. Our specific comments and recommendations are detailed below:

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