FDA Responds to EWG Sunscreen List

Posted: June 29, 2007

The US Food and Drug Administration (FDA) recently released a statement in response to the Environmental Working Group's (EWG's) sunscreen report that claimed the FDA fails to set meaningful sunscreen standards...

The US Food and Drug Administration (FDA) is currently working on regulations for over-the-counter (OTC) sunscreen drug products that would address, among other things, UVA testing and SPF labeling issues. The regulation is currently in its final clearance.

Depending on its ingredients, a sunscreen product in the United Stated is regulated under either the new drug approval process, or under the OTC Drug Review ("monograph" system). Most sunscreens are regulated under the OTC monographs. The final monograph for sunscreen products was issued in May 1999 and can be found at: www.fda.gov/cder/otcmonographs/Sunscreen/sunscreen_FR_19990521.pdf

This final monograph is based on a previous series of proposals for which the FDA sought comment as early as 1978 and it specifies the ingredients allowed in sunscreens, testing requirements and labeling. This rule provides for SPF testing and "broad spectrum protection" labeling for products that absorb both UVA/UVB rays.

The FDA believes that approved sunscreens are safe and effective when used as directed. Sunscreens are an important part of a person's total sun protection strategy, but sunscreen use alone will not prevent all of the possible harmful effects due to sun exposure, according to agency statements. For more information, log on to the FDA Web site: www.fda.gov/cder/Offices/OTC/understanding_spf_sunscreen.htm