Regulatory Review: The Proposed Amendment for Sunscreen Products in the United States

On Aug. 27, 2007, the US Food and Drug Administration (FDA) published the long-awaited Proposed Rules (PR) for sunscreens in the Federal Register, which can be found at: This column reviews some of the changes included in the amendment, citing pages of this document to provide additional details.

On May 21, 1999, the FDA issued the Final Monograph (FM) for Sunscreen Drugs2 in order to comply with the 1997 Food and Drug Administration Modernization Act mandating an FM no later than 18 months after the Act’s passage. This FM went into effect May 21, 2001, but the FDA deferred UVA labeling and testing for future action. On June 8, 2000, the FDA extended the compliance date of the FM to Dec. 31, 2002, to allow time for the FDA to issue rules for UVA labeling and testing. Upon reaching the December 31 deadline, the FDA furthered stayed the issuance of these new rules. Finally on Sept. 3, 2004, the FDA issued an indefinite stay until the rules were issued. Each succeeding year, the FDA issued failed to meet target dates. Finally, in August 2007, they were issued.

It is important to note that these are only proposed and not final rules. Currently, companies that place sunscreens on the US market can comply either with the old rules stated in the FM, or with the newly proposed rules in their entirety—companies cannot cherry-pick parts from the two sets of rules with which to comply or they risk severe repercussions from the FDA including inspections, warning letters or even seizure of goods since the products would be deemed as misbranded.

More in SPF/Sun