FDA Strengthens Sunscreen Testing And Label Requirements
This article was originally published in The Rose Sheet
As early as June 2012, sunscreens that fail “broad spectrum” tests or have an SPF less than 15 must warn that they have not been shown to prevent cancer or early skin aging, according to an FDA final rule.
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SPF claims would be capped at SPF 60+ under FDA’s proposed rule, and companies would be required to label products using the lowest SPF measured in testing and maintain test records that would be accessible to FDA during inspections. The proposal also includes new broad-spectrum requirements, among a host of other changes.
The nonprofit publication’s 2018 sunscreen ratings and buying guide reflect its own SPF testing in which a third of sunscreens again underperformed dramatically compared with labeled SPFs. Low-scoring brands may face a new wave of false-advertising litigation, with many related suits still pending in federal and state courts.
FDA’s 2016 request for contractor services to perform SPF testing on US-marketed sunscreen products has come up in litigation challenging brands’ SPF claims. The agency told Rose Sheet the issue of accurately labeled SPFs is a concern, but declined to provide further update on what it characterized as a pending matter.