FDA Extends Deadline for New Sunscreen Labels/Tests

The Food and Drug Administration's (FDA) has extended the compliance dates for the sunscreen labeling and testing requirements.

The 2011 Sunscreen Final Rule had separate compliance dates for large and small volume manufacturers. Both dates are being delayed by 6 months, according to a statement from FDA.

For OTC sunscreen products with annual sales of $25,000 or more (which are the majority of the sunscreen market), FDA has extended the compliance date from June 18, 2012 to December 17, 2012.

For OTC sunscreen products with annual sales of less than $25,000, the compliance date has been extended from June 17, 2013 to December 17, 2013.

The official notice of the delayed compliance date is to be published in today's Federal Register, May 11, 2012.

According to an FDA spokesperson, after reviewing the timeline, FDA concluded that although some manufacturers have already implemented the new testing and labeling requirements for some products, others would be unable to complete implementation of the final rule by the original compliance dates for all products.

FDA was concerned that manufacturers who anticipated not being able to complete the broad spectrum testing and product relabeling before the original compliance date might decide to entirely discontinue, at least for the short term, their sunscreens with broad spectrum ingredients, even though many of these products can be expected, ultimately, to pass the final rule’s new broad spectrum test.And, FDA said it was concerned that manufacturers might decide to continue to market these broad spectrum sunscreen products, but remove all the broad spectrum labeling claims from the products.

Extending the compliance date would reduce the risk of having large quantities of peak “sun season” inventory to be out of compliance with the final rule once the compliance deadline takes effect. FDA concluded that this could result in denying consumers valuable broad spectrum labeling information and possibly limiting the quantities of sunscreens currently available in the marketplace, at least in the short term.

Extending the compliance date reduces the risk of having large quantities of peak “sun season” inventory to be out of compliance with the final rule once the compliance deadline takes effect.