12.14.12
The US Food and Drug Administration's Final Rule on Sunscreens goes into effect Dec. 17, 2012. For sunscreen products marketed under the OTC Monograph System, the compliance date for products with sales of $25,000 or more is Dec. 17, 2012.
For sunscreen products marketed under the OTC Monograph System with sales of less than $25,000 the compliance date is Dec. 17, 2013. The long-awaited Rule should not be confused with the illusive Final Monograph that has yet to be issued. The process leading to this point has been lengthy, and while this occasion marks a new stage, we are far from finalizing all outstanding issues.
According to Nadim Shaath, president, Alpha R&D, the Final Rule means that most OTC sunscreen products introduced or delivered for introduction into interstate commerce, on or after Dec. 17, 2012, must comply with the testing and labeling requirements of the Sunscreen Final Rule published June 17, 2011.
The three most significant changes in the labeling requirements are with “broad spectrum” protection and the new requirement that the SPF must be above 15 to qualify as a sunscreen in order to make the claim that “sunscreen reduces the risk of skin cancer and early skin aging when used as directed,” and the changes in the requirement of the Drug Facts box, according to Shaath.
However, FDA still requests comments on the possible warnings and direction for spray usage and issues regarding dosage forms. Spray safety and SPF 50+ labeling are still subject to finalization pending the outcome of the comments period and evaluation.
According to the ANPR, towelettes and powder products are not eligible for consideration under the pending OTC Sunscreen Monograph and would therefore be subject to regulatory action. FDA does not currently consider these products covered by the OTC Monograph system.
More info: Nadim Shaath, Email: alpharnd@aol.com
For sunscreen products marketed under the OTC Monograph System with sales of less than $25,000 the compliance date is Dec. 17, 2013. The long-awaited Rule should not be confused with the illusive Final Monograph that has yet to be issued. The process leading to this point has been lengthy, and while this occasion marks a new stage, we are far from finalizing all outstanding issues.
According to Nadim Shaath, president, Alpha R&D, the Final Rule means that most OTC sunscreen products introduced or delivered for introduction into interstate commerce, on or after Dec. 17, 2012, must comply with the testing and labeling requirements of the Sunscreen Final Rule published June 17, 2011.
The three most significant changes in the labeling requirements are with “broad spectrum” protection and the new requirement that the SPF must be above 15 to qualify as a sunscreen in order to make the claim that “sunscreen reduces the risk of skin cancer and early skin aging when used as directed,” and the changes in the requirement of the Drug Facts box, according to Shaath.
However, FDA still requests comments on the possible warnings and direction for spray usage and issues regarding dosage forms. Spray safety and SPF 50+ labeling are still subject to finalization pending the outcome of the comments period and evaluation.
According to the ANPR, towelettes and powder products are not eligible for consideration under the pending OTC Sunscreen Monograph and would therefore be subject to regulatory action. FDA does not currently consider these products covered by the OTC Monograph system.
More info: Nadim Shaath, Email: alpharnd@aol.com