Back in June 2011, the administration issued a 'Final Rule' for the labelling of sunscreens being marketed without an approved application (i.e., being marketed under the OTC monograph) which was initally set to come into effect in June 2012, however, for products with annual sales greater than $25,000, the deadline was extended until today.
This 'Final Rule' requires some manufacturers of OTC sunscreen products to pass new broad spectrum testing procedures and to make sure that their labeling is in order, to avoid potential misbranding charges.
Broad spectrum sunscreens with SPF values of 15 or greater will be permitted to make claims related to skin cancer and early skin aging and non broad spectrum will be required to include a warning that the product only protects against sunburn, not skin cancer or early skin aging.
According to the FDA, products with annual sales of less than $25,000 will have until December 17, 2013 to comply and that after that date, “all manufacturers of products with annual sales greater than $25,000 may not introduce sunscreens that are not compliant with the new rule into the marketplace.”
..rule should not be confused with 'Final Monograph'
Manufacturers should note that whilst this long-awaited rule marks a new stage in finalizing outstanding issues in the area of suncreens, it should not be confused with the 'Final Monograph' that has yet to be issued.
According to Alpha R&D president, Nadim Shaath, although the three most significant changes in the labeling requirements are with 'broad spectrum' protection, the FDA will still be requesting 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."
Labeling furore
In recent years, the FDA has received concerns over its sunscreen monograph from public interest groups like Friends of the Earth, and The International Center for Technology Assessment and Consumers Union, who say that it is missing the key health threat that nanotechnology poses.
Nanoscale ingredients are widely used in sunscreens where particle size and design are utilized to optimize the performance of the sun-blocking ingredients titanium dioxide (TiO2) and zinc oxide (ZnO) rub on clear instead of white.
Despite this, several organizations including the Personal Care Products Council are backing the Administration, agreeing that it had 'evaluated available scientific literature, tested sunscreen nanoscale ingredients and concluded they do not penetrate the skin'.