|FDA Issues Regulations on Sunscreens: Will The Consumer Be Protected?|
|July 04, 2011 by Donald Riker, PhD|
On June 14 the FDA issued its long-awaited final regulations governing sunscreen products in the US. When operative in the summer of 2012 consumers will gain added confidence that products protect skin against both UVA & UVB rays. Critics argue that some products may still not be protective enough against aging and skin cancer even when tested. Aerosol sprays, wipes, etc. may get further scrutiny.
The FDA began the sunscreen regulatory process in 1978, 33-year process still continuing. Finally rules have been adopted that govern labeling, testing and claims. Previously the testing and claims made for sun protection were biased towards UVB rays, those that relate to tanning, not so much UVA rays responsible for skin damage. Now new required testing procedures followed by revised labeling help make broad spectrum protection more transparent to consumers.
The final regulations require manufacturers to test each product for its UVA & UVB blockage. For products that pass minimum requirements of SPF >15 labeling will reflect "Broad Spectrum" protection but only after testing supports that claim. "Broad Spectrum" protection infers a balance between UVA & UVB performance. To get that performance consumers are required to reapply sunscreen every two hours. As for claims products that have SPF of 15 or more may make skin cancer and skin aging claims. However, absolute claims of "waterproof", "sweatproof" and "sunblock" are not allowed. "Water resistant" claims of 40 or 80 minutes must be proven. Finally, FDA left open to comment capping the maximum level of protection to 50+.
Most interestingly FDA initiated a process seeking comment on the effectiveness of various dose delivery forms of sunscreens in a process reminiscent of their position on topical pain patches in which they carved out the issue of dose forms from the final rule. The OTC monograph process, originally intended to be a review of ingredient, not product, efficacy, is shaping into a process based on the dose form of ingredients. The explosion of new dose forms to apply sunscreens since the monograph began has clearly fueled FDA uncertainty. Aerosol sprays, in particular, seem hit & miss in their application and apply a thin, likely uneven, film to the skin surface. Nevertheless, the consumer appreciates their convenience. It is likely that manufacturers will need to agree on and recommend testing procedures aimed at application uniformity that can be applied to all forms. In the meantime the older forms of combination ingredients that can be visualized on application may be the best bet.
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