June 24, 2011

What? FDA Has Sunscreen Rules?

On June 14, 2011, and 33 years late, the FDA FINALLY issued a rules statement about sunscreens. This has been long-awaited and much needed for assisting consumers in deciphering the hype about sunscreens.

Sunscreen labels will now have a statement about being a broad spectrum to show the offer some protection against ultraviolet A radiation (UVA) as well as ultraviolet B radiation (UVB). Now the maximum SPF level a product can claim will be “50+”. This maximum is because the FDA says there is no convincing evidence that SPF levels higher that 50 have any meaningful effect.

FDA did stand firm in insisting that sunscreens claiming swim/sweat protection specify how many minutes the protection lasts. This means testing and published results for the FDA to verify. The FDA has also evaluated data and set up testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and this will enable consumers to become informed on which products offer the greatest benefit.

UVB is responsible for sunburn and plays a major part in the causation of skin cancer and affects the outer layer of skin only. UVA is less intense than UVB, but is up to 50 times more prevalent than UVB. It penetrates to the deeper layers of the skin and is the dominant tanning factor and is linked to skin aging. While it may cause skin cancer, it can damage skin DNA.

Will the manufacturers be allowed to claim that their product prevents skin cancer? Yes, if they protect against UVA and have as SPF of 15 or higher. Products will need to specify if they protect only against UVB (SPF rating only) or whether the protect against UVA and UVB (SPF rating plus “Broad Spectrum” claim.

Since consumer groups have been waiting since 1978 for new rules, most were expecting more and are of course claiming that this just scratches the surface of what need to be accomplished. Of course they have lots of expectations after waiting 33 years for even this.

The new rules will take effect in one year for most manufacturers, although those with annual sales of less than $25,000 have two years to comply.

Read the article from medscape here. And my blog early about sunscreens here.

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