FDA issues new guidelines to test sunscreen efficiency

Around 3.5 million Americans suffer from skin cancer every year. In view of this looming threat, FDA has issued new protocols which, for the first time, will allow sunscreen products to mention their protection against pre-mature skin aging and skin cancer.

Food and Drug Administration on Tuesday published fresh regulations for tagging sunscreen products, to provide users with better understanding on products’ benefits.

Under the new protocol, FDA will check products’ efficiency at preventing UVA and UVB rays. The guidelines allow the companies to tag ‘broad spectrum’ if their products protect from UVB rays and a fraction of UVA rays as well.

FDA had been examining the guidelines issue since 1978. The agency has come up with the new proposal after it found the interim 2007 proposed guidelines confusing for the users.

Products to mention UVA & UVB protection factor
The newly proposed guiding principles would help "to reduce consumer confusion," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation.

The products with Sun Protection Factor (SPF) above 15 could now onwards be tagged ‘broad spectrum’ stating product’s effectiveness in reducing the risk of pre-mature skin aging and skin cancer. While the products under SPF 15 must mention that they have not been guarding against any such risks.

Where UVA radiation is mainly responsible for tanning and sun burn, both UVA and UVB are held responsible for premature skin aging and skin cancer.

The agency has also asked the companies to specifically mention how long their SPF lasts, i.e. ‘either 40 minutes or 80 minutes’.

Highest protection ceiling, SPF 50
Again as per the new protocol from now onwards, no product will be able to claim an SPF higher than 50.

In Woodcock’s words "We don't have sufficient data to show that those with an SPF higher than 50 provide greater protection,"

Terms such as ‘sun block’, ‘water proof’, ‘sweat proof’ will be disallowed owing to lack of evidence against such claims. However, products may claim to be ‘water resistant’, stated FDA reports.

Meanwhile, the issue on the potential skin threats, due to zinc oxide or titanium dioxide present in the sunscreens, has been solved. As per the findings, these chemicals do not infiltrate the skin, and hence pose no skin threats, Woodcock notified.