FDA proposes new rules for sunscreens

27 August, 2007:

The United States Food and Drug Administration (FDA) has proposed a new rating system for sunscreens that would, for the first time, alert consumers as to how well they block dangerous ultraviolet A (UVA) rays.

At present, most commercial sunscreens only screen out ultraviolet B (UVB), not UVA, which is associated with longer and more serious damage deep within the skin.

Labels would have up to four stars indicating their effectiveness against UVA rays, the FDA said.

Both UVA and UVB increase skin cancer risks and skin aging.

The changes proposed by the FDA are undergoing a 90-day period of public comment before being published in a final draft form. According to the FDA, those rules would only go into effect 18 months later.

Dr Douglas C Throckmorton, deputy director of FDA’s Center for Drug Evaluation and Research, said the US health regulator has long been attempting to make recommendations on UVA protection. Only now has the agency settled on which tests it will accept for rating UVA protection.

The new rating – called ‘extra UVA protection’ – would be in addition to the sun protection factor (SPF), which is already on sunscreens. SPF measures the effectiveness of the product in preventing sunburn from UVB rays.

UVB radiation causes sunburn, but UVA can damage skin tissue below the surface. Both UVA and UVB cause skin cancer and aging such as wrinkles and sunspots.

FDA officials say the agency considers that protection from both UVB and UVA radiation is equally important at this time, because scientific data demonstrates that both have harmful effects on the skin.

The proposed ratings system for UVA sunscreens would rate them on a scale of one to four stars – one star for low UVA protection, two stars for medium protection, three stars for high protection, and four stars for the highest protection available in an over-the-counter sunscreen.

If a sunscreen does not have at least ‘one star’ of protection, the FDA would require that the product have a ‘no UVA protection’ marking on the label near the SPF value.

Ratings for UVA would be based on two tests: The first measures the sunscreen’s ability to reduce the amount of UVA radiation that passes through it. The second measures a product’s ability to prevent tanning. This test would be similar to the SPF test used to determine the effectiveness of sunscreens to block UVB rays.

Sunscreens would carry a ‘warnings’ statement in the ‘Drug Facts’ box. The warning will say that “UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.”

Besides, the label would also warn that “UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.”

Directions would tell people to reapply sunscreen at least every 2 hours.

The warning is intended to alert consumers that sunscreen is only a part of protecting yourself from sun exposure, according to the FDA.

The proposal has guidelines for testing that manufacturers need to do to support their claims. Under the rule, sunscreens could have a maximum SPF of 50+ unless test data shows that a higher number is warranted.

In addition, the definition of SPF would change from ‘sun protection factor’ to ‘sunburn protection factor.’ This change will prevent “the impression of solar invincibility and a false sense of security,” according to the FDA’s proposal.