The U.S. Food and Drug Administration Tuesday issued its first update to chemical sunscreen product regulations in nearly 33 years — a ruling that has been delayed for decades by the sunscreen industry itself and which is already drawing sharp criticism from consumer protection groups.

The new rules will be phased in by next summer while a proposal to limit SPF product claims to a maximum of “50+” will have to go through other hoops before becoming a standard.

A disappointment to watchdog groups: “The FDA continues to allow oxybenzone, retinyl palmitate and several other ingredients in sunscreens despite scientists’ concerns about their toxicity,” the non-profit Environmental Working Group reported on its web site.

Taking effect in the net year, according to FDA:

1. Broad Spectrum Designation. Sunscreens that block UVB and UVA and have a rating higher than 15 will be able to carry the “broad spectrum sunscreen” designation — which will allow the manufacturer to advertise that usage of the product can reduce the risk of skin cancer and early skin aging “if used as directed with other sun protection measures.”Sunscreens today cannot advertise skin cancer prevention, but third party groups have promoted that on behalf of sunscreen manufacturers for more than 25 years.

   “FDA’s inclusion of the caveat ‘if used as directed with other sun protection measures’ should not be overlooked or under-appreciated,” Smart Tan Vice President Joseph Levy said. “FDA is still not saying that SPF alone prevents melanoma – although we fully expect ‘Sun Scare’ groups to spin it that way in the coming weeks.”

   FDA states on its web site announcing the new rules: “Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.”

2. Waterproof, sweatproof and sunblock out. According to FDA, manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because these claims overstate their effectiveness.
   
   
3. Instant protection claims. Sunscreens also cannot claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application (for example: “instant protection”) without submitting data to support these claims and obtaining FDA approval.
4. Water resistance claims. Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.
5. Drug Facts. All sunscreens must include standard “Drug Facts” information on the back and/or side of the container.

Those rules will take effect by summer 2012 or earlier. Additionally, FDA has proposed that SPF ratings be capped at “50+” because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50. That proposal is still subject to comment.

FDA’s new ruling has already drawn sharp criticism from a consumer watchdog group that has been calling for legitimate product safety testing on sunscreen for several decades.

“FDA’s action offers some noticeable improvements for consumers, such as limiting misleading claims” said David Andrews, Ph.D, a senior scientist with Environmental Working Group. “However, it is clear that FDA caved to industry and weakened its safety standards. Its earlier draft proposed stronger health protections.”

According to Andrews, the agency’s final rule for UVA protection has been substantially watered down from a draft circulated in 2007. “The agency’s weak standard for UVA protection will not allow consumers to differentiate between superior and mediocre products,” Andrews said. “FDA’s rule will allow most products on the U.S. market to use the label ‘broad spectrum sunscreen,’ even though some will not offer enough protection to assure Americans they can stay in the sun without suffering skin damage from invisible UVA radiation. For that reason, about 20 percent of products that meet the new FDA standards could not be sold in Europe, where UVA standards are strict.”

EWG has promoted that over-use of chemical sunscreen may be a problem too — as UV exposure is the body’s primary and intended source of vitamin D production. But when sunscreen is used, EWG has lobbied for safer chemicals and broad-spectrum blocking.

“FDA’s new standards don’t go far enough to protect you from the sun,” Andrews said. “Consumers will have to turn elsewhere, like EWG’s online guide, to find the safest, most effective sunscreens. After 33 years of delay, it is evident people just can’t trust FDA on this issue.”

What Does It Mean?

FDA’s new rules have already received considerable press — most of it suggesting that the new rules will help consumers prevent skin cancer. How do you answer questions about SPFs this summer?

1. Sunscreen is still a chemical product designed to prevent sunburn. That’s what we stand for too.
2. Tanners who use sunscreen are still less likely to sunburn outdoors as compared to non-tanners who use sunscreen. Melanin in the skin is still the body’s natural SPF which, when combined with sunscreen, multiplies its effectiveness at preventing sunburn.

Smart Tan will continue to follow the SPF story and send Smart Tan members special advisories on what they mean for your tanning business.

To read EWG’s statement and its sunscreen safety recommendations, click here.

To read FDA’s new rule click here.