Planned sunscreen rules leave some red

A proposed regulation that would change how the sun protection factor (SPF) is listed on sunscreen labels has riled some in the cosmetics industry. 

The Food and Drug Administration (FDA) has been considering regulations on sunscreen since 1978. More than 30 years later, in June of this year, the agency released a batch of proposed and finalized rules dealing with sunscreen, including one regulation for tighter labeling restrictions that bans misleading terms like “waterproof” and “sweat-proof” on the products. The label rules would go into effect by the summer of 2012.

{mosads}Another proposed regulation from the FDA would also limit how high sunscreen-makers can label the SPF of their products. The rule would have sunscreens that are marked with SPF of 60, 70 or more to be labeled with “50+” instead. An FDA spokeswoman said there isn’t enough data to support the higher SPF figures.

“The proposed rule, if finalized, would limit the maximum SPF value on sunscreen labels to ‘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,” said Shelly Burgess, a FDA spokeswoman.

Some sunscreen-makers have bristled at that contention, saying higher SPF can help prevent skin cancer or slow skin aging. Companies like Johnson & Johnson and Energizer Personal Care — which markets well-known sunscreen brands like Hawaiian Tropic and Banana Boat — voiced their opposition in public comments filed on the rule.

“By capping the SPF at 50, many consumers will no longer have the choice to use the higher protection levels that they currently find suitable for their individual needs,” Johnson & Johnson said in its comment on the proposed SPF rule filed last month. “Higher SPF sunscreens are safe, effective and are an essential cornerstone of helping to keep the public protected from damaging effects of ultraviolet radiation.”

Farah Ahmed, who leads the sunscreen task force for the Personal Care Products Council, said the industry is divided on the issue.

“The higher you go, the level of the burn protection tapers off. … For someone who doesn’t burn at 50, what is the point of using 80 for burn protection?” Ahmed said. “But there are other additional clinical benefits from a higher SPF, such as possibly protecting against aging, skin cancer prevention and for people more sensitive to the sun.”

Ahmed said the trade group, which includes cosmetic-makers like Avon, Bath & Body Works and Mary Kay, is neutral on whether SPF should be capped at SPF 50+ since its companies can’t come to a consensus.

One lawmaker is keeping a close eye on the process. In May, Sen. Jack Reed (D-R.I.) proposed legislation that would require the FDA to finalize the sunscreen regulations in 180 days, including the SPF proposal. But so far the agency has been aggressively moving to institute the rules on its own — so much so that Reed’s bill is not needed at the moment, according to a spokesman for the senator.

“I would say that Sen. Reed is hopeful that the FDA is going to act on this issue and that would negate the need of our bill,” said Chip Unruh, Reed’s press secretary. “We’re watching it closely and don’t want this process dragged on any further than it has.”

Watchdog groups have favored the FDA proposal as well. Jason Rano, senior legislative analyst with the Environmental Working Group (EWG), said capping the SPF figure better informs consumers.

“It gives people a false sense of security of how often they need to reapply [sunscreen] and we don’t know how effective it is,” Rano said.

EWG has long called for a cap on SPF in sunscreen labels. The environmental watchdog group filed comments last month supporting the proposed FDA rule.

Rano said some sunscreen-makers oppose the label cap because a higher SPF number on their bottle can attract more consumers.

“I think partially it is a marketing device. What’s bigger is always better, right?” Rano said. “If I’m buying a sunscreen, I’m going to lean towards the higher number because I think it is going to give me more protection. That’s not always the case.”

The comment period for the proposed SPF regulation has closed, but it’s not clear when the FDA will release the final rule.

“FDA has not set an expected date for finalizing the SPF 50+ cap proposal. That date will depend on the data submitted in response to the proposed rule,” Burgess said.