Long-awaited FDA sunscreen guidelines shouldn’t affect many industry players

After 33 years of dilly-dallying over regulations, the U.S. Food and Drug Administration’s new sunscreen guidelines shouldn’t have a huge effect on many of the industry’s major players. We take a quick look at the new guidelines, which come a year after SNEWS’ multi-part investigation into the misleading and confusing world of sunscreens.

After 33 years of dilly-dallying over regulations, the U.S. Food and Drug Administration’s new sunscreen guidelines released June 14 shouldn’t have a huge effect on many of the industry’s major players.

Most companies already abided by what was considered upfront marketing, labeling and testing, although a few will still be forced to axe now-banned terms like “waterproof” and “sweatproof” from labels and claims, and they may need better backup for the claim “broad spectrum.”

As SNEWS discovered in a Maggie award finalist investigative series in May and June 2010, the world of sunscreens was left mostly unmonitored by the government despite consumer trust that labels were toeing the line of regulations.

Turns out there really were no regulations since the FDA had begun to try to finalize one in 1978. That left unknowing consumers not only at risk for wrinkles and a whole lot more, but also awash in confusing claims, labeling, guidelines and ingredient safety.

Read the entire series by going to where you can find the stories’ three parts on May 26, 28 and 31, 2010, plus extra parts covering resources (May 31), an editorial about the research project (June 4), and sunscreen recommendations (June 14).

The regulations were long-awaited and nixed a proposed star rating system to rank UVA dangers as a companion to the SPF rating that rates only UVB dangers. UVB are the rays that cause sunburn and aging skin, while UVA penetrate deeper, weaken tissues, and are blamed for cancer. The regulations will take affect in a year although manufacturers with annual sales less than $25,000 will have two years to comply.

“The proposed rules will have minimal effect on the daily operations at Aloe Up,” said Neal Klein, director of sales for 18-year-old Aloe Up ( “Our distribution model was established on high quality products and trust-worthy product marketing.”

David Kulow, president of All Terrain (, told SNEWS his company has been following what it thought the regulations would be to save problems and money when they did become reality.

“We’re ready,” Kulow said. “It’s not going to be a big thing for us.

“We’re happy the regulations finally came out,” he added, “because there has been some uncertainty over what they would be.”

All in all, the regulations will be good for the consumer, industry officials said.

“I think it’s great and long overdue,” said Jeff Kletter, president of Kinesys ( “I think this is a great way to weed out a number of claims, that are simply not proven or true.”

Kulow too said this should help consumers weed out “marketing gimmicks.”

“It’ll be more clear for the consumers,” Kletter said.

Beyond the industry, some national organizations have applauded the regulations after 33 years of waiting.

“FDA’s recognition today of the important role sunscreens play in protecting the public not only from sunburn but also from skin cancer and premature aging due to the sun is a very significant victory for public health,” said the Personal Care Products Council in a statement. “We are also pleased that FDA reaffirmed there are no safety issues with any of the sunscreen active ingredients, including nanoscale titanium dioxide and zinc oxide.”

The outspoken Environmental Working Group additionally called them “too little, too late” in a statement.

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

In sum, the regulations, once they go into effect in a year for many companies, will crank down on labeling, limit SPF claims of protection, add UVA verbiage requirements, force sunscreeen values to top out at “50+,” and require that brands state details behind water-resistance claims.

Click here to read an FDA FAQ on the new regulations.

Click here to access additional FDA information, including video and links to other resources.

Click here to access the entire nearly 200-page document.

Therese Iknoian