The year was 1978, and Americans were basking and bronzing in the sun like never before.
Solar reflectors and tanning solutions promising “fast-acting” results were popular with sunbathers in search of the “healthy tan.” And fashion models such as Farrah Fawcett sported a bronzed ideal of beauty.
But not everyone was a fan of tans. Concerned that Americans’ sun-worshiping ways would lead to epidemic levels of skin cancer, federal health officials ordered the Food and Drug Administration to create regulations to help consumers choose sunscreens wisely.
In May--some 21 years after the FDA got its marching orders--the agency finally issued its regulations, long delayed by bureaucratic snafus and the completion of scientific studies on sun exposure.
One might think that after two decades of examination, debate and introspection, the FDA’s so-called monograph on sunscreens would be one dandy document.
But many skin specialists are feeling burned.
While the monograph will do away with some of the worst sunscreen marketing abuses, such as sunscreen products that tout themselves as “waterproof” or offering “all-day protection,” the regulations have infuriated many dermatologists.
Dr. Darrell Rigel, a professor at New York University and president of the American Academy of Dermatology, says he was disappointed that the FDA didn’t come up with stronger recommendations, and he criticized the agency for not holding public hearings on the subject.
“What is the rush after 21 years?” Rigel says. “If you’re going to do it, do it right.”
The FDA declined formal comment on the document but did allow a spokesperson to clarify particular points with the condition that the official not be named.
According to the agency, however, the major labeling changes include:
* A new SPF rating system that goes from 2 to “30 plus.”
* A ban on marketing terms the FDA deems misleading, such as “waterproof,” “sun block,” “visible and infrared light protection” and “all-day protection.”
* Lotions that do not contain a chemical sunscreen must carry a warning stating that fact and noting that exposure of unprotected skin can cause skin damage or cancer even if you don’t burn.
Much of the disappointment with the new regulations--which will take effect in 12 to 24 months--surrounds the confusion-plagued Sun Protection Factor rating. Sunscreens will be able to carry an SPF number ranging from 2 to 30 plus. Sunscreen products will no longer be able to list values of 45 or higher.
Dermatologists say the FDA’s decision undermines years of public health campaigns urging consumers to use at least SPF 15 products and higher-rated SPFs for people with sun-sensitive skin.
“We built up the SPF 15 [standard] that now has been defeated. I feel very sorry and sad about this,” says Dr. Medhukar A. Pathak, chairman of the photobiology committee for the Skin Cancer Foundation, a nonprofit group based in New York City.
Rigel says dermatologists wanted a minimum rating of SPF 15 “because most people under-apply sunscreen and get only 20% to 50% of the protection they should be getting.” And he says the FDA’s decision to limit the highest rating to 30 plus doesn’t make sense.
“No company will have an incentive to do research for something better [than SPF 30] because they won’t get any credit for it,” Rigel says.
But the FDA says that the 30-plus cap was needed because manufacturers were trying to outdo each other with higher and higher SPF numbers that had no basis in fact and were misleading to consumers.
Misconceptions and Misleading Labels
Many consumers mistakenly assume that an SPF 30 product offers twice the sun protection of an SPF 15. An SPF 15 rating means that the sunscreen will be 93% effective in absorbing UVB radiation; by comparison, an SPF 30 product offers 97% protection. Any percentage increase after 30 offers incremental protection, such as 98% or 99%, and is difficult to measure.
“There is really no adequate test to measure for protection above 30,” says the FDA spokesperson. “If someone comes up with an adequate way to measure protection over SPF 30, then we will consider it.”
But very sun-sensitive individuals benefit from even incremental SPF protection, argues Dr. John Epstein, a clinical professor of dermatology at UC San Francisco and a member of the Skin Cancer Foundation’s photobiology committee.
“There is an advantage to a higher SPF,” he says. “Some people are very sensitive to the sun and get a lot of skin cancers. And those people should wear as strong a sunscreen as you can get.”
The new regulations will also create optional labeling categories of “mild” (SPF 2-12), “medium” (SPF 13-29) and “high” (SPF 30 plus) protection. But the categories are not to the liking of many health experts.
Because public health guidelines recommend using at least an SPF 15 product, the entire “mild” category and part of the “medium” category offer inadequate protection, dermatologists contend.
“The [sunscreen] industry wants a lower SPF number for consumers who want tanning. But tanning still damages the skin,” Pathak says. “Would you use an antiperspirant that was minimally protective? If you have been told to protect yourself, then why use something of minimal protection? [SPF 12], in my definition, is not a sunscreen.”
The FDA’s spokesperson downplayed the criticism of the categories, saying, “Anyone who wants more protection should use a higher SPF.”
Rating System Applies Only to UVB Radiation
Dermatologists also are critical of the FDA for releasing a rating system that applies only to UVB radiation, the solar radiation that causes sunburn and is represented under the SPF rating system. In recent years, scientists have found that UVA radiation causes premature aging and also may contribute to some forms of skin cancer.
“This is a new issue. We don’t have enough information to come up with a standard, validated measure of UVA,” says Dr. Mona Saraiya, a medical epidemiologist with the U.S. Centers for Disease Control and Prevention. “The best we can do, at this point, is to tell people to use a sunscreen that protects against both.”
But, says Rigel: “There are a couple [UVA testing] methods. The FDA decided to punt.”
According to the FDA, there is no timetable for selecting a UVA measuring system.
Manufacturers will still be allowed to label products as providing both UVA and UVB protection, even though the amount of UVA protection is not quantified. Sunscreens with UVA protection often are labeled as having “broad spectrum” protection or contain a chemical such as Parsol 1789 or oxybenzone.
Don’t Skimp, Say Dermatologists
Dermatologists are also chagrined that the agency chose not to make a recommendation on how much sunscreen should be applied. Most people need to apply about one ounce of sunscreen--about one-fourth of the typical bottle--to cover their exposed skin. But studies show that most people use only one-third to one-half that amount and, thus, are getting far less sun protection than the SPF achieved if the sunscreen is applied adequately.
“People put on the sunscreen and think they can be out all day without hurting themselves,” Epstein says. “We think what the monograph should have done is say, ‘Put on sunscreens liberally.’ ”
But the FDA has chosen not to advise consumers on this point.
“We don’t tell people how much they should use because there are so many different skin types,” the FDA spokesperson says. “What we do is provide SPF numbers.”
There is general agreement, however, that sunscreens are not working as well as officials had probably hoped back in 1978 and that consumers need to think about other ways to avoid skin cancer and sun-damaged skin.
Organizations like the AAD, the Skin Cancer Foundation and the Centers for Disease Control in Atlanta have begun emphasizing a triad of sun protection factors: using sunscreen, wearing protective clothing and staying out of the sun during peak radiation hours.
“I don’t see controversy about sunscreens as much as misunderstanding about their role,” says Cynthia Jorgensen, a behavioral scientist at the CDC. “I see a desire among consumers for something that is a magic bullet. The picture, in reality, is a lot more complicated than that.”