Nonprofit Organization Turns Up the Heat on the FDA Over Sunscreen Safety

When selecting a sunscreen, do you read the label? Or do you just quickly grab the one with the highest sun protection factor (SPF)? Well, you may be going about it all wrong.

The newly released 11^th annual Guide to Sunscreens from the Environmental Working Group (EWG) — a nonprofit, nonpartisan organization dedicated to protecting human health and the environment — highlights some of the areas in which the Food and Drug Administration (FDA) can improve the making, marketing and regulation of sunscreen.

“After 11 years of reviewing the sunscreen market, we see persistent problems that won’t be resolved until the FDA completes its rule-making process and raises the bar on sun protection,” Sonya Lunder, EWG senior analyst and lead author of the 2017 Guide to Sunscreens, said in an interview with CURE. “The FDA must cap SPF values at 50-plus; review and approve new, modern ingredients that offer stronger sun protection; and consider the hazards of active and inactive ingredients in sunscreen.”

To examine the safety of sunscreens in the United States, EWG investigated more than 880 beach and sport sunscreens, 480 moisturizers and 120 lip products containing SPF. The researchers estimated ultraviolet (UV) protection based on the combination and percent of active ingredients, and then flagged ingredients with potential hazards like skin irritation, allergy or hormone disruption.

Researchers found that nearly 75 percent of the products contained less than the labeled SPF, and some contained ingredients such as oxybenzone, a hormone disruptor, and retinyl palmitate, a form of vitamin A that may be harmful to the skin. In fact, government test data shows more skin tumors and lesions on animals treated with retinyl palmitate and exposed to sunlight, reported the EWG in its guide. And, although the use of Vitamin A has dropped by more than half since 2010, it was still found in 14 percent of the products surveyed for 2017.

In addition, EWG found an increase in the availability of mineral-only sunscreens, doubling from 17 percent of products in 2007 to 34 percent in 2017. EWG noted that products using zinc oxide and titanium dioxide are stable in sunlight, don’t often contain potentially harmful additives and offer a good balance between protection from both UVA and UVB.

Since 2011, the FDA has upped its regulations to include warning labels about skin cancer and aging, as well as introduced new broad-spectrum — protects from both UVA and UVB — testing standards. And, labels are no longer allowed to include misleading claims like “waterproof” or “sunblock.”

“The FDA is currently ignoring a large body of evidence that UV filters and inactive ingredients have potential harmful effects like hormone disruption, skin damage and serious skin allergy,” said Lunder. “We want the FDA to change the marketing of sunscreen so people understand its limitations. Capping SPF will help.”

The guide states that “people mistakenly assume that bigger numbers are better, but in reality, higher SPF ratings don’t necessarily offer greater protection from UV-related skin damage and may lead users to spend too much time in the sun.”

Although the FDA proposed to cap SPF values at 50-plus in 2011, that regulation has yet to be finalized. Meanwhile, SPF values on labels are rising. The guide found that 69 products claimed to be SPF 70 and higher, including 13 products advertised as SPF 100 or higher.

There was also a 27 percent increase in the number of spray sunscreens, which the EWG and FDA warn can pose an inhalation risk and may not provide a thick enough, even coating on the skin.

“We were surprised to see that sunscreen companies sell ultra-high SPF products and aerosol sprays despite the FDA expressing concerns about their safety and effectiveness,” Lunder said. “These practices won’t change until the agency finalizes its rules for sunscreens.”

When it comes to cancer risk and sunscreen, the National Cancer Institute reports the rate of new melanoma cases among American adults has tripled since the 1970s, from 7.9 per 100,000 people in 1975 to 25.2 per 100,000 in 2014. This is despite increased awareness about sun protection.

And while sunscreen offers a layer of protection against skin cancer, Lunder said other precautions should be taken.

“All sunscreens offer incomplete protection from harmful UV rays,” she said. “They rub off and break down so you’ll need to apply a very thick coat and reapply frequently. Clothing is more failsafe skin protection.”