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Majority of sunscreens tested would flunk proposed FDA safety tests, report says

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Nearly two-thirds of all sunscreens evaluated by the Environmental Working Group would not pass safety tests proposed by the US Food and Drug Administration,...

Posted: May 15, 2019 8:30 AM

Nearly two-thirds of all sunscreens evaluated by the Environmental Working Group would not pass safety tests proposed by the US Food and Drug Administration, the consumer advocacy group announced Wednesday.

The group released its analysis as part of its 2019 Guide to Sunscreens, a yearly report on sunscreen safety that the nonprofit began in 2006.

The group said it analyzed the ingredients and performance of more than 1,300 products with sun protection factor, or SPF; 750 of those are marketed as beach and sport sunscreens. The analysis involves only a fraction of the sunscreen products sold in the United States today, which the FDA estimates to number over 12,000.

The report said that over 60% of the products tested did not offer adequate sun protection or contained potentially harmful chemicals.

The Environmental Working Group has reported similar results in the past. What makes this year's report different, said Director of Healthy Living Science Nneka Leiba, is that the 2019 products were judged using FDA safety guidelines proposed in February.

"Even though we've come up with similar results in our guide before, comparing it to the FDA's actual proposed standards is really strong," Leiba said. "So the fact that 60% of the market seemingly wouldn't be considered safe and effective by the FDA is a huge deal."

The big deal of skin cancer

Skin cancer strikes more Americans each year than all other cancers combined. Melanoma, the most deadly form, accounts for only 1% of all skin cancers, but most of the deaths, according to the American Cancer Society. Its statistics show that the rates of melanoma have been steadily rising over the past 30 years; worldwide, melanoma is the 19th most diagnosed cancer.

While many people today turn to sunscreens as their first choice for sun protection, it wasn't until recently that sunscreen ingredients were regulated by the FDA, said Dr. Len Lichtenfeld, acting medical director of the American Cancer Society.

"We couldn't even be certain what was in the product until the FDA came out with some rules that define how to test sunscreens and how to label them," he said.

The need for additional testing

In February, the FDA called for additional testing of a dozen common sunscreen ingredients after finding that high levels of four of them -- avobenzone, oxybenzone, ecamsule and octocrylene -- can enter a person's bloodstream after just one day of use. The chemicals remained in the body for at least 24 hours after the last sunscreen application.

The most-studied chemical in sunscreens, oxybenzone, has been linked to damage to coral reefs and marine life, as well as lower testosterone levels in adolescent boys, hormone changes in men, and shorter pregnancies and disrupted birth weights in babies. Researchers, however, caution about assuming a direct cause-and-effect relationship without further studies.

The Environmental Working Group found that two-thirds of the sunscreens in its 2019 report contain oxybenzone, often with varying mixtures of the other common chemicals.

The FDA study did not show that oxybenzone and the other ingredients can cause health issues, experts stress, only that the chemicals could be absorbed. The FDA, the American Cancer Society and the Environmental Working Group, among others, recommend that consumers continue to use sunscreen appropriately.

If concerned, experts suggest that consumers look for products with zinc oxide and titanium dioxide, which studies show are not absorbed into the skin.

In a statement in February, the national trade council for sunscreen, cosmetic and personal care products said the findings might confuse consumers and discourage the use of sunscreen. "The presence of sunscreens in plasma after maximal use does not necessarily lead to safety issues," said Alex Kowcz, chief scientist for the Personal Care Products Council.

The problem with 100+ SPF coverage

In the proposed rules, which are in the public comment phase, the FDA also calls for a cap on SPF levels on sunscreen products. SPF applies only to the UVB rays of the sun, which burn the skin. Sunburns are a leading cause of melanoma.

The FDA says there is no good data showing that sunscreens can protect past a level of 60+ SPF, and therefore labeling sunscreen at levels higher than 60+ could be misleading by providing a false sense of sun protection.

The Environmental Working Group's new report said that more than 10% of the 1,300 products it tested were labeled as SPF 50 or higher.

Sunscreens often boost SPF to 100+ and higher, the report says, but often fail to adequately protect against equally dangerous UVA rays, which age and damage the DNA in skin cells, contributing to skin cancer.

"Using a sunscreen with poor UVA protection on a vacation is similar to taking a trip or two to a tanning salon," said David Andrews, senior scientist with the group.

Only sunscreens labeled as broad-spectrum protect against both types of ultraviolet light. The FDA's proposed guidelines say sunscreens with an SPF of 15 or higher must be broad-spectrum, offering protection against UVA rays.

In addition, the FDA wants the extra UVA protection to rise along with UVB protection. So as a product moves toward SPF 60+, so too grows the level of UVA protection.

Based on its modeling, the Environmental Working Group says that 25% of all sunscreen products it tested on the market today would fail the new FDA standards for UVA protection.

Concerns about spray sunscreens

The possible danger posed by spray and powder forms of sunscreen application is another area of FDA concern. Sprays are potentially combustible, and both sprays and powders can enter the lungs if particles are small enough.

Environmental Protection Agency studies of particle pollution, the fine film of water and dust/chemical/soot/acid particles that hangs in the air, show that anything 10 micrometers in diameter or less poses the greatest health problems because they can enter the lungs.

"Once inhaled, these particles can affect the lungs and heart and cause serious health effects in individuals at greatest risk, such as people with heart or lung disease, people with diabetes, older adults and children (up to 18 years of age)," the EPA says.

Based on data from studies and input from the Personal Care Products Council and several other manufacturers, the FDA is planning on placing sprays under the "generally accepted as safe" or GRASE category, as long as they are tested to be sure that particles are too large to be inhaled. Powders, however, require additional testing to be placed into that category, the FDA says.

The 2019 Environmental Working Group report shows that spray sunscreens are on the rise, with more than a fourth of the products in the guide available in spray form. Due to the lack of definitive testing, the group recommends that all sprays be avoided.

The standards set in the proposed FDA guidelines could easily be changed by lobbying efforts and additional data, Leiba said. But the group, which has been petitioning the FDA for increased scrutiny for years, is heartened that many of their safety suggestions are being evaluated.

In the meantime, consumers should continue to protect their skin from the sun and choose sunscreens with the lowest risk, she said.

"It's been a while since I've seen the FDA really showing their concern about sunscreen," Leiba said. "If the FDA's doing that, it really means that consumers need to take heed."

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