Study: Sunscreen Chemicals Enter Bloodstream at Potentially Unsafe Levels

Dennis Thompson wrote . . . . . . . . .

For years, you’ve been urged to slather on sunscreen before venturing outdoors. But new U.S. Food and Drug Administration data reveals chemicals in sunscreens are absorbed into the human body at levels high enough to raise concerns about potentially toxic effects.

Bloodstream levels of four sunscreen chemicals increased dramatically after test subjects applied spray, lotion and cream for four days as directed on the label, according to the report.

The levels far exceed the FDA-set threshold which require topical medications to undergo safety studies, said Dr. Kanade Shinkai, a dermatologist with the University of California, San Francisco School of Medicine.

“It’s not like they went a little bit over,” she said. “It’s really quite high, orders of magnitude higher than that.”

However, experts are quick to say you shouldn’t stop using sunscreen because of this study. At this point, the known risk of harm from the sun’s rays exceeds the potential risk posed by these chemicals.

“I am concerned that people are going to stop wearing sunscreen,” Shinkai said. “We know ultraviolet light from the sun has very deleterious effects on the skin. It causes photoaging. It causes sunburn. And, as such, it causes melanoma and [other] skin cancer.”

Dr. Michele Green, a dermatologist with Lenox Hill Hospital in New York City, agreed.

“I think it’s confusing,” Green said. “While it’s more than the FDA recommends for their toxicology, we really don’t know what that means in terms of human health. I would not want people to stop using sunscreen based on this one study.”

Possible effects on hormones

The sunscreen study was led by the FDA’s Dr. David Strauss, and appears May 6 in the prestigious Journal of the American Medical Association, one of the nation’s leading medical journals.

Most sunscreens on the shelf use chemicals such as oxybenzone, avobenzone and octocrylene to block harmful rays. These organic chemicals absorb ultraviolet radiation and convert it into a small amount of heat.

However, animal studies have raised concerns that the chemicals, oxybenzone in particular, might disrupt normal hormone patterns in people, the FDA researchers noted in their study.

“These molecules are chemical rings, essentially, and they absorb light,” said Shinkai, who co-wrote an editorial accompanying the study. “Chemical rings are also the fundamental basis for a lot of hormones, and chemical rings tend to enter cells.”

Oxybenzone has been found in human breast milk, amniotic fluid, urine and blood, the FDA researchers said.

For its study, the FDA randomly had 24 adults apply either a sunscreen spray, lotion or cream four times a day for four days. The participants applied the sunscreen to three-quarters of their body surface.

The study took place in a lab, and the agency drew 30 blood samples from each participant over a week to see whether the chemicals in the sunscreen got absorbed through the skin.

Levels of oxybenzone, avobenzone, octocrylene and ecamsule increased in the bloodstream after sunscreen use, researchers found.

“There is definitely reason for concern, because if you think about it, any medication you buy over the counter, you would expect that everything in there has been tested, it’s safe, it’s effective,” Shinkai said. ‘This has never been proven for sunscreen.”

More real-life data needed

But it was a very small-scale laboratory study that simply shows the need for more research, said Dr. Raman Madan, a dermatologist with Northwell Health’s Huntington Hospital in Huntington, N.Y.

“While this is a starting point, the relevance of this result is unknown,” Madan said. “There needs to be further studies done to show what this really means. While it could have real-world consequences, it could very well mean nothing.”

The study also differs from real life in that people applied the sunscreen while hanging about a lab, Shinkai said.

“They weren’t doing the things people typically do when they use sunscreen,” such as swimming or working in the yard, Shinkai said. Because of this, their exposure might differ from that of everyday people.

The Consumer Healthcare Products Association (CHPA), a group representing sunscreen makers, also said it’s far too soon for consumers to have doubts about these products.

“Sunscreen manufacturers, FDA, and dermatologists are aligned on the goal of protecting the public from the harmful effects of the sun,” the group said in a statement. “Sunscreens save lives.”

CHPA said the FDA is committed to learning more about the safety of chemicals within sunscreens, however, and the new data “is consistent with these efforts.”

Options are out there

The FDA has been tussling with sunscreen manufacturers over studies to test the safety of their products, said Shinkai.

The agency has set a November 2019 deadline for manufacturers to provide safety data on their sunscreens, including evaluations of systemic absorption, the risk of cancer from the chemicals, and their effect on reproductive health, Shinkai said in her editorial.

The publication of this study might be intended to put pressure on the sunscreen industry to meet the deadline, she said.

“The FDA is a regulatory agency. It’s not a testing agency. For them to perform a research study is highly unusual,” Shinkai said. “I think that’s an important thing that suggests how concerned they were about this issue, and maybe perhaps the frustration on their part.”

People who are concerned about the safety of chemical sunscreens can opt to use mineral sunscreens, Shinkai said.

Those sunscreens rely on zinc oxide and titanium dioxide to reflect sunlight from the skin, rather than absorbing it like chemical sunscreens.

“These we know are safe,” Shinkai said of mineral sunscreens. “This is something that is evidence-based.”

Source: HealthDays


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FDA Strengthens Sunscreen Rules

The U.S. Food and Drug Administration took steps to tighten regulation of over-the-counter sunscreen products.

Included in the proposed rule are updates on sunscreen safety, sun protection factor (SPF) requirements, and the effectiveness of insect repellent/sunscreen combinations.

“The proposed rule that we issued today would update regulatory requirements for most sunscreen products in the United States, to better ensure consumers have access to safe and effective sun care options in line with the latest science,” FDA Commissioner Dr. Scott Gottlieb said during a media briefing Thursday morning.

The proposal “applies only to sunscreen active ingredients currently on the market in the United States without FDA-approved application. And that’s actually the vast majority of sunscreens available in the United States,” added Dr. Theresa Michele, director of the division of nonprescription drug products at the FDA’s Center for Drug Evaluation and Research (CDER).

Under the proposed rule, two of the 16 active ingredients in sunscreens — zinc oxide and titanium dioxide — are now considered safe and effective, while two others (PABA and trolamine salicylate) are not. No sunscreens sold in the United States contain PABA or trolamine salicylate.

Safety data for 12 other sunscreen ingredients is not sufficient to determine if they are safe and effective, the agency added.

“Therefore,” said Dr. Janet Woodcock, director of the CDER, “we are asking for additional clinical and non-clinical data on these 12 ingredients.”

The Environmental Working Group (EWG), a watchdog organization for consumer health, called the new initiative way overdue.

“After more than 40 years, the FDA is at last taking serious steps to finalize rules that would require sunscreen companies to make products that are both safe and effective,” David Andrews, senior scientist at EWG, said in a news release.

He pointed to one ingredient, oxybenzone, in particular.

“For a decade, EWG has worked to raise concerns about sunscreens with oxybenzone, which is found in nearly all Americans, detected in breast milk and potentially causing endocrine disruption,” Andrews said. “Today the FDA recognized those concerns.”

Woodcock noted that labeling changes will also make it easier for consumers to understand what they are buying.

“Since 1999, new scientific evidence has helped to shape FDA’s perspective on what active ingredients could be considered safe and effective, among other things,” Woodcock said in a CDER statement.

“I want to emphasize that the proposed rule does not require any sunscreen products to be removed from the market at this time,” she added. “Manufacturers will be able to provide comment and submit data on the proposals contained in the proposed rule, including safety data for active ingredients for which insufficient data [now] exist.”

Types of sunscreen generally considered safe and effective include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks.

Meanwhile, “we have found sunscreen powders eligible … but are requesting additional safety and efficacy data on powders before they can be included [in the proposed rule]. We are proposing to exclude wipes, towelettes, body washes, shampoos and other dosage forms,” Woodcock said.

Also, products that combine sunscreens with insect repellents are not generally considered safe and effective, the agency stated.

Under the rule, the maximum sun protection factor on sunscreen labels would be raised from SPF 50+ to SPF 60+.

“We are proposing to permit the marketing of sunscreen products formulated with SPF values up to 80, but not above, unless the product has an approved [new drug application],” Woodcock explained.

Sunscreens with SPF values of 15 and higher will be required to be broad spectrum, and broad spectrum protection against UVA radiation must also increase as SPF increases, the rule states.

“This will ensure that these products provide consumers with the protections they expect against skin cancer and early skin aging,” Woodcock said.

New sunscreen label requirements will include listing of active ingredients on the front of the bottle and other requirements for the front of sunscreen bottles — all meant to help consumers better understand what the sunscreens they are buying can actually do.

Source: HealthDay


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