Sunscreen Rules Are Getting Their Biggest Overhaul In Decades With FDA Now Wondering Which Ingredients Might Do More Harm Than Good; 12 Major Chemicals Are On The ‘Questionable’ List

The UV-Blocking Ingredients Have Never Been Tested Because They Were Approved Decades Ago; But New Data Shows Those Same Chemicals Can ‘Seep Into Bloodstream’ And This Demands Swifter Action By Feds & Industry Before New Rules Are Finalized In November   

Schumer To FDA: Uncloud All Ingredients In Sunscreen Before Closing The Book On Its New Rules

Amidst a rare rewrite of the rules for sunscreen and with new Food and Drug Administration (FDA) findings in hand that reveal many of its ingredients can ‘seep into the bloodstream’ after twenty-four hours from application, U.S. Senator Charles Schumer is demanding the federal agency review ALL the active ingredients in sunscreen to determine which ingredients should be removed before ink on the new rules dries, which is set to occur in November of this year.

“There is no doubt about it: sunscreen has been a life-saver, but that doesn’t mean we can’t use the latest science and the best data to ensure that it is as safe as possible,” said U.S. Senator Charles Schumer. “That’s why, amidst the rare rewrite of sunscreen rules, where the FDA is looking into everything from packaging to protection, the one thing I am urging them to not get wrong and to move swiftly to address relates to the ingredients. We know very little about some of them and what they might do in our bloodstream, but we have the ability and the technology to find out.”

In February of 2019, the FDA announced its intention to update the regulatory requirements for most sunscreen products in the U.S. According to the FDA, the goal here is to “addresses sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements.” The FDA also proposed updates to how products are labeled to make it easier for consumers to identify key product information.

Specifically included in the FDA’s sunscreen rule change proposal is clear indication that the agency desires to know more about twelve active ingredients. Currently, there are sixteen active ingredients that make up the variety of OTC sunscreen brands. Only two of these active ingredients –zinc oxide and titanium dioxide—are considered safe and effective. Another two ingredients –PABA, an acid, and trolamine salicylate—are not considered abundantly safe and effective. The FDA is proposing those two ingredients be banned altogether. But for the other twelve chemicals, there is a big question mark. And while the FDA is seeking more information on the other twelve, Schumer said new research showing that sunscreen seeps into people’s bloodstreams is enough evidence that the FDA needs to double down on its efforts and use this rule change as a chance to make sure sunscreen is safe for generations to come.

“The FDA must uncloud all additives in sunscreen before closing the book on the new rules and industry must fully cooperate with this cause, because if we can make sunscreen safer for children and adults—an OTC product without a single side effect—it will do even more good for the millions of people who slather it on each year,” Schumer added.

According to the EPA, Chemical sunscreens contain UVB or UVA absorbing ingredients and these chemicals create a thin film on the skin that reduces ultraviolet radiation penetration to the skin. These ingredients include chemicals like oxybenzone, avobenzone, octisalate, octocrylene, homosalate and octinoxate, to name a handful. It is these additives Schumer says need swifter review in the midst of a sunscreen rules change.

Moreover, Schumer says another recent study which showed the aforementioned chemicals can ‘seep into the bloodstream’ after twenty-four hours from application raises the stakes on his push.

“The joint JAMA and FDA findings which detailed bloodstream absorption with some of the ingredients demand a renewed screen test because that study only left us with concerns and was devoid of answers on what to do.” Schumer said.

The conclusion of the recent ingredient study “presented the need for further studies to determine the clinical significance of the findings.” Schumer, today, said the FDA should hit the gas on this work because “we don’t want people to discontinue the use of sunscreen because they are worrying about their bloodstream, but we also want to make sure the product is as safe as possible and manufactured using only the current and best available science.”

Schumer added that as the summer months heat up it is critical that New Yorkers routinely use sunscreen. “Skin cancer affects more than 3 million people each year, and responsibly using sunscreen is one of the best ways to prevent it. I want to be very clear: New Yorkers should not and cannot stop using sunscreen. That is exactly why it is so critical that the FDA get this right,” he said.

Schumer’s letter to Acting FDA Commissioner Norman Sharpless appears below:

Acting Commissioner Sharpless:

I write today amidst your agency’s rewrite on the rules for sunscreen, which are set to be completed in November of 2019. I also write on the heels of new findings that detailed concerns with active ingredients in the product and their absorption into the human bloodstream.

Specifically, as it concerns the proposed rule changes for sunscreen ingredients, I applaud your agency’s work in determining that two foundational additives are generally recognized as safe and effective (GRASE). I further applaud your agency’s work in determining that another separate two chemicals lack the standards to be classified as GRASE, and I support the FDA’s intent to remove these ingredients from the manufacturing process.

However, as it concerns the remaining twelve anchor ingredients used across the industry, there is no time to waste in getting to the bottom of several questions as soon as possible, particularly on bloodstream absorption. While we do not want to discourage the use of sunscreen, armed with the best available science and data, we are compelled to act and research ways to make the product safer for the millions of children and adults who apply it daily.

The recent findings on bloodstream absorption left consumers and lawmakers with more questions than answers. We want sunscreen to be an over-the-counter product that saves lives with zero side effects. The technology of today encourages us, and suggests, that we can meet this challenge. Coupled with cooperation from industry, I believe your agency can expedite the review of the chemicals in question and deliver unclouded information on sunscreen to the public. I encourage the FDA to do all it can to achieve this directive before the new rules are finalized in November.

Under former Commissioner Gottlieb, the work on this front had been aggressive: from packaging to protection and ingredients. I again urge your agency to expedite the review of all sunscreen ingredients and invite you to call upon me at any point should legislative or other action be required to more swiftly compel the timely cooperation of industry along the way.


U.S. Senator Charles Schumer

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