FDA advances new proposed regulation to make sure that sunscreens are safe and effective

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The U.S. Food and Drug Administration today issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States.

This significant action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options. Among its provisions, the proposal addresses sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information.

“Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays, yet some of the essential requirements for these preventive tools haven’t been updated in decades. Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin. Sunscreen usage has changed, with more people using these products more frequently and in larger amounts. At the same time, sunscreen formulations have evolved as companies innovated. Today’s action is an important step in the FDA’s ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens,” said FDA Commissioner Scott Gottlieb, M.D. “The proposal we’ve put forward would improve quality, safety and efficacy of the sunscreens Americans use every day. We will continue to work with industry, consumers and public health stakeholders to ensure that we’re striking the right balance. To further advance these goals, we’re also working toward comprehensive OTC reform, which will help foster OTC product innovation as well as facilitate changes necessary for the FDA to keep pace with evolving science and new safety data.”

The agency is issuing this proposed rule to put into effect final monograph regulations for OTC sunscreen drug products as required by the Sunscreen Innovation Act. OTC monographs establish conditions under which the FDA permits certain OTC drugs to be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) and not misbranded. Over the last twenty years, new scientific evidence has helped to shape the FDA’s perspective on the conditions, including active ingredients and dosage forms, under which sunscreens could be considered GRASE.

In the proposed rule, the FDA makes the following proposals for sunscreens marketed without FDA-approved applications:

  • Proposes that, of the 16 currently marketed active ingredients, two ingredients – zinc oxide and titanium dioxide – are GRASE for use in sunscreens; two ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens due to safety issues. There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data.
  • Proposes that dosage forms that are GRASE for use as sunscreens include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks. Powders are proposed to be eligible for inclusion in the monograph, but additional data are requested before powders can be included in the monograph. Wipes, towelettes, body washes, shampoos and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph.
  • Proposes to raise the maximum proposed SPF value on sunscreen labels from SPF 50+ to SPF 60+.
  • Proposes to require sunscreens with an SPF value of 15 or higher to also provide broad spectrum protection and that, for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation also increases. These proposals are designed to ensure that these products provide consumers with the protections that they expect.
  • Proposes new sunscreen product label requirements to assist consumers in more easily identifying key information, including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum and water resistance statements.
  • Proposes to clarify FDA’s expectations for testing and record keeping by entities that conduct sunscreen testing to ensure that the FDA can assess industry compliance with regulations.
  • Proposes that products that combine sunscreens with insect repellents are not GRASE.

“It is important that, as this rulemaking effort moves forward and the FDA gathers additional scientific information, given the recognized public health benefits of sunscreen use, consumers continue to use sunscreen in conjunction with other sun-protection measures,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “To help make sure this effort is successful, the FDA is looking to industry to gather the data needed to help ensure that products marketed to offer protection from the sun’s effects are safe and deliver on these promises.”

As this rulemaking process proceeds, OTC sunscreen products will continue to be available on the market for consumer use. Sunscreens are only one element of a skin-cancer prevention strategy. Other sun protective behaviors include: wearing protective clothing that adequately covers the arms, torso and legs; wearing sunglasses and a hat that provides adequate shade to the whole head; and seeking shade whenever possible during periods of peak sunlight.

The FDA is seeking public comment on the proposed rule and will consider comments provided as the agency works towards developing a final rule.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


(Mercola.com) First off, let me make it very clear that sunscreen is widely overused. There are some circumstances where it is wise and appropriate to use but those cases are few and far between. For the most part, you just need to avoid the sunscreen and rely on sensible sun exposure. Get out of the sun or wear clothing the moment your skin starts to turn light pink.

Having laid that foundation, the U.S. Food and Drug Administration (FDA) recently proposed new regulations1 to “make sure sunscreens are safe and effective.” If enacted, this could have a transformative effect on the sunscreen industry as a whole.

Importantly, as I’ve noted on a number of occasions, of all the active sunscreen ingredients used in products on the U.S. market, only two — non-nano-sized zinc oxide and titanium dioxide — have been deemed safe for human use by the FDA.

Yeah, I know what you’re likely thinking. You can trust the FDA about as far as you can throw them. It’s a captured agency and essentially controlled by the very industry it is seeking to regulate. However, there appear to be no vested interests here and I believe they got it right this time.

In its proposal, the FDA admits it does not have enough scientific data to draw any conclusions about the safety of 12 of the 16 active sunscreen ingredients on its list, and asks industry to help in providing more data to perform a “rigorous assessment” of all active ingredients on the market.

Two of the 16 ingredients, PABA and trolamine salicylate, have been deemed unsafe, or not generally recognized as safe (GRAS), and are not currently in use according to the FDA.

The proposal also includes broad updates to labeling requirements, as well as SPF-related changes. For the latter, FDA wants sunscreens with an SPF of 15 or higher to provide broad spectrum protection against both UVA and UVB rays, not just UVB as is currently the case. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said:2

“It is important that, as this rulemaking effort moves forward and the FDA gathers additional scientific information, given the recognized public health benefits of sunscreen use, consumers continue to use sunscreen in conjunction with other sun-protection measures.

To help make sure this effort is successful, the FDA is looking to industry to gather the data needed to help ensure that products marketed to offer protection from the sun’s effects are safe and deliver on these promises.”

Evidence of Toxicity Exists For Several Sunscreen Ingredients

One of the 12 active sunscreen ingredients the FDA claims to be unsure about is oxybenzone, found in an estimated 70 percent of sunscreens. This, despite studies showing this chemical acts as an endocrine disruptor and has been linked to reduced sperm count3 in men and endometriosis4 in women.

Research by the Centers for Disease Control and Prevention shows 96 percent of the U.S. population has oxybenzone in their bodies, which is a testament to just how much sunscreen people are using.

Indeed, daily use of sunscreen is one of the reasons cited by the FDA for the need to update safety regulations. People are using far more sunscreen these days, so exposure to potentially hazardous ingredients is of far greater concern than in decades past.

Oxybenzone is also lethal to certain sea creatures, including horseshoe crab eggs, and researchers warn the widespread use of oxybenzone-containing sunscreens pose a serious threat to coral reefs and sea life.5 This effect is what prompted Hawaiian lawmakers to ban the sale of sunscreens containing oxybenzone and octinoxate, both of which have been linked to severe coral damage.6,7

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