Feb. 21, 2019 -- The FDA has issued a long-awaited plan to update regulations for sunscreen products marketed in the U.S. The move could mean major changes to some popular sunscreens, many of which include chemicals the agency says have not been proved safe.
The proposed rule covers the safety of sunscreen ingredients and various sunscreen dosage forms, SPF, and requirements for testing, labeling, and broad-spectrum protection.
The FDA is seeking more information on some popular sunscreen ingredients, including oxybenzone and avobenzone.
"This action is an important step in the FDA's effort to take into account modern science to assure the safety and effectiveness of sunscreens," FDA Commissioner Scott Gottlieb, MD, said at a news briefing Thursday.
The proposed rule would bring nonprescription, over-the-counter (OTC) sunscreens marketed without FDA-approved applications up to date with the latest science. The FDA wants to put into effect the final regulations for sunscreen drug products, known as OTC monograph regulations, as required by the Sunscreen Innovation Act. The OTC monographs allow certain drugs to be marketed without new drug applications because they are generally recognized as safe and effective, which the FDA refers to as GRASE.
Overview of Proposed Rules
Theresa Michele, MD, director of the Division of Nonprescription Drug Products in the FDA Center for Drug Evaluation and Research, said the new rules include:
- Active ingredient safety. "First, we propose that of the 16 currently marketed active ingredients, two -- zinc oxide and titanium dioxide -- are great for use in sunscreens," she says. Two other ingredients, PABA and trolamine salicylate, are not considered safe, she said. These two ingredients are not currently on the U.S. market. "There are 12 ingredients for which we propose there are insufficient data [to make a positive GRASE determination]."
- Dosage forms. Sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks are considered GRASE. More information is needed on the safety of powders. Wipes, towelettes, body washes, shampoos, and other forms will be categorized as new drugs, as the FDA has not received data showing their eligibility yet.
- SPF. The rule would raise the maximum SPF (sun protection factor) value on labels from 50 plus to 60 plus. "We believe there is not data to support benefit in an SPF above 60," Michele says. But the FDA proposes to permit products with SPF up to 80, to give manufacturers flexibility. Products with an SPF of 15 or higher must also provide broad-spectrum protection. As SPF increases, the protection against UVA rays must also increase.
- Labeling. Active ingredients must be on the front of the product, which Michele says brings sunscreens in line with other OTC drugs. There should also be a notification on the front label to read the skin cancer and skin aging alert for products that have not been shown to help prevent skin cancers. The format for labeling SPF, broad spectrum, and water resistance will be revised.
- Testing. The FDA will clarify what it expects from the industry for testing and record-keeping on their products.
- Combination products. "We propose that products that combine sunscreen with insect repellents are not GRASE," Michele says.
More on the 12 Ingredients Needing More Study
According to the FDA, 12 sunscreen ingredients lack enough data to support whether they are GRASE. They are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone.
Among the concerns are that oxybenzone ''is absorbed through the skin to a greater extent than previously understood," the rule says. There are questions about is potential to be an endocrine disrupter, a chemical that can cause cancer, birth defects, and other developmental disorders. Nearly all of the 12 have limited or no data about their absorption, the FDA says.
Several sunscreen makers did not respond to requests for comment. But a spokesperson for Johnson & Johnson, which makes sunscreens, said the company continues to "believe in the science that shows high SPF provides significantly greater protection, compared to lower SPF."
The UV filters in its products, Kim Montagnino says, "meets or exceeds the rigorous testing standars of the U.S. FDA."
The company also supports the FDA's proposed changes to labeling that "reinforce the important role that sunscreens play in protecting against UV exposure, which is the leading cause of skin cancer," Montagnino says.
The Consumer Healthcare Products Association (CHPA) says: ''We look forward to submitting comments and continuing the dialogue with FDA to reinforce the safety and efficacy of sunscreens." The industry group, which represents over-the-counter product manufacturers, notes that ''sunscreens save lives, that's why millions of Americans use sunscreen products on a daily basis.''
During the interim between the proposal and the final ruling, the association urges consumers to continue using sunscreens on the market.
"It's about time the FDA regulated sunscreens more and made it easier for consumers to understand the options," says Michele S. Green, MD, a Manhattan dermatologist. She reviewed the new proposed rules.
"A lot of companies are going to go nuts," she predicts, since many manufacturers include the 12 ingredients for which more data is called for. Meanwhile, she will tell her patients not to panic and not to throw away sunscreens. If they are worried, they should look for products with the two ingredients deemed safe by the FDA for now, she says.
But Henry W. Lim, MD, a dermatologist at Henry Ford Hospital in Detroit, says the research to date doesn’t show problems with chemical sunscreens. Lim has done consulting for various sunscreen makers.
While the academy generally supports many of the proposed changes, he says the main challenge to him is the proposal for more data on the 12 ingredients to show they are safe and effective.
"We have not seen any significant problems, health effects with sunscreens including endocrine effects," Lim says.
The concern that oxybenzone, a popular ingredient, may be an endocrine disrupter, is primarily based on animal studies, he says. Research on people does not demonstrate problems with endocrine disruption with oxybenzone use.
Lim and his colleagues looked at the 2001 study done in animals exposed to oxybenzone, which triggered concern because it found the ingredient increased uterine size in animals.
To put the finding in perspective, Lim's team considered the dose used in the animal study and the average use of oxybenzone products. They concluded that the application regimens and time periods required to get the same blood levels as found in the animal study are basically unattainable.
Bottom line, Lim says, is that a woman in the U.S. would have to apply a half ounce of oxybenzone-containing sunscreen, a typical amount used, to about 25% of her body, or the typically exposed areas, for 277 years to achieve the same blood levels.
“It’s important to understand that the proposed rule does not conclude that the sunscreens currently on the market are unsafe," said Suzanne M. Olbricht, MD, president of the American Academy of Dermatology Association (AADA), in a statement.
Still, Scott Faber, senior vice president for government affairs at Environmental Working Group, said at a press briefing that the FDA’s announcement will “cause a sea change in how sunscreens are formulated.”
His organization welcomes the proposed regulations, especially the request for more information on products such as oxybenzone. On its website, EWG notes that, ''Over the course of 12 years, EWG has uncovered mounting evidence that one common sunscreen chemical, oxybenzone, poses a hazard to human health and the environment. It is an allergen and a hormone disrupter that soaks through skin and is measured in the body of nearly every American."
EWG wants companies to go oxybenzone-free by 2020.
Advice for Consumers
The FDA will accept comments from industry and others for 90 days after the proposed regulations are published in the Federal Register on Feb. 26.
Until the FDA gets more information, such as on the 12 ingredients they are seeking more data for, ''consumers should continue to use broad-spectrum sunscreens of 15 SPF or higher, along with other sun protection measures," Michele says.