FDA Wants to Update Sunscreen Regulations

Mar 22, 2019

The FDA proposed a new rule last month to update sunscreen regulations for the U.S. market, which could mean major changes to some popular sunscreens, many of which include chemicals the agency says have not been proved safe.

“This significant action is aimed at bringing nonprescription, over-the-counter 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,” according to the FDA.

In a news briefing last month, FDA Commissioner Scott Gottlieb described the move as “an important step in the FDA’s effort to take into account modern science to assure the safety and effectiveness of sunscreens.”

Sunscreen usage has changed, he said, with more people using it more frequently and in larger amounts. “At the same time, sunscreen formulations have evolved as companies innovated. 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 proposed rule covers the safety of sunscreen ingredients and various sunscreen dosage forms, SPF, and requirements for testing, labeling and broad-spectrum protection.

Active ingredients. Two of the 16 currently marketed active ingredients are A-OK by all standards – zinc oxide and titanium dioxide. Two other ingredients, PABA and trolamine salicylate, are not considered safe, and are not currently on the U.S. market. Twelve more lack sufficient data for a designation of GRASE (“Generally Recognized as Safe and Effective”): cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone and avobenzone.

Among the concerns is that oxybenzone “is absorbed through the skin to a greater extent than previously understood.” Based on animal testing, questions have arisen about its potential to be an endocrine disrupter, a chemical that can cause cancer, birth defects and other developmental disorders. Environmental Working Group’s Senior Vice President for Government Affairs, Scott Faber, has told reporters the FDA’s announcement will “cause a sea change in how sunscreens are formulated.” EWG wants to eliminate oxybenzone from all commercially made sunscreens by 2020.

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.

Sun Protection Factor. The rule would raise the maximum SPF value on labels from 50-plus to 60-plus. (SPFs above 60 are not believed to have any greater benefit). 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. The higher the SPF, the greater need be the UVA protection.

Labeling practices. Active ingredients must be on the front of the product, to bring sunscreens in line with other OTC drugs. The front label should also have a 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.

Combination products. Sunscreen/insect repellent combo products are not GRASE.

Long Beach Island’s own Lizzy Beyer, who has her own line of natural skincare products called Current All Natural, agrees the proposed changes are a big step in understanding the chemicals used in mainstream sunscreens and will push companies to change their formulas – “but I hope the FDA will take it one step further,” she said. “Following the lead of Hawaii and Florida, I hope the FDA will ban oxybenzone and similar chemicals.”

Beyer’s desire to create all-natural products grew out of her strong interest in environmental sustainability, she explained. “As I learned more, I realized a lot of these chemicals in sunscreen and other beauty products that are bad for the environment are under research because there is reason to think that they are harmful to the human body as well.”

She sees the relationship between Earth and human wellness as symbiotic.

“If it is bad for the planet, it is probably bad to put on your body,” she said. “The skin is the body’s largest organ, and everything that you put on it is absorbed into your blood stream.” She cited recent landmark court cases in California such as Monsanto Round Up and Johnson & Johnson talc baby powder as “further evidence that we need to do more research and not just trust companies to do it for us.”

“On a local level,” she continued, “there are thousands of visitors to the LBI region every summer. Most of them are wearing sunscreen and swimming in the ocean. These chemicals from the sunscreen are not only being absorbed through their skin, but also being washed off into the ocean. It has been confirmed that oxybenzone is detrimental to coral reefs. While the LBI region does not have much coral to worry about, I think it’s safe to assume that these chemicals are harming other marine organisms as well.”

The FDA is currently accepting public comment for 90 days from Feb. 26. Until the final ruling, consumers are urged to continue using sunscreens on the market with an SPF of at least 15, in addition to other practical sun protection measures.

“Sunscreens are only one element of a skin-cancer prevention strategy,” the FDA advises. “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.”

— Victoria Ford

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