FDA Extends Comment Period for Proposed Rule for OTC Sunscreen Drug Products
BY LINDA BONVIE
Ever since the FDA first began its rule-making process on sunscreens 33 years ago, there have been major safety questions looming over the majority of brands that line store shelves. And that’s not just regarding how well (or not) they protect you from a risky sunburn, but also about any potential dangers from the chemicals they contain.
To give us even further pause as we pack our gear for the beach or pool, just last month FDA researchers discovered that four common sunscreen chemicals when used for just one day could penetrate into the bloodstream of study volunteers in levels that exceeded the FDA’s “testing threshold.” One, oxybenzone, reached that distinction in only two hours of use.
Of course, the experts’ knee-jerk response to those findings was a reminder to keep on using sunscreen until regulators figure it all out – along with a reassuring comment from the FDA that the mere fact that a chemical can be absorbed into our bloodstream doesn’t mean that “the ingredient is unsafe.”
Unsafe or not for people, the city of Key West, the state of Hawaii and the Western Pacific nation of Palau have all enacted bans on sunscreens containing both oxybenzone and octinoxate, scheduled to take effect in 2021, for the purpose of protecting coral reefs. According to the National Park Service up to 6,000 tons of sunscreen residues land in coral reef areas every year, which was found in studies to cause “bleaching and death” of these living undersea ecosystems.
The “good news” is that the FDA’s foot-dragging examination of sunscreens has finally reached the regulatory “proposed rule” stage, with an extension of the comment period to June 27. One of the purposes of this proposal is to close the pesky data gaps on 12 sunscreen ingredients that the agency knows so little about they can’t even tell us if they are “generally recognized as safe and effective” (otherwise known as GRASE). Two ingredients were determined to be definitively not GRASE, but fortunately, according to the Environmental Working Group (EWG) report, they are rarely used these days.
In considering regulations for over-the-counter (OTC) sunscreen products, the FDA is proposing a rule to determine the degree to which these products may continue to be marketed as “generally recognized as safe and effective” (GRASE), and are not misbranded. Fortunately, the comment period allowing you to suggest further study has been extended to June 27. Submit a comment now and urge that the FDA not only investigate the potential health consequences of oxybenzone in humans, but also consider environmental and ecological impacts, along with data from animal models.
And curiously enough, despite the huge amounts of these products that we slather on our skin day in and day out, they don’t appear to be protecting Americans against the most dangerous kind of skin cancer, melanoma, of which cases have doubled since 1982.
So, if you’re planning for some summer days outdoors, here are five important things to know when it comes to practicing safe sun:
- What sunscreens are “safe and effective”? Actually there are plenty of good choices, all containing one of two ingredients the FDA considers GRASE and that the EWG has recommended: zinc oxide and titanium dioxide. The big brands have figured that out too, and you’ll find those ingredients used not only in smaller niche products, such as Badger (a top-rated EWG brand), but also by big names like Coppertone.
- Steer clear of oxybenzone. Despite the FDA’s “don’t worry” approach to this chemical (one of the most commonly used ingredients in sunscreens), studies have found it likely to be an endocrine disruptor, one that’s easily absorbed in large amounts through the skin, that’s been detected in human breast milk, amniotic fluid, urine and blood. Kids, of course, are going to be much more vulnerable to any such dangers.
- Stop spraying! As the EWG points out, sunscreen sprays can be a significant inhalation hazard. In a preliminary test, the FDA found that three out of 14 sunscreen sprays were risky enough to not meet the proposed standards for safety, but didn’t bother to release the names of those products. So your best bet is to avoid them all.
- Don’t count on the SPF. Even the FDA is saying that high SPF, or sun protection factor numbers, are misleading. If you think that a higher number means you can stay out longer in the sun without being burned… well, case in point! In reality, SPF 50 is as high as you need to go. What’s missing, however, from the lion’s share of U.S.-available products is adequate protection from UVA rays, the kind that penetrate deep into the skin. And that’s true no matter how high the SPF number may be. What you want in a sunscreen is “broad spectrum” protection against both UVA and UVB, what you’ll get from a zinc oxide or titanium dioxide product.
- Cover up and make your own shade. Don’t depend entirely on sunscreen to save your skin from a burn. Wear a UPF (for ultraviolet-protection factor) fiber, long-sleeve shirt when out in the sun, and a bandana made of similar material around your neck. They’re cool, dry fast, and can be worn in the water. Get a pop-up tent or umbrella for the beach or pool and wear a wide-brimmed hat for those beach walks.
But remember, you need a certain amount of vitamin D every day, especially the kind your own body makes when unprotected skin is exposed to the sun. A study done in 2017 by researchers from the Touro University California College of Osteopathic Medicine, concluded that vitamin D deficiencies (which are incredibly common) may be due in large part to excessive use of sunscreens.
The researchers advised a walk with exposed arms and legs from 5 to 30 minutes during midday at least twice a week. They also commented that while vitamin D is found in lots of foods, such as fatty fish and eggs, those with certain health problems such as kidney disease, Crohn’s and type 2 diabetes can have a decreased ability to metabolize D from food.
Linda and Bill Bonvie are regular bloggers for Citizens for Health and the co-authors of Badditives: The 13 Most Harmful Food Additives in Your Diet – and How to Avoid Them.