After a 33-year-long delay and mounting frustrations from the natural sunscreen industry and the Environmental Working Group (EWG), the Food and Drug Administration (FDA) has finally introduced its sunscreen requirements, which address "broad spectrum," "waterproof," and other unsubstantiated marketing claims. A step in the right direction—but the EWG and natural mineral-based sunscreen manufacturers are pointing out significant regulation loopholes that will affect consumers.
FDA sunscreen requirements highlights
Under the new requirements—which the FDA will enforce by June 2012 (consumers and retailers will likely see changes on sunscreen packaging prior to then)—any company wanting to make "broad spectrum” claims must now test for UVA protection, in addition to UVB. "The FDA was supposedly legislating about UVA three years ago; it's about time," says Amy Wechsler, MD, a New York-based dermatologist. "Europe and Australia have been doing it for years."
The new "broad spectrum" labeling requirement will force some manufacturers to change formulations if they want to claim to be broad spectrum, which is an issue consumers are educated about, says Paul Halter, lead formulator for Colorado-based mineral sun care company Goddess Garden. "There's a greater and greater appreciation for using those full-spectrum mineral active titanium dioxide and zinc oxide sunscreens, rather than chemicals sunscreens, which have various issues." The regulations will mean more work for anyone in the industry, says Halter (even including mineral sunscreen companies ranked highest on the EWG's safe sunscreen list, which will also have to adjust labeling) and are "very positive."
Manufacturers are also prohibited from making misleading claims like "waterproof" or "sweatproof," or identifying their products as "sunblocks." While the regulations don't relate directly to a formulation's efficacy and safety, they will help "provide clarity and truth in marketing," says Jentri Provenzano, marketing coordinator at W.S. Badger, a leading manufacturer of mineral sunscreens. Other approved regulations include requiring non broad-spectrum sunscreens below SPF 15 to contain a warning statement about skin cancer and skin aging. (Get a complete list of the FDA requirements.)
The greatest controversy in the manufacturing community has been over the continued acceptance of high SPFs (those more than 50), which Halter says is "the most flagrant marketing that is not consistent with the science." Limiting SPF claims to 50+ (rather than, say SPF 100), didn't make it past the "FDA proposed regulations" list.
"No data suggests that anything higher is of greater value to the consumer, and we believe that. That's something we've always abided by," says Halter. In fact, very few mineral-based sunscreens will boast an SPF above 30—which typically requires a vast increase of active, often chemical, ingredients that boost UVB protection only slightly (97 percent for an SPF 30 versus about 98 percent for an SPF 50).
Beyond SPFs, the EWG has been vocal over the FDA's complete disregard for some of the skin care industry's most dangerous ingredients, which appear in various chemical sunscreens: oxybenzone and retinyl palmitate. There is also question over whether the the new broad-spectrum requirement is sufficient; a minimum protection from 370 nanometer UVA wavelengths could lead to inadequate UVA protection, according to the EWG (though both Provenzano and Halter say this number offers significant protection) and is too rudimentary to allow consumers to differentiate between levels of UVA protection.
Plus, it's a downgrade from the Four-Star System the FDA was considering three years ago, says the EWG. Manufacturers currently using this UVA-rating system say the FDA should have supported it. "We do not understand why the FDA doesn't simply adopt the standards the EU already uses to test and convey UVA protection to the public. 'Broad spectrum' is simply vague," says Michael J. Russ, president of Oceana Naturals, LLC, a distributor of natural sunscreen MelanSol.
The newly approved statements about skin cancer also pose risks, say some manufacturers. "What bothers us the most is the direct language that ties the use of an SPF 15 sunscreen or higher to the prevention of skin aging and skin cancer when there is no actual evidence that they perform this function," says Russ. Badger questions whether such claims may give consumers a "false sense of protection."