U.S. Consumers Have Few Options for UVA Protection
EWG has determined that only one-third of high SPF products offer strong protection against both UVA and UVB rays, making U.S. sunscreens worse overall than those sold abroad. Despite claims on sunscreen labels, there's no such thing as an all-day, sweat-proof, waterproof sun block. Similarly, many products advertise but do not actually provide "broad spectrum" sun protection. A product survey by sunscreen maker Proctor & Gamble in 2004 noted that a third of products that claimed broad spectrum protection on the label didn't actually provide it (Nash 2004).
A major obstacle to progress is the federal Food and Drug Administration, which has never managed to sign, seal and deliver the sunscreen regulations it began developing in 1978. The latest draft of those rules was issued in 2007 but ended up in regulatory limbo, where it remains (FDA 2007).
Even though it can't seem to close the deal on its regulation, the FDA insists that manufacturers who make sunscreens for the American market stick to a list of 17 ingredients. A rule issued in 1999 and never updated limits concentrations and combinations (FDA 1999).
EWG's analysis of beach and sport sunscreens shows that because of FDA's limits on sunscreen ingredients, not a single product sold on the U.S. market this year would achieve FDA's proposed highest rating for UVA protection – four stars.
By contrast, sunscreen makers catering to the European market can choose among 28 active ingredients. EWG's analysis showed that many European sunscreens would achieve four-star ratings under the proposed FDA system. Five years ago some U.S. sunscreen makers began seeking FDA approval to use some of these compounds. They are still waiting.
That's a crucial lapse when it comes to UVA protection, because seven compounds that effectively block UVA are available for use in Europe, but only three in the United States. Among the UVA filters approved in Europe are three – Tinosorb S, Tinosorb M and Mexoryl SX – that are between 3.8 times and 5.1 times more protective than the maximum allowable concentration of Avobenzone, the most common UVA filter in the U.S. products (BASF-Ciba 2010).
Tinosorb S and Tinosorb M, used in European compounds for a decade, appear to be relatively non-toxic, according to manufacturer data provided to the European Union and FDA (Ciba 2000).
The available data for Mexoryl SX, on the market in Europe since 1991, does not raise toxicity concerns, EWG's analysis has found. FDA has not approved it for general use but has permitted L'Oréal to use it in a small number of products sold under its "LaRoche-Posay" and "Kiehl's" brands, where it is called "Ecamsule."
FDA's delays in complete its safety and effectiveness reviews of these UVA filtering ingredients creates a Catch-22 for manufacturers who might want to adopt the proposed FDA rating system, because no U.S. product can currently achieve four stars (Osterwalder 2009b, FDA 2007). The prospects for voluntary compliance would likely improve, should FDA remove this roadblock by approving more modern ingredients or lifting restrictions on sunscreen concentrations and combinations.
In the absence of solid, up-to-date regulations, sunscreen makers get away with making unsubstantiated marketing claims that their products offer "broad spectrum UVA and UVB protection" -- because they can. Ad hype can soar as sky-high as bogus SPF numbers.
The agency projects that its proposed rule for UVA screen testing and labeling, issued August 2007, could be finalized as early as October 2010 (Reginfo 2010). But even if the agency meets that deadline – and there are no guarantees – the rule would not likely go into force for at least two more summers.
Proposed UVA Rating System Is a Step Forward
EWG's analysis found that the agency's proposal has some positive features: a reasonably simple rating scheme that would classify label product's UVA protection from zero stars ("no protection") to four stars ("very high protection"). But it has some drawbacks.
The proposed FDA rule merely requires disclosure of UVA protection offered by a sunscreen. Under these rules it will still be legal to sell a product with zero stars, which offers no UVA protection.
Some critics argue that listing UVA and UVB protection separately will confuse customers who will chose amongst products with 16 different possible combinations of low, med, high and very high protection from UVA and UVB rays (Osterwalder 2009a). This is especially true in the United States, where many sunscreens offer extremely high protection from sunburn but minimal UVA protection.
Europe has sidestepped both of these issues by requiring all sunscreens to have a baseline level of UVA protection that is roughly equivalent to a three star product in the FDA's proposed scheme. This allows consumers to select a product that provides adequate sunburn protection based on their skin tone and intensity of sun exposure, and at the same time, to be assured that the product protects against UVA rays as well.
Another criticism is that the FDA approach requires blocking against all UVA rays instead of targeting those parts of the UVA spectrum that actually cause harm by provoking damages like free radicals or melanoma. EWG would support this approach when science establishes appropriate health-relevant metrics.
The regulatory vacuum leaves consumers in the dark about how much protection their sunscreens really offer against UVA rays. EWG believes that despite its imperfections, the FDA proposal would go a long way toward filling this gap. The agency has asked sunscreen makers to adopt the proposed star-based rating system while the regulatory system grinds to a conclusion (FDA 2007), but so far no company has done so.
To demonstrate how that system would work, EWG analyzed this year's leading sunscreens with SPF 30 or higher to determine how they would stack up if the FDA's star ratings were in force today. The analysis showed that:
- Neutrogena products offered the highest average UVA protection, at nearly three stars, while Panama Jack offered the lowest, at two stars, considered "medium" protection.
- More than half of all sunscreens with "high" SPFs (30 or greater) offered only "low" or "medium" UVA protection. This means that people using products advertising "broad spectrum" UVA/UVB protection may still be exposing their skin to excess, damaging UVA radiation.
- At least seven popular products that were labeled in 2010 with "high" sunburn protection (SPF>=30) provided only low, one-star UVA protection.
Comments