The Environmental Working Group suggests that nearly four out of five sunscreens on the US market contain "worrisome ingredients" or offer "inferior protection," with the latter failing attributed to their UVA-protective element or lack thereof.

In its May 24 Sunscreen Guide – the 10^th edition of the NGO's annual market analysis and product ranking – the group takes aim once again at popular sunscreen ingredients oxybenzone and retinyl palmitate, use of which factored in a new roundup this year of "worst-scoring kids' sunscreens" Also see "EWG's Abiding Sunscreen Concerns Cast Shadow Over 13 Kids' Formulas" - HBW Insight, 26 May, 2016..

According to EWG, oxybenzone is a hormone disruptor and allergen, and retinyl palmitate can be carcinogenic when exposed to sunlight. Regulatory authorities, physician associations and cancer organizations tend to disagree, however, based on available peer-reviewed scientific literature taken as a whole.

EWG also suggests that Americans are being "shortchanged" when it comes to UVA protection due to a dearth of approved sunscreen actives that guard against long-wave UV rays and "lax" regulation that sets a weak standard for broad-spectrum claims.

In fact, the NGO estimates that half of the 750 sunscreens it evaluated for the 2016 report "would not offer enough UVA protection to be sold in Europe," despite presumably meeting FDA's broad-spectrum testing standard.

The good news, according to EWG, is that 99% of products in this year's sunscreen guide filter at least some UVA rays, up 18% from 2007. The issue is a matter of degree, the organization suggests.

“There have been some improvements in sun protection, but there is still a lot to be done to improve the quality of sunscreens,” says EWG Senior Analyst Sonya Lunder. “Most of the products sold in the US aren’t as good as they should be and don’t offer enough protection against ultraviolet rays," UVA in particular.

While UVB rays are the primary cause of sunburn, UVA rays can "cause more subtle damage," potentially leading to skin aging, immune system suppression and melanoma, according to the NGO.

FDA's final rule on sunscreen testing and labeling, issued in June 2011, requires UVA protection to be proportional to SPF value, so that as the latter increases the former does as well Also see "FDA Strengthens Sunscreen Testing And Label Requirements" - HBW Insight, 20 June, 2011..

However, EWG sees an EU recommendation on sunscreen efficacy and related claims as representing a stronger standard for SPF/UVA proportionality. The 2006 recommendation holds that for optimal protection, the protection factor measured in UVA testing should be at least 1/3 of that measured by SPF testing.

Notably, an EU recommendation is non-binding, whereas FDA's rule has the force of law. Trade group Cosmetics Europe offers a standardized UVA logo that firms in the EU can adopt to communicate their adherence to the recommended minimum for UVA protection in relation to SPF.

EWG also continues to take the position that "despite scant evidence, the government still allows most sunscreens to claim they help prevent skin cancer."

Such statements in the NGO's reports have prompted strong reactions from the Personal Care Products Council. In a May 25 statement, the trade group's Chief Scientist Beth Lange says, "The claims made by EWG could keep consumers from using sunscreen altogether."

EWG Claims Built On Shaky Ground

EWG's assertions about sunscreens' UVA-protective potential in the US compared with products in Europe are based largely on published perspective from Brian Diffey, emeritus professor of photobiology at Newcastle University in the UK.

In opinion pieces featured in peer-reviewed JAMA Dermatology and the Journal of the American Academy of Dermatology, the now retired professor points to research indicating that certain European sunscreens provide more uniform protection across the UV spectrum, and specifically greater absorbance in the UVA range (315-400 nm), compared with selected US sunscreens.

The difference is attributed to the availability of newer UV filters in the EU that are stalled in FDA's review process in the US.

However, Diffey also notes that the divergent levels of protection in the UVA range can occur even when products subject to comparison meet both FDA's and the EU's recommended broad-spectrum standard.

His point in these pieces, incidentally, was not to compare the efficacy of sunscreens or the relative merits of regulations on either side of the Atlantic, but to examine whether the minimum critical wavelength set by both FDA and the European Commission (370 nm) is the optimal threshold, and whether the performance of newer broad-spectrum UV filters warrants stronger cancer-prevention claims.

Despite passage of the Sunscreen Innovation Act, there remain just 17 UV filters approved for use in the US versus 27 available to formulators in Europe, including more advanced UVA-protective ingredients.

According to Lunder, EWG's suggestion that half of the US sunscreens it surveyed would not be marketable in Europe due to inadequate UVA protection was based on a review of active-ingredient concentrations on product labels. The approach is questionable given the complexity of broad-spectrum calculations, and regardless, products containing approved UV filters that fall short of the EU's broad-spectrum recommendation can still be sold in the EU since the recommendation is not legally binding.

According to a May 2015 statement from PCPC, "the vast majority of sunscreens on the U.S. market that meet FDA's 'Broad Spectrum' test also meet Europe's UVA test." However, there's also limited insight into how that conclusion was reached.

EWG's assertion that Americans "have fewer choices and notably poorer protection from ultraviolet A rays than Europeans" does hold up, as a number of advanced UVA filters available in Europe have yet to be approved by FDA.

Only a handful of sunscreen actives currently permitted for use in the US offer UVA protection, with a smaller subset protecting to some extent against both UVB and UVA radiation. The latter includes oxybenzone, dioxybenzone, zinc oxide and titanium dioxide, according to the Skin Cancer Foundation.

Overall, there are 27 approved UV filters available to formulators in Europe, where sunscreen is regulated as a cosmetic, compared with 17 in the US, where sunscreens are classified as OTC drugs.

The US Sunscreen Innovation Act, passed in late 2014, raised stakeholder hopes that more sunscreen actives would be speeding to market. However, the legislation's deadlines for FDA review of sunscreen ingredients only expedited determinations from the agency that the eight UV filters in its queue need more supporting data to be designated GRASE (generally recognized as safe and effective) Also see "PASS Reacts To Sunscreen TEA Denials: Has FDA ‘Moved The Goal Post’?" - HBW Insight, 27 February, 2015..

Among the ingredients under consideration are broad-spectrum filters bemotrizinol and bisoctrizole, marketed by Germany-based BASF as Tinosorb S and Tinosorb M, respectively, as well as UVA filter ecamsule, which L'Oreal S.A. markets as Mexoryl SX and combines with drometrizole trisiloxane, or Mexoryl XL, for their synergistic effects.

According to EWG, all four "appear to be more effective than avobenzone, the most common UVA filter permitted by the FDA."

Even as the NGO calls for more and better UV-protection ingredients in the US, it already has concerns about one UV filter pending before FDA –enzacamene, which EWG says has been linked to hormone disruption. Merck & Co. Inc. submitted the ingredient for review in 2002, but has since sold its Coppertone and other consumer brands to Bayer AG and indicated in reports that it is no longer pursuing the enzacamene monograph listing.

FDA has released draft guidance regarding safety and effectiveness data requirements for sunscreen ingredients to support firms' efforts ([A#02160229004]).

Regardless, EWG suggests, as other stakeholders have, that it may take years for the sponsors of pending sunscreen ingredient applications to satisfy FDA's requests. It's not entirely clear whether the NGO, known for its adherence to the precautionary principle and a hazard-based approach to safety assessment, is critical of the rigor FDA is bringing to its evaluation of the next-generation UV filters.

Sunscreen Not A Cancer Preventer?

As for EWG's suggestion that evidence does not demonstrate sunscreen's capacity to prevent skin cancer, the group's position is partially supported by statements from FDA in connection with its final rule on sunscreen testing and labeling, issued in June 2011.

"To date," the agency says, "there are no clinical studies demonstrating that use of any sunscreen alone can prevent skin cancer."

On the basis of that observation, FDA chose to limit related labeling claims for qualifying products. Under the final rule, any sunscreen with an SPF of at least 15 that meets the agency's broad-spectrum testing standard can indicate in their Drug Facts panel that it, "if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."

However, communicating to consumers that use of sunscreen alone is not a proven skin-cancer prevention strategy is different from suggesting that it does not help in preventing skin cancer at all.

EWG sees its messaging as valuable in that it discourages consumers from putting too much faith in sunscreen and exposing themselves to more sun than they ordinarily might.

"EWG strongly disagrees with FDA’s decision to allow sunscreen makers to claim that their products prevent cancer. We are concerned that this policy will lead people to rely on sunscreen use alone to mitigate their cancer risk, and that this may backfire," the group states.

While acknowledging that skin-care incidence is on the rise, the NGO advises consumers not to rely on sunscreen as a tool to prolong their time in the sun. Its foremost recommendations are to cover up, avoid sunburns and stay away from tanning beds.

PCPC contends that EWG's messaging could be a disservice to consumers who interpret it as meaning that sunscreen use has no utility whatsoever as a skin-cancer prevention measure.

The trade organization cites research from the Skin Cancer Foundation indicating that roughly 90% of non-melanoma skin cancers and 86% of melanomas are associated with exposure to UV radiation. "Daily use of an SPF 15 or higher sunscreen reduces the risk of developing melanoma by 50 percent," PCPC says.

EWG's Claims About US Sunscreen Market, Skin-Cancer Prevention Analyzed

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