PCPC vs. EWG: The Sunscreen Battle

WASHINGTON—As of late, vitamin A, or more specifically, retinyl palmitate, and other sunscreen ingredients have come under fire from the Environmental Working Group (EWG), who, in its 6^th Annual Summer 2012 Guide to Sunscreen Dos and Don’ts, says, “Vitamin A (retinyl palmitate) causes skin cancer in laboratory tests" and “Oxybenzone is a hormone disruptor and skin allergen."

Now that FDA has pushed back the sunscreen deadline for meeting new testing requirements and removing terms such as “block" and “waterproof" to Dec. 17, 2012, EWG also filed a Freedom of Information request with FDA, requesting any and all documented communications between it and officials with the industry’s trade associations.

However, the Personal Care Products Council (PCPC) doesn’t agree with EWG’s warning against vitamin A and others. “Allegations contained in EWG’s 2012 sunscreen report disregard or distort an extensive body of scientific research on the safety, efficacy and health benefits of sunscreen and could confuse consumers and discourage them from using sunscreen," said Farah Ahmed, chair, PCPC.  “With skin cancer rates on the rise, this does a great disservice to consumers and undermines the efforts of public health advocates to educate people about the importance of using sunscreen as part of their sun protection regimen.

“By challenging the medical and scientific consensus that sunscreen products are safe and effective, the EWG report defies the scientific assessments of sunscreen products and ingredients by regulatory authorities in the United States, the European Union and Canada. In the U.S. sunscreens are regulated as over-the-counter drugs by FDA and are subject to rigorous safety and efficacy substantiation."

Ahmed went on to say that retinyl palmitate has been used safely for many years in various personal care products and is approved by FDA for use as a food additive and has been reviewed twice by the Cosmetic Ingredient Review (CIR) and found to be safe. “A large body of evidence suggests that retinoids have anti-cancer effects in humans," PCPC said.

"Oxybenzone, also known as Benzophenone-3, protects the skin from harmful UV rays," Ahmed continued. "FDA and regulatory authorities in Canada and the European Union have approved the use of oxybenzone as a safe and effective sunscreen ingredient. While EWG alleges a connection between oxybenzone and hormone or endocrine disruption, current scientific research does not support such a link in humans."

In fact, PCPC supported FDA deadline extension, as did the American Academy of Dermatology (AAD). “In August 2011, the Council requested FDA to extend the compliance date for its final sunscreen rule out of a serious concern for a potential shortage of sunscreens on the market because industry was unable to complete transitioning their product labeling before the deadline," Ahmed said. “Echoing the same concern, FDA provided an additional six months for industry to implement the new rule. The final sunscreen rule requires that any product labeled on or after the compliance date meet the requirements of the rule. In other words, older products can remain on the market and when sold-out be replaced by products with the new label.  This further validates that sunscreens with both new and old labels are safe and effective."

In January 2011, the National Toxicology Program (NTP) released a study, “Photococarcinogenesis Study Of Retinoic Acid And Retinyl Palmitate," found mice treated with small doses of retinyl palmitate and UV light developed skin tumors faster than untreated, light-exposed mice or those treated only with a control cream. There were more numerous tumors on every animal treated with retinyl palmitate. A panel comprised of independent scientists unanimously confirmed the study’s conclusion that retinyl palmitate “enhanced the photocarcinogenic activity" of sunlight.

This study, conducted at a federal research center co-hosted by FDA and NTP, along with several others vitamin A-UV ray interaction studies is the foundation for EWG’s argument against retinyl palmitate’s (and other common sun care ingredients’) inclusion in sunscreens.

“EWG urges FDA to expedite review of the latest scientific evidence bearing on the safety of forms of vitamin A and other common sunscreen ingredients that may be toxic or carcinogenic," the agency was reporting saying last June. “Until the government takes decisive action, consumers can have no confidence that the regulatory system for sunscreens and cosmetics is screening out suspect ingredients. With no clear guidance from FDA, consumers must rely on tools like EWG’s sunscreen guide and Skin Deep database to identify and avoid suspect ingredients in common products."

At this point, consumers have to decide for themselves. The science is there, and EWG's, AAD's and PCPC's opinions are there. So unless FDA bans vitamin A and/or oxybenzone, consumers need to make up their own minds, because it’s clear the industry is still at odds with sunscreen safety.

Personally, I'm not sure why FDA's role in cosmetic regulation needs to be modernized. Isn't that what PCPC and EWG and CIR and other trade associations and non-profits are for? To report research findings, educate consumers on how to dissect label claims, make the public aware of potentially hazardous chemicals, have conflicting opinions, etc.? To give consumers the information they need to make up their own minds and then let the free market weed out the dishonest?