Sunscreen Regulations: Why 'Final' is Not the Right Word

May 6th, 2014

Robert Ross-Fichtner, Focal Point Research Inc.

Over the past 25 years, no category of “cosmetics” has seen change like sunscreens. None has created the scientific and regulatory debate; done more to confound industry, regulators and consumers; been subjected to more meetings (and created more paperwork to shred)... This is due to a steep learning curve about these products, an ever-changing understanding of ultraviolet radiation, and an evolution in thinking about skin cancer as well as how to regulate sunscreens. Just when it seems that sunscreens have hit some kind of finality, something changes.

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Look no further than the number of years, in fact decades, that were required for the United States¹ to update its drug Monograph for sunscreens, with Canada following shortly thereafter.² Whether or not one agrees with these decisions, most will agree that a clear impression of finality was given. But as is typical, with this ever-changing category, authorities are now reconsidering. In Canada, for example, it is entirely possible that simple sunscreens like foundations and moisturizers will be reclassified as cosmetics. And in the United States, there is speculation that the entire monograph system might be scrapped.

Changing Attitudes

Start by looking at how attitudes toward the sun have evolved. During this author's lifetime, consumers of Western nations have completely changed their views of the sun. There was a time when people streamed to the beach, armed only with a bottle of baby oil. The folklore was that this would somehow “maximize” one's tan. Most sun worshipers in the 1960s ended up looking like heavily basted roasted turkeys. Over the years, they traded their beautifully bronzed, youthful skin for deeply wrinkled, old-looking skin. Sadly, many died of malignant melanoma, the most severe type of skin cancer.

Fast forward to today's confused and split society. On one hand, there are high rates of skin cancers; in response, sophisticated technologies have been developed to mitigate the sun’s UV rays. On the other hand, there are also cases of “sun phobia,” and consumers applying SPFs in winter months in low sun latitudes. And yet, a trip to Florida, California or the Mediterranean during the North American winter would find lounge chairs lined up, with rows of white bodies desperately trying to change color and return home with proof of a beach vacation.

Rating System

The earliest sunscreens could miraculously prevent sunburn. The U.S. military went looking for this technology during World War II.³ The now-famous SPF value began in the 1970s to communicate to consumers just how much sunburn protection they were buying. Of course, regulators had to decide what these products were. In North America, they became drugs. In Europe, they were cosmetics, and worldwide, they are classified in various ways. This became, and still is, a huge challenge for companies trying to meet the global consumer need for these products.

With time, industry and society learned more about skin cancer and the need for sunscreens to provide broader-spectrum coverage. It became commonly known that UVB causes sunburn while UVA relates to skin cancer. Many experts began to feel that SPF values were not nearly as important as a product’s ability to protect against skin cancer. This led to a separate debate about communicating UVA and broad-spectrum benefits to consumers, and whether a separate numerical rating system was in order.

By virtue of its 2011 Monograph, the U.S. Food and Drug Administration (FDA) decided a new rating system was not warranted; but specific tests were outlined to measure broad-spectrum capabilities.

“UVA testing started with a UVA/UVB claim, went to a PFA number and is back to a weaker ‘broad-spectrum’ claim,” says Craig Weiss, of Consumer Product Testing Labs. "PFA, or Protection Factor A, was in vogue for a period of time to quantify the amount of UVA radiation protection. I don’t expect we’ve seen the end of this debate, as the learning builds on skin cancer and UV radiation."

Protecting Consumers

All of this technical language really misses the point about why governments regulate sunscreens: it is their obligation to help protect citizens from harm, and in this particular case, the harm is skin cancer. This author seriously doubts that governments care whether consumers get wrinkles and look like prunes, which is where the regulation of sunscreens becomes confusing. Sunscreens are not “cosmetics” in the manner of eye shadows, but they are also not “drugs” in the manner of topical steroids. So frankly, they don't really fit either regulatory scheme.

So what could be the appropriate regulatory approach for these products? North Americans often look to Europe and say, “they are only cosmetics over there.” This of course completely misses the point that in order for a cosmetic to be sold in Europe, it requires a drug-like dossier, GMP compliance and even mandatory complaint reporting. For those following developments in emerging China, sunscreens are considered “special cosmetics” as opposed to “general cosmetics,” meaning they require extra attention upon registration. According to Chinese Quality and Technology Certification and Consulting Services Centre (QTCCC),⁴ China is considering placing cosmetics into three different groups based on risk. Sunscreen products would remain in the top category. Interestingly, this model is incredibly similar to that used for medical devices around the world, where a simple bandage is Class I, up to a cardiac pacemaker that is Class IV. As expected, the regulatory burden gets higher with every classification.

As skin cancer has become better understood, interesting statistics have emerged. According to Cancer Research UK,⁵ the highest rates of malignant melanoma, the most serious skin cancer, are in Sweden, and the lowest are in Greece and Cyprus. This is counterintuitive, given their geographies. Also, Australia and New Zealand continue to top the list of serious skin cancers, which is often attributed to their British and European heritage. Without a doubt, skin type affects the chances of developing skin cancer; but what has emerged is a model showing that not all people are at the same risk for skin cancer. Factors include skin type and color, style of dress and sun exposure habits. Of course, this includes holidaying in the sun and letting one's guard down, something that many can attest to.

At the same time, society has become so increasingly sun phobic that the beneficial effects of sunlight are not considered. Sunlight generates vitamin D in skin, and more and more evidence links vitamin D deficiencies to all kinds of disease states. Multiple sclerosis, cancers and a surprising number of other diseases are speculated to be based on vitamin D deficiency. In fairness, some of this is purely dietary. Many people do not drink milk or consume foods rich in vitamin D. However, looking at the distribution of diseases, some skew to the Northern and Southern latitudes where people have far less exposure to sunlight. The science in this area is still emerging. So far, a link to sunscreen use and vitamin D deficiency has not been found.⁶

Future Developments

So, as “final” as the Sunscreen Monographs in North America may seem, many questions remain. These will no doubt inform the future regulatory and scientific developments of sunscreens, leading to further regulatory evolution.

As a few examples:

1. Are consumers better served if sunscreens are regulated as drugs, or some type of “super” cosmetic? Given their importance in mitigating skin cancers, there's an argument to me made for “super cosmetic.” At the same time, this type of classification has proven to restrict flexibility and innovation, keeping many well-established sunscreen active ingredients off the market. The recent tabling of the “Sunscreen Innovation Act” in the U.S. Congress underscores the paralysis that has existed in modifying these fundamentally important products when they are classified as drugs. This Act would require the FDA to approve more sun-absorbing actives.

2. Since some subpopulations are clearly more at risk, do they have special needs? For example, do the Scandinavians or Australians deserve unique or more powerful formulas? Do they need much more detailed education about the risks and rewards from the sun? From what the industry knows, this is really not a one-size-fits-all consumer need.

3. There is much discussion in the industry that consumers do not use sunscreen properly during high exposure periods, such as at the beach or during sports. Is there a packaging innovation waiting, where we could sell single use packets and detailed dosing regimens, just like taking dietary supplements? Perhaps if a 200-pound male is going to spend six hours in the sun, he would march to the beach with three “doses” appropriate for his body size, to be applied every two hours.

4. Should cosmetic scientists and the nutrition community have a meeting of the minds and discuss their roles in understanding vitamin D? Surely it's an important enough matter for some serious consideration.

Those who have lived with the chemistry and regulation of sunscreens for a long time are still humbled by a lack in true understanding of this important class of products. In this case, all they can do is stimulate discussion, encourage innovation and work with regulatory bodies. The amount of effort and continual change in the sunscreen category are testimony to their profound importance in the industry because unlike most cosmetic products, they can and do directly impact the health of consumers.

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