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The Sunscreen Fix

<p>We need better sunscreens. Here's how to get it right.</p>

We need better sunscreens. Here's how to get it right.

Sunscreen is an integral part of sunny days. It allows people that would normally sunburn pursue outdoor activities. Use of sunscreen in susceptible individuals reduces the risk of developing skin cancer.

Sunscreen is sold over the counter, and in 1978 the Food and Drug Administration (FDA) decided to regulate it as it does over the counter medications. This is counter to the myriad cosmetics and supplements on the market over which the FDA has no input and may contain a statement such as “the FDA has not evaluated the safety or efficacy of this product.”  It places the burden on sunscreen manufacturers to demonstrate that their sunscreens are safe, rather than the level that is expected of cosmetic and supplement manufacturers, which are regulated only if their products are deemed unsafe.

Partially due to this decision, and general bureaucratic regulatory sludge, no new sunscreen chemicals have been approved for use in the United States (US) in the last 15 years. (The FDA has rejected all sunscreen product applications since Avobenzone in 1999).

Instead, we are stuck with sunscreen chemicals such as oxybenzone, which has been heavily criticized as a known endocrine disruptor and allergen, and is toxic to coral reefs.

Meanwhile, Europeans enjoy sunscreen formulations that have been developed in the last few decades, have wider spectrum coverage, and also may maintain longer efficacy after application. Many European countries, which are often notoriously stingy in their approval of medications, have been satisfied regarding the safety of these chemicals. The FDA could learn from their approval process and data, and the subsequent (apparently) safe use of these products for many years by European consumers.

 

Skin cancer survivors and sunscreen advocates increasingly became outraged that new sunscreen formulations have been unavailable in the US. The situation became so dire that the typically divided US Congress passed, and President Obama signed, the Sunscreen Innovation Act of 2014. It compelled the FDA to review eight new sunscreen chemicals that have been widely used in Europe for years. The FDA did review and reject the 8 new sunscreen chemicals decreeing that manufacturers must provide further data to show that their products are "generally recognized as safe and effective."

Theresa Michelle, MD, the Director of Nonprescription Drug Products at the FDA, wrote a response to these concerns, stating that the process is ongoing. She noted that the FDA is constrained by the limitations that it operates under, namely the constraint of proving that the sunscreens are “generally recognized as safe and effective” prior to approval.

Unfortunately, it is unlikely that the corporations that submitted the applications are willing to jump through the necessary hoops, since proving safety is very time-intensive and costly. Even if they are willing, it may be many years before we have available sunscreens whose formulations are not decades old.

So how do we fix this situation? Is the FDA doing more harm than good by not allowing sunscreen formulations that have been used for years in Europe into the US? While we know that UVA rays are a cause of skin cancer, are better formulations being held up based on lack of a negative (that they do not cause harm)? Negatives such as this are notoriously difficult to prove.

 

What are potential solutions, both short and long-term?

  1. Consumers that want sunscreens that are newer and likely more effective can purchase from overseas suppliers. This is costly and inconvenient.

  2. The FDA could create a separate category for sunscreens, and drop the "generally recognized as safe and effective" requirement. They could require inclusion of labeling language that the safety of these products, especially for children and pregnant women, has not been established.

  3. Sunscreens could be placed in the same category as cosmetics by the FDA.

  4. The situation could remain unchanged, and awaiting new sunscreen approval could take years, if not decades.

 

Options 1 and 4 are untenable, from a practical and health standpoint. Clearly, the FDA needs to change its definition and regulation of sunscreens. Option 2 makes the most sense, since it gives consumers informed choice. Those that are concerned about chemicals could use zinc oxide or titanium dioxide, and the rest could have better, longer lasting sun protection formulations.


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Excellent scientific article by Burnett and Wang at Wiley Online Library (.pdf) http://onlinelibrary.wiley.com/doi/10.1111/j.1600-0781.2011.00557.x/epdf

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