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Food and Drug Administration

Food and Drug Administration

After nearly a decade, the FDA is finally on the verge of wrapping up sunscreen label changes. The objective of this years-long effort is to provide consumers with more clarity on the level of sun protection provided by sunscreen products.

Has it been worth the effort?

We’ll see.

There’s no doubt that sunscreen advertising has confused consumers.  The sun protection factor (SPF) rating, for example, is widely misunderstood. Many consumers consider SPF an indication of how long they can stay in the sun. Others believe that the higher number offers exponentially more protection. Neither is true.  In addition, current SPF ratings don’t measure the amount of UVA protection provided by the sunscreen. (Follow the link above for a full explanation of  SPF.)

So what is the FDA likely to require in sunscreen labeling?

Salynn Bolyes of WebMD has done a splendid piece of reporting on what we can look for…and the likely controversies going forward.  Here are her conclusions on what will be contained in the new regulations.

  • For the first time, manufacturers will have to provide information on how much UVA a sunscreen protects against.
  • The FDA will prohibit manufacturers from claiming sun protection factors of more than 50+.
  • Terms like “sunblock,” “waterproof,” “sweat-proof,” and “all-day protection” will no longer be allowed.
  • Labels will advise consumers to wear sun protective clothing, limit time in the sun, and reapply sunscreen every two hours, especially after swimming or perspiring.

In addition to the above, the FDA is also considering including other proposals to include in the new regulations.

  • Almost two years ago, the FDA unveiled a proposed four-star rating system, with one star representing low UVA protection and four stars representing the highest UVA protection available in an over-the-counter product. But the four star rating system applies only to UVA.
  • According to Boyles’ reporting, the FDA is also considering a proposal to prohibit sunscreens from claiming that they protect against skin cancer and premature skin aging. While we know that sunscreens alone don’t prevent skin cancer, they are an essential tool in an overall sun protection program.

According to Boyles, sunscreen manufacturers may challenge the 50+ regulation and have expressed vigorous opposition to the proposed ban on skin cancer and skin aging protection claims.

Our concern is that the new regulations don’t increase consumer confusion further. For example, will the four star proposal be included with SPF? How will consumers understand that a star refers to UVA? Will SPF continue to refer only to UVB protection? In addition, while we certainly agree that sunscreen alone doesn’t protect against UV rays, it’s an essential component of a sun safe program. Surely, manufacturers will be permitted to make these claims, otherwise why would consumers buy sunscreen at all?

No doubt these are thorny questions, but the FDA has had nearly ten years to think about them.  In the meantime, skin cancer rates have more than doubled.

According to Boyles, the FDA expects to finalize the label rules by the end of the year. We’ll see then whether it’s achieved in making sunscreen–its advantages and limitations–clearer and more understandable for consumers. Or whether it’s achieved the opposite.

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One Response to “FDA to Roll Out New Sunscreen Regs by End of the Year”

  1. Raelynn says:

    I’m actually quite in favour of how the EU has dealt with the labelling legislation for their sunscreens. SPF and PPD. granted that PPD is not the perfect way to measure UVA protection, it is an easier way to understand the effectiveness as compared to say the PA+++ not the Boots Star method, neither of which provides a numerical number which leads to speculation and guessing.

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