Observations Yankee Doodling

My New Year’s wish is for an effective sunscreen

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g7729 (Published 19 December 2014) Cite this as: BMJ 2014;349:g7729
  1. Douglas Kamerow, senior scholar, Robert Graham Center for policy studies in primary care, and associate editor, The BMJ
  1. dkamerow{at}aafp.org

President Obama signs bill to help US close the sunscreen gap

And now for something completely different: sunscreens and health policy. The United States, bastion of high technology, may in the next year or two finally catch up to the rest of the world in the availability of effective sunscreen preparations. In a rare show of bipartisanship between Republicans and Democrats and of cooperation between Congress and the White House, Congress passed and the president has now signed into law the Sunscreen Innovation Act.

A little background. The sun’s ultraviolet rays are of two major types, both deleterious to human skin and health. UVB rays cause burning and contribute to cancer risk, and UVA rays, penetrating more deeply, cause skin aging and also increase cancer risk. SPF, the skin protective factor number that we’ve all come to love and search for on our sunscreen’s label, measures only the sunscreen’s effectiveness in blocking UVB rays. Thus, it does not tell the whole story.

Regulators have been late in appreciating the importance of UVA rays in causing pathology. The Food and Drug Administration, which has jurisdiction over such things in the US, came out with new regulations only in 2011. At that time the FDA mandated several important changes, barring inaccurate terms such as “waterproof” and “sun block” from sunscreen labels. They also introduced and defined a new label term, “broad spectrum,” which for the first time acknowledged the importance of ingredients that block UVA rays. Only products meeting FDA standards for blocking both UVA and UVB could be so labelled.1

So far, so good. But very few UVA blocking chemicals have been approved by the FDA. Those in use, such as oxybenzone and avobenzone, may not block all wavelengths of UVA rays. Manufacturers have submitted other, newer UVA blockers to the FDA, but no new sunscreen ingredients have been approved since 1999.2 Despite years of carping by interested parties, nothing has happened.

Hopes were raised in 2002, when the FDA introduced a new process to shorten approval time for over the counter drugs that have been available elsewhere previously for at least five years. It allowed manufacturers to use data on safety and effectiveness from similar countries. This so called time and extent application (TEA) process was supposed to allow the FDA to approve new ingredients within 3-6 months. Nothing has happened, though, and despite the TEA process at least eight ingredients are currently waiting for an FDA decision.2

One of the newer UVA blockers, for example, is ecamsule, which is widely available in European sunscreen products. L’Oreal applied for and received FDA approval for a few preparations that include ecamsule, but they were approved under new drug approval rules as complete formulations only. As a result, ecamsule cannot be used in other products, by L’Oreal or anyone else. The few ecamsule containing products that have been approved in the US cost 3-5 times as much as other sunscreens.

So Americans have needed to go abroad to get affordable, effective sunscreens. New preparations with better UVA blocking ingredients are widely available throughout Europe, the Caribbean, and Australia.3 In a recent review, the independent product evaluation company Consumer Reports was able to find only seven US products that did well enough against both UVA and UVB rays to be recommended.4

Since this is Washington, DC, frustration with the FDA’s lack of activity finally led to the creation in 2013 of a lobbying group, the Public Access to Sunscreens Coalition. With membership including various cancer support groups, dermatologists, and (of course) the major sunscreen and chemical manufacturers, they set about to “establish a regulatory pathway for timely pre-market review of new, safe, and effective sunscreen ingredients.”5 They crafted and lobbied for passage of a new law, applying only to sunscreens, that would set specific deadlines for prompt review by the FDA of these chemicals, the Sunscreen Innovation Act.6

The law creates an approval schedule specifically for sunscreen ingredients used in over the counter preparations. The FDA must render a decision on the eight pending sunscreen ingredient applications according to a new, expedited timeline, with some decisions expected in as soon as six months. New applications must be evaluated within 10 months.

The bill recently passed both houses of Congress and, amazingly, was quietly signed into law by President Barack Obama on 26 November. There were no formal announcements and no signing ceremony, as he effectively over-ruled his own FDA. Maybe by next summer, but surely by summer 2016, we should have some affordable, highly effective sunscreens when we head for the beach or pool.

A small victory to end a dreary year on a sunny note.

Notes

Cite this as: BMJ 2014;349:g7729

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References

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