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Senators Push FDA for Stronger Sunscreen Standards

Published in CQ Roll Call
By Emily Ethridge


Beachgoers reaching for the sunscreen this summer may notice some new labels on the bottles, including warnings that the product may not protect against skin cancer.

This is the first summer that the Food and Drug Administration’s rules for over-the-counter sunscreen labeling are in full effect. Labels will now feature information about whether the products protect against both UVA and UVB rays; whether they help prevent sunburn, skin cancer and premature aging; and if and for how long they are water-resistant.

A group of nine senators, however, wants the FDA to do much more. Although the agency has finalized many of the regulations it proposed in 2011, it has yet to complete them all — including rules regarding spray sunscreens and sunscreens advertising SPFs of 50 or higher. SPF stands for sun protection factor.

“We urge you to do more to ensure that consumers can purchase sunscreen products and products containing sun protection with the knowledge that they meet the FDA’s enforceable standards and offer the strongest possible protection,” the senators wrote in a recent letter to FDA Commissioner Margaret A. Hamburg.

The lawmakers emphasized that the new labeling rules are necessary to educate consumers and protect them against skin cancer. The National Cancer Institute estimates that this year more than 76,000 people will be diagnosed with melanoma, the most dangerous form of skin cancer, and almost 9,500 will die from it.

According to the American Cancer Society, more than 2 million of the skin cancers diagnosed each year could be prevented by protecting against sun exposure and avoiding indoor tanning.

The FDA’s new labeling rules are already a big change for sunscreen manufacturers. They can no longer promote their products as “waterproof” or “sweatproof” or say they provide “instant protection” without FDA approval. In addition, products that don’t offer broad-spectrum coverage or have an SPF above 15 must carry alerts that they do not prevent skin cancer or premature skin aging.

The final regulations became effective in June 2012, but the FDA postponed compliance dates for most sunscreen products until December 2012 to avoid a potential shortage last summer — a delay the lawmakers criticized.

Although the senators praised the agency for enforcing those regulations this summer, they pushed the agency to do more. They asked Hamburg to strengthen labeling by finalizing a proposed regulation that would require sunscreen products with SPF values of more than 50 to be labeled as “50+.”

The FDA has said there is insufficient data to show that products with SPFs of more than 50 provide greater protection against the sun than products with SPF 50 — and the senators agree.

“For instance, one product with an SPF of 30 was found to protect against 97 percent of the sun’s UVB rays, while a product labeled with an SPF of 100 may protect against 98 percent of the sun’s rays,” they said in the letter.

The lawmakers also expressed concern that spray sunscreens and other formulas may not provide the same level of sun protection as typical lotion sunscreens. The FDA has requested additional data on spray sunscreens to establish their effectiveness and to determine whether they pose safety concerns from accidental inhalation. The agency also requested more data on sunscreen oils, creams, gels and sticks.

“The FDA has received numerous comments on the labeling proposal, draft guidance and requests for data that were issued in June 2011. The agency is currently evaluating the data and information included in these comments,” agency spokeswoman Andrea Fischer said in an email.

In addition, the lawmakers asked the FDA to look into reviewing and approving new sunscreen ingredients that they say could offer stronger protection.

Democratic Sen. Jack Reed of Rhode Island, one of the letter’s signatories, said in a statement that eight applications for new sunscreen ingredients have been pending with the agency for years — some for up to a decade — and many of the ingredients are already being used in other countries.

The senators asked what action the agency has taken to review those ingredients and whether the FDA plans to develop a process to approve them. Along with Reed, the signers are independent Sen. Bernard Sanders of Vermont and Democratic Sens. Richard Blumenthal of Connecticut, Dianne Feinstein of California, Al Franken of Minnesota, Kirsten Gillibrand of New York, Patrick J. Leahy of Vermont, Charles E. Schumer of New York and Sheldon Whitehouse of Rhode Island.

The Environmental Working Group is also pushing the agency to do more when it comes to sunscreen labeling and testing. In reviewing the sunscreen market in May, the environmental health research and advocacy organization found that the FDA’s regulations had resulted in only “minimal improvements” in the products being sold.

Nearly all sunscreens on the market met the FDA’s standards for providing broad spectrum coverage, the group said, but added that the agency’s standards are “the weakest in the modern world.”

The FDA says products passing the broad spectrum test will provide protection against both ultraviolet B radiation and ultraviolet A radiation, both of which can cause sunburn, skin cancer and premature aging. Sunburn is caused primarily by UVB radiation.

Farah Ahmed, the chair of the Personal Care Products Council’s Sunscreen Committee, protested the EWG’s findings. She said the group was promoting “false and misleading assertions” about sunscreen, which may prompt consumers not to use the products at all.

Congress recently tried to combat skin cancer caused by sun exposure by including a 10 percent tax on indoor UV tanning services beginning in July 2010. The tax also served as a revenue raiser for the health care overhaul (PL 111-148, PL 111-152).

However, the U.S. Treasury inspector general for tax administration found that the number of businesses paying the tax was much lower than what had been expected. The Joint Committee on Taxation estimated the tax would raise $200 million in fiscal 2011, but the IRS received tanning tax returns reporting only $36.6 million over that time frame.

Part of the difficulty came from finding the businesses that were liable for paying the tax, the inspector general said. The report also noted that the IRS could have done more to inform businesses of their filing responsibilities to bring them into compliance. The IRS agreed with the inspector general’s recommendations and published final regulations on the tanning tax in June.

In other congressional action on the issue, four House members — Republicans Charlie Dent of Pennsylvania and Peter Roskam of Illinois and Democrats Jim Cooper of Tennessee and Carolyn B. Maloney of New York — have established a congressional caucus to support legislation and policies addressing skin cancer.

Recently, doctors have been pushing for students to be allowed to bring sunscreen to school without restrictions. Because of FDA regulations, sunscreen is considered an over-the-counter medication, and laws in many states ban children from bringing any medication to school without a doctor’s note.

At its meeting in June, the American Medical Association adopted a policy supporting the exemption of sunscreen from that OTC medication ban.

“Students shouldn’t need to get a note from their physician in order to protect themselves from sun damage while they are at school,” AMA board member Alexander Ding said in a statement. “Even just a few sunburns can increase a child’s risk of skin cancer later in life, and they should be able to apply and reapply sunscreen at school.””

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