From Chemical Week (Subscription)
By Vincent Valk
From Chemical Week (Subscription)
By Vincent Valk
Published in The Hill
By Julian Hattem
Public health advocates are seeing red over the federal government’s failure to approve new ingredients for sunscreen.
The Food and Drug Administration (FDA) has spent more than a decade reviewing sunscreen products that have long been on store shelves in Europe, Canada, Mexico and other countries.
The delay has gone on long enough, say lawmakers, skincare companies and public health organizations who want to do something about the 3.5 million Americans who are diagnosed with skin cancer every year.
“The fact that we have things on the market in other developed countries for over a decade that are not available here just doesn’t make any sense,” said Tim Turnham, executive director of the Melanoma Research Foundation.
Applications to approve three new sunscreen chemicals have been sitting at the FDA since 2002 with no response. Five more have since been added to the list.
The applications have been tied up in an arcane FDA process for reviewing products that have been on the market “to a material extent and for a material time” in other countries. That process, known as the Time and Extent Application (TEA), is broken, according to advocates who want the new sunscreen ingredients approved.
FDA spokeswoman Andrea Fischer told The Hill in an email that the agency is “working diligently to evaluate the submitted data” according to current standards.
Fischer added that the FDA was “also investigating ways, consistent with existing regulations, to inform stakeholders in a more expedited fashion on the status of TEAs that are currently being evaluated.”
Supporters of the new sunscreen ingredients aren’t satisfied with that response.
Wendy Selig, head of the Melanoma Research Alliance, compared the delay to a halt for a new cancer treatment.
“If we’re basically saying what’s out there now is what we knew about 10 years ago, think about what we knew on the treatment side. That would be ridiculous, right?” she said.
FDA approval would allow sunscreen manufacturers to make a wider variety of products. The new formulations might be appealing to people who don’t currently use sunscreen, industry officials told The Hill, and get more people to protect themselves from ultraviolet rays.
The delay is also discouraging skincare companies from even trying to develop new products for the U.S. market.
“There are other fillers that have been developed and launched within the past decade that haven’t even been submitted because the backlog has not been cleared out yet,” said Al Pearce, a senior marketing manager at the BASF skincare company.
The health and skincare groups are part of a coalition that has been launched to pressure the FDA to act on the submissions.
But they’re not alone, as lawmakers in Congress have also taken notice of the delays.
In recent weeks, nine legislators including Sens. Jack Reed (D-R.I.), Dianne Feinstein (D-Calif.) and Chuck Schumer (D-N.Y.) sent a letter to FDA Commissioner Margaret Hamburg calling it “critical" that sunscreens “contain ingredients that offer the strongest possible protection from the sun.”
Reed has been working with Sen. Johnny Isakson (R-Ga.), to “explore possible ways to improve this process so that new sunscreens with demonstrated safety and effectiveness can come to the market," according to a statement to The Hill from Isakson spokeswoman Lauren Culbertson.
She added that Isakson was “very troubled by the lengthy delays“ in approving the applications. “As a skin cancer survivor, Sen. Isakson believes it is important for Americans to have access to the best sunscreen products,” she said.
In the House, the annual agriculture appropriations bill under consideration instructs the FDA to finish its review of the sunscreen ingredients by next June.
The legislation also requires the FDA to work with Congress, cancer groups and manufacturers “to develop a new process that will allow safe and effective sunscreen ingredient market applications to receive a final decision from FDA within one year of application date.”
In a letter to Rep. John Dingell (D-Mich.) earlier this month, FDA Deputy Commissioner for Policy, Planning and Legislation Sally Howard wrote that a proposed rule on three of the sunscreen ingredients is expected in September.
But that’s little comfort to the coalition looking for the ingredients to be approved.
“I wouldn’t say that we’re cynical and skeptical, except there is a little bit of wait-and-see attitude,” said Turnham, “except not very much interest in waiting very long.”
Published in CQ Roll Call (Subscription)
By Emily Ethridge
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."