WASHINGTON, D.C. –  As Ohioans spend their summer months in the sun, U.S. Sen. Sherrod Brown (D-OH) urged the U.S. Food and Drug Administration (FDA) to continue working toward the strongest possible sunscreen products and ensure that they are properly marketed to consumers.

“Sunscreen products are critical to protecting our skin from harmful rays that can lead to skin cancer. But the U.S. hasn’t approved new over-the-counter sunscreen ingredients in over a decade despite our law aimed at expediting the review of new ingredients,” said Brown. “As Ohioans spend their summers outdoors, we must make sure they are protected. The FDA must continue developing new products and making sure consumers are aware of the protections the sunscreens they purchase provide.”

In a letter to FDA Acting Commissioner Stephen Ostroff, Brown encouraged the agency to:

  • Make sure products are marketed clearly to consumers. Approximately four years ago, the FDA proposed limiting the sun protection factor (SPF) value on labels to “SPF 50+” after some researchers found that higher SPF numbers do not necessarily correlate with stronger sun protection. The letter encourages FDA to finalize this rule. Misleading labels with higher SPF values could encourage consumers to use less sunscreen than recommended or apply less often.
  • Continue progress on new ingredients. Last year, the President signed into law the Sunscreen Innovation Act – cosponsored by Brown – to speed up the review process for sunscreen products that have been marketed overseas for years. While FDA has met the deadlines set forth by the legislation, no new sunscreen ingredients have been approved as a result. The letter urges the FDA working with ingredient sponsors to ensure that products are not only safe and effective, but also available to American consumers in a timely manner. It has been over a decade since FDA last approved new ingredients for over-the-counter sunscreen, while consumers in Europe and Canada have had access to new sunscreen products throughout this time.
  • Ensure efficacy of sunscreen sprays. Aerosol-based products are becoming more popular among consumers, but may not provide the same level of protection from the sun as lotion-based products. There may also be serious inhalation risks associated with sunscreen sprays.  FDA issued an Advance Notice of Proposed Rulemaking on dosage forms of sunscreen, in particular sunscreen sprays, in June 2011. The letter urges the FDA to move forward with that rulemaking to ensure that all dosage forms of sunscreen products available on the market are both safe and effective.

The Sunscreen Innovation Act, cosponsored by Brown, was signed into law in December 2014 and will strengthen the potency of U.S. sunscreen by expediting the bureaucratic review process of the active ingredients in sun protection products – manufactured in Ohio by BASF, L’Oreal, and Ashland Inc. – that are already used in sunscreen technologies available to consumers in Canada and the European Union (EU), but not in the U.S.

There are more than two million cases of skin cancer in the United States each year and 90 percent are the result of harmful sun exposure. Melanoma, the most deadly type of skin cancer, kills nearly 10,000 Americans a year, and yet Americans do not have access to the most advanced sunscreen products that Canadians and those in the EU do.

The FDA is responsible for ensuring the safety and effectiveness of all drugs, including over-the-counter (OTC) drugs, like sunscreen, and their ingredients. But the FDA has a backlog of pending sunscreen ingredients to review, which dates as far back as 2003. The FDA last approved a new ingredient for use in sunscreen products in 1999.

Full text of the letter is below.

Stephen Ostroff, M.D.
Acting Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

 

Dear Commissioner Ostroff:

With the arrival of summer, millions of Americans are spending time outdoors and may not be adequately protected from the sun.  As such, we write to urge you to finalize parts of the over-the-counter sunscreen monograph pertaining to the testing and labeling of sunscreen sprays and use of sun protection factor (SPF) numbers higher than 50. 

According to the Centers for Disease Control and Prevention (CDC) skin cancer is the most common form of cancer in the U.S., and melanoma is the most deadly type of skin cancer.  The rate of melanoma cases has doubled from 1982 to 2011 and the CDC estimates that 21,000 cases of melanoma could be avoided annually using sun protection measures. More than 90 percent of melanoma skin cancers are due to skin cell damage from ultraviolet (UV) radiation exposure. Yet, with effective protection, some of these cancers could be prevented.

We have made progress since FDA first looked into the deceptive practices of sunscreen products over 30 years ago.  In 2011, FDA took an important step, one we had long urged, to finalize components of the sunscreen monograph related to the testing and labeling of sunscreen lotions.  Additionally, last year, the President signed into law the Sunscreen Innovation Act to speed up the review process for sunscreen products that have been marketed overseas for years.  While FDA has met the deadlines set forth by the legislation, we are disappointed that no new sunscreen ingredients have been approved as a result.  We urge you to continue working with ingredient sponsors to ensure that products are not only safe and effective but also available to American consumers in a timely manner. It has been over a decade since FDA last approved an over-the-counter sunscreen, while consumers in Europe and Canada have had access to new sunscreen products throughout this time.

We must also work to ensure that the sunscreens currently available are marketed clearly for consumers.  Sunscreen lotions and sprays are increasingly marketed at higher SPF numbers even though some researchers have found higher numbers do not always correlate with proportionately stronger protection.  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 SPF 100 may protect against 98 percent of the sun’s rays.  Nearly four years ago, FDA proposed to limit the maximum SPF value on sunscreen labels to “SPF 50+” for exactly that reason.  These misleading labels may encourage consumers to spend more time in the sun, use less sunscreen than is recommended, or apply sunscreen less often.  We urge FDA to finalize this proposed rule as soon as possible to better protect consumers from misleading labels on sunscreen products. 

Additionally, we remain concerned about the effectiveness and safety of sunscreen sprays.  Aerosol-based products are becoming more popular among consumers, but may not provide the same level of protection from the sun as lotion-based products.  There may also be serious inhalation risks associated with sunscreen sprays.  FDA issued an Advance Notice of Proposed Rulemaking on dosage forms of sunscreen, in particular sunscreen sprays, in June 2011, and we urge FDA to also move forward with that rulemaking to ensure that all dosage forms of sunscreen products available on the market are both safe and effective.

We urge you to do more to ensure that consumers can purchase sunscreen products with the knowledge that they meet FDA’s enforceable standards and offer the strongest possible protection.  Thank you for your continued work to ensure that Americans have access to safe and effective sunscreen products.  

 

Sincerely,

 

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