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Letter to the Margaret Hamburg, Commissioner of US Food and Drug Administration - Consumers Purchasing Sunscreens

Senator Dianne Feinstein (D-Calif.), along with Senators Jack Reed (D-R.I.), Al Franken (D-Minn.), Kirsten Gillibrand (D-N.Y.), Chuck Schumer (D-N.Y.), Patrick Leahy (D-Vt.), Bernie Sanders (D-Vt.), Sheldon Whitehouse (D-R.I.) and Richard Blumenthal (D-Conn.), today sent a letter urging the Food and Drug Administration (FDA) to ensure consumers can purchase sunscreen products that are safe, effective and offer the strongest possible protection.

This is the first summer in which the FDA's new rules governing sunscreen testing and labeling are in effect. Though this is an important step, the senators urged the FDA to implement standards for newer products such as sprays, increase labeling standards and approve new ingredients that could provide greater protection against the sun's harmful rays.

Text of the letter to the FDA follows:

The Honorable Margaret A. Hamburg, M.D.
Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Commissioner Hamburg:

We write to urge you to complete action on parts of the monograph pertaining to the testing and labeling of sunscreen sprays and use of sun protection factor (SPF) numbers higher than 50. We also want to share our concern that the Food and Drug Administration (FDA) has delayed the approval of critical ingredients used in sunscreens.

As you know, FDA first looked into the deceptive practices of sunscreen products over 30 years ago. Since then, the rate of melanoma in this country has doubled. According to the American Cancer Society, over two million individuals will be informed that they have a preventable form of skin cancer in 2013. Yet, with the summer months soon upon us, millions of Americans will be spending time outdoors and may not be adequately protected from the sun.

We appreciate the action taken by the FDA in 2011 to finalize components of the sunscreen monograph related to the testing and labeling of sunscreen lotions. This was an important step, and one we had long urged. However, more action is needed.

When Americans purchase and use over-the-counter sunscreen products they assume they are protected from harmful UVA and UVB rays, but the current protection that they are afforded could be misleading or worse inaccurate. For example, 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. In addition, there are some sunscreen lotions and sprays that continue to use increasingly higher SPF numbers even though 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 with a SPF of 100 may protect against 98 percent of the sun's rays. Lastly, it is our understanding that the FDA has yet to approve, let alone review, new ingredients for sunscreen that may offer stronger protection against the sun's rays.

It is critical that consumers have access to sunscreen products that are accurately labeled and contain ingredients that offer the strongest possible protection from the sun. In an effort to understand what is delaying action on these critical issues, we request answers to the following questions:

1. How many comment letters did the FDA receive in response to the proposed rule regarding the use of SPF numbers greater than 50 and in response to the advanced notice of proposed rulemaking regarding sunscreen sprays?

2. When does the FDA plan to publish a final rule with respect to the use of SPF numbers greater than 50 and a proposed rule regarding sunscreen sprays?

3. What type of enhanced protection from the sun's rays could individuals receive from ingredients that have yet to be approved for use in sunscreens?

4. What action has the FDA taken to review these ingredients?

5. Does the FDA plan to develop a process to approve these ingredients? If so, when?

Once again, 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.

Thank you for your attention to this matter. We look forward to your prompt reply.

Sincerely,

Feinstein
Reed
Franken
Gillibrand
Schumer
Leahy
Sanders
Whitehouse
Blumenthal


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