Tell the FDA to Remove the Monograph for Oxybenzone!

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Tell the FDA to Remove the Monograph for Oxybenzone!

The National Institutes of Health has determined that sunscreen chemicals which filter out ultraviolet rays may impair male fertility. There are twenty-nine “benzophenone-type UV filtering chemicals” in personal care products that protect skin and hair from sun damage. Researchers found that men with high exposure to two chemicals in particular had a 30% reduction in their ability to reproduce.

To avoid the lengthy and expensive new drug approval process, sunscreen ingredients are governed by monograph (a written standard for active ingredients). If a monograph has been issued for a product, all a company has to do is show that it has met the standards of that monograph to be allowed on the market. One of the monographs the FDA approved in 1999 is for oxybenzone, which breaks down to 4-OH-BP, one of the two chemicals that cause infertility.

Ask the FDA to remove the monograph for oxybenzone. It’s a dangerous chemical and should immediately be banned from sunscreens. Also ask the FDA to speed up its review of proposed new ingredients. Their long delays in reviews make consumers less safe.

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Stephen Ostroff

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Please Remove the Monograph for Oxybenzone

Dear [Decision Maker],

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The National Institutes of Health has just determined that sunscreen chemicals which filter out ultraviolet rays in sunscreen lotions may impair male fertility. There are twenty-nine "benzophenone-type UV filtering chemicals" in personal care products that protect skin and hair from sun damage. Researchers found that men with high exposure to two chemicals in particular had a 30% reduction in their ability to reproduce.

As you know, sunscreens are technically classified as drugs. But to avoid the lengthy and expensive new drug approval process, sunscreen ingredients are governed by monograph -- if a monograph has been issued for a product, all a company has to do is show that it has met the standards of that monograph to be allowed on the market. One of the monographs your agency approved in 1999 is for oxybenzone, which breaks down to 4-OH-BP, one of the two chemicals that cause infertility.

I am writing to ask the FDA to remove the monograph for oxybenzone. It's a dangerous chemical and should immediately be banned from sunscreens.

I would also ask that your agency speed up its review of proposed new ingredients for sunscreens. If there is a new and potentially safer sunscreen ingredient, a manufacturer's viable alternative is the Time and Extent Application. TEAs are meant to allow companies to bring technically new ingredients to the US consumer market, based on their use in other countries. The FDA then is supposed to review the ingredient to see whether it can be Generally Regarded As Safe and Effective (GRASE) for use in sunscreen.

Your agency is on the record as saying you would "strive to complete TEA evaluations in 90-180 days" -- yet the FDA has not approved a TEA for any sunscreen active ingredient since 2002. Only recently did you issue a first determination that GRASE status would not be established for two ingredients.

The FDA's long delays in reviewing ingredients make consumers much less safe. Please expedite this process so we can go out in the sun without fear of becoming ill from our sunscreen lotions!

Sincerely,
[Your Name]
[Your Address]
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Protecting Natural Health