Tell FDA to regulate unlabeled and untested nanomaterials in sunscreens!

The Food and Drug Administration has recently proposed a new labeling rule for sunscreens and is requesting public comment on the issue of nanotechnology and its use in sunscreens.

The agency is behind the curve: Many sunscreen manufacturers are already adding nanoparticles to sunscreens to make sun-blocking ingredients appear clear instead of white. These engineered nanoparticles are being added for marketability, without appropriate labeling or agency-reviewed safety information. Thus far, these nanotechnology-laced products are treated by FDA like any other products or product ingredients; yet scientists agree that nanoparticles are fundamentally different substances that can create new and unique risks to human health and the environment and need new forms of safety testing.

Tell FDA nanotech sunscreens need to be safety tested, regulated and clearly labeled.

Sample Letter for Campaign

Subject: Docket No. 2006P-0210: Regulate unlabeled and untested nanomaterials in sunscreens

Dear [ Decision Maker ] ,

Dear FDA Commissioner Andrew C. von Eschenbach, Docket No. 2006P-0210 and 1978N-0038

I write to express my serious concerns about the FDA's failure to regulate nano-sunscreens, and the rapid introduction of these potentially hazardous nanomaterials into our bodies and into our environment (Docket No.'s 2006P-0210 and 1978N-0038). Many sunscreen manufacturers are now including potentially dangerous nanoparticles in their sun care products without any FDA premarket review. Scientists have found that the fundamental properties of matter can change at the nano-scale, creating physical and chemical properties distinct from those of the same material in bulk form.

FDA's current mere reliance on manufacturers' assurances of safety make me and my family into guinea pigs. While using sunscreens to block dangerous UV rays we may be unnecessarily exposing ourselves and our families to a new danger. Even though these nano-sunscreens are applied in large amounts directly on the skin, the jury is still out on their safety. Unlike larger particles, once inside the body nanoparticles can enter vital organs, tissues, and even our bodies' cells. While we still don't have a very good understanding about what levels of nano exposure might be unsafe, available scientific studies have shown that nanoparticles used in sunscreens can cause severe damage to our DNA, disrupt the function of our cells, and even lead to cell death.

I urge FDA to address the human health and environmental risks presented by nano-sunscreens, and to require manufacturers to clearly label their nano-sunscreens as such. Only with labeling can I make educated decisions about what I put on my body and into the environment. Product labeling also makes possible the documentation of potential environmental releases, human exposures, and accountability for adverse impacts.

Until such actions are taken, I fully support a moratorium on the release of nano-sunscreens, and the recall of nano-sunscreens already on the market.

Thank you for taking my views under consideration.

Sincerely,

Campaign Launched:
November 01, 2007

Background Information

Nanotechnology is a powerful platform technology for taking apart and reconstructing nature at the atomic and molecular level. It involves the manipulation of matter at the nanometer (nm) scale, one-billionth of a meter. The nano-scale is exceedingly tiny: A human hair is huge by comparison, about 50,000 nm thick; the head of a pin is about 1 million nm across.

Scientists have found that the fundamental properties of matter can change at the nano-scale, creating physical and chemical properties distinct from those of the same material in bulk form. Nanoparticles have unprecedented mobility, and readily enter the human body and gain access to the blood stream via inhalation and ingestion. In addition, the jury is still out on the ease of their skin penetration. Studies have raised numerous red flags, with some showing that certain nanoparticles can be toxic to human tissue and cells. Once inside the body, nanoparticles can cross biological membranes, cells, tissues, and organs more efficiently than larger particles. Once in the blood stream, nanomaterials can circulate throughout the body and can be taken up by the organs and tissues including the brain, liver, heart, kidneys, spleen, bone marrow, and nervous system. In addition, unlike larger particles, nanoparticles are transported within cells and taken up by cell mitochondria and the cell nucleus, where they may interfere with normal cellular function, cause oxidative damage and even cell death. The length of time that nanoparticles remain in organs and the dosage that may cause harmful effects remains unknown. Because of these new properties, scientists agree that nanoparticles can create new and unique risks to human health and the environment, like enhanced toxicity and seemingly limitless mobility. These risks require new forms of safety testing. Existing studies have raised red flags demonstrating that current nanomaterials already in commerce may be extremely damaging to living organisms and systems.

Despite these concerns, many sunscreen manufacturers still choose to “enhance” their products with nanoparticles even though they are not necessarily more effective at blocking radiation from the sun. Consumer Reports recently tested nano-sunscreens and found no correlation between their presence and sun protection. The reason manufacturers are lacing their sunscreens with these particles has more to do with marketing: the size-dependent optical properties of nanoparticles make the sunscreens transparent and presumably more desirable to consumers.

Moreover, the unregulated commercialization of these products poses unknown dangers to the environment once they are released into the waste stream. The same unique mobility and toxicity concerns that apply to human health apply to environmental risks. Even simply detecting these engineered substances in the environment is a new challenge.

Thus far, nanotechnology-laced products are treated by the Food and Drug Administration (FDA) like any other products or product ingredients. In 2006 CTA, joined by other consumer health and environmental groups, petitioned FDA to stop ignoring the new dangers presented by these new materials and force manufacturers to label these new nano-products, including nano-sunscreens (Docket No. 2006P-2010). This public comment period is the public’s first chance to tell FDA what its priorities should be with regard to nanotechnology generally and nano-sunscreens specifically.

Further Resources:

International Center for Technology Assessment 2006 Legal Petition to FDA on Regulation of Nanotechnology and Nano-Sunscreens: http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf

Petition Executive Summary: http://www.icta.org/doc/Nano%20petition%20ex%20summary.pdf

Friends of the Earth Report: A Consumer Guide for Avoiding Nano-Sunscreens (2007)
http://www.foe.org/nano_sunscreens_guide/Nano_Sunscreens.pdf

Friends of the Earth Report: Nanomaterials, Sunscreens, and Cosmetics: Small Ingredients Big Risks (2006): http://www.foe.org/camps/comm/nanotech/nanocosmetics.pdf

Principles for the Oversight of Nanotechnologies and Nanomaterials: http://www.icta.org/doc/Principles%20for%20the%20Oversight%20of%20Nanotechnologies%20and%20Nanomaterials_final.pdf

Executive Summary/Press Release of Principles: http://www.icta.org/press/release.cfm?news_id=26

Consumer Reports: http://www.consumerreports.org/cro/health-fitness/beauty-personal-care/sunscreen-7-07/overview/0707_sunscreen.htm

Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies - Consumer Product Database: http://www.nanotechproject.org/44