January 2008
FDA Commissioner Andrew C. von Eschenbach,
U. S. Food and
Drug Administration
5600 Fishers Lane,
Rockville MD 20857-0001
Docket No. 2006P-0210 and 1978N-0038
Dear Commissioner von Eschenbach,
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.
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