FDA to Look at Nano-products...Again

The Food and Drug Administration is once again holding an “information gathering” public meeting on nanotechnology, a powerful new technology for taking apart and reconstructing nature at the atomic and molecular level.  Like Yogi Berra said, “it’s déjà vu all over again.” 

FDA held the same meeting two years ago, in autumn 2006.  Even then, the agency was behind the curve: Many products that contain unlabeled nanomaterials, including food and food packaging products, were already on market shelves.  Now, two years have passed since that meeting and the agency’s continuing stance can be aptly summarized as “all talk, no action.” 

Many new nano-products continue to come to market, at an average of four to five a week.  Unfortunately nano-products are still treated by FDA like any other products or product ingredients; yet scientists agree that nanomaterials are fundamentally different substances that create new and unique risks to human health and the environment and need new forms of safety testing. 

A public comment period is open now through October 24, 2008 - Take action now!

Sample Letter for Campaign

Subject: Docket No. 2008-N-0416 and Docket No. 2006P-0210

Dear [ Decision Maker ] ,

Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852

Comments on Docket No. 2008-N-0416 and Docket No. 2006P-0210(FDA regulation of nanotechnology materials; public meeting)

I write to express my serious concerns about the FDA's regulatory oversight of nanomaterials in consumer products.

Hundreds of consumer products containing manufactured nanomaterials are already available on U.S. market shelves, including food and food packaging products. New nanomaterial products are coming out at a rate of four to five a week.

In the absence of labeling, public debate or laws to ensure safety, products created using nanotechnology have entered the food chain. Millions of dollars are being spent by government and industry to apply nanotechnology in areas of food processing, food packaging, and agricultural production.

Industry analysts estimate that there are between 150-600 nano-foods and 400-500 nano-food packaging products already on market shelves worldwide.

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. We know that the new properties of nanomaterials also create new risks, like enhanced toxicity, and there is a growing library of scientific studies demonstrating that some of the nanomaterials now being used in foods and agricultural products introduce new risks to human health and the environment.

Nanoparticles can gain assess to the blood stream following ingestion. Once inside the body, the super-tiny size of these materials gives them unprecedented mobility and access to the human body; they can access cells, tissues, and organs that larger particles cannot. The length of time that nanoparticles remain in organs and what dose may cause harmful effects remains unknown.

It does not appear that FDA is ready for this wave of nano-food products. I am very concerned about the rapid introduction of these potentially hazardous nanomaterials into our bodies and into our environment without adequate scientific study to ensure that we understand their risks and can prevent harm occurring to people and the environment.

For these reasons, I strongly request that FDA act urgently to shore up its regulation of these substances to account for their fundamentally different properties and their associated dangers, including requiring new nano-specific testing and the labeling of all nanomaterial products, including nano-food products.

Because there are no regulations to require labeling of nano-ingredients and additives in food and packaging there is no way for anyone to choose to eat nano-free. Only with labeling can I make educated decisions about what I buy and put in and on my body. Until such actions are taken, I fully support a moratorium on the manufacture of nanomaterial consumer products and the recall of products currently on the market.

Sincerely,

Campaign Launched:
August 28, 2008


Background Information

Nanotechnology is a powerful platform technology to take apart and reconstruct 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 nanoparticles’ ability to penetrate the skin. 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. Scientists agree that because of their new properties and seemingly limitless mobility,  nanoparticles can create new and unique risks to human health and the environment, notably enhanced toxicity. 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.

By 2010 the nano-food market could be worth $6 billion.  Many of the world's leading food companies - including H.J. Heinz, Nestle, Hershey, Campbell, General Mills, PepsiCo, Sara Lee, Unilever, and Kraft - are investing heavily in nanotechnology applications. Nanoparticles of silver, titanium dioxide, and zinc oxide, materials now used in dietary supplements and food packaging, have been found to be highly toxic to cells in studies.  Nano-silver, the most common commercialized nanomaterial, is being used in numerous food packaging items, cutlery, baby bottles, and kitchen appliances and cleaners for its “germ-killing” power.  This same powerful strength can destroy important beneficial microorganisms in nature as well.
 
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 the environment.  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 nanomaterials and force manufacturers to label these new nanoproducts, including nano-sunscreens (Docket No. 2006P-2010).  In 2008 CTA filed a similar legal action with the Environmental Protection Agency (EPA) on the unregulated potential environmental and health dangers of nano-silver consumer products.    
   
Further Resources:

International Center for Technology Assessment 2008 Legal Petition to EPA on Regulation of Nano-silver Products, http://www.nanoaction.org/nanoaction/page.cfm?id=244

Friends of the Earth, Report, Out Of The Laboratory And Onto Our Plate: Nanotechnology in Food & Agriculture (2008), http://action.foe.org/content.jsp?content_KEY=3965&t=2007_Healthy-People.dwt, and http://www.foe.org/pdf/nano_food.pdf

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