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FDA Proposes Rules for Nanoparticles

On Friday, April 20, 2012, the U.S. Food and Drug Administration (FDA) issued tentative guidelines for food and cosmetic companies interested in using nanoparticles.

“This is an emerging, evolving technology and we’re trying to get ahead of the curb to ensure the ingredients and substances are safe.” — Dennis Keefe, director of FDA’s Office of Food Additive Safety

Nanosphere

SOURCE: Chad Mirkin, Northwestern University

The FDA is “an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products” (Source: FDA Press Release).

Nanoparticles are nanoscale materials generally less than 100 nanometers (a billionth of a meter) in diameter.  To put the size in perspective, 100 nm is about 500 times smaller than the diameter of human hair.  Something so small that they can’t be seen with a standard microscope.

But materials enhanced with nanoparticles can have physical, chemical, and biological properties that differ from those of their larger counterparts as the video below illustrates.

According to the FDA Press Release: “The submicroscopic particles are increasingly showing up in FDA-regulated products like sunscreens, skin lotions and glare-reducing eyeglass coatings. Some scientists believe the technology will one day be used in medicine, but the FDA’s announcement did not address that use.”

So are American consumers safe?  The FDA does its best, but it’s limited in resources and scope.  For example, it has less authority over cosmetics than food additives.   Nanotechnology has been used in cosmetics since the 1990s. “Generally, the FDA does not review cosmetics before they launch, and companies are responsible for assuring the safety of their products” (Source: AP News: FDA proposes rules for nanotechnology in food).  In addition, it’s limited testability.  How do you test for a problem you never knew existed?  How do you test for dangers that don’t show symptoms for ten or twenty years? What happens to the stuff when you’re done with it?  What impact does it have on the environment?  When it “decays,” what does it turn into?

I was a test engineer in the medical industry, and I was astonished by how sloppy some of the regulatory tests were handled.

In our rush for better products and profits, we may be endangering ourselves.  Time for additional testing and thinking is worth the cost.

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In my science fiction short story, Death Has no Shadow, a nanotechnology accident releases swarms of microscopic robots called forger nanites into the environment and a science intern finds that her lab is their target.

Healing Stones – Part 2: Targeted Cancer Therapy

How do you get a nano-robot to target and kill just cancer cells but leave healthy cells alone?

Think like a suicide bomber:

  1. Carry a concealed mass killing weapon like a bomb,
  2. Act and look like you belong,
  3. Get into the enemy’s site, and
  4. Blow it up.

Nanotechnology for medicine does not necessarily mean robotic machinery. On the nanometer scale, the mechanism is more like a virus and can better be characterized by bio-chemistry. A nano-scaled robot uses molecular keys (cell targeting ligands) and special polymers (diblock copolymers) instead of gears and cogs.

This video explains it best:

So what are the healing stones?  They are theoretical first-aid nano-bot factories and delivery systems.  See other “Healing Stone” articles for more information.

Of all the future technological breakthroughs noted on this site, I hope this one comes first.

See Recruiting Angles for nano-medicine in action.

Image and video from Frank Gu Research Group, Department of Chemical Engineering, University of Waterloo, Ontario, Canada.