The United States Food and Drug Administration (USFDA) has issued three final guidance documents and one draft guidance for the development of nanotechnology products.  The final guidance documents address 1) the FDA’s overall approach for all of the products that it regulates; 2) the effects of significant manufacturing process changes and the safety and regulatory status of food ingredients and food contact substances; and 3) the safety of nanomaterials in cosmetic products. The draft guidance covers the use of nanomaterials in food for animals.

The FDA’s interest in the application of nanotechnology is based in large part on its application to conventional substances may result in product attributes that are different from those present in conventionally-manufactured products.  Nanomaterial may possess novel physicochemical properties as a result of the seemingly simple dimension alteration that can affect the biological behavior of the material as a result of the increased surfaces-area-to-volume rates, morphology, surface features, and charge.  Nanotechnological alterations may even affect the biodistribution, biocompatability, and toxicity of a material (e.g. may affect absorption rate in body).

Nanotechnology is a generic phrase for manufacturing, science, and engineering conducted at the 1 to 100 nanometer scale.  A nanometer is a billionth of a meter, and there are more than 25,000,000 nanometers in an inch.  To fully grasp the scale of nanotechnology, consider that a single page of newspaper is roughly 100,000 nanometers thick, or if a marble compared to the size of the earth is the same scale as one nanometer to a meter.  For more nanotechnology 101 see: http://www.nano.gov/nanotech-101/what/definition

See: http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm; http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm300661.htm; http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm300886.htm; http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM401508.pdf