August 15, 2008
FDA Nanotechnology Public Meeting Sept 8, 2008
From the FDA:
The Food and Drug Administration (FDA) is announcing a public meeting to gather information that will assist the Agency in implementing the recommendations of the Nanotechnology Task Force Report. For more information on the Nanotechnology Task Force and for a copy of this Report please visit: http://www.fda.gov/nanotechnology/.
Part of the meeting will deal with Food and Color Additives, including food contact substances. Some of the questions to be addressed are:
- Can you identify specific classes of food ingredients or packaging components derived from or incorporating nanotechnology that you would identify as raising or not raising unique safety concerns and why?
- In your experience, what analytical methods and tools have proven to be of the most use to you in characterizing nanoscale materials? Looking to the future, can you suggest methods that might be developed or refined to augment those methods currently used?
- What physical characteristics of food-related nanoscale materials are of greatest concern regarding the safety of dietary consumption?
- Nanoscale food ingredients and food packaging may behave differently than macroscale materials. For example, nanoscale materials may agglomerate in food, interact with other components of the food matrix, and interact in the human body following ingestion. What methods are you using to characterize nanoscale materials in the food matrix and in the human body following ingestion?
- Are the current FDA Redbook toxicological endpoints and array of toxicity tests used for assessing the safety of macroscale food ingredients and packaging components sufficient to describe the toxicity of their nanoscale counterparts, or must new endpoints and assays be considered? Are you aware of any other toxicity tests not presently in wide use that may be more suitable? Are there toxicity tests that could be used to bridge data on macroscale ingredients to their nanoscale counterparts?
- Is nanotechnology applied to food ingredient and food packaging production primarily to create new effects for such compounds or to enhance existing effects? What are the perceived impacts on regulatory status or good manufacturing practice in each of these scenarios?
- How can FDA better communicate issues of regulatory status and safety of food ingredients and packaging components derived from nanotechnology to the public and industry?
More from the FDA website -- includes meeting specifics, agenda, federal register notice, and how to submit comments. The deadline for comments is October 24, 2008.
Here's another source for information on nanotechnology: National Nanotechnology Initiative (http://www.nano.gov/)
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FDA approved an investigational new drug application with a Phase 1 trial go-ahead for a nano-enabled cancer drug. The biopharmaceutical company developed a cyclodextrin-based polymer system to delver its "Cyclosert" nanoparticles that are between 30 and 60 nm in diameter.
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