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Posted: September 8, 2008
Consumers Union experts to deliver comments today at FDA Nanotechnology Public Meeting
(Nanowerk News) The Food and Drug Administration (FDA) is holding a public meeting today to gather information that will assist the Agency in implementing the recommendations of the Nanotechnology Task Force Report.
Dr. Michael Hansen, senior scientist, Consumers Union will deliver comments on food and color additives, including food contact substances.
His comments state: "Consumers Union urges FDA to recognize that nanoscale particles exhibit novel properties and/or behaviors, compared to their larger counterparts, and raise unique safety concerns, so that a separate safety assessment must be required before such nanoscale particles/materials can be used for any food ingredient or packaging component that comes in contact with food. We, thus, agree with the recommendation of the UK Royal Society, and the European Commission’s expert panel, which have stated that nanoparticles should be considered different that the normal size counterparts and separate safety assessments should be performed on them. Furthermore, FDA should require labeling of such ingredients immediately."
Carolyn Cairns, program leader, Consumers Union will deliver comments on drugs and cosmetics.
Her comments state: "We hope FDA will use the results of this meeting to greatly accelerate such efforts and that we won’t be here two years from now, still waiting for action to be taken. FDA’s delay in making nano-specific safety testing a pre-requisite for approval impedes the development of critical analytical tools needed to characterize the presence, toxicity and fate of engineered nano-materials (ENMs) already in commerce. FDA should not approve nanoscale ingredients in the face of such ignorance, particularly for widespread, exposure-intensive applications of questionable medical benefit. Consumers Union has been investigating potential risks and benefits from nanomaterials in consumer products for several years and CU's comments are based on our research and tests of several nano-enabled products, including sunscreens. CU's recommendations about the type of analytical data that FDA should be demanding for pre-market approval of new drugs and over-the-counter treatments can be summarized as follows:
1. Treat nanomaterials as new across the board and drop Generally Recognized as Safe (GRAS) status for all nanoscale ingredients.
2. Require all nanomaterials to be characterized according to features known to impact safety (such as size, charge, shape and surface coatings and purity) using validated testing and standardized nomenclature.
3. Build product-specific risk analysis procedures to assess the direct and indirect impacts and fate of nanomaterials in the systems in which they will be used including their interactions with excipients.
4. Where results of product-specific exposure, toxicity and efficacy tests are available for safety analysis, ensure that they accurately reflect the true conditions in which the products will be used."
Their comments will also be made available at http://www.consumersunion.org/
The meeting will be held at the University Systems of Maryland, The Universities at Shady Grove Conference Center from 8:30am to 5pm. For more information visit: http://www.fda.gov/nanotechnology/.