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ICMAD Responds to Suit Against FDA Over Nanotechnology
Posted: January 23, 2012
In response to the suit filed against the US Food and Drug Administration (FDA) by a coalition of six consumer safety and environmental groups over the FDA's lack of nanotechnology regulation, Independent Cosmetic Manufacturers & Distributors (ICMAD) has sent an exclusive response to Cosmetics & Toiletries magazine, as shown below. Cosmetics & Toiletries magazine recently ran a news item discussing the details of the suit.
"While the plaintiffs have based their right to judicial review on allegations of the FDA’s failure to timely commence regulatory action on their petition, their purpose appears to be to force the administration into commencing some form of enforcement action. Based upon this, ICMAD expects the FDA to seek early dismissal of the lawsuit.
Beyond the procedural issues presented by the lawsuit, a review the information in their petition and complaint suggests that the foundation of their position is derived from theoretical activity and risk of these compounds that is obtained from calculations of particle size to surface areas ratios. While greater surface area to particle size ratio can theoretically contribute to different physical and chemical activity, and possibly even toxocological properties of a chemical, without appropriate data there is no way to prove or disprove this theoretical proposition. Neither their petition nor their complaint appear to contain the type of conclusive scientific studies that the FDA requires to make safety determinations. Based upon their stated precautionary principles, the coalition may not be able to obtain the type of scientific data that the FDA requires to take action on a class of compounds.
While the coalition's action will raise awareness of their issues, the FDA has, in fact, been studying nanotechnology and its use in FDA-regulated products. As with any new technology, the FDA must carefully consider the evidence as it is presented in accordance with its regulatory charge."