Posted: January 23, 2008

FDA beginning to address nanotechnology regulatory concerns

(Nanowerk News) Hundreds of nanotechnology products, including foods, medicines and medical devices, now have reached the market, and their number will grow exponentially in the years ahead. But the main regulating body, the Food and Drug Administration, is just beginning to address the unique issues presented by this groundbreaking technology, according to an Insighter article, written by Beryl Lieff Benderly, posted on the Food and Drug Law Institute's website,
In a July 2007 report, a special FDA nanotechnology task force concluded that, while the agency has the capability to meet these challenges, it needs to take specific action soon to get ready. However, according to the Insighter article, FDA has not made public its plans for responding to the task force report. "We are beginning the planning for the priority activities defined in the task force report," FDA spokesperson Crystal Rice told FDLI.
"FDA has not done much, if anything, publicly.... They are in an information- gathering and internal assessment phase," said Julia A. Moore, Deputy Director of the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars (WWC) in Washington, D.C., during an interview for the Insighter article. Nonetheless, "I'm very sure that they are doing things. This is a high priority of [Commissioner Andrew] von Eschenbach and the agency," she continued. "It's really a matter of making sure that they have the resources and the expertise and... of taking a look at their statues and ensuring that they are nano-ready."
Many "nano materials will turn out to be good and wonderful and beneficial," Moore said. Given the newness and complexity of nano techniques and materials, however, "it would be unprecedented" if they did not present some risks, she continued. Despite this, "there has not been major investment" in looking for such risks, and FDA "needs to have the resources and the capacity to explore them."
Other experts also question FDA's current nano preparedness. Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?, a report by former FDA Deputy Commissioner for Policy Michael R. Taylor published in 2006 by the WWC nanotechnology project, states that "FDA is not 'nano ready'" because "gaps exist in FDA's legal toolbox" and "FDA lacks necessary resources." But, Taylor adds, "Even within its current authority and resources, FDA can and should take some immediate steps to address the first wave of nanotechnology products now entering the market, including perhaps the most fundamental one of setting the criteria for determining when a nanoscale material is 'new for legal and regulatory purposes' and 'new for safety evaluation purposes.'"
The Food and Drug Law Institute and the Woodrow Wilson Center Project on Emerging Nanotechnologies, in partnership with Burdock Group and Arizona State University, are sponsoring the 1st Annual Conference on Nanotechnology Law, Regulation and Policy Feb. 28-29, in Washington, D.C. Nanotechnology News and Small Times are offering marketing assistance in the landmark meeting.
The full text of the Insighter piece is posted at
Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal; the bimonthly magazine Update; FDA Directory; and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field.
Source: FDLI
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