FDA Is Not Nanotech-Ready; Former Official Says FDA Lacks Resources & Faces Legal Gaps

EMBARGOED 12:01 A.M. OCT. 5, 2006

Oct 04, 2006, 01:00 ET from Woodrow Wilson International Center for Scholars

    WASHINGTON, Oct. 4 /PRNewswire/ -- A new report released today,
 Regulating the Products of Nanotechnology: Does FDA Have the Tools It
 Needs? by Michael Taylor, a former Deputy Commissioner for Policy at the
 Food and Drug Administration (FDA), examines the agency's capacity to
 properly regulate new products containing nanotechnology materials --
 including food, drugs, medical devices, dietary supplements and cosmetics.
 Taylor's report comes days before FDA's first major public meeting on
 nanotechnology oversight, scheduled for October 10, 2006.
     The report, commissioned by the Woodrow Wilson Center's Project on
 Emerging Nanotechnologies, finds FDA's resource base severely eroded. "The
 pressures of expanding regulatory responsibilities and the increasing cost
 of doing business, coupled with the failure of Congress and successive
 administrations to adequately fund even FDA's base operations, are a real
 threat to FDA's ability to effectively oversee nanotechnology," said
 Taylor. "But FDA's lack of 'nano-readiness' is about more than dollars,"
 according to Taylor. "There are important gaps in FDA's legal authority
 that hamper its ability to understand and manage nanotechnology's potential
 risks. This is particularly true in the area of cosmetics and dietary
 supplements, and in the oversight of products after they reach the
     "Finally," argues Taylor, "there are over 300 manufacturer-identified
 nanotechnology consumer products being sold to Americans. FDA should take
 some immediate steps to gather information about this first wave of
 nanotechnology products and to set the criteria for determining when a
 nanoscale material is 'new' for legal, regulatory and safety purposes. By
 acting promptly, FDA will be in a better position to prevent regulatory and
 safety problems rather than having to react later, after the fact."
     "Nanotechnology is emerging rapidly as a transformative technology
 across virtually every product category FDA regulates," stated David
 Rejeski, director of the Project on Emerging Nanotechnologies. "Its
 enormous potential to benefit consumers and patients will be realized,
 however, only if its safety is understood and reasonably assured. Consumers
 rely on the FDA to judge what is safe and unsafe. Unless the FDA addresses
 potential nanotechnology risks now, public confidence in a host of valuable
 nanotechnology-based products could be undermined."
     In his report, Taylor reviews Congress and FDA's history of responding
 to new technologies and the public's longstanding expectation that FDA
 should be able to both ensure the safety of novel products before they
 enter the market and detect and swiftly correct problems that arise after
 marketing begins. "FDA has a leadership role to play on nanotechnology,"
 Taylor said, "but it is incumbent on society, acting through Congress, to
 give FDA the legal tools and resources it needs to do the job."
     Taylor hopes his report stimulates an active and necessary discussion
 about the tools FDA needs and the approach it should take to lead globally
 in bringing forward nanotechnology's potential benefits, as well as
 managing its risks. "In addition to addressing potential risks, FDA has an
 equally critical public health responsibility to foster timely introduction
 of the beneficial new medical products made possible by nanotechnology,"
 Taylor said. "Business and health leaders alike should join in ensuring
 that FDA has the scientific tools and knowledge it needs to say 'yes' to
 safe and effective new products," Taylor remarked.
     The Project on Emerging Nanotechnologies will release Mr. Taylor's
 report at a briefing on Thursday, October 5, from 12 Noon to 1:00 PM. ET at
 the Woodrow Wilson International Center for Scholars, located at 1300
 Pennsylvania Avenue, N.W., Washington, D.C., 5th floor conference room.
     The briefing will be webcast live at http://www.wilsoncenter.org/nano
     About Nanotechnology
     Nanotechnology is the ability to measure, see, manipulate, and
 manufacture things at an atomic and molecular scale, usually between 1 and
 100 nanometers. A nanometer is one billionth of a meter; a human hair is
 roughly 100,000 nanometers wide.
     The market opportunity for nanotechnology is substantial. Emerging
 nanotechnology was incorporated into more than $30 billion in manufactured
 goods in 2005 -- more than double the previous year. In 2014, Lux Research
 projects that $2.6 trillion in global manufactured goods will incorporate
 nanotechnology, or about 15 percent of total output. The U.S. invests
 approximately $3 billion annually in nanotechnology research and
 development, which accounts for approximately one-third of the total public
 and private sector investments worldwide.
     About the Author
     Michael R. Taylor is a professor at the University of Maryland School
 of Medicine, where he conducts research on policy, resource, and
 institutional issues that affect the success of public health agencies in
 carrying out their prevention missions. Previously, he was a senior fellow
 and director of the Risk, Resource, and Environmental Management Division
 at Resources for the Future (RFF) and remains an RFF University Fellow.
 While at RFF, Taylor co- founded the Food Safety Research Consortium, which
 he chairs. Prior to RFF, Taylor served in government, practiced law in
 Washington, and worked in private industry. He was administrator of the
 USDA's Food Safety and Inspection Service from 1994 to 1996; deputy
 commissioner for policy at the Food and Drug Administration from 1991 to
 1994; and an FDA staff lawyer and executive assistant to the FDA
 Commissioner from 1976 to 1981. He practiced food and drug law as a partner
 in the law firm of King & Spalding for ten years and served as vice
 president for public policy at Monsanto Company. Taylor has served on
 several National Academy of Sciences (NAS) committees and currently serves
 on the Advisory Committee of the Partnership to Cut Hunger and Poverty in
 Africa and the Board of Trustees of Resolve, Inc. He received his law
 degree from the University of Virginia and his B.A. in political science at
 Davidson College.
     The Project on Emerging Nanotechnologies is an initiative launched by
 the Wilson Center and The Pew Charitable Trusts in 2005. It is dedicated to
 helping business, government and the public anticipate and manage possible
 health and environmental implications of nanotechnology. For more
 information about the project, log on to http://www.nanotechproject.org.
     Contact: Sharon McCarter
              Phone: (202) 691-4016
              Jenny Zawila
              Phone: (202) 336-7962

SOURCE Woodrow Wilson International Center for Scholars