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
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
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
Phone: (202) 336-7962
SOURCE Woodrow Wilson International Center for Scholars