The latest news from academia, regulators
research labs and other things of interest
Posted: February 20, 2008
FDA needs to systemically collect vital nanotechnology data, attorney says
(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 regulatory body, the Food and Drug Administration, is not yet
systematically collecting basic nanomaterial information, says John C.
Monica, Jr., a partner at the law firm of Porter Wright Morris & Arthur
LLP, in Washington, D.C, and head of the firm's nanotechnology practice
In an Insighter article, posted on the Food and Drug Law Institute's
website, http://www.fdli.org, Monica notes that FDA maintains that current laws
and rules are probably adequate for most nanotechnology products regulated
by the agency. But such issues of authority are overshadowed by an even
more basic question of agency oversight, according to Monica, who writes:
"To illustrate, try this: Place a general telephone call or email inquiry
to FDA and ask whether the agency keeps a list of FDA-approved products
employing nanoscale materials. Then dig deeper and call each of the six FDA
centers (CDER, CFSAN, CBER, CVM, CDRH, and NCTR) and ask the same question.
Unfortunately, no such list exists. In fact, FDA freely admits that it does
not currently track this information."
Thus, Monica asserts, the larger question becomes whether the agency
can appropriately react if a future problem is discovered related to the
"nanoness" of one of its regulated products. Until the science is in,
products using nanotechnology should be tracked and specifically monitored,
concludes Monica. "FDA must be prepared to investigate whether other
approved products might be susceptible to similar problems. The public will
demand nothing less," says Monica, adding: "Right now, unfortunately, FDA
does not even know which products contain nanoscale materials and has no
definitive way of quickly making this determination."
The Food and Drug Law Institute's 1st Annual Conference on
Nanotechnology Law, Regulation and Policy, co-sponsored by Woodrow Wilson
International Center for Scholars Project on Emerging Nanotechnologies, in
partnership with Burdock Group and Arizona State University, Feb. 28-29 in
Washington, D.C., will focus on this and other important legal and
regulatory issues concerning nanotechnology.
For more information on the conference, visit http://www.fdli.org/conf or
contact Michael Levin-Epstein, Editor-in-Chief, (202) 222-0897 or
The full text of the Insighter piece is posted at http://www.fdli.org
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.