Nanotechnology Now

Our NanoNews Digest Sponsors

Heifer International

Wikipedia Affiliate Button

Home > Press > FDA opens dialogue on nanotech regulation

Buckyballs—strong, rigid molecules forming structures that resemble soccer balls—are a major subject of research in nanotechnology. Some are being investigated for their potential use in FDA regulated products.
Buckyballs—strong, rigid molecules forming structures that resemble soccer balls—are a major subject of research in nanotechnology. Some are being investigated for their potential use in FDA regulated products.

Abstract:
The Food and Drug Administration is now opening a dialogue on nanotechnology by publishing proposed guidelines on how the agency will identify whether nanomaterials have been used in FDA-regulated products.

FDA opens dialogue on nanotech regulation

Silver Spring, MD | Posted on June 16th, 2011

In 1959, a Nobel Prize-winning physicist challenged his colleagues to use submicroscopic particles to manufacture a wide range of products—an idea that captivated the imagination of scientists and inspired the science fiction movies "Fantastic Voyage" and "Innerspace."

Fifty years later, "nano" (small) technology has moved from the science fiction realm to scientific fact, and federal regulators are laying the groundwork for monitoring a new generation of medical devices, drugs, cosmetics, and other products.

The Food and Drug Administration is now opening a dialogue on nanotechnology by publishing proposed guidelines on how the agency will identify whether nanomaterials have been used in FDA-regulated products.

The guidelines—"Draft Guidance for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology"—were published in the Federal Register Tuesday.

FDA Commissioner Margaret A. Hamburg, M.D., says the guidelines provide a starting point for the nanotechnology discussion. "Our goal is to regulate these products using the best possible science," Hamburg says. "Understanding nanotechnology remains a top priority within the agency's regulatory science initiative and, in doing so, we will be prepared to usher science, public health, and FDA into a new, more innovative era."

Possible Uses

The guidelines list things that might be considered when deciding if nanotechnology was used on a product regulated by FDA—including the size of the nanomaterials that were used, and what their properties are.

And FDA wants industry leaders and the public to weigh-in.

Nanotechnology—the science of manipulating materials on a scale so small that it can't be seen with a regular microscope—could have a broad range of applications, such as increasing the effectiveness of a particular drug or improving the packaging of food or cosmetics.

"Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated medical products, foods, and cosmetics," says Carlos Peña, director of FDA's emerging technology programs. "But because materials in the nanoscale dimension may have different chemical, physical, or biological properties from their larger counterparts, FDA is monitoring the technology to assure such use is beneficial."

In other words, using nanotechnology can change the way a product looks or operates, Peña says.

Although the technology is still evolving, it's already in use as display technology for laptop computers, cell phones, and digital cameras. In the medical community, a number of manufacturers have used nanotechnology in:

* Drugs
* Medical imaging
* Antimicrobial materials
* Medical devices
* Sunscreens

Ritu Nalubola, FDA's senior policy advisor and expert on nanotechnology, says FDA-regulated industries are also exploring new uses for nanotechnology. The agency's goal is to protect and promote public health while supporting innovation.

FDA will continue to monitor advancements in nanotechnology and its use in regulated products. The agency encourages industry consultation and will offer technical advice and guidance to manufacturers, as needed, to enhance product development, benefit, and safety.

"FDA has experience with regulating emerging technologies. Challenges of regulating nanotechnology are not unlike those related to other emerging and cross-cutting scientific and policy issues," Nalubola says.

Agency experts haven't identified specific safety concerns involving nanotechnology in FDA regulated products, but nanomaterials can, in some cases, raise safety issues. Because of this, FDA scientists continue to examine data to decide if and when additional studies are needed.

FDA Task Force

Peña says it's critical for FDA to understand how the changes in physical, chemical, or biological properties that have been documented in nanomaterials affect the safety, effectiveness, performance, or quality of a product that contains nanomaterials. Because of this, the agency has a robust science and research agenda to help us answer these questions, he says.

In 2006, FDA formed the Nanotechnology Task Force with an eye toward identifying and addressing ways to evaluate the potential effects on health from FDA-regulated nanotechnology products.

A year later, the task force recommended that FDA issue guidelines to industry and take steps to address the potential risks and benefits of drugs, medical devices, cosmetics, and other FDA-regulated products that incorporate nanotechnology. The proposed guidelines are the first step toward developing policies that guide regulation of products using nanotechnology. The agency plans to develop additional guidelines for specific products in the future.

FDA is working with the White House, the National Nanotechnology Initiative, other U.S. government agencies, and international regulators to focus on generating data and coordinating policy approaches to ensure the safety and effectiveness of products using nanomaterials.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

####

About Food and Drug Administration
The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

Finally, FDA plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

For more information, please click here

Contacts:
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

1-888-INFO-FDA (1-888-463-6332)

Copyright © Food and Drug Administration

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

Searching for errors in the quantum world September 21st, 2018

Viral RNA sensing: Optical detection of picomolar concentrations of RNA using switches in plasmonic chirality September 21st, 2018

UT engineers develop first method for controlling nanomotors: Breakthrough for nanotechnology as UT engineers develop first method for switching the mechanical motion of nanomotors September 21st, 2018

Nanobiotix: Update on Head and Neck Phase I/II Trial with NBTXR3 and Other program data presented at ImmunoRad 2018 September 20th, 2018

Preparing for Nano

How nanoscience will improve our health and lives in the coming years: Targeted medicine deliveries and increased energy efficiency are just two of many ways October 26th, 2016

Searching for a nanotech self-organizing principle May 1st, 2016

Nanotechnology is changing everything from medicine to self-healing buildings: Nanotechnology is so small it's measured in billionths of metres, and it is revolutionising every aspect of our lives April 2nd, 2016

Durnham University's DEEPEN project comes to a close September 26th, 2012

Products

CTI Materials drives nano commercialization with it's patented surfactant free nanoparticle dispersions August 15th, 2018

NEI Corporation introduces UV-Protect Technology to NANOMYTE® Coating Line April 9th, 2018

STMicroelectronics Peps Up Booming Social-Fitness Scene with Smart Motion Sensors for Better Accuracy, Longer Battery Life, and Faster Time to Market January 2nd, 2017

Cutting-edge nanotechnologies are breaking into industries November 18th, 2016

Govt.-Legislation/Regulation/Funding/Policy

UT engineers develop first method for controlling nanomotors: Breakthrough for nanotechnology as UT engineers develop first method for switching the mechanical motion of nanomotors September 21st, 2018

Researchers develop microbubble scrubber to destroy dangerous biofilms September 19th, 2018

Researchers managed to prevent the disappearing of quantum information September 14th, 2018

New photonic chip promises more robust quantum computers September 14th, 2018

Nanotubes/Buckyballs/Fullerenes/Nanorods

Carbon nanodots do an ultrafine job with in vitro lung tissue: New experiments highlight the role of charge and size when it comes to carbon nanodots that mimic the effect of nanoscale pollution particles on the human lung. September 12th, 2018

Graphene nanotubes outperform ammonium salts and carbon black in PU applications September 11th, 2018

S, N co-doped carbon nanotube-encapsulated CoS2@Co: Efficient and stable catalysts for water splitting September 10th, 2018

Peering into private life of atomic clusters -- using the world's tiniest test tubes September 6th, 2018

Nanomedicine

Viral RNA sensing: Optical detection of picomolar concentrations of RNA using switches in plasmonic chirality September 21st, 2018

UT engineers develop first method for controlling nanomotors: Breakthrough for nanotechnology as UT engineers develop first method for switching the mechanical motion of nanomotors September 21st, 2018

Nanobiotix: Update on Head and Neck Phase I/II Trial with NBTXR3 and Other program data presented at ImmunoRad 2018 September 20th, 2018

NUS researchers invent new test kit for quick, accurate and low-cost screening of diseases: Test results are denoted by a color change and could be further analyzed by a smartphone app, making it attractive as a point-of-care diagnostic device September 19th, 2018

Materials/Metamaterials

How a tetrahedral substance can be more symmetrical than a spherical atom: A new type of symmetry September 14th, 2018

Peering into private life of atomic clusters -- using the world's tiniest test tubes September 6th, 2018

Cannibalistic materials feed on themselves to grow new nanostructures September 1st, 2018

Environmentally friendly photoluminescent nanoparticles for more vivid display colors: Osaka University-led researchers created a new type of light-emitting nanoparticle that is made of ternary non-toxic semiconductors to help create displays and LED lighting with better colors t August 29th, 2018

Personal Care/Cosmetics

A Comprehensive Guide: The Future of Nanotechnology September 13th, 2018

Graphene finds new application as anti-static hair dye: New formula works as well as commercial permanent dyes without chemically altering hairs March 22nd, 2018

Programmable materials find strength in molecular repetition May 23rd, 2016

Common nanoparticle has subtle effects on oxidative stress genes May 11th, 2016

NanoNews-Digest
The latest news from around the world, FREE



  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project