Nanotechnology Now

Our NanoNews Digest Sponsors



Heifer International

Wikipedia Affiliate Button


android tablet pc

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The guidelines—"Draft Guidance for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology"—were published in the Federal Register Tuesday.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

Vegetable oil ingredient key to destroying gastric disease bacteria: In mice, therapeutic nanoparticles dampen H. pylori bacteria and inflammation that lead to ulcers and gastric cancer November 25th, 2014

Research yields material made of single-atom layers that snap together like Legos November 25th, 2014

Blu-ray disc can be used to improve solar cell performance: Data storage pattern transferred to solar cell increases light absorption November 25th, 2014

A*STAR SIMTech wins international award for breaking new ground in actuators: SIMTech invention can be used in an array of industries, and is critical for next generation ultra-precision systems November 24th, 2014

Preparing for Nano

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

Technical Seminar at ANFoS 2012 August 22nd, 2012

Nanotechnology shows we can innovate without economic growth April 12th, 2012

Thailand to host NanoThailand 2012 December 18th, 2011

Products

Biosenta Inc. Updates New Household Disinfectant Testing Results; It Kills 100% of a Broad Range of Deadly Molds, Fungi, Bacteria, and Viruses, Including Ebola and Enterovirus D68 November 20th, 2014

NEI Development Update on NANOMYTE® TC-5001, a Protective Coating for Zinc-Plated and Galvanized Steel November 8th, 2014

HZO Teams With Deutsche Telekom to Unveil the Waterproof Tolino Vision 2 eReader: The New HZO Protected eReader Ushers in a New Era of Waterproof Electronics, Providing a Seamless User Experience Without the Risk of Using Port Doors and Mechanical Seals October 10th, 2014

7th Nanotechnology Festival, Exhibition Kicks Off Work in Iran October 7th, 2014

Govt.-Legislation/Regulation/Funding/Policy

Vegetable oil ingredient key to destroying gastric disease bacteria: In mice, therapeutic nanoparticles dampen H. pylori bacteria and inflammation that lead to ulcers and gastric cancer November 25th, 2014

Research yields material made of single-atom layers that snap together like Legos November 25th, 2014

Researchers engineer improvements of technology used in digital memory November 24th, 2014

An Inside Job: UC-Designed Nanoparticles Infiltrate, Kill Cancer Cells From Within November 24th, 2014

Nanotubes/Buckyballs

Tesla NanoCoatings Increasing Use of SouthWest NanoTechnologies Carbon Nanotubes (CNTs) for its Infrastructure Coatings and Paints: High Quality SMW™ Specialty Multi-wall Carbon Nanotubes Incorporated into Teslan®-brand coatings used by Transportation, Oil and Gas Companies November 19th, 2014

Graphene/nanotube hybrid benefits flexible solar cells: Rice University labs create novel electrode for dye-sensitized cells November 17th, 2014

SouthWest NanoTechnologies to Demonstrate 3D Capacitive Touch Sensor Featuring Transparent, Thermoformed Carbon Nanotube Ink at Printed Electronics USA 2014 (Booth J25) -- “Conductive and Semiconducting Single-Wall Carbon Nanotube Inks” will be Topic of Company Presentation November 10th, 2014

Neural Canals Produced in Iran for Recovery of Sciatica Nerve November 8th, 2014

Nanomedicine

Vegetable oil ingredient key to destroying gastric disease bacteria: In mice, therapeutic nanoparticles dampen H. pylori bacteria and inflammation that lead to ulcers and gastric cancer November 25th, 2014

Research reveals how our bodies keep unwelcome visitors out of cell nuclei November 24th, 2014

ASU, IBM move ultrafast, low-cost DNA sequencing technology a step closer to reality November 24th, 2014

An Inside Job: UC-Designed Nanoparticles Infiltrate, Kill Cancer Cells From Within November 24th, 2014

Materials/Metamaterials

Research yields material made of single-atom layers that snap together like Legos November 25th, 2014

Aromatic food chemistry to the making of copper nanowires November 24th, 2014

Novel Method Found for Connection of Metallic Alloys to Polymers November 23rd, 2014

Sustainable Nanotechnologies Project November 20th, 2014

Personal Care

Sunblock poses potential hazard to sea life August 20th, 2014

AQUANOVA receives Technology Leadership Award 2014 FROST & SULLIVAN honors NovaSOL® Technology again August 12th, 2014

Nanotechnology used in sunscreens: a Mexican achievement May 14th, 2014

Production of Nanocapsule from Sea-Buckthorn Extract in Iran May 3rd, 2014

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




  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More












ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project







© Copyright 1999-2014 7th Wave, Inc. All Rights Reserved PRIVACY POLICY :: CONTACT US :: STATS :: SITE MAP :: ADVERTISE