Featured Article
Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Biology / Biochemistry
Article Date: 21 Apr 2012 - 12:00 PDT
email to a friend 
printer friendly 
opinions 
On Friday, the US Food and Drug Administration (FDA) proposed two new draft guidelines for the evaluation and use of nanomaterials in food and cosmetics The documents are available for public comment for 90 days.
The agency said in a Consumer Update that this is the continuation of a "dialogue" that started in June 2011, when they issued a draft of the first guideline on the subject, one that helps industry decide whether an FDA-regulated product involves the use of nanotechnology, by considering for instance the size and properties of the materials.
The first of these latest two guidelines, "Guidance for Industry: Safety of Nanomaterials in Cosmetic Products" deals with what manufacturers should consider to ensure the safety of cosmetics made using nanomaterials.
The second guideline, "Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes", is for the food industry.
Dr Dennis Keefe, director of the FDA's Office of Food Additive Safety, said the guidance covers "any manufacturing process change that might affect a food substance's identity, intended uses, or the way it behaves in the body after it is eaten".
Nanomaterials are tiny engineered particles, measured in billionths of a meter, that are too small to be seen under a microscope. They are increasingly being used in FDA-regulated products, to change the way they look or operate.
For example, nanomaterials can be added to lotions and moisturizing creams to give a smoother feel, and to makeup to create a more natural look.
Dr Linda Katz, director of the agency's Office of Cosmetics and Colors, said:
"Right now, we don't have any information to make us believe that use of nanotechnology in cosmetics would cause a safety issue."
"We will continue to monitor cosmetic products, and if safety issues arise, we will follow up to make sure that the products are safe for consumer use," she added.
Cosmetic manufacturers do not have to get FDA approval to sell their products.
In the food industry, nanotechnology is being investigated for its potential to improve taste, texture and shelf life. Applications include food packaging that combats bacteria and detects spoilage, and increasing the bioavailability of nutrients (the rate at which they are absorbed in the body).
Experts have also suggested that one day nanomaterials may be used to make drugs more effective, but the draft guidelines the FDA have proposed so far do not cover medical applications.
Carlos Peña, director of the agency's emerging technology programs, said:
"Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated medical products, foods, and cosmetics."
"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," he added.
FDA Commissioner Dr Margaret A Hamburg, said:
"Our goal is to regulate these products using the best possible science."
"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," she added.
The FDA began looking into nanotechnology in 2006, when it set up the Nanotechnology Task Force to identify ways to evaluate the potential effects of the technology on health.
In 2007, the task force recommended the agency issue guidelines to industry, and start addressing the potential risks and benefits of FDA-regulated products that use the technology, such as drugs, medical devices, cosmetics, food substances, and packaging.
Meanwhile in Britain, the government is also looking into the safety of nanotechnology. In their 2010 report on nanotechnologies and food, a science and technology committee of the House of Lords of the British Parliament, said there were several features of nanomaterials that raise potential health and safety concerns.
One area that concerns the committee is the size and exceptional mobility of nanoparticles: they are small enough, if ingested, to penetrate cell membranes of the lining of the gut, with the potential to access all areas of the body, including the brain and even inside the nuclei of cells.
Another is their solubility and persistence: for instance, what happens to insoluble nanoparticles? If they can't be broken down and digested or degraded, can they accumulate and cause damage to organs? The inorganic metal oxides and metals are thought to be the materials likely to pose the most risk in this area.
And a further area of concern is because of their high surface area to mass ratio, nanoparticles are highly reactive, and may for instance, trigger as yet unknown chemical reactions, or by bonding with toxins, allow them entry into cells that they would otherwise have no access to.
Written by Catharine Paddock PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Please use one of the following formats to cite this article in your essay, paper or report:
MLA
23 Apr. 2012.
Please note: If no author information is provided, the source is cited instead.
posted by Clemons Kunkel on 21 Apr 2012 at 1:03 pm
It a good idea to research this further. We can not stop the advancement of mankind, but we must make sure this is a safe way to go. I think we can advance a lot by Nanomaterials in all the field. This is a new frontier that can change the planet. I am for Nanomaterial advancement.
| post followup | alert a moderator |
posted by Theo J.A. van Aerts on 21 Apr 2012 at 1:08 pm
AS long as its longterm effects are unknown and shown what being seen yet, as is shown in :
Meanwhile in Britain, the government is also looking into the safety of nanotechnology. In their 2010 report on nanotechnologies and food, a science and technology committee of the House of Lords of the British Parliament, said there were several features of nanomaterials that raise potential health and safety concerns.
One area that concerns the committee is the size and exceptional mobility of nanoparticles: they are small enough, if ingested, to penetrate cell membranes of the lining of the gut, with the potential to access all areas of the body, including the brain and even inside the nuclei of cells.
Another is their solubility and persistence: for instance, what happens to insoluble nanoparticles? If they can't be broken down and digested or degraded, can they accumulate and cause damage to organs? The inorganic metal oxides and metals are thought to be the materials likely to pose the most risk in this area.
And a further area of concern is because of their high surface area to mass ratio, nanoparticles are highly reactive, and may for instance, trigger as yet unknown chemical reactions, or by bonding with toxins, allow them entry into cells that they would otherwise have no access to.
NO nanoparticles can be safely used in any food - and or plants.
| post followup | alert a moderator |
posted by Daniel on 21 Apr 2012 at 1:51 pm
Don't you remember your mother saying "leave well enough alone"? Enough already!
| post followup | alert a moderator |
posted by abe farr on 21 Apr 2012 at 2:30 pm
nanotechnology is the way of future in our lives.
as a scientist , i can not say i am not bias but
then i believe in advancing science for the better
of mankind.
| post followup | alert a moderator |
posted by sima p on 21 Apr 2012 at 3:30 pm
You state the article is available for public opinion for 90 days. where ? At last give us information to follow up on.
It is concerning that the FDA approves items in food etc.. where safety has not been prove, Also will we know what products will include this
| post followup | alert a moderator |
posted by Guinn E. Pig on 21 Apr 2012 at 5:34 pm
It sure sounds like the FDA is just allowing all of these products on the market, using the public as guinea pigs. But don't worry, they'll be ready to respond if a health issue arises... like they did with Vioxx and a bunch of other pharmaceuticals... Ooops, guess it causes heart attacks, and thousands of you are now dead, with others surviving but quality of life destroyed... thanks FDA- you stopped them from pushing Vioxx, after they made $ billions per year. Merck paid 2 settlements, which totalled less than their profits... One of the settlements was for nearly $1 billion for misbranding the product, advertising it's safety and literally pushing it on people for uses unapproved by the FDA.... what does it take for a company to get put out of business?
| post followup | alert a moderator |
posted by in4it on 21 Apr 2012 at 6:30 pm
Guess what? we are all lab rats for the government now. First used on the military during nam. Agent Orange, now our food.
| post followup | alert a moderator |
'FDA Proposes Guidelines For Nanomaterials In Food And Cosmetics'
Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.
If you write about specific medications or operations, please do not name health care professionals by name.
All opinions are moderated before being included (to stop spam)
Contact Our News Editors
For any corrections of factual information, or to contact the editors please use our feedback form.
Please send any medical news or health news press releases to:
Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.
0 comments:
Post a Comment