FDA Proposes Guidelines For Nanomaterials In Food And Cosmetics
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.
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Sources: FDA Consumer Updates.;
"Nanotechnologies and Food HL 22-I, First Report of Session 2009-10 -- Volume I: Report"; House of Lords -
Science and Technology Committee; published by TSO (The Stationery Office) 8 Jan 2010; ISBN 9780108459221.
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