April 22, 2012
FDA Guidelines Address Nanotechnology Use In Food, Cosmetics
The US Food and Drug Administration (FDA) released a pair of draft guidelines Friday addressing the possible use of nanotechnology -- tiny engineered materials that are too minute to be seen under a microscope -- by manufacturers in the food and cosmetic industries.
The two draft guidance documents are entitled “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives” and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products," the FDA said in a news release.
According to Catharine Paddock, Ph D, of Medical News Today, nanoparticles can be used in products like lotions and moisturizers to create a smoother feel and in make-up products to give them a more natural appearance. In food products and packaging, they can be used to improve their taste and texture, while also working as a preservative and increasing the rate in which nutrients are absorbed into a person's body, she added.
In the food draft guidance, the FDA said that the use of nanotechnology in the manufacturing process (including packaging) could impact the core identity, the safe consumption levels, and the regulatory status of the product, and ultimately could result in a regulatory submission to the FDA. As for cosmetics companies, while they do not need to receive permission from the agency to sell their product, the FDA warns that producers are legally responsible for the safety and accurate labeling of the products which they market.
"The submicroscopic particles are increasingly showing up in FDA-regulated products like sunscreens, skin lotions and glare-reducing eyeglass coatings," the Associated Press (AP) reported on Friday. "Some scientists believe the technology will one day be used in medicine, but the FDA´s announcement did not address that use."
“Understanding nanotechnology remains a top FDA priority. FDA is strengthening the scientific tools and methods for evaluating food products, cosmetics, drugs and medical devices,” FDA Commissioner Margaret A. Hamburg, M.D., said in a statement. “We are taking a prudent scientific approach to assess each product on its own merits and to not make broad, general assumptions about the safety of nanotechnology products.”
Hamburg's agency first began investigating nanotechnology in 2006, when it established the Nanotechnology Task Force to evaluate the technology's potential affect on human health, Paddock said. The following year, they sent recommendations to agencies asking producers of FDA-regulated goods to begin studying the impact of nanoparticles on not just food and cosmetics, but packaging, drugs and other medical devices as well.
"Meanwhile in Britain, the government is also looking into the safety of nanotechnology," she said. "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," Paddock added. "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?"