FDA issues draft guidelines on approval process for use of nanoparticles in food and cosmetics

By Dr. Ananya Mandal, MDApr 23 2012

The United States Food and Drugs Administraton (FDA) has proposed that food companies that want to use tiny engineered particles called nanoparticles in their packaging may have to provide extra testing data to show the products are safe.

The FDA has issued two tentative guidelines Friday for food and cosmetic companies interested in using nanoparticles, which are measured in billionths of a meter. Nanoscale materials are generally less than 100 nanometers in diameter. A human hair is 80,000 nanometers thick. The agency said that these nano particles are increasingly showing up in FDA-regulated products like sunscreens, skin lotions and glare-reducing eyeglass coatings.

The two released draft guidance documents are entitled “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the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The draft guidance suggests the FDA may require food companies to provide data establishing the safety of any packaging using nanotechnology. At present the companies aren’t required to seek regulatory approval before launching products containing established ingredients and materials, such as caffeine, spices and various preservatives.

But FDA officials said Friday that foods and packaging containing nanoparticles may require more scrutiny. “At this point, in terms of the science, we think it’s likely the exemption does not apply and we would encourage folks to come in and talk to us,” said Dennis Keefe, director of FDA’s office of food additive safety. Keefe said companies are studying whether nanoparticles can reduce the risk of bacterial contamination in certain foods. He said the agency is aware of just one food package currently on the market that uses nanoparticles but did not identify it. He said more are expected in coming years.

“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, 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.”

“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.”

The FDA has previously stated its position that nanotechnology is not inherently unsafe; however, materials at the nanoscale can pose different safety issues than do things that are far larger. “This is an emerging, evolving technology and we’re trying to get ahead of the curb to ensure the ingredients and substances are safe,” Keefe pointed out.

Nanoparticles are used in skin moisturizer, mineral make up and other cosmetics. The FDA has less authority over cosmetics than food additives. Generally, the FDA does not review cosmetics before they launch, and companies are responsible for assuring the safety of their products.

“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,” Catharine Paddock, Ph D, of Medical News Today 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?” she said.

The FDA will take comments on both proposals for 90 days. There is no deadline for finalizing the documents.