“In 1959, a Nobel Prize-winning physicist challenged his colleagues to use submicroscopic particles to manufacture a wide range of products,” the United States Food and Drug Administration writes in a consumer update on nanotechnology uploaded on its website on April 20.
The idea “captivated the imagination of scientists and inspired the science fiction movies ‘Fantastic Voyage’ and ‘Innerspace,’” the federal regulator continues. “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 agency says.
Aware that consumer products using nanotechnology may have unknown effects on the human body, the U.S. health regulator is now advising companies in the food and cosmetic industries to study the safety of these tiny particles further.
On April 20, the FDA issued two draft guidelines calling for more studies and placing on manufacturers the burden of proving that their use of nanotechnology in the food, cosmetic and packaging products they market is safe.
Nanoparticles are measured in billionths of a meter. Human hair is 80,000 nanometers thick; a sheet of paper is 100,000 nanometers thick. By comparison, nanoscale materials have diameters that are typically less than 100 nanometers.
The science of manipulating materials on a scale so small that they can’t be seen with a regular microscope — that’s nanotechnology. And it has a broad range of potential applications — from making food packaging bacteria-resistant, to increasing the effectiveness of medications or altering the look and feel of a cosmetic.
But nanoparticles may be able to penetrate the skin, or move between organs — and the health effects of these are yet unknown.
And while the technology is still evolving, it’s actually being increasingly used in many consumer products:
• As display technology for laptop computers, cell phones and digital cameras.
• In glare-reducing eyeglass coatings, skin lotions and sunscreens.
• In the medical community, in medications, antimicrobial materials, medical imaging and medical devices.
Some scientists even believe that nanotechnology will soon be widely used in the field of medicine, but the FDA’s announcement didn’t touch on this just yet.
Under longstanding federal regulations, food manufacturers in the U.S. aren’t required to seek regulatory approval before launching new products that contain established ingredients and materials — like various preservatives, spices and caffeine. But now, under the new draft guidance, the FDA warns that food and their packaging that contain nanoparticles may be required to undergo more scrutiny.
At the same time, the agency was careful to reiterate that nanotechnology isn’t inherently unsafe. The FDA was just being on the cautious side since materials at such a tiny scale may pose safety issues than the same materials in their normal size.
The two draft guidance documents are:
• “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”
• “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.”
The draft guidelines on nanotech in food
The food draft guidance describes the factors manufacturers should consider when determining whether alterations in manufacturing processes — including those involving nanotechnology, constitute a significant change.
The new guidance:
• Recommends that a safety assessment should take into account those changes — as well as the bioavailability and toxicity of the food or “contact substance” like packaging.
• May require food companies to provide data establishing the safety of any packaging using nanotechnology.