“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.
The factors that should be considered are those that may:
• affect the identity of the food substance
• affect the safety of the use of the food substance
• affect the regulatory status of the use of the food substance
• warrant a regulatory submission to FDA
Manufacturers have the responsibility of determining whether the altered food or contact substance they are about to market is
• authorized under a food additive or color additive regulation
• warrants a regulatory submission to the FDA
This 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,” says Dennis Keefe, director of the FDA’s Office of Food Additive Safety.
Among many other applications, nanotechnology is being now studied in food packaging to combat bacteria, detect spoilage and to improve nutrients’ bioavailability — or the degree and rate a consumer absorbs these nutrients, Keefe explains.
The FDA is aware of just one food package currently on the market that uses nanoparticles, he says, but doesn’t identify it. And more nano-packaging products are expected to be developed in coming years, he says.
“The consequences (to consumers and to the food industry) of broadly distributing a food substance that is later recognized to present a safety concern have the potential to be significant,” the draft guidance says.
Under longstanding regulations, makers of most U.S. food additives and ingredients can simply tell the FDA that their ingredients are “generally recognized as safe” before they can legally bring them to market. But the regulator says that new nanotechnology products don’t automatically fall into this category. This means that manufacturers would have to prove additional safety data before these nano-additives are approved.
But Dr. Jaydee Hanson, policy director at the public health advocacy group, The International Center for Technology Assessment, which sued the FDA last year for being slow to respond to its petition in nanotechnology criticizes the food guidance. He says it’s late — and not tough enough. The European Union requires companies to prove that a nanotech product is safe before it can be sold to consumers, he points out. By contrast, the FDA has only issued voluntary guidelines for companies.
The draft guidelines on nanotech in cosmetics
The cosmetic products draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products.
Key points include:
• Cosmetics do not require FDA approval before being sold. But while these aren’t subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products.
• The legal requirements for cosmetics made using nanomaterials are the same as those for other cosmetics.
• Cosmetics that contain nanomaterials must be labeled properly.
• Standard safety tests may need to be modified or new methods developed to ensure that the safety assessments of cosmetic products with nanomaterials are appropriate and effective.
Currently, nanomaterials are already being used in lotions and moisturizing creams for a smoother feel and in makeup to create a more natural look — and the FDA says companies should do additional testing of such cosmetics.
“Right now, we don’t have any information to make us believe that use of nanotechnology in cosmetics would cause a safety issue,” says Dr. Linda Katz, director of FDA’s Office of Cosmetics and Colors. “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.”
Because the FDA doesn’t require cosmetic companies to submit safety data before selling their products, the guidance are unlikely to have a significant impact on large cosmetic firms like Avon Products Inc, which already comply with European rules.
Avon admits that it adds nanomaterials like titanium dioxide or zinc oxide to cosmetic products to let sunscreens rub in without leaving white marks to boost protection against the sun’s ultraviolet rays — but it says EU approved these products, saying they were proven safe.
Understanding nanotech is top FDA priority
“Understanding nanotechnology remains a top FDA priority. FDA is strengthening the scientific tools and methods for evaluating food products, cosmetics, drugs and medical devices,” the FDA says.
“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,” says Commissioner Dr. Margaret A. Hamburg.
This is why both draft guidances merely encourage manufacturers to consult with the agency before taking their products to market. These consultations can help FDA experts thresh out safety issues, as well as queries about the regulatory status of nanomaterials in cosmetics, food and packaging.
Erik Olson, director of food programs at Pew Health Group, a consumer advocacy group, praises this as a step in the right direction. “The FDA is essentially saying (to companies), we don’t think you can just make your own decision (that) a nanomaterial is safe without telling us,” Olson said. “That’s a fairly new development.”
Meanwhile, the federal agency stresses that the two guidance documents aren’t intended to provide guidance to manufacturers about the use of nanomaterials in medications, medical devices and other similar in other products.
Aware that strong science is critical to the FDA’s ongoing review of the products it regulates, the agency is investing in an FDA-wide nanotechnology regulatory science program that aims to develop the data and tools needed to identify the properties of nanomaterials and assess the impact these may have on food and cosmetic products.
Open for public, continuing dialog
The two new guidelines are open for public comment and the FDA says it will carefully consider all relevant and substantive comments in drafting the final guidance documents. But to ensure that the agency is able to take comments — electronic or written — into consideration, these should be submitted within 90 days of the publication of the notices of availability in the Federal Register.
The new April guidelines only continue a dialog on nanotechnology begun by the FDA in 2011. In June of that year, the regulator published its first draft guideline, “Draft Guidance for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.” It’s still reviewing and receiving comments on this document from the public.
Regulating emerging technologies widely in use
“Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated medical products, foods, and cosmetics,” says Carlos Peña, director of FDA’s emerging technology programs. “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.”
But Ritu Nalubola, Ph.D., FDA’s senior policy advisor and expert on nanotechnology is quick to reassure U.S. consumers that, “FDA has experience with regulating emerging technologies.” She says the challenges of regulating nanotechnology are not unlike those related to other emerging and cross-cutting scientific and policy issues.”
Public health advocates sue FDA
In 2006, the International Center for Technology Assessment filed a petition asking the FDA to create a separate category to regulate nanotechnology because of its “unique human health and environmental risks.” Late last year, it sued the FDA for being slow to reply.
Hanson, the center’s policy director, says the legal action may have prompted the agency to issue guidance for nanotech in food and cosmetics — after a delay of six years. “It’s good that they’re making recommendations in this area, but they haven’t gone far enough,” he says.
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