By Andreas von Bubnoff
Small Times Contributing Editor
Oct. 13, 2006 — The U.S. Food and Drug Administration’s Nanotechnology Task Force got more than just a mixed message Tuesday when it convened experts and stakeholders to get advice as to whether the agency should regulate nanotechnology products.
Some said current regulations are sufficient, while others said safety testing is long overdue, especially for products like cosmetics. But they also disagreed as to how to define a nanoparticle, and even if there should be such a definition in the first place.
“This public meeting is a necessary development,” said George Kimbrell, executive director of the International Center for Technology Assessment, one of several health and environmental groups that filed a legal petition with the FDA in May that called for nano-specific toxicity testing and mandatory labeling of nano products.
Kathy Jo Wetter of the ETC group, an environmental group that also signed the petition, said substances on the nanoscale can behave very differently from their larger counterparts. “‘Probably adequate,’ as [the] FDA now considers its current framework, is not good enough,” she said.
But Matthew Jaffe, a lawyer who attended the meeting on behalf of the United States Council for International Business, called current FDA regulations on issues like cosmetics and other items both “significant and adequate.”
Jaffe said there is “some uncertainty” over the environmental health and safety effects of nanotechnology, but humans have been exposed to nanoparticles “for eons” and developed natural response mechanisms against them. “A room like this one may contain 20,000 natural nanoparticles per cubic centimeter,” he said.
The meeting expanded beyond the regulation debate to encompass also questions about “perception”. David Rejeski, director of the Wilson Center’s Project on Emerging Nanotechnologies, said the public’s perceptions were at stake. He said a recent poll the Center commissioned showed that the public trusts the FDA more than industry when it comes to minimizing the risks of scientific advancements.
An inventory of nanotech consumer products maintained by the Wilson Center lists more than 320 “nanotech” products whose manufacturers claim to harness some form of nanotechnology, he said. The FDA needs to specifically regulate nanotech quickly in order to keep the public’s trust, he argued. “As we introduce nanotechnology into the marketplace, the most important variable is going to be trust,” Rejeski said. “It takes years to build, [but] you can destroy it in a few days.”
The issue of labeling consumer products as “nanotech” also came up at the meeting, especially as it pertained to cosmetics and other products that people might ingest or apply to their skin.
John Balbus of Environmental Defense said the FDA should seek pre-market authority to test the safety of cosmetics and personal care products. Size matters, he said, adding that the FDA needs to recognize that.
Erich Pica of Friends of the Earth, an environmental group, said that while it’s still unclear if nanoparticles in cosmetics can penetrate the skin, they can cause free radicals to form, and some face and anti-aging creams contain carbon fullerenes. “We believe these products should be tested and proven safe before they are out on the market,” Pica said.
But Annette Santamaria, a toxicologist who spoke for the Cosmetic, Toiletry and Fragrance Association (CTFA), an industry group, said that nanoparticles of titanium dioxide and zinc oxide have been used in sunscreens for almost two decades and their safety has been thoroughly demonstrated. “In vitro and in vivo studies provide compelling evidence that nanoscale particles of titanium dioxide remain on the surface of the skin and do not penetrate the skin,” she said.
She added that the FDA’s current regulatory processes for evaluating ingredients in personal care products are “more than adequate for ensuring their safety regardless of their size or how they are manufactured.”
Fullerenes are “not expected to be toxic in topical products,” and must be declared on a label, said John Bailey, the CTFA’s executive vice president.
Asked by one of the Task Force co-chairs, Norris Alderson, whether the cosmetics industry would label products that contain nanomaterials, Bailey said he would only see a need to do so if there was a safety concern for the public.
Whatever the case, labeling nano products may be difficult, as long as experts disagree on what, exactly, is a nanoparticle or nanotechnology. “That’s something the Task Force will be dealing with,” Alderson said. “Do we need a definition for nanotechnology, and then use that as a basis for labeling a product that contains nanomaterials?”
But experts at the meeting disagreed on how to define the size of nanoparticles, or even if there should be a definition in the first place.
Martin Philbert of the University of Michigan School of Public Health doesn’t think there should be. “Is 101 nanometers no longer toxic?” Philbert asked, referring to the definition used by the National Nanotechnology Initiative (NNI) that the size of nanoparticles is roughly between 1 and 100 nanometers. The NNI is the U.S. government program that coordinates nanotech research and development.
“There is no such thing as nanotechnology, as far as the FDA is concerned,” Philbert added. “We need to get away from labeling things and get down to the business of risk analysis.”
In fact, many published nanotechnology-based drugs are larger than 100 nanometers, said Neil Desai of Abraxis BioScience Inc., a company that makes such drugs.
Indeed, several experts said the toxicity of nanomaterials needs to be assessed on a case-by-case basis, based on more than just size. For example, certain nanoparticles are more toxic when they are smaller, but only if positively charged, not if they are negatively charged, said Stacey Harper, a toxicologist at Oregon State University.
Similarly, the toxicity of nanoparticles called dendrimers depends on their surface charge as well, said Scott McNeil, director of the National Cancer Institute’s Nanotechnology Characterization Laboratory. “It’s very difficult to generalize,” he said.
One thing seems certain: The Nanotechnology Task Force won’t have an easy task to come up with recommendations in its report to the FDA’s Acting Commissioner, Andrew von Eschenbach, in nine months.