Nanotechnology need not be flagged: U.S. FDA
Food, drugs, medical devices and cosmetics that contain minuscule engineered particles don't necessarily need special labelling to alert consumers, a U.S. federal task force recommends.
The U.S. Food and Drug Administration should consider each product using nanotechnology on a case-by-case basis, an agency task force said in a report being issued Wednesday. An outside expert called the recommendation agood first step.
The FDA is considering how it should regulate these products, which are made with tiny particles measured by the nanometre, or a billionth of a metre. By comparison, a human hair is about 80,000 nanometres across.
Submicroscopic nanoparticles increasingly crop up in FDA-regulated products like sunscreens, glare-reducing eyeglass coatings and antimicrobial wound dressings.
The task force recommended that the FDA boost its understanding of the science and improve its now-limited ability to detect nanoparticles in both the body and the products it regulates.
Report doesn't call for more regulatory powers
It doesn't call for — and the agency says it doesn't need — additional regulatory authority. Nor does the agency believe products incorporating the technology are inherently riskier in a way that would require across-the-board labelling.
"At this point, we lack an ability to say that nanoscale alone raises safety concerns worthy of putting on the label," said Randall Lutter, the agency's deputy commissioner for policy.
A nanotechnology expert said the report essentially defers the labelling issue.
"The agency has got to grapple with that issue," said Andrew Maynard, chief science adviser to the Project on Emerging Nanotechnologies, funded by the Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts.
Maynard said it's not enough to say an ingredient is in a product. Producers should disclose whether it's at a nano scale if its size causes it to act in a new or different way, he said.
In general, the FDA has sufficient regulatory authority over food additives and drugs to address any special concerns the use of nanotechnology might raise, the task force found.
But FDA authority over other cosmetics, dietary supplements and food ingredients is less comprehensive. For those products, the agency should request safety data from companies that are using nanoscale materials in those products and issue safety guidelines for those companies, the report said.
Health Canada has said it recognizes that new regulatory approaches may have to be adopted in the nanotechnology field.