In 1959, a Nobel Prize-winning physicist challenged his colleagues to use submicroscopic particles to manufacture a wide range of products—an idea that captivated the imagination of scientists and inspired the science fiction movies “Fantastic Voyage” and “Innerspace.”
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 U.S. Food and Drug Administration is continuing a dialogue on nanotechnology begun in 2011 by publishing proposed guidelines on the evaluation and use of nanomaterials in FDA-regulated products.
The first draft guideline, “Draft Guidance for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology” was published in the Federal Register in June, 2011. The FDA is still reviewing and receiving comments on this document from the public.
In April 2012 the FDA is issuing two new draft guidelines for manufacturers of food substances and cosmetics, which are also open for public comment.
FDA Commissioner Margaret A. Hamburg, M.D., says the guidelines provide a starting point for the nanotechnology discussion. “Our goal is to regulate these products using the best possible science,” Hamburg says. “Understanding nanotechnology remains a top priority within the agency’s regulatory science initiative and, in doing so, we will be prepared to usher science, public health, and FDA into a new, more innovative era.”
Nanotechnology—the science of manipulating materials on a scale so small that they can’t be seen with a regular microscope—could have a broad range of applications, such as increasing the effectiveness of a particular drug or improving the packaging of food or altering the look and feel of a cosmetic.
“Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes” describes factors industry should consider when determining whether a significant change in the manufacturing of a food substance affects its identity, safety or regulatory status (such as whether a substance is covered by an existing food additive regulation). A food substance is one that is added to food or to food packaging for purposes that include improving taste, texture, or shelf life.
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, Ph.D., director of the Office of Food Additive Safety.
Keefe added that nanotechnology now is being studied in food packaging to combat bacteria and detect spoilage, and to improve the bioavailability (the degree and rate at which a substance is absorbed into one’s system) of nutrients, among other applications.