FDA 'Steps up' for Nanotechnology

In a memorandum issued by the White House 1 today (June 9th, 2011) the US government set in place more rigorous standards for the regulation and oversight of nanomaterials 2. Nanomaterials can be defined as those materials with at least one dimension in the nanoscale range, generally between 1nm and 100nm. For a reference, 100nm equates to about 1/1000th the width of an average human hair, or in magnitude smaller even than most bacteria. According to the U.S. memorandum, federal agencies must increasingly seek out and develop information about the potential effects of nanomaterials on human health and the environment. These agencies, including the FDA, are instructed to ‘take into account new knowledge’ as soon as it becomes available, and to ‘actively communicate’ potentials risks, or benefits, of specific uses of nanomaterials to the public.


“Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation. It must be based on the best available science. " – President Obama, January 18, 2011

For nanotechnology, a field that has been gaining in popularity and impact since physics great Richard Feynman’s talk “There’s Plenty of Room at the Bottom” in 1959, it is about time the FDA took a step towards regulating the field and its products. Nanotechnology has applications in many different areas, including medicine, information technology, and alternative energy. While research in the field is yielding many beneficial products, including ‘smart’ drugs that fight cancer, yet other uses of nanotechnology in food and cosmetic products are raising concerns: Do we really know how these tiny particles may be affecting human health and the environment? The issue with nanomaterials is that they can act radically different from the exact same base material at larger dimensions. For example, the consumption of nanoparticles of silica by a pregnant mother may have negative effects on a developing human embryo, whereas bulk silica (akin to common sand) is an FDA approved food additive and has no demonstrated health effects. Nanoparticles used in environmental applications may accumulate and persist in the human system, thus causing issues of toxicity or reproductive complications. Alternatively, nanoparticles approved for human use may cause unforeseen negative impacts on our environment. The federal government is saying that we need to know more about these potential impacts; it has raised yearly spending on the environmental, health and safety side of its nanotechnology initiative by almost $86 million in the last 6 years 3. And the FDA is now responding with its own increased regulation over nanotechnology.

The FDA, or U.S. Food and Drug administration, has drafted a Guidance for Industry on aspects of nanotechnology, to be released tomorrow. The guidance will help industry and others to not only decide what classifies as a ‘nano’ product, but when they should consider implications for safety and public health, and respond with appropriate actions for regulatory status over such products. According to the FDA, the size of the nanomaterial is of paramount importance, and should be more studied further for its role in nanomaterial characteristics such as impact on health. By learning more about the various properties of nanomaterials, and what give them these properties, “any questions related to the regulatory status, safety, effectiveness, or public health impact of these products can be appropriately and adequately addressed.”

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(1) Jointly by the Office of Science and Technology Policy, Office of Management and Budget, and the United States Trade Representative

(2) Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials

(3) From $37.7 million in fiscal year 2006 to $123.5 million in 2012.

Bawa R (2011). Regulating Nanomedicine – Can the FDA Handle it? Current drug delivery, 8 (3), 227-34 PMID: 21291376