On June 9, 2011, the FDA issued a draft guidance on the applications of nanotechnology in FDA regulated products. Particularly, the draft guidance is intended for public comment by manufacturers, suppliers, importers and stakeholders as to “whether FDA-regulated products contain nanomaterials or otherwise involve the application of nanotechnology.” As the draft makes clear, while the FDA’s guidance documents do not establish “legally enforceable responsibilities,” they do describe the FDA’s “thinking” on a particular topic and should be viewed as recommendations for an industry.
In its draft guidance, the FDA listed two primary “Points to Consider” for public comment regarding whether a product contains nanomaterials:
- Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or
- Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.
The FDA’s draft guidance should be viewed in conjunction with the “Memorandum for the Heads of Executive Departments and Agencies, Re: Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials” issued on June 9, 2011 and applicable to various Executive agencies. Thus, the FDA’s underlying focus, in light of the Memo on Policy Principles, is whether the particular “properties or phenomema” of nanomaterials pose certain public safety and health risks:
In sum, agencies will continue their science-based approaches subject to the particular rules governing each area of regulatory oversight and their existing statutory authorities. Federal agencies that have regulatory responsibilities must continue to implement sound policies to protect public health, safety, and the environment…
Nanomaterials should not be deemed or identified as intrinsically benign or harmful in the absence of supporting scientific evidence, and regulatory action should be based on such scientific evidence. Where there is evidence of either safety or likely harm, the corresponding regulatory actions are usually clear. For some statutes, the mere existence of a hazard, regardless of the probability of it causing harm, may trigger some form of regulatory action. In general, however, and to the extent consistent with law, regulation should be based on risk, not merely hazard, and in all cases the identification of hazard, risk or harm must be evidence-based. In applying these principles, regulators should use flexible, adaptive, and evidence-based approaches that avoid, wherever possible, hindering innovation and trade while fulfilling the Federal Government’s responsibility to protect public health and the environment.
Along with the possible public health and safety implications of the FDA’s interest in nanotechnology, some commentators also are viewing the increased government regulation in nanotechnology as a “glass-half-full,” allowing for an increase in approved uses of nanotechnology–particularly, in an area such as medicine where there have been innovative uses of nanomaterials, such as carbon nanotubes, for cancer treatment and treatment after a heart attack. However, it will remain to be seen whether Washington’s interest in the field of nanotechnology will encourage its development and expand nanotech applications, or ultimately bog down and stifle the field with excessive regulation.
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