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|Lynn L. Bergeson
Bergeson & Campbell, P.C.
On June 9, 2011, the Food and Drug Administration (FDA) posted on its home page a Draft Guidance on Considering Whether an FDA-Regulated Product Involves Application of Nanotechnology. FDA announced the availability of the Draft Guidance in the June 14, 2011, Federal Register. 76 Fed. Reg. 34715. FDA states that this document is the first step in providing regulatory clarity about the use of nanomaterials in FDA-regulated products and other more product-specific guidance documents are likely to follow. Specifically, the Draft Guidance is "intended to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products." Comments on the Draft Guidance are due August 15, 2011.
June 16th, 2011
FDA Issues Draft Guidance on Nanotechnology: Agency Will Accept Public Comment for 60 Days
On June 9, 2011, the Food and Drug Administration (FDA) posted on its home page a Draft Guidance on Considering Whether an FDA-Regulated Product Involves Application of Nanotechnology. FDA announced the availability of the Draft Guidance in the June 14, 2011, Federal Register. 76 Fed. Reg. 34715. FDA states that this document is the first step in providing regulatory clarity about the use of nanomaterials in FDA-regulated products and other more product-specific guidance documents are likely to follow. Specifically, the Draft Guidance is "intended to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products." Comments on the Draft Guidance are due August 15, 2011. The Draft Guidance is available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm
The Draft Guidance does not propose a definition of nanotechnology or nanomaterials, nor does it change the regulatory requirements for developing or marketing products. Instead, the Draft Guidance enumerates several "points to consider" in determining whether an FDA-regulated product contains nanomaterials. These points will also guide the Agency and manufacturers in determining whether the incorporation of nanotechnology raises potential implications for safety, effectiveness, or public health that should be considered when such products are developed and reviewed. FDA will take public comment on the Draft Guidance for 60 days after publication in the Federal Register of the availability of the Draft Guidance.
Points to Consider
According to the Draft Guidance, the Agency will consider two questions when it is considering whether an FDA-regulated product contains nanomaterials or otherwise involves the application of nanotechnology:
- 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.
FDA makes it clear that these questions will apply not only to "new" products, but will also apply to presently marketed products where manufacturing changes alter the dimensions, properties, or effects of the product or any of its components.
Rationale for FDA's Consideration of Nanomaterials and Nanotechnology
FDA is particularly interested in the "deliberate manipulation and control of particle size to produce specific properties, because the emergence of these new properties or phenomena may warrant further evaluation." This use is distinct from the more familiar use of biological or chemical substances that may naturally exist at small scales, including at the nanoscale, such as microorganisms or proteins.
The Agency will use size as a factor in determining whether a product is composed of nanomaterials that should be reviewed. FDA suggests that applicants use a range of approximately 1 nm to 100 nm as a first reference point as materials in this size range can exhibit new or altered physico-chemical properties that enable new applications.
FDA is also interested in the properties or phenomena exhibited by materials at the nanoscale. The Draft Guidance notes that nanotechnology is often used to facilitate applications that can affect the safety, effectiveness, performance, quality, and, where applicable, public health impact of FDA-regulated products. The Draft Guidance states: "For example, dimension-dependent properties or phenomena may be used for functional effects such as increased bioavailability, decreased dosage, or increased potency of a drug product, decreased toxicity of a drug product, better detection of pathogens, enhanced protection offered by improved food packaging materials, or improved delivery of a functional ingredient or a nutrient in food." The properties and phenomena may be due to altered chemical, biological, or magnetic properties, altered electrical or optical activity, increased structural integrity, or other unique characteristics of nanoscale materials not normally observed in their larger counterparts. In addition, considerations such as routes of exposure, dosage, and behavior in various biological systems are critical for evaluating the wide array of products under FDA's jurisdiction.
The Draft Guidance also notes that materials or end products can exhibit properties or phenomena attributable to a dimension(s) above the approximate 100 nm range used by many as an upper limit for defining a nanomaterial. A reduction in size can lead to properties that are different from those of conventionally-scaled material although the material or end product itself may not necessarily be within the nanoscale range. Thus, importantly FDA suggests an upper bound of one micrometer (i.e., 1,000 nm) as a "reasonable parameter for screening materials with dimensions beyond the nanoscale range" for further examination to determine whether these materials exhibit properties or phenomena attributable to their dimension(s) and relevant to nanotechnology. This is a broad range, considerably larger than other "considerations" offered by other agencies.
The Guidance is the third nano-related document issued in the past several days. Summaries of the other two documents are available at http://www.lawbc.com/news/2011/06/epa-proposes-policy-on-nanoscale-materials-in-pesticide-products/ and http://www.lawbc.com/news/2011/06/white-house-etipc-releases-policy-principles-concerning-regulation-and-oversight-of-nanotechnology-and-nanomaterials/ It is clear that since the Administration's "principles" document was issued, agency-specific missives such as the FDA Draft Guidance were soon to follow.
As with any FDA Guidance to Industry, this document does not establish legally binding obligations on either the Agency or entities regulated by it. Rather, it conveys FDA's current thinking on the topic to help manufacturers, suppliers, importers, and other stakeholders understand how the Agency intends to approach products that might contain nanomaterials or utilize nanotechnology. FDA specifically notes that this area is likely to evolve quickly and it intends for its policy to be iterative, adaptive, and flexible. See Q&As accompanying Draft Guidance; available at http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm258391.htm