Hamburg: Nanotechnology Regulation Likely to Become 'More Nuanced,' Outlines Regulatory Approach

Posted 23 April 2012 | By

After releasing new nanotechnology standards for food and cosmetic products, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg says the agency's approach to the regulation of nanotechnology products is likely to become "more nuanced" over time.

Writing in the journal Science, Hamburg writes the agency has "long encountered the combination of promise, risk, and uncertainty that accompanies emerging technologies."

"Nanotechnology is not unique in this regard," explained Hamburg, adding the novelty of nanotechnology products does not negate the agency's directive to ensure safe and effective products.

"FDA does not categorically judge all products containing nanomaterials or otherwise involving the application of nanotechnology as intrinsically benign or harmful," but rather as products to be regulated under existing statutory authority, wrote Hamburg.

Hamburg also laid out the agency's regulatory approach towards nanotechnology products, which she said will include the following attributes:

A product-focused, science-based regulatory policy that takes into account the effects of nanomaterials in the particular biological and mechanical context of each product and its intended use.

Manufacturers should consult with the FDA early in their development process to facilitate a mutual understanding of the scientific and regulatory issues for their nanotechnology products.

Regulatory approaches taken towards food products may differ from approached taken toward pharmaceutical products as a result of the differing benefit:risk paradigms. "The result may be divergent regulatory outcomes for different product classes and different applications of nanomaterials, even where objective measures of risk are similar," writes FDA.

Premarket review processes for these products require applicants to submit data to answer questions related to the safety, effectiveness (where applicable), or regulatory status of the product. Individual premarket review procedures include attention to whether the use of nanomaterials suggests the need for additional data on safety or effectiveness, as applicable.

Industry must work with current information in product development, and continue to monitor products once marketed. FDA encourages industry to consult early with the agency to address questions related to the regulatory status, or to the safety, effectiveness, or other attributes of products that contain nanomaterials or otherwise involve application of nanotechnology.  

FDA will collaborate, as appropriate, with domestic and international counterparts on regulatory policy issues, including with the Emerging Technologies Interagency Policy Coordination Committee and its foreign regulatory counterparts.

Guidance documents will emerge over time, and (depending upon the product-class) will address interpretation of relevant statutory and regulatory standards, and provide guidance on the technical data needed to meet those standards (see list below for guidances already published). FDA will tailor guidances to the unique confluence of the statute governing the product-class, the level of scientific knowledge relevant to those applications, and the likely extent of effects on human and animal health.

Read more:

Hamburg: FDA's Approach to Regulation of Nanotechnology Products

Regulatory Focus - FDA Issues Draft Guidance on Inclusion of Nanomaterials in Cosmetic Products


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