FDA Stays the Course on Nanotechnology

By Ricardo Carvajal—

During a session at the Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, senior FDA staff confirmed that the agency does not intend to issue regulations specific to products derived through nanotechnology, or to establish a definition of nanotechnology for regulatory purposes. Furthermore, the agency continues to regard the 2007 Nanotechnology Task Force Report as current, and has no plans to update it.

Representatives from the different FDA centers addressed their plans to develop and issue guidance documents that address nanotechnology. CFSAN has already updated its guidance on the kinds of information that the agency requires in regulatory submissions for food contact substances, and has a similar update for direct additive submissions nearing publication. CFSAN is also considering a guidance on the regulatory consequences of changes in the manufacture of a substance covered by a food additive regulation or a new dietary ingredient notification. With respect to color additives, CFSAN has a guidance in the early stages of development.

Neither CDER nor CDRH intend to issue nanotechnology-specific guidance documents in the near term. Both centers expressed a preference for developing additional experience with the issues posed by products derived through nanotechnology before trying to address them through guidance. In the interim, developers and manufacturers of all FDA-regulated products derived through nanotechnology are encouraged to consult with FDA early on to ensure that concerns about safety, efficacy, and quality are adequately addressed.