facturers, by providing them with an indication of what types of testing and data would be required for approval, it would also provide the FDA with information that could be helpful as it develops the necessary guidance.

The third and final speaker of this session, Fred Degnan of King & Spaulding, broached some of the same issues that Tarantino did, but as Degnan put it, “from a practicing lawyer’s perspective.” He agreed with Tarantino that the FDA’s statutory authorities provide the agency with the necessary tools for evaluating and regulating the safety of nanomaterials with novel properties and that the FDA’s existing procedures and systems are adequate to evaluate and regulate nanotechnology in food. In fact, the Food Additive Amendment (FAA) of 1958, which was enacted in response to a post-WWII public health scenario created by the sudden availability of thousands of new synthetic chemicals, was designed to address the very same types of safety issues presented by the use in food of nanomaterials with novel properties. However, he argued that the basis of good regulation is in written guidance, not just “chatting” (to borrow Tarantino’s expression). Any type of written guidance, even if preliminary, would be of enormous benefit, not just for improving industry understanding but also for ensuring public confidence that FDA is engaged and focused on nanotechnology issues. This is particularly true of nanomaterials introduced into food products that have previously been exempt from premarket approval because they are Generally Recognized as Safe (GRAS).

Again, there was an open discussion period at the end of the session. Most of the questions pertained to issues around toxicology and whether there are any established criteria for how to proceed; how to encourage early industry consultations with the FDA; whether there is an approximate timeline for when the FDA will be providing written guidance pertaining to nanomaterials with novel properties in food products; and under what, if any, circumstances a food designed to deliver nutrients can and should be considered a drug for the purposes of regulation.



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