The U.S. FDA regulates a wide range of products, including foods, cosmetics, drugs, devices, veterinary products, and tobacco products some of which may utilise nanotechnology or contain nanomaterials.
Consistent with Executive Order 13563 on improving regulation, as well as with the White House policy statements on regulating emerging technologies and applications of nanotechnology, FDA states that it supports innovation and the safe use of nanotechnology in FDA-regulated products under appropriate and balanced regulatory oversight. The US FDA’s regulatory approach will have the following attributes:
The following draft guidance documents reflect the FDA’s current thinking regarding the use of nanotechnology or nanomaterials in FDA-regulated products:
FDA also reiterated its advice for consultation with the Agency in other draft guidance documents. Manufacturers of new dietary ingredients and of devices subject to the 510(k) premarket notification requirement are encouraged to meet with the Agency to address questions related to the use of nanotechnology or nanomaterials in these products:
Further information regarding FDA’s nanotechnology related activities and policy developments can be found on the FDA website.