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US Food and Drug Administration

FDA_200The 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.

FDA’s Approach to Regulation of Nanotechnology Products

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:

  • Maintaining its product-focused, science-based regulatory policy;
  • Respecting variations in legal standards for different product-classes; 
  • Where premarket review authority exists, attention to nanomaterials is being incorporated into standing procedures; 
  • Where statutory authority does not provide for premarket review, consultation is encouraged to reduce the risk of unintended harm to human or animal health; 
  • Continuing post-market monitoring; 
  • Industry remains responsible for ensuring that its products meet all applicable legal requirements, including safety standards; 
  • Collaborating, as appropriate, with domestic and international counterparts on regulatory policy issues; 
  • Both for products that are not subject to premarket review and those that are, offering technical advice and guidance, as needed, to help industry meet its regulatory and statutory obligations.

Product-specific Guidance

The following draft guidance documents reflect the FDA’s current thinking regarding the use of nanotechnology or nanomaterials in FDA-regulated products:

FDA also reiterated its advice for consultation with the Agency in other draft guidance documents.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.

Did you know?

100 nm is the size below which the EU recommendation of the definition of nanomaterials applies.