The FDA said that changes in a product’s manufacturing process, including those using nanotechnology, could affect a food’s safety or its regulatory status. Consulting with agency experts could help address these issues, it said.
FDA commissioner Margaret Hamburg said in a statement: “Understanding nanotechnology remains a top FDA priority. FDA is strengthening the scientific tools and methods for evaluating food products, cosmetics, drugs and medical devices. We are taking a prudent scientific approach to assess each product on its own merits and to not make broad, general assumptions about the safety of nanotechnology products.”
The draft guidance said that nanomaterials are most commonly understood to be those that have been intentionally manipulated, manufactured or selected to have at least one dimension in the size range of approximately 1 to 100 nanometers.
However, it added: “We believe it is appropriate to take into account the potential importance of material size and the evolving state of the science…In the specific instance of nanotechnology, a food substance manufactured for the purpose of creating very small particle sizes with new functional properties likely would not be covered by an existing GRAS determination for a related food substance manufactured without using nanotechnology.”
In this case, when a food intentionally contains very small particles manufactured to have different functions from the same substance with a larger particle size, the agency said that there are likely to be questions regarding the evidence and general recognition of their safety. These questions are likely to warrant premarket review and approval by the FDA, it said.
In a paper prepared ahead of the new draft guidance’s release on Friday, Hamburg reiterated the agency’s decision not to adopt a definition for nanotechnology, although she said the FDA’s approach“may become more nuanced in light of experience”.
The guidance is open for comment for 90 days, and is available online here. The agency has not given a deadline for finalizing the guidance.