Having just attended a nanotech conference in Washington in June, it was interesting to note that the FDA issued a number of guidelines within the same period for companies using nanotechnology in products regulated by the government. Broadly they issued three guidelines for industry which are based around:

  • whether an FDA regulated product involves the application of Nanotechnology
  • safety of Nanomaterials in cosmetic products
  • assessing the effects of significant manufacturing process changes, including emerging technologies

The general position within these documents is to ask some key questions that will indicate whether a product will be considered to include nanotechnology or not. The criteria include whether the product has material within the nanoscale range (1nm to 100nm) or whether the product is engineered to exhibit unique properties due to its dimensions.

Nanotechnology FDA Guidance

A large part of the FDA work – which mirrors activity in the EU – is driven by concerns about the potential toxicological impact of nanomaterials on the environment. In fact during the Nanotech conference I listened to an excellent presentation by Brendan Casey from the FDA in which he talked about the physio-chemical characterisation of extracts of silver nanoparticles containing medical devices. During the talk he emphasised the requirement for improved quantitative tools beyond Dynamic Light Scattering (DLS) that could potentially provide number-based (size) distributions for nanoparticles released into the environment and taken up by living organisms.

In a case of “here’s one I prepared earlier”, I was actually completing a talk at the conference on this topic which looked at some of the potential methods for improved sizing resolution in line with the recommended EU definition on nanomaterials. The talk covered DLS and how through the use of a known light scattering standard e.g. Toulene, you can get a better understanding on the number of nanoparticles in solution. Additional techniques covered during the talk included linking DLS with a separations device like Field Flow Fractionation (FFF) and other techniques such as Nanoparticle Tracking Analysis (NTA) and Resonant Mass Measurement (RMM).

Nanomaterials have great application potential, however there are certain concerns about the impact that they might have on the environment. This is increasing both the research and regulations that have been implemented within the space. As far back as 2009, ISO issued a standard on critical physio-chemical parameters that should be monitored on nanomaterials and they included:

  •  Dimensions and granulometric distribution
  • Shape
  • Specific surface area
  • Surface charge
  • Composition and purity
  • Crystalline Structure
  • Level of crystallinity
  • Coatings and surface composition

A large part of the function of my team and I within Malvern is to understand the drivers and trends within the market that are driving development and manufacturing requirements, and to drive our own product innovation activities towards addressing them. There is still some debate on the priority of physio-chemical parameters within toxicology studies, however I am confident that we are well placed to meet any of the characterisation challenges that might arise from the research.

Check out these resources for further information:

Full FDA Guidance on Nanotechnology:

Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

Guidance for Industry: Safety of Nanomaterials in Cosmetic Products

Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives

Relevant Blog Posts:

Meeting global energy needs: can nanomaterials change the world?

Nanoparticles UNITE!

Q&A – Optimization and characterization of nanomaterials for drug delivery