FDA Refines Its Thinking on Nanotechnology

By Ricardo Carvajal –

FDA finalized three guidance documents that address various aspects of the use of nanotechnology in products regulated by the agency: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Safety of Nanomaterials in Cosmetic Products, and 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.  FDA also issued a fourth guidance document in draft form, Use of Nanomaterials in Food for Animals.

The overall thrust of FDA’s approach to regulating products derived through nanotechnology remains unchanged.  That is, FDA will continue to regulate those products under its existing authorities, is not establishing any nanotechnology-specific regulatory definitions, and remains principally interested in products “deliberately manipulated by the application of nanotechnology” (as opposed to “products that contain materials that naturally occur in the nanoscale range”).  That said, the final guidance documents include a number of modifications that make them worth a close read for those with an interest in the topic.

For example, the draft guidance on considering whether a product involves nanotechnology identified two points to consider, one of which was “whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm).”  The final version of the guidance tweaks that point to state “whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1 nm to 100 nm)” (emphasis ours).  The revision is more consistent with FDA’s interest in “deliberate and purposeful” application of nanotechnology, and also appears to more clearly acknowledge the wide range of morphologies achievable through nanotechnology.

As an additional example, the draft guidance on nanomaterials in cosmetics briefly noted that traditional toxicity testing might need to be modified with respect to a number of factors, such as methods to prevent agglomeration.  The final version of the guidance delves into this issue in greater detail, and provides several examples of why traditional methods might not be suitable. 

Similarly, the draft guidance on effects of manufacturing changes on the regulatory status of food ingredients briefly noted that traditional safety tests might have limited applicability to nanomaterials, and stated that safety studies should be appropriately validated for such materials.  The final guidance explains that “variability has been reported when traditional toxicity tests have been used to assess nanomaterials,” and goes on to lay out FDA’s expectations for method validation. 

The draft guidance on nanomaterials in food for animals addresses similar analytical challenges.  Comments on that draft guidance are due by September 10.