FDA issues guidance on the use of nanomaterials in animal food.

  • Nanotechnology refers to emerging technology that uses materials in the nanoscale range (with at least one dimension in the size range of approximately 1 nanometer (nm) to 100 nm).  Nanomaterials may exhibit different chemical or physical properties, or even different biological effects, as compared to their larger-scale counterparts.  Nanotechnology may be used to produce FDA-regulated products such as foods, drugs, and cosmetics.  FDA has developed an approach to the regulation of nanotechnology products and has issued various guidance documents on the regulation of nanomaterials in specific product categories.
  • In August 2015, FDA issued a final guidance document regarding the regulation of nanomaterials in food for animals. Nanomaterials intended for use in animal food are subject to the same regulatory pathways as conventional materials, but FDA notes in its guidance that, “[a]t this time, [the Agency is] not aware of any animal food ingredient engineered on the nanometer scale for which there is generally available safety data sufficient to serve as the foundation for a determination that the use of such an animal food ingredient is [generally recognized as safe] GRAS.”  Parties interested in using nanomaterials in animal food in the United States thus are encouraged to submit a food additive petition (FAP) to FDA to permit such use.  The guidance specifies various considerations that manufacturers should take into account when preparing an FAP for a nanomaterial animal food additive.
  • Significantly, the Agency excludes from the scope of the guidance any materials or end products that contain naturally-occurring substances in the nanoscale range or that contain incidental quantities of nanomaterials with no further deliberate manipulation or engineering.  FDA’s guidance applies to “materials or end products that involve the application of nanotechnology to deliberately manipulate or control particle size in order to produce specific technical effects.”  The guidance therefore is of most direct relevance to parties seeking to harness nanotechnology to develop novel materials for use in animal food.