The FDA has published draft guidance describing its current position on the use of nanomaterial in food for animals. See “Guidance for Industry, Use of Nanomaterials in Food for Animals, Draft Guidance,” available at http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM401508.pdf. The draft guidance is aimed at food intended for animal consumption that 1) consists entirely of nanomaterials, 2) contains nanomaterial as a component, or 3) otherwise involves the application of nanotechnology.
The FDA uses the terms nanotechnology, nanoscale, or nanomaterial to define materials that have been engineered to have at least one dimension in the size range of 1 to 100 nanometers that has been engineered to exhibits properties or phenomena attributable to its dimensions. See “Considering whether an FDA-regulated product involves the Application of Nanotechnology,” available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm.
Notably, the guidance does not call into question those substances that naturally exist in the nanoscale range (e.g. microorganisms) or those products that contain incidental amounts of nanomaterial (e.g. conventional manufacturing processes resulting in nanoparticles). Instead, the draft guidance seeks comments regarding nanoparticles deliberately manipulated or controlled in order to produce specific technical effects.
The FDA is particularly interested in the application of nanotechnology because its application to conventional substances may result in product attributes that are different from those present in conventionally-manufactured products. Nanomaterial may possess novel physicochemical properties as a result of the seemingly simple dimension alteration which can affect the biological behavior of the material as a result of the increased surfaces-area-to-volume rates, morphology, surface features, and charge. Nanotechnological alterations may even affect the biodistribution, biocompability, and toxicity of a material (e.g. may affect absorption rate in body).
Because the nano-version of an otherwise GRAS (generally recognized as safe as defined in 21 USC 321(s)) material may have significantly different affects from its large-particled brethren with the identical chemical composition, it may very well alter the final product. At present, the FDA is not aware of any animal food ingredient which uses nanotechnology for which there is generally available safety data that would satisfy the GRAS criteria. Therefore, a pre-market analysis of the product by the FDA may be necessary.
The Center for Veterinary Medicine provides guidance for those submissions in Guidance for Industry #221 under which the FDA recommends information regarding the 1) identity and characterizations of the nanomaterial, 2) the manufacturing methods and controls used in the creation of the nanomaterial, 3) the intended use, level, and labeling of the nanomaterial, 4) the analytical method capable of determining the chemical composition and amount of nanomaterial in the food product, 5) safety evaluation and proposed tolerances, 6) a section covering proposed regulation including technical specifications and limitations to ensure safety, and 7) an environmental assessment of the nanomaterial including potential adverse impact which may differ from that of the material in its larger-scale. See “Guidance for Industry, Recommendations for the Preparation and Submission of Animal Food Additives Petitions,” available at http://www.fda.gov/downloads/AnimalVeterinary/GuidanceCompliance Enforcement/GuidanceforIndustry/UCM367746.pdf.