14 Aug 2015
FDA Issues Guidance on Use of Nanomaterials in Food for Animals
The FDA has issued a guidance document outlining its current thinking regarding the use of nanomaterials or the application of nanotechnology in food for animals. The document is intended to assist industry and other stakeholders in identifying potential issues related to the safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology but does not establish legally enforceable responsibilities.
The FDA regulates foods and substances added to food under the FD&C Act. Section 201(s) of the FD&C Act defines a "food additive" as "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food." Section 201(s) of the FD&C Act excludes from this definition any substance that is generally recognised as safe (GRAS) among qualified experts under the conditions of its intended use, or that qualifies for any of the other exemptions from the food additive definition (e.g., new animal drug, colour additive, etc.)
Food additives require pre-market approval based on data demonstrating safety. The FDA issues food additive regulations specifying the conditions under which an additive has been demonstrated to be safe and, therefore, may be lawfully used. A food that contains an unapproved food additive is deemed to be unsafe under section 409(a) and adulterated under section 402(a)(2)(C)(i) of the FD&C Act. Therefore, in order to use a food additive in animal food the FDA must issue a food additive regulation prescribing the conditions under which the additive may be safely used.
Under section 201(s) of the FD&C Act, the use of a food substance may be shown to be GRAS either through scientific procedures or, for a substance used in food before 1958, through either scientific procedures or experience based on common use in food. General recognition of safety based upon scientific procedures requires the same quantity and quality of scientific evidence as is needed for approval of a food additive petition.
The FDA has not established regulatory definitions of "nanotechnology," "nanomaterial," "nanoscale," or other related terms. As described in a June 2014 guidance document, when considering whether an FDA-regulated product involves the application of nanotechnology the agency will ask (i) 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); and (ii) whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s) even if these dimensions fall outside the nanoscale range, up to one micrometre (1,000 nm).
The guidance document indicates that the application of nanotechnology may result in product attributes that differ from those of conventionally-manufactured products, and thus may merit examination. However, the FDA does not categorically judge all products containing nanomaterials or otherwise involving the application of nanotechnology as intrinsically benign or harmful. Rather, for nanotechnology-derived and conventionally-manufactured animal food products alike the agency considers the characteristics of the finished product and its safety for its intended use. The FDA's consideration of nanotechnology applications in animal food is consistent with the agency's guidance and with the broader federal guidance on regulatory oversight of emerging technologies and nanotechnology.
Because the application of nanotechnology may result in new or different physicochemical properties, specific data should be used as evidence to show that the use of the nanomaterial version of the animal food ingredient is safe for its intended use, even if it shares the same chemical composition as a larger-scaled animal food ingredient that is determined to be GRAS for that intended use or is a food additive approved for that intended use. There are animal food ingredients that are approved as food additives or that are GRAS for their intended uses that could be manufactured to significantly alter their particle size or size distribution into the nanoscale range. In some instances, these changes could result in a material with different properties. In such cases, manufacturers should conduct safety assessments that are based on data and information relevant to the nanomaterial version and not rely entirely on the data and information used to determine the safety of a larger-scaled material with the same chemical composition.
The FDA adds that for nanotechnology applications in animal food there currently are questions related to the technical evidence of safety as well as the general recognition of that safety that are likely to be sufficient to warrant formal pre-market review and approval by the agency, rather than to satisfy criteria for GRAS status. Indeed, the FDA is not aware of any animal food ingredient engineered on the nanometre 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 GRAS.
Additionally, where there is a lack of general recognition of the safety of a nanomaterial animal food ingredient for its intended use it is likely that a GRAS notice for such an ingredient would not meet the criteria of CVM's pilot GRAS notification programme. Therefore, pre-market review and approval of the animal food ingredient by the FDA may be warranted. The FDA therefore recommends that companies seek advice from the agency even if they believe that the generally available data and information could form a basis for a determination of GRAS status of an animal food substance that involves nanotechnology.