With the growing interest in and use of nanomaterials in food, cosmetics, and medical products, FDA has established and expanded its review of and regulation over such use, including the use in animal feed. These materials have been developed as animal feed additives to “improve nutrient uptake or reduce the presence of naturally present toxins which improve the overall health status of animals while allowing for efficient feed utilization,” as identified by the Nanotechnology Industry Association.
FDA, interested in the alterations of the properties or functions of animal feed “that involve the application of nanotechnology to deliberately manipulate or control particulate size in order to produce specific technical effects,” just published the Draft Guidance Document #220, titled “Use of Nanomaterials in Food for Animals,” for public review and comment.
Some key points for the industry to consider, based on FDA’s draft guidance include:
- Contact FDA-CVM to determine whether the product falls within the scope of FDA’s interest in nanotechnology, and if so, to identify the extent and type of testing necessary for FDA approval;
- Premarket review and approval of nanomaterials may be required where the material results in new or different physiochemical properties, and where there is a lack of recognition that the material is safe for its intended use.
Food Additive Petitions that may be required for FDA approval should include at least the following sections:
- Identity-the nanomaterial must be identified and characterized, chemically and physically, when possible;
- Manufacturing Methods and Controls-based on the intended use in specific forms of feed (i.e., dry or liquid) for the intended species, include information on the product stability; any toxicity associated with its byproducts and/or impurities; the methods to produce and extent of uniform distribution in feed;
- Intended Use, Use Level, and Labeling-labeling requirements to avoid misbranding are required, consistent with the general requirements for listing feed ingredients;
- Analytical Methods-“to determine the identity, purity, quality, and strength of the nanomaterial animal food additive” specific analytical methods of detection of these materials is suggested;
- Safety Evaluation and Proposed Tolerances for the Food Additive-safety for both humans and animals must be addressed for approval of a food additive, and based on the altered characteristics of feed adsorption, distribution and/or accumulation that could affect safety, based on the intended use of the feed additive;
- Proposed Regulation-FDA recommends that this section include technical specifications to properly identify the nanomaterial, as well as any limitations to ensure safety;
- Environmental Assessment-contact FDA about the potential for adverse environmental effects resulting from the manufacture, distribution and/or use of the nano-feed additive, and whether particular exclusions may apply.
As the field of nanotechnology continues to expand, these and other regulatory hurdles will have to be addressed before the benefits of these materials can be used to enhance the health and well-being of animals.