Three final guidance documents and one draft guidance were recently released on FDA nanomaterials regarding the development of nanotechnology in food, dietary supplements, and cosmetic products and reflects FDA’s current thinking in the area.

The FDA is not looking to make a categorical judgement on nanotechnology but rather approach nanotechnology products on a case by case basis. With this thinking in mind, each guidance document directs manufacturers to consult with FDA regarding their nanotechnology product before going to market. It is recommended that consultation for each nanotechnology product start with the FDA as early as possible in order to help facilitate the design of the product to meet FDA requirements for safety, effectiveness, public health impact, and regulatory status. In this article we describe FDA nanomaterial current thinking in each guidance documents and their current focus for each product category.

Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
This guidance document outlines the FDAs nanomaterial approach to factors to consider when deciding whether a product involves the use of nanomaterial or nanotechnology. It outlines what industry must consider in regards to safety, effectiveness, public health impact, and regulatory status. When approaching the FDA with a new manufacturing technology involving nanomaterial, the FDA will request clarification on the following points for food, dietary supplement, and cosmetic products:

1. Whether the material or end product is engineered to have at least one dimension in the Nano scale range
2. Whether the material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its nanomaterial size, even if these dimensions fall outside the nano scale range, up to one micrometer (1,000 nm)

Final Guidance for Industry: Safety of Nanomaterial in Cosmetics
This cosmetic guidance documents encourages manufacturers to focus more on test method development and the data needed to support the substantiation for product safety and to consult with FDA when doing this. The focus of the FDA with this guidance is on safety assessments for cosmetics with nanotechnology.

Final Guidance for Industry: 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
This guidance takes a broad approach to significant or novel manufacturing process changes involving all products under the FDA food umbrella including dietary supplements when considering FDA nanomaterials. As per FDA, the key areas that they would like all manufacturers to consider and consult with them on before making significant or novel changes are as follows:

• Does the new process affect the identity of the food substance;
• Does the new process affect the safety of the use of the food substance;
• Does the new process affect the regulatory status of the use of the food substance
• Does the new process warrant a regulatory submission to FDA?

If the food ingredient deviates from its specified regulations in 21 CFR or its GRAS status conditions then a new petition may need to be filed with FDA. This is one of the reasons why FDA is encouraging all manufacturers in the food industry to consult with FDA before making significant changes especially when it involves nanotechnology.

Draft Guidance for Industry: Use of Nanomaterials in Food for Animals
This draft guidance addresses issues related to the use of FDA nanomaterials in food ingredients intended for use in food for animals. The focus of this guidance is on food ingredients for animals that:

• Consists entirely of nanomaterial which were not naturally occurring,
• Contains nanomaterial as a component that was not naturally occurring in the ingredient,
• Involves the application of nanotechnology to a food ingredient already on the market.

Public comments on this draft guidance were requested by September 10, 2014, and we are now waiting for final guidance.

dicentra can assist with product evaluations which involve the application of novel technology. We can assist with regulatory strategy when deciding to apply nanotechnology to food, dietary supplement, and cosmetic ingredients and facilitate communications and discussions with the FDA to expedite regulatory approval for getting your product to market.

dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. Contact us at info@dicentra.com or at 1-866-647-3279.