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New FDA Guidance on Use of Nanotechnology in Regulated Products

Friday, June 27, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration issued June 24 three final guidances and one draft guidance designed to provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products. One final guidance addresses the FDA’s overall approach for all products that it regulates, while the two additional final guidances and the draft guidance provide specific guidance for the areas of foods, cosmetics and food for animals, respectively.

The FDA emphasizes that it has made no categorical judgment that nanotechnology is inherently safe or harmful and will continue to consider the specific characteristics of individual products. All four guidance documents encourage manufacturers to consult with the FDA early in the product development process to facilitate a mutual understanding about specific scientific and regulatory issues relevant to the product and help address questions related to its safety, effectiveness, public health impact and/or regulatory status.

Determining if Regulated Products Use Nanotechnology. This guidance outlines overarching considerations for all FDA-regulated products and identifies two points to consider when determining whether a product involves the use of nanotechnology. It is intended to help manufacturers, suppliers, importers and other stakeholders identify when they should consider potential implications for regulatory status, safety, effectiveness or public health impact that may arise with the application of nanotechnology in FDA-regulated products. The FDA notes that these two points are intended to be a broad screening tool and reflect the fact that the agency’s interest extends to the properties exhibited by products that involve the use of nanotechnology and does not focus on size alone. The FDA may further refine these points as the science evolves.

Cosmetics. This guidance describes the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products and encourages manufacturers to consult with the FDA on test methods and data needed to support the substantiation of a product’s safety. It indicates that cosmetics and cosmetic ingredients (with the exception of color additives) must be safe for consumers under labeled or customary conditions of use and must be properly labeled and that cosmetics manufactured using nanomaterials are subject to the same legal requirements as any other cosmetics. The guidance notes that while the framework currently in use for assessing the safety of cosmetics is generally appropriate for cosmetics containing nanomaterials, data needs and testing methods should be evaluated in light of the properties, behaviors and/or effects that may be exhibited by nanomaterials used in cosmetic products.

Food Ingredients and Food Contact Substances. This guidance alerts manufacturers to the potential impact of any significant manufacturing process change, including changes involving nanotechnology, on the safety and regulatory status of food substances. It also describes the factors that manufacturers should consider when determining whether a significant change in manufacturing process for a food substance already in the market (a) affects the identity of the food substance, (b) affects the safety of the use of the food substance, (c) affects the regulatory status of the use of the food substance, and (d) warrants a regulatory submission to the FDA.

Food for Animals. This draft guidance addresses issues related to the use of nanotechnology in food ingredients intended for use in food for animals. It addresses the legal framework for adding substances to food for animals and includes recommendations for submitting a food additive petition for a nanomaterial animal food ingredient. Public comments are requested by Sept. 10.

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