FDA Issues Guidelines on Safe Development of Nanotechnology Products

The agency issued three final guidances and one draft guidance to provide regulatory clarity for industry on the use of nanotechnology.

The U.S. Food and Drug Administration has issued three final guidances and one draft guidance on the use of nanotechnology in manufacturing in order to provide greater "regulatory clarity" for the industry, according to a press release from the agency. One final guidance covers the agency's overall approach for the products being regulated and the other two final guidances and the draft guidance provide recommendations for food, cosmetics, and food for animals.

"Our goal remains to ensure transparent and predictable regulatory pathways, grounded in the best available science, in support of the responsible development of nanotechnology products," said FDA Commissioner Dr. Margaret A. Hamburg. "We are taking a prudent scientific approach to assess each product on its own merits and are not making broad, general assumptions about the safety of nanotechnology products."

FDA points out it does not "make a categorical judgment that nanotechnology is inherently safe or harmful, and will continue to consider the specific characteristics of individual products." Nanotechnology is an emerging technology that allows scientists to create and manipulate materials on an incredibly small scale measured in nanometers.

According to the FDA, the guidances are: 

Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

The guidance outlines overarching considerations for all FDA-regulated products, identifying points to consider when determining whether a product involves the use of nanotechnology. It is intended to help industry and others 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.Final Guidance for Industry: Safety of Nanomaterials in Cosmetics

The guidance describes 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.

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

The 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. This guidance also describes considerations for determining whether a significant manufacturing process change for a food substance already in the market affects the identity, safety, or regulatory status of the food substance, potentially warranting a regulatory submission to the FDA.

Draft Guidance for Industry: Use of Nanomaterials in Food for Animals

This draft guidance addresses issues related to the use of nanotechnology in food ingredients intended for use in food for animals. Public comments on this draft guidance are requested by Sept. 10, 2014.

FDA will continue to pursue ongoing scientific research and regulatory efforts and will consider new studies and data, as they become available, to determine future actions. Science is a critical component of the agency’s ongoing review of products. FDA has invested in a nanotechnology regulatory science program that will enhance the agency's scientific capabilities. Additional guidance for industry will be developed as needed.

FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices.

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