(HealthDay News) — The U.S. Food and Drug Administration has released three final guidance documents and one draft guidance document in an effort to provide greater regulatory clarity for industry on the use of nanotechnology.
Noting that nanotechnology has a wide range of potential applications, the FDA has provided guidance relating to nanotechnology use in industry, with specific guidance for foods, cosmetics, and foods for animals.
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The final and draft guidance documents relate to use of nanotechnology in FDA-regulated products. One of the final guidance documents for industry outlines points to consider when determining whether a product involves nanotechnology, and should help industry and others to know when to consider potential implications for regulatory status, safety, effectiveness, or public health impact.
Another final guidance document describes safety assessments of nanomaterials when used in cosmetic products. The third final guidance document relates to assessing the effects of manufacturing process changes, including nanotechnology, on the safety and regulatory status of food substances. The draft guidance document relates to the use of nanotechnology in food ingredients intended for animal food.
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“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,” FDA Commissioner Margaret A. Hamburg, MD, said in a statement.
“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.”