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FDA Issues New Guidances on Nanotechnology
Posted: April 26, 2012
The US Food and Drug Administration has issued two new draft guidances on the use of nanotechnology by the cosmetics and foods industries: “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products,” and “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The cosmetic product draft guidance explains that the legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products. To conduct safety assessments for cosmetic products containing nanomaterials, standard safety tests may need to be modified or new methods developed.
The food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may: affect the identity, safety or regulatory status of the use of the food substance; or warrant a regulatory submission to FDA. Both guidances encourage manufacturers to consult with the agency before taking products to market.
Electronic or written comments should be submitted within 90 days of the publication of the notices of availability in the Federal Register. The FDA will carefully consider all relevant, substantive comments during the development of the final guidance documents. Electronic comments should be submitted to www.regulations.gov. Written comments should be submitted to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 USA.