FDA

Lynn L. Bergeson and Michael F. Cole, "Fullerenes Used in Skin Creams," Nanotechnology Law & Business, Volume 9, Issue 2, June 2012.

Since the discovery of fullerenes in 1985, the scientific and business communities have been exploring possible commercial applications for these intriguing materials. This article will explore one such application, the use of fullerenes in skin creams. We will discuss the perceived advantages of such use, the concerns expressed regarding risks to health and the environment from fullerenes in skin cream, and the research reported to date on cosmetic usage. The article will conclude with a discussion of the initiatives undertaken by manufacturers and government regulators to address the safe use of fullerenes, as well as selected future issues confronting those seeking to commercialize fullerenes in skin creams.

Lynn L. Bergeson, "FDA’s Regulation of Nanotechnology: Will the New Draft Guidance Help Industry?," Nanotechnology Law & Business, Volume 8, Issue 3.

The U.S. Food and Drug Administration's (FDA) approach to nanotechnology is the subject of intense interest for at least three reasons. First, many promising and visible applications of nano-technology include cosmetics, sunscreens, pharmaceuticals, dietary supplements, and medical devices. These products are subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act (FFDCA). Second, FDA faces unique challenges in regulating products of nanotechnology be-cause of the product-based regulatory structure created under the FFDCA. The rapid increase in nanotechnology applications in FDA-regulated products raises questions regarding the adequacy of the FDA's product-based approach given the differing statutory authorities FDA has over these product categories. Third, for regulatory purposes under the Act, FDA classifies medical products as drugs, devices, biologics, or combination products. A product’s mode of action determines which FDA Center has primary jurisdiction over the product. As nanotechnology matures, the distinctions between and among these classifications will blur, further stressing FDA's ability effectively to oversee products of nanotechnology subject to its jurisdiction.

Lynn L. Bergeson, "Topical Briefing on recent Lawsuit filed against US FDA," Nanotechnology Industries Association Newsletter, January 7, 2012.

On the 21st of December 2011, a U.S. coalition of nonprofit consumer safety and environmental groups filed a lawsuit against the U.S. Food and Drug Administration (FDA) for alleged failure to regulate what the coalition deems health and environmental risks stemming from nanotechnology-enabled products put on the market. The coalition was led by the International Center for Technology Assessment (ICTA) and represents the following plaintiffs: Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and the Institute for Agricultural and Trade Policy.

Lynn L. Bergeson, "Toxicity Testing Moves Ahead," Chemical Processing, September 2010.

Who would have thought that an automated laboratory working around the clock could screen chemical substances for interactions with biological targets at speeds mere mortals could hardly consider — let alone match? Well, this is exactly what is occurring today thanks to a collaborative effort known as "Tox21" among the U.S. Environmental Protection Agency (EPA), the National Toxicology Program (NTP), and the National Institute of Health Chemical Genomics Center (NCGC). Recently, the U.S. Department of Health and Human Services, Food and Drug Administration (FDA) joined the initiative. This column describes this ground-breaking partnership.

Lynn L. Bergeson and Michael F. Cole, "FDA Regulation of Food Packaging Produced Using Nanotechnology," Food Safety Magazine, April/May 2006.

Food packaging materials must comply with the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Nanopackaging for the most part involves the use of materials that are not intended to have any effect on the food in the package, but may contact the food if the material migrates from the packaging. Such materials are regulated as indirect food additives or food contact substances. There are precedents that permit the marketing of indirect food additives without the need for clearance, and there is a regulatory process in place to review additives that require approval. The critical question in the food packaging area, as in every regulated industry, is whether existing precedents and process will be sufficient to address any issues that arise as the application of nanotechnology matures.

Michael F. Cole, "RFID, Nano-Tools and the Electronic Safety Net: Nanotechnology may revolutionize the use of RFID in the battle against counterfeit drug imports," Health & Personal Care Magazine, February 2006.

Radio frequency identification (RFID) technology is revolutionizing the business of tracking inventory and, soon, the U.S. Food and Drug Administration (FDA) will use it to combat counterfeit drugs. The challenges of RFID adoption, in turn, might act as an additional impetus to the development of nanotechnology solutions. FDA views RFID as the most promising technology to combat the flow of counterfeit drugs to U.S. consumers, and encourages the adoption of RFID by manufacturers and distributors. 

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