FDA

Lynn L. Bergeson, "Enlisting Modern Technologies to Ensure a Safe Food Supply," Natural Resources & Environment, Volume 31, Issue 3, Winter 2017.

Nanotechnology, biotechnology, and synthetic biology are the ploughs and tractors of the twenty-first century. These precision farming tools are ensuring a sustainable food supply otherwise threatened by climate change and population growth, among other global challenges. Genetically modified E. coli is being used to produce synthetically derived pheromones, substances beneficially used in agricultural applications to attract, capture, and eliminate harmful pests. Nanopesticides and nanofertilizers are being effectively used in drought-stricken regions, eliminating or minimizing the need for conventional agricultural chemicals. These and similar technologies are essential to enable today’s agricultural professionals to compete with an increasingly unforgiving Mother Nature and an ever-increasing demand for food.

 

These emerging technologies do not come without potential risks, however. How to regulate them is a  subject upon which stakeholders disagree.

 

Against this backdrop, this article considers emerging agricultural technologies, and discusses domestic agricultural oversight systems and their ability to keep pace with innovation. As discussed below, the domestic governance system is capable of addressing comprehensively the potential risks posed by these evolving technologies. The system, however, could be improved by better integration of measures  to educate policy makers and regulators on these technologies, and greater involvement by the private  sector in facilitating a predictable flow of information on these technologies to all stakeholders.

Lynn L. Bergeson, "FDA Issues Final Guidance on Use of Nanomaterials in Food for Animals," Nanotechnology Now, August 5, 2015.

On August 4, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance document entitled "Guidance for Industry: Use of Nanomaterials in Food for Animals." The Guidance is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology.

Lynn L. Bergeson, Carla N. Hutton, "FDA’s Final and Draft Nanotechnology Guidance Documents: No Big Surprises," Nanotechnology Law & Business, Spring 2015.
On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidance documents and one draft guidance document that FDA believes will provide greater regulatory clarity for industry and other stakeholders on the use of nanotechnology in FDA-regulated products. In this article, Lynn Bergeson and Carla N. Hutton review the recent guidance and highlight important considerations.
Lynn L. Bergeson, "FDA Issues Final and Draft Nanotechnology Guidances," Nanotechnology Now, June 24, 2014.

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide "greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products." See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402499.htm. One final guidance addresses FDA's overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals, respectively.

Lynn L. Bergeson, "FDA Finds Current Regulatory Review Processes Protect Public from Risks of Nanomaterials," Nanotechnology Now, October 29, 2013.

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) posted a blog item on October 24, 2013, concerning the use of nanotechnology to develop new drugs.

Lynn L. Bergeson, "Edible Nanotechnology," Pollution Engineering, July 2012.

The FDA issues two new draft guidance documents on nanotechnology in food substances and cosmetics.

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, "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.

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