Category: FDA

November 16, 2007

Bush Administration Releases Principles for Nanotechnology Environmental, Health, and Safety Oversight

On November 8, 2007, the Office of Science and Technology Policy (OSTP) and the Council on Environmental Quality (CEQ) issued a memorandum regarding “Principles for Nanotechnology Environmental, Health, and Safety Oversight.” According to the memorandum, OSTP and CEQ “led a multi-agency consensus-based process” to develop principles intended to guide the development and implementation of policies for nanotechnology environmental, health, and safety oversight at the agency...
November 13, 2007

First Annual Nanotechnology Safety for Success Dialogue Held in October

On October 25-26, 2007, the European Commission (EC) held the First Annual Nanotechnology Safety for Success Dialogue. Presentations included: Food applications of nanoscience and nanotechnologies — Ms. Sue O’Hagan, Confederation of the Food and Drink Industries of the European Union (CIAA); Consumer products applications of nanoscience and nanotechnologies — Dr. Michael Holman, Lux Research; Health applications of nanoscience and nanotechnologies — Dr. Carole...
August 24, 2007

FDA Releases Proposed Rule Regarding Sunscreens

Yesterday the Food and Drug Administration (FDA) released a proposed rule that would amend the final monograph for over-the-counter (OTC) sunscreen drug products as part of FDA’s ongoing review of OTC drug products. The proposed rule addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, would introduce four-star rating system for the level of UVA protection, and would require a warning...
July 26, 2007

FDA Nanotechnology Task Force Issues Report

On July 25, 2007, the Food and Drug Administration (FDA) Nanotechnology Task Force issued its report, which addresses regulatory and scientific issues and offers recommendations for each. The Task Force intends its report to outline ways for FDA to enhance its knowledge of nanotechnology to support its oversight for products using such technology, and to inform interested stakeholders what information may be needed to support the marketing of FDA-regulated products that use...
July 19, 2007

Council of State and Territorial Epidemiologists Issues Statement on the Occupational and Environmental Risks of Nanotechnology

The Council of State and Territorial Epidemiologists (CSTE) recently issued a position statement on nanotechnology risks. The CSTE statement observes that the “health, safety and environmental effects of nanomaterials are poorly understood,” and that “our limited knowledge of [nanotechnology’s] potential harm is cause for concern.” Among other things, CSTE calls: for increased funding for research on the environmental, health, and safety impacts of nanotechnology;...
June 18, 2007

FDA Announces New Advisory Committee to Address Risk Communication

On June 4, 2007, the Food and Drug Administration (FDA) announced a new advisory committee intended to counsel FDA on how to strengthen the communication of risks and benefits of FDA-regulated products to the public. The Risk Communication Advisory Committee will: Help FDA better understand the communication needs and priorities of the general public; Advise FDA on the development of strategic plans to communicate product risks and benefits; and Make recommendations to FDA on what...
June 5, 2007

July Issue of Consumer Reports Includes Article on Nanotechnology

The July 2007 issue of Consumer Reports includes an article entitled “NANOtechnology: Untold Promise, Untold Risk.” According to Consumer Reports, while nanotechnology “promises to be the most important innovation since electricity and the internal combustion engine,” “some applications might pose substantial risks to human health and the environment.” The article states that nanomaterials are already being used in consumer products such as car wax,...
April 17, 2007

Joint Economic Committee of Congress Releases a New Study on Nanotechnology

In mid-March 2007, Representative Jim Saxton (R-NJ), the ranking minority member of the Joint Economic Committee (JEC), released a new Congressional study on nanotechnology. On balance an extremely positive report, the JEC Study “discusses the range of sciences currently covered by nanotechnology,” describes “what nanotechnology is and how it relates to previous scientific advances,” as well as “the most likely future development of different technologies in a variety of...
March 22, 2007

Senate Requests GAO Review of NNI

In a March 15, 2007, letter, the Senate Committee on Commerce, Science, and Transportation and the Congressional Nanotechnology Caucus requested that the Government Accountability Office (GAO) review the National Nanotechnology Initiative (NNI), which was created to accelerate the discovery, development, and deployment of nanoscale science and technology. For fiscal year 2006, NNI received $1.2 billion in research and development funding, and 22 federal agencies, including the...
April 1, 2006

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,...