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During the February 18, 2009, Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, Dr. Jonathan Sackner-Bernstein, Associate Center Director for Post-Market Operations at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), stated that FDA will not issue guidance until companies bring products to them so that FDA can learn more about the effects of nanotechnology. Sackner-Bernstein acknowledged that the...

On January 14, 2009, the Project on Emerging Nanotechnologies (PEN) released a report entitled A Hard Pill To Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements, which describes problems at the Food and Drug Administration (FDA) in regulating nano-enabled dietary supplements and offers recommendations for improving oversight. According to the report, FDA’s ability to regulate the safety of such dietary supplements “is severely limited by lack of...

On October 17, 2008, the European Food Safety Authority (EFSA) began a public consultation on its draft scientific opinion in relation to nanoscience and nanotechnologies and food and feed safety.  EFSA’s draft opinion focuses on engineered nano materials (ENM) that could be deliberately introduced into the food chain and elaborates on approaches to risk assessment. EFSA states that it “is not an assessment of any specific application of ENM.” According to EFSA,...

On October 30, 2008, Consumers Union petitioned the Food and Drug Administration (FDA) to require a full safety assessment on the use of engineered nanoparticles, particularly in cosmetics, sunscreens, and sunblocks, and “to investigate possible enforcement action to ensure accurate labeling as to the presence or absence of nanoparticles.” Consumers Union cites new findings in the December 2008 issue of Consumer Reports, and states that the findings “confirm...

The United States Food and Drug Administration (FDA) held its publicized Public Meeting on Nanotechnology on Monday, September 8, 2008, near its main offices in Rockville, Maryland. The meeting consisted of a plenary session led by Dr. Norris Alderson, Co-Chair of the FDA Nanotechnology Task Force, followed by separate breakout sessions for prescription and over-the-counter (OTC) drugs, cosmetics, medical devices, food and color additives (including food contact substances), and...

The National Institute of Standards and Technology (NIST) will hold an October 8-9, 2008, workshop regarding enabling standards for nanomaterial characterization.  According to the workshop overview, there is an “urgent need” to elevate new protocols and practices for characterizing the physicochemical properties of nanomaterials, and their in vitro and in vivo properties with respect to biological systems, to that of internationally accepted standards to accelerate research,...

The August 2008 issue of Environmental Health Perspectives includes an article entitled “Nano-Food Chain Link Examined,” which reports on recent research by the U.S. National Institute of Standards and Technology (NIST) regarding whether nanomaterials biomagnify in the food chain. NIST reports that certain nanomaterials may not accumulate in the food chain, but notes that additional research is necessary before any generalizations can be made regarding environmental and human safety of...

In an August 7, 2008, Federal Register notice, the U.S. Food and Drug Administration (FDA) announced that it will convene a public meeting on September 8, 2008, on FDA-regulated products that may contain nanoscale materials. According to the Federal Register notice, FDA also is seeking public comments and available data “that will assist [FDA] in further implementing the recommendations of the Nanotechnology Task Force Report . . . relating to the...

On May 19, 2008, the Department for Environment, Food, and Rural Affairs (DEFRA) posted its sixth quarterly report on the Voluntary Reporting Scheme (VRS) for engineered nanoscale materials. According to the report, DEFRA received no new submissions this quarter, and to date has received only nine submissions since the VRS’s launch in September 2006:  seven from industry, and two from academia. The report states that DEFRA, in partnership with the United Kingdom Technology Strategy Board,...

On March 12, 2008, the Department for Environment, Food and Rural Affairs (DEFRA) released a supplementary guidance document for the Voluntary Reporting Scheme (VRS). DEFRA prepared the supplementary guidance document to complement the existing VRS guidance. Chapter 2 describes the rationale and benefits of the VRS. Chapter 3 provides a specific list of the relevant physical, chemical, toxicological, and ecotoxicological data to include when reporting under the...

On January 23, 2008, the European Food Safety Authority (EFSA) issued a notice entitled “Call for Scientific Data on Applications of Nanotechnology and Nanomaterials used in Food and Feed.” According to the notice, EFSA is seeking data that could be useful as it prepares an initial scientific opinion for the European Commission (EC) regarding the risks arising from nanoscience and nanotechnologies on food and feed safety and the environment. The EC asked EFSA to identify the nature...

According to a report recently released by the Danish Ministry of Health and Prevention, nanotechnology research, development, and applications are covered by existing legislation. The report, which includes an English summary, reviews existing national and international legislation in the areas of foods, medicines, the environment, chemicals, and the working environment in relation to current knowledge of nanotechnological products and processes.  The report also includes a...

According to the December 22, 2007, fifth quarterly report for the Department for Environment, Food, and Rural Affairs’ (DEFRA) Voluntary Reporting Scheme (VRS) for engineered nanoscale materials, DEFRA received no new submissions since publication of the previous quarterly report in September 2007. DEFRA is in the process of updating the VRS documentation to clarify the purpose and aims of the VRS and provide supplementary guidance for anyone submitting data. DEFRA intends...

On December 19, 2007, the Department for Environment, Food and Rural Affairs (DEFRA) published a report entitled Characterising the Potential Risks Posed by Engineered Nanoparticles: A Second UK Government Research Report, which follows up on DEFRA’s 2005 report and 2006 progress report. The report reviews the status of research pertaining to the environmental, health, and safety (EHS) issues relating to engineered nanoparticles, and places the United Kingdom’s (UK) research...

The Food and Drug Law Institute (FDLI) and the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) will hold a conference on February 28-29, 2008, on “Nanotechnology Law, Regulation and Policy.” Questions addressed during the conference will include: How is the Food and Drug Administration (FDA) going to implement its Nanotechnology Task Force Report? How is the Occupational Safety and Health Administration (OSHA) going to deal with nanotech...

In a recent speech at the 9th Annual Food Regulation and Labeling Standards Conference, Steve McCutcheon, CEO of Food Standards Australia New Zealand (FSANZ), said that FSANZ has begun analyzing the potential implications of nanotechnology on the food supply chain. FSANZ hopes that, by the time it receives its first application to approve the use of the technology in food, it will already have sufficient scientific and medical information to make an informed decision.

The European Food Safety Authority (EFSA) met the week of November 19, 2007, to begin reviewing the regulation and risk assessment of nanotechnology. The European Commission (EC) issued a mandate for a complete evaluation by March 31, 2008, but EFSA responded that, because of the range of differing properties and safety profiles, it will not be able to complete its review by this deadline. EFSA instead proposed to issue an initial scientific opinion by Summer 2008. EFSA...

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...

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...

According to the fourth quarterly report for the UK’s Voluntary Reporting Scheme (VRS) for Manufactured Nanomaterials, the Department for Environment, Food, and Rural Affairs (DEFRA) received no new submissions during the most recent quarter. Since the VRS began in September 2006, DEFRA has received a total of nine submissions, seven from industry and two from academia. In late July 2007, the Advisory Committee on Hazardous Substances (ACHS) reported the findings...