All Knowledge & Insights By Date

The Institute for Agriculture and Trade Policy (IATP) issued a June 29, 2011, report entitled Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, which claims that at least 1,300 products with engineered nanotechnology materials (ENM) have been commercialized, “despite myriad uncertainties about the public health and environmental effects of ENMs.” According to the report, several steps are needed for an operative and mandatory regulatory structure for nanotechnology...

In a September 27, 2010, press release, the National Institutes of Health (NIH) announced that it will award $9.4 million over three years to support four research projects in regulatory science.  NIH will make the awards in partnership with the U.S. Food and Drug Administration (FDA), which will contribute approximately $950,000.  According to the press release, the projects include research on nanoparticles and their characterization. NIH states that the projects were chosen “because...

On September 23, 2010, the Food and Drug Administration (FDA) will hold a public workshop entitled “Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.” According to FDA, the purpose of the workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or using nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these topics and...

On July 20, 2010, Representative Janice Schakowsky (D-IL) introduced the Safe Cosmetics Act of 2010 (H.R. 5786), which would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) “to ensure the safe use of cosmetics.” Under the bill, the Secretary of the Food and Drug Administration (FDA) would: Monitor developments in the scientific understanding of any adverse health effects related to the use of nanotechnology in the formulation of cosmetics; and Consider scale-specific hazard...

On June 3, 2010, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science (OPS) posted on its website a Manual of Policies and Procedures (MAPP) entitled “Reporting Format for Nanotechnology-Related Information in CMC Review.” The purpose of the MAPP is to provide chemistry, manufacturing, and controls (CMC) reviewers within OPS with the framework by which relevant information about nanomaterial-containing drugs will now be...

In a March 2, 2010 letter, the Food and Drug Administration (FDA) responded to the Environmental Working Group’s (EWG) July 15, 2009, letter concerning sunscreen guidelines. EWG criticized the FDA for not having guidelines for sunscreen safety and efficacy. According to EWG, companies continue to profit by misleading consumers about the protection offered by their products. EWG urged FDA to publish a final rule for its August 2007 draft sunscreen...

During the 68th annual meeting of the American Academy of Dermatology, on March 4, 2010, dermatologist Adnan Nasir, M.D., Ph.D., F.A.A.D., gave a presentation on nanotechnology and how nanoparticles may eventually be used in cosmetic products. According to Dr. Nasir, the cosmetic industry leads all other industries in the number of patents for nanoparticles, which have the potential to enhance sunscreens, shampoos, conditioners, lipsticks, eye shadows, moisturizers, deodorants, after-shave...

According to a June 8, 2009, article, Dr. Annette McCarthy of the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition stated on June 6, 2009, at the Institute of Food Technologists’ annual meeting that the “regulatory authority is sufficient to address nanotechnology but there are further questions.” McCarthy recommended that petitions to the FDA seeking acceptance of a nanotech food additive or coloring should address its “impact on identity and...

On April 28, 2009, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Oversight of Next Generation Nanotechnology, which calls for the creation of the Department of Environmental and Consumer Protection, which would oversee product regulation, pollution control and monitoring, and technology assessment. According to report author J. Clarence Davies, Ph.D., the agency would be primarily a scientific agency with a strong...

On March 17, 2009, the U.S. Food and Drug Administration (FDA) announced that it has completed a “proof-of-concept” study of a test that “quickly and accurately detects the presence of even the smallest amount of the deadly anthrax toxin.” According to FDA, the proof-of-concept study relies on a nanotechnology-based test platform built from tiny molecular-sized particles. The europium nanoparticle-based immunoassay (ENIA) was able to detect the presence of a protein made by the...

On March 10, 2009, the Food and Drug Administration (FDA) announced a collaboration with the Alliance for NanoHealth (ANH) and its members. According to FDA, the collaboration is intended to “help speed development of safe and effective medical products in the emerging field of nanotechnology.” Under a memorandum of understanding, FDA and ANH will work to increase the knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and...

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 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,...

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...

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...

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...