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...
Category: FDA
On March 29, 2010, the U.S. Environmental Protection Agency (EPA) announced its action plan on bisphenol A (BPA). In its press release, EPA states that the BPA action plan "focuses on the environmental impacts of BPA and will look to add BPA to EPA's list of chemicals of concern and require testing related to environmental effects." EPA notes that, in January 2010, the Food and Drug Administration (FDA) announced that it had some concerns about the potential human health impacts of BPA, and...
March 12, 2010
FDA Responds to EWG’s Letter Concerning Sunscreen Guidelines
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...
On March 5, 2010, the U.S. Government Accountability Office (GAO) released a report entitled Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS). The Federal Food, Drug, and Cosmetic Act (FFDCA) exempts generally recognized as safe (GRAS) substances, which include spices, artificial flavors, emulsifiers and binders, vitamins and minerals, and preservatives, from the general requirement that companies obtain Food and Drug...
True to her word, yesterday U.S. Environmental Protection Agency (EPA) Administrator Lisa P. Jackson announced action plans on phthalates, long-chain perfluorinated chemicals (PFC), polybrominated diphenyl ethers (PBDE) in products, and short-chain chlorinated paraffins (SCCP). This EPA initiative announces actions that are almost breathtaking in scope, and its development and implementation of the action plan items will set a number of new precedents -- and possibly shape future...
On October 27-28, 2009, the Ninth Antimicrobial Workshop was held in Arlington, Virginia. The American Chemistry Council (ACC) Biocides Panel, the Consumer Specialty Products Association (CSPA), and ISSA sponsored the Workshop, which was conducted in coordination with the U.S. Environmental Protection Agency (EPA) Antimicrobials Division. The Workshop included presentations on the following topics: Eco-Claims for Disinfectants and Sanitizers; Current Activities/Future Directions for the EPA...
This memorandum outlines research being sponsored, conducted, or planned by the U.S. Food and Drug Administration (FDA) regarding nanoscale materials. FDA has indicated repeatedly that it needs additional information on the characterization of such materials to make informal decisions regarding the safety of regulated products that incorporate nanotechnology.1 While those decisions are for the most part in the future, there is at least one use of nanotechnology in drug and cosmetic products...
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...
March 18, 2009
FDA Assessing Feasibility of Using Nanotechnology Test to Detect Anthrax Following a Bioterrorist Attack
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...