The U.S. Food and Drug Administration (FDA) released on August 17, 2011, a document entitled Advancing Regulatory Science at FDA: A Strategic Plan. FDA states that its core responsibility is to protect consumers by applying the best possible science to its regulatory activities. FDA notes that rapid advances in innovative science have provided new technologies to discover, manufacture, and assess novel medical products, and to improve food safety and quality. To keep pace with and use...
Category: FDA
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...
The U.S. Environmental Protection Agency (EPA) is currently scheduled to publish on July 26, 2011, an advance notice of proposed rulemaking (ANPR) concerning testing of bisphenol A (BPA). EPA will request comments on requiring toxicity testing to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations. EPA will also seek comments on requiring environmental testing consisting of sampling and monitoring for BPA...
The June 27, 2011, issue of BNA Daily Environment Report quotes Lynn L. Bergeson regarding the Food and Drug Administration's (FDA) response to the International Center for Technology Assessment's (ICTA) petition concerning nanoscale ingredients in sunscreen.
June 17, 2011
FDA Takes Action to Update Sunscreen Testing and Labeling and States Nanoscale Ingredients Are Not Absorbed
On June 14, 2011, the U.S. Food and Drug Administration (FDA) took long-awaited action to update regulations for testing and labeling over-the-counter (OTC) sunscreen products. The Agency emphasized that the primary intent of its initiative was to establish a consistent standard for testing and labeling sunscreen products to reduce consumer confusion and encourage proper use of these products to enhance their protective function. The most significant elements of FDA's action include changes in...
June 10, 2011
FDA Issues Draft Guidance on Nanotechnology: Agency Will Accept Public Comment for 60 Days
On June 9, 2011, the Food and Drug Administration (FDA or the Agency) posted on its home page a Draft Guidance on Considering Whether an FDA-Regulated Product Involves Application of Nanotechnology. The Agency states that this document is the first step in providing regulatory clarity about the use of nanomaterials in FDA-regulated products and other more product-specific guidance documents are likely to follow. Specifically, the Draft Guidance is "intended to help industry and others identify...
June 9, 2011
White House ETIPC Releases Policy Principles Concerning Regulation and Oversight of Nanotechnology and Nanomaterials
On June 9, 2011, the Office of Science and Technology Policy (OSTP) announced that the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles specific to the regulation and oversight of applications of nanotechnology. The principles are intended to guide the development and implementation of policies, as described in the title "U.S. Decision-making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials" that occur at...
Two of the trade associations named as negotiators by the U.S. Food and Drug Administration (FDA) regarding its proposal for the imposition of generic drug user fees have filed comments regarding the proposal that may frame their negotiating posture with the Agency going forward. The Society of Chemical Manufacturers and Affiliates' (SOCMA) Bulk Pharmaceutical Task Force and the European Chemical Industry Council's (CEFIC) Fine Chemicals Group urged FDA to impose a registration fee on each...
March 28, 2011
FDA to Hold Food Advisory Committee Meeting on Possible Link between Food Dyes and ADHD in Children
On March 30 and 31, 2011, the Center for Food Safety and Applied Nutrition (CFSAN) of the U.S. Food and Drug Administration (FDA) will hold a Food Advisory Committee meeting on the possible link between synthetic dyes in food products and behavioral issues in children, such as attention deficit hyperactivity disorder (ADHD). Members of the Food Advisory Committee have been charged to "consider available relevant data on the possible association between consumption of certified color...
March 24, 2011
Jayne Bultena Joins Bergeson & Campbell, P.C. and Brings Valuable Experience to Its FDA Practice
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Jayne Bultena has joined B&C as Of Counsel. Ms. Bultena brings a distinguished background on a wide range of matters arising under the Federal Food, Drug, and Cosmetic Act. She has represented Fortune 100 companies, start-ups, and venture capital investors on several issues, including developing and implementing...