What's New at FDA
FDAFDA Proposed Rule Would Require Sponsors to Report Suspected Falsification of Data - February 22, 2010 The Food and Drug Administration (FDA) has issued a proposed rule that would require research sponsors to report affirmatively to the Agency any "information indicating that any person has or may have engaged in the falsification of data" in connection with FDA-regulated human or animal studies conducted by or for the sponsor "in support of applications and petitions for FDA product approvals and authorization of certain labeling claims." 75 Fed. Reg. 7412, 7413 (Feb. 19, 2010). Comments regarding the proposed rule must be submitted by May 20, 2010. For more information please contact: Jonathan M. Weinrieb First Lady Launches Childhood Obesity Initiative; President Obama Creates a Task Force on Childhood Obesity - February 11, 2010 On February 9, 2010, First Lady Michelle Obama launched Let's Move, an initiative with the ambitious goal of solving the problem of childhood obesity in a generation. On the same day, President Barack Obama signed a Presidential Memorandum creating a Task Force on Childhood Obesity. Together, these actions signal a sustained, multifaceted campaign against childhood obesity by the Obama Administration. Importantly, both Let's Move and the Presidential Memorandum clearly state that their goal is to solve the epidemic of childhood obesity within a generation, suggesting an aggressive approach. The involvement of the First Lady will likely ensure high visibility. For more information please contact: Robert A. Hahn FDA Announces Launch of PREDICT Screening System for Food Imports - February 9, 2010 The Food and Drug Administration (FDA) has announced the launch of a new electronic screening tool for food imports: Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT). PREDICT is a risk-based screening system that automatically scans hundreds of databases for information that may affect FDA's admissibility determination. For example, PREDICT will check for the following: a product's inherent risk rating (e.g., raw seafood has a higher inherent risk); whether a company (e.g., producer, shipper) or product is subject to an Import Alert; the compliance history of the relevant companies (e.g., producer, shipper, importer) and product, including recalls, inspection results, and results of field exams and sample analyses of previous entries; the admissibility history of the producer, exporter, importer, and consignee; open source intelligence about the product, producer, and foreign locale from which the product originated (e.g., extreme weather conditions such as floods or extreme heat); and anomalies in entry data. The system also looks for patterns and associations. For more information please contact: Robert A. Hahn First Lady and HHS Announce Obesity Initiative - February 1, 2010 On January 28th, First Lady Michelle Obama and the Department of Health and Human Services (HHS) announced an initiative to reduce overweight and obesity in adults and children-The Surgeon General's Vision for a Healthy and Fit Nation. Mrs. Obama, HHS Secretary Kathleen Sebelius, and Surgeon General Regina Benjamin plan to help Americans lead healthier lives through better nutrition, regular physical activity, and by encouraging communities to support healthy choices. For more information please contact: Kathryn E. Balmford Senate Bill Would Create New Nanotech Safety Program at FDA - January 28, 2010 On January 21, 2010, Senators Mark Pryor (D-AR) and Benjamin Cardin (D-MD) introduced the "Nanotechnology Safety Act of 2010" (S. 2942), a bill which would create a new nanotechnology program within the Food and Drug Administration (FDA). The bill was referred to the Senate Committee on Health, Education, Labor and Pensions. The bill would amend the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services, in consultation with the Secretary of Agriculture, to establish within FDA a program on "the health and safety implications of nanotechnology in everyday products and develop[s] best practices for companies who employ nanotechnology." Specifically, the bill calls for "a program for the scientific investigation of nanoscale materials included or intended for inclusion in FDA-regulated products, to address the potential toxicology of such materials, the effects of such materials on biological systems, and interaction of such materials with biological systems." The program would be led by a program manager and would be required to develop a detailed strategic plan. FDA would be required to report to Congress on the work of the program no later than March 1, 2012 and March 1, 2014. For more information please contact: Jonathan M. Weinrieb FDA Provides an Update on Bisphenol A - January 19, 2010 The Food and Drug Administration (FDA) has provided an update regarding its thinking about bisphenol A (BPA). BPA is a chemical used in polycarbonate plastic and in the epoxy resins used to line metal food and beverage containers. In September 2008, the National Toxicology Program (NTP) completed a review of BPA And concluded that there is "some concern" about BPA's effects on the development of the brain and prostate gland and for behavioral effects in fetuses, infants, and children at current levels of exposure to BPA. FDA now agrees with the NTP's conclusion that there is reason for "some concern" about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants, and children. According to FDA, studies using standard toxicity tests thus far support the safety of BPA at current levels of human exposure. However, recent studies using novel approaches to test for subtle effects have given FDA some concern about potential effects on the brain, behavior, and prostate gland in fetuses, infants, and young children. For more information please contact: Robert A. Hahn FDA Announces Michael Taylor Named Deputy Commissioner for Foods and Head of the Office of Food Safety - January 14, 2010 The Food and Drug Administration (FDA) has announced that Michael R. Taylor is the new Deputy Commissioner for Foods and the head of the Office of Food Safety. Mr. Taylor had been serving as senior advisor to FDA Commissioner Margaret Hamburg. He has a long career of public service, including previous jobs as FDA Deputy Commissioner for Policy and Administrator of the U.S. Department of Agriculture's Food Safety and Inspection Service. In those previous positions, he was responsible for developing and implementing the existing HACCP regulations for seafood, juice, and meat and poultry products; implementing the Nutrition Labeling and Education Act of 1990; and declaring E. coli O157:H7 an adulterant in ground beef. Taylor also has co-authored two books about reforming food safety regulation: Stronger Partnerships for Safer Food - An Agenda for Strengthening State and Local Roles in the Nation's Food Safety System, and Harnessing Knowledge to Ensure Food Safety - Opportunities to Improve the Nation's Food Safety Information Infrastructure. For more information please contact: Robert A. Hahn National Salt Reduction Initiative Announced - January 14, 2010 New York City, together with 40 other city and State governments and national health organizations, has announced the launch of the National Salt Reduction Initiative (NSRI). The NSRI is a voluntary initiative to reduce the levels of salt and sodium in both packaged foods and restaurant foods. The NSRI is a voluntary effort to persuade food manufacturers and restaurants to reduce the salt content of their products. Its goal is to reduce sodium in packaged foods and restaurant foods by 25% over 5 years, thereby reducing sodium intake in the U.S. population by 20% over the same period. The NSRI claims that a sodium reduction of this magnitude would prevent tens of thousands of premature deaths each year. For more information please contact: Robert A. Hahn Kellogg Discontinues Immunity Structure/Function Claim for Rice Krispies in Settlement with Oregon Attorney General - January 11, 2010 The Kellogg Company (Kellogg) has entered into a settlement with the Oregon Department of Justice under which the company has agreed to discontinue use of the claim "helps support your child's immunity" for breakfast cereals with added vitamins A, B, C, and E. Under the terms of the settlement, Kellogg will cease nationwide shipments of the cereals bearing the claim by January 15, destroy 2.5 million units of packaging with the claim, and cease making such claims unless the company provides the Oregon Department of Justice with advance notice and competent scientific evidence supporting the claim. In addition, Kellogg will contribute nearly 500,000 boxes of cereal bearing the claim to the Oregon Food Bank and Feeding America. The cereals involved include Rice Krispies, Cocoa Krispies, Frosted Krispies, and MultiGrain Jumbo Krispies. While Kellogg has not admitted wrongdoing under the settlement and continues to assert that the immunity claim is truthful and not misleading, a company spokesperson was reported as saying that Kellogg has no plans to make further immunity claims for its cereals. For more information please contact: Robert A. Hahn Consumer Group CSPI Issues Report Calling for Comprehensive Food Labeling Reform - December 31, 2009 The consumer group Center for Science in the Public Interest (CSPI) has issued a report entitled Food Labeling Chaos: The Case for Reform. The report offers a detailed critique of current Food and Drug Administration and U.S. Department of Agriculture's Food Safety and Inspection Service food labeling regulations and policies, as well as specific recommendations for change. According to CSPI, problems with food labels can be broken down into three categories: Improving the nutrition facts panel; improving ingredient labeling; and stopping false and misleading health-related claims. For more information please contact: Robert A. Hahn OIG Publishes Report on Industry Compliance with FDA's Food Facility Registration Requirement - December 16, 2009 The Department of Health and Human Services' Office of Inspector General (OIG) has published a report concerning industry compliance with the Food and Drug Administration's (FDA) food facility registration requirement. The OIG study was undertaken as part of its ongoing food safety work to determine the extent to which selected domestic food facilities (1) register with FDA and (2) provide complete and accurate information in their food facility registrations. For more information please contact: Kathryn E. Balmford FDA and FSIS Public Meeting on Tracing Systems for Food - December 15, 2009 The Food and Drug Administration and the U.S. Department of Agriculture, Food Safety and Inspection Service held a public meeting on product tracing systems for food on December 9-10, 2009. The agencies are also requesting public comments on product tracing systems and on the specific questions set forth in their November 3, 2009 Federal Register notice. Comments must be submitted by March 3, 2009. The public meeting concerned tracing systems for all food, including animal feed and dietary supplements. The principal emphasis was on traceability in connection with foodborne outbreaks, which was addressed on the first day of the meeting. The second day focused on specific elements/issues in product tracing. For more information please contact: David L. Durkin FDA Issues Draft Guidance Concerning Legally Formulating and Labeling Liquid Dietary Supplements Versus Beverages - December 8, 2009 The Food and Drug Administration (FDA) has issued a draft guidance entitled "Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods." While comments on guidance documents may be submitted at any time, to ensure agency consideration in development of its final guidance, comments should be submitted to FDA by February 2, 2010. The draft guidance is in response to two trends observed by FDA in the marketing of beverages: (1) the marketing of beverages as dietary supplements, despite the products being represented as conventional foods (e.g., labeled as a "beverage," "drink," "water," or "juice"), and (2) the marketing of beverages that contain novel ingredients (e.g., added botanicals or their extracts) that may be unapproved food additives. For more information please contact: Kathryn E. Balmford FDA Releases IFT Report on Food Traceability - December 8, 2009 The Food and Drug Administration (FDA) has released a report prepared by the Institute of Food Technologists (IFT) on the creation of effective product tracing systems for food. The IFT report, Traceability in Food Systems: Technical Report, was commissioned by FDA in 2008. According to FDA, the IFT report is part of the public record that FDA will consider in determining ways to improve the traceability of food products. For more information please contact: Robert A. Hahn |
