Proceedings of the LSRO Workshop: Prebiotics and the Health Benefits of Fiber: Current Regulatory Status, Future Research, and Goals
The Life Sciences Research Organization (LSRO) in Bethesda, Maryland announces the publication of the supplement, “Prebiotics and the Health Benefits of Fiber: Current Regulatory Status, Future Research, and Goals”, in the May issue of the Journal of Nutrition.
The supplement was developed from a workshop organized by LSRO that took place on the FASEB Campus, in Bethesda, MD, in February, 2011. Read the full press release.
FDA’s Emphasis on New Dietary Ingredient Notifications
The Food and Drug Administration’s (FDA’s) newly released New Dietary Ingredient (NDI) Notification Draft Guidance has stirred up a hornet’s nest of commentary, and the dietary supplement industry,
manufacturers and distributors alike, must prepare for closer FDA scrutiny. Read the full press release.
Review Article on the Effect of Specific Nutrients and Supplements on Mental Energy Published in the Journal of Nutrition
The Life Sciences Research Organization, Inc. (LSRO) has published a review article in the December 2010 issue of Nutrition Reviews entitled Do Specific Constituents and Supplements Affect Mental Energy? Review of the Evidence. Read the full press release.
Proceedings of the Conference on Equol, Soy, and Menopause Research Published in the Journal of Nutrition
The Life Sciences Research Office (LSRO) announces publication of the Equol, Soy, and Menopause Supplement in the July issue of the Journal of Nutrition. The manuscripts in the supplement are based on presentations made at the Equol, Soy, and Menopause Research Leadership Conference organized by LSRO that took place in Washington, DC, in June 2009. Read the full press release.
LSRO Issues Review on the Scientific Evidence Underlying Key US Recommendations
on Cholesterol
on Cholesterol
The Life Sciences Research Office (LSRO) has published a review article in the June 2010 issue of Nutrition Reviews that summarizes a December 2008 conference entitled Conference on Cholesterol: Where Science and Public Health Policy Intersect. Organized by LSRO and sponsored by the Egg Nutrition Center, the conference elaborated the scientific data supporting the US nutrition policy recommendations to limit dietary cholesterol and analyzed the consequences of the policy on US government-sponsored food programs, eating patterns, and health of the US population.
Read the full press release.
LSRO Publishes Monograph: "The Role of Innovations and Technology in Meeting Individual Nutrition Needs"
The Life Sciences Research Office (LSRO) announced the publication of the proceedings of the workshop, "The Role of Innovation and Technology in Meeting Individual Nutrition Needs", in the February, 2010 issue of the Journal of Nutrition. View the press release.
Defining Fiber and Whole Grains
Dr. Falk presented a talk entitled Defining Fiber and Whole Grains: The Challenges and Regulatory Implications as part of a symposium entitled Fiber: The Heart of Whole Grain at the annual meeting of the Institute of Food Technologist (IFT) in Anaheim, CA. The presentation was based on the findings from a new LSRO report that evaluated the effect of applying the U.S. Food and Drug Administration (FDA) definition of whole grains and whole grain foods on the strength of scientific evidence in support of claims for risk reduction of cardiovascular disease and diabetes. Please follow these links to view the press release or to Dr. Falk's slides for the IFT presentation.
Differentiating the Health Risks of Categories of Tobacco Products
An independent, comprehensive evaluation of the scientific literature compared the risk of use of smokeless tobacco products to smoking cigarettes, in an attempt to identify the critical characteristics that contribute to an evaluation of risk, and to determine whether there is sufficient evidence to categorize smokeless tobacco products according to risk. Click here for more information.
Whole Grain Intake, Cardiovascular Disease, and Diabetes: A Review
The Life Sciences Research Office, Inc. (LSRO) conducted an independent review of the scientific literature to evaluate how changes in the U.S. Food and Drug Administration (FDA) definition of whole grains affects claims that consumption of whole grains reduces the risk of cardiovascular disease (CVD) and diabetes. Click here for more information.
LSRO participated in a Webinar: "Strategic Initiatives Driving Consumer Demand for Omega-3 EPA/DHA Food and Supplement Products"
LSRO Executive Director, Dr. Michael Falk, addressed the issues that will be discussed in the upcoming LSRO Workshop that will assess the regulatory environment for obtaining RDI and Daily Values for the omega-3 long chain fatty acids, EPA and DHA. The webinar, sponsored by the Global Organization for EPA and DHA Omega-3, was webcasted live on March 7, 2008. For the Webinar Agenda (PDF file) click here. For more information on the upcoming Workshop on EPA and DHA click here.
LSRO Completes the Reduced Risk Review Project by Publishing the Third Report: "Exposure Assessment in the Evaluation of Potential Reduced Risk Tobacco Products"
LSRO announces the publication of the last report on the Reduced Risk Review Project (RRRP). In this report a team of independent scientists and physicians critically reviewed and identified the available exposure assessment methods for evaluating potential reduced-risk tobacco product. To read the full press release click here. For more information on the entire project and the other two reports click here.
Biological Effects Assessment in the Evaluation of Potential Reduced-Risk Tobacco Products
The LSRO announces publication of a report that details the conclusions of a team of independent scientists and physicians who critically reviewed and identified preclinical and clinical methods that can be used to examine the biological effects of Potential Reduced Risk Tobacco Products (PRRTPs). This study will be of interest to academic, government and industry researchers; tobacco control and public health organizations; agencies with regulatory oversight of tobacco products, such as the Federal Trade Commission; to individuals involved in the development of legislation providing regulatory authority over tobacco products, public health organizations and their staff; and to current smokers. Read the full press release.
Scientific Testing And Evaluation Process Developed For Potential Reduced-Risk Tobacco Products
A new study from the Life Sciences Research Office, Inc. (LSRO), Scientific Methods to Evaluate Potential Reduced-Risk Tobacco Products, outlines laboratory and clinical testing approaches for the assessment of tobacco products with the potential to reduce the risks of cigarette smoking for individuals who switch from cigarettes to these products. Read the full press release.
Seminar Series Launched to Address Technical Issues in Regulatory Risk Assessment
A recent National Academies of Science report emphasized the need to improve quality, consistency, and transparency in risk assessments performed by government agencies but criticized an Office of Management and Budget proposal aimed at addressing these needs. A new CHRA seminar series will provide a forum for a broad-based discussion of the issues related to regulatory risk assessment. Read the full press release.
LSRO Completes Review of Dietary Guidelines of Cholesterol Intake for the American Egg Board
A new study is available that discusses why various nations’ dietary guidelines differ in their treatment of food cholesterol. The study report catalogs the extensive history of cholesterol dietary guidelines, making it a unique and valuable reference. Click here to read the full press release.
Risk Analysis Expert to Speak at RAPS Meeting
Dr. Catherine St. Hilaire of LSRO has been invited to speak on the subject of Risk Analysis and Risk Management by the Baltimore/DC Regulatory Affairs Professionals Society (RAPS) at their meeting on June 22, 2006. Click here to see the full press release; click here to see the presentation slides.
LSRO AND MediRegs Reach Agreement on Referral Services
On April 10, 2006, LSRO announced that it has entered into a referral agreement with MediRegs, Inc., the leading provider of healthcare regulatory and compliance databases in the United States. Click here to see the full press release.
LSRO AND MediRegs Reach Agreement on Referral Services
On April 10, 2006, LSRO announced that it has entered into a referral agreement with MediRegs, Inc., the leading provider of healthcare regulatory and compliance databases in the United States. Click here to see the full press release.
Dr. Catherine J. Klein Receives Award
On February 13, 2006, Dr. Catherine J. Klein, a senior scientist with LSRO, received the Research Workshop Top Abstract award from the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) in Dallas, TX. The prestigious award, presented during the Rhoads Lecture and Research Awards Ceremony, marks the beginning of Clinical Nutrition Week. The award recognizes her research relating to the loss of trace elements following trauma and during continuous renal replacement therapy. Klein and three colleagues are finalizing a paper on the topic, which will be published this summer. She had received the Rhoads Research Foundation Small Grants Award from A.S.P.E.N. in 1997 to support magnesium and zinc balance studies in critically ill patients treated with continuous renal replacement therapy. Click here to see the full press release.
Dr. Michael Falk Discusses Nutrigenomics
Every day, Americans review the calorie, fat content, and other nutrients of the foods they eat in the endless warfare to control weight. But there is another consideration to what we eat -- the chemicals in foods and supplements that alter the molecular expression and structure of our individual genetic makeup. This interaction is known as "nutrigenomics," a newly emerging scientific and physiological process that examines what a person consumes via foods, nutrients supplements and pharmaceuticals, and the impact it has on the individual directly and through their personal genome. At this time, there is little research on how nutrients and other micro-molecules impact a person's genes. The study of nutrigenomics is the first giant step in filling this void. The evolution of this science is the subject of presentations being offered by two highly regarded scientists: Dr. Michael Falk, of LSRO, and Dr. Frederic Abramson, President and Chief Executive Officer, AlphaGenics, Rockville, MD. They will be discussing the interaction between diet and DNA at a BioAlliance Network event entitled, "What You Eat Can't Kill You, But…Your DNA Won't Save You." The event is being held at the Tech Council of Maryland, a division of the Maryland Department of Business and Economic Development, on January 26, 2005, from 7:30-9:30 AM. Click here to see the full press release.
New Ways To Help Soldiers in Combat: Assessing Promising Technologies
The New England Journal of Medicine has reported that the US military’s on-the-ground surgical strategy is aimed at “damage control, not definitive repair, unless it can be done quickly.” Part of the strategy is due to today’s mobile medical teams, which are equipped with powerful and efficient tools that can treat extensive injuries that result from mortar attacks and suicide bombers near the battlefront. Despite the change in strategy and improvements in care, hemorrhaging (blood loss) – caused by bullets and exploding munitions fragments – is a major cause of death in combat. With thousands of lives at stake, two branches of the military have joined forces to find a better way to assess new products that can reduce blood loss. Our report provides recommendations to the military as to how they can best identify, nurture and support the next generation of resuscitation fluids and adjunct therapies.
Please click here to see the full press release or our executive summary of the study.
Are Dental Fillings Safe?
Despite its long history of use, dental fillings (or "amalgam") have stirred controversy because of their mercury content. For nearly a century concerns have been raised about the adverse effects that may arise from the inhalation and absorption of mercury vapor after amalgam is placed in the mouth. Our expert panelists and in-house researchers conducted an in-depth investigation into the safety of dental amalgam considering some 950 scientific and medical studies published during the last decade. Are mercury fillings safe? Click here to find out.
Can Eating Walnuts Reduce the Risk of Heart Disease?
Our findings, published in the Journal of Nutrition, evaluated the evidence substantiating the health claim that eating nuts – especially walnuts – reduce and prevent coronary heart disease (CHD). We found that, using the FDA guidance for determining that a dietary benefit is related to reducing a common disease, in adults that this nut is good for the heart. Click here to read more.
Can Risks to Smokers Be Measured?
Can the toxicological effects for smokers be measured? Our reports conclude that they can. In this study we evaluated how best to determine the potential risk of non-tobacco additives for cigarette smokers. The report, entitled The LSRO Report on Review of Ingredients Added to Cigarettes consists of two volumes: Phase One: The Feasibility of Testing Ingredients Added To Cigarettes and Phase Two:Scinetific Criteria for the Evaluation of Ingredients Added to Cigarettes. In Phase One the methods of producing cigarettes and current methodologies for evaluating the risks of cigarette smoking were investigated. Phase Two focused on the development of an approach to testing ingredients to determine whether an ingredient changes the adverse human health effects of smoking. Click here to learn more, read the full press releases, or download a copy of the executive summaries .
Postmarket Surveillance of Dietary Supplements
Protecting the health of those who consume dietary supplements is of great importance to the public, responsible manufacturers and government regulators. We concluded that an effective postmarket surveillance program for dietary supplements could enhance the likelihood that true adverse effects, unknown at the time of marketing, are identified. We included specific, detailed advice concerning the required components of such a system and provide a framework for building a postmarket surveillance system that can be implemented by the individual dietary supplement manufacturers and the industry as a whole. Click here to read the full press release or download a copy of the executive summary.
Will There Be Fewer Scientists In the Coming Years?
Will there be enough scientists in the coming years? This investigation examined the demographic trends that would be required to supply the number of scientists required and the demand for these scientists in certain areas in the coming years. Please read the executive summary for more information.