News
New JAMA Study Raises Research QuestionsWASHINGTON, D.C.— A study published in the December 5 issue of the Journal of the American Medical Association (JAMA aised important philosophical issues regarding nutrient research and demonstrated the confusion when new research contradicts earlier work.“The scientific community—from scientists to journalists to consumers—wants conclusive answers, consequently we’re always looking at what the ‘study du jour’ tells us and trying to make it answer all questions,” said Andrew Shao, Ph.D., vice president, scientific and regulatory affairs, Council for Responsible Nutrition. “But the reality is that science doesn’t always move forward—there is some back and forth—and while research may seem to contradict itself, that should not be interpreted to mean one type of study trumps another, particularly when different studies ask and answer different questions.” The JAMA review set out to evaluate the change over time in the quantity and content of citations for two observational studies. One concerned the major cardiovascular benefits associated with vitamin E supplementation. The other examined the protective effects of beta-carotene on cancer and estrogen on Alzheimer’s disease. Subsequent articles citing the studies were analyzed. The researchers gathered and reviewed 172 articles on vitamin E and cardiovascular health, 16 articles on beta-carotene and cancer prevention and 47 articles on estrogen for dementia prevention, rating them as favorable, equivocal and unfavorable. The sampled articles were published in 1997, 2001 and 2005 (before, early and late after publication of refuting RCTs) related to vitamin E and cardiovascular health and in 2006, which referenced highly cited articles proposing benefits associated with beta-carotene and cancer. Pertaining to vitamin E the researchers found that, despite the large RCTs that received a great deal of media attention, more than half of the articles that cited the observational studies were favorable towards a beneficial effect of supplemental vitamin E. The study authors write, “Even among articles that cited the contradicting HOPE [RCT] trial, rather than the positive epidemiological studies, the majority in 2005 still could not conclude that vitamin E was ineffective.” “This suggests that researchers interpret research differently, depending on their bias and expertise,” said Shao. “For pure scientific purposes, here’s a valid hypothesis to test: conduct a trial on secondary prevention in heart patients with a lifetime of bad habits that likely contributed to their heart disease to determine if a nutrient might provide some benefit. But it’s not valid to conclude from the results of that study that the nutrient doesn’t work. We can’t expect a simple vitamin supplement to reverse heart disease. So if that doesn’t happen, we must interpret the results appropriately by placing the study in the proper context and acknowledge that the results don’t answer the question of whether supplemental amounts of vitamin E in a healthy population could have prevented heart disease had it been used consistently over time in combination with other antioxidants.” The findings from the JAMA literature review related to beta-carotene and cancer and estrogen and dementia were similar, with the researchers finding that more than 62% of the articles in each of the subsets were favorable. “The RCTs with negative results attempted to answer the question, ‘can a supplemental nutrient treat or reverse a disease or a lifetime of unhealthy habits in patients who are also taking prescription medications?’” said Shao. “The observational studies with positive results attempted to answer the question, ‘if we start with a mostly healthy population generally free of disease, can we identify various diet/nutrient and lifestyle factors that make them more or less prone to disease?’ These are very different questions, making the studies incompatible for direct comparison and demonstrating that one type of study can’t necessarily be used to refute the other. We firmly believe that RCTs should not be thought of as the only rigorous research approach. As the study authors point out, ‘when randomized and observational studies disagree, it is incorrect to assume that nonrandomized studies are always wrong.’ Rather, we should put studies into the appropriate context and evaluate the total body of evidence, which includes RCTs and observational studies, and other types of research. We hope that the publication of this analysis will encourage all of those within the scientific community to become more involved in this discussion.” |
| published date: 12-04-2007 |
FDA Encouraged to Review EPA and DHA Omega-3 ScienceSALT LAKE CITY, UT --In response to the US Food and Drug Administration’s (FDA) notice of proposed rulemaking prohibiting nutrient content claims on products with EPA and DHA omega-3 fatty acids, the Global Organization for EPA and DHA Omega-3s (GOED) has urged the FDA and/or the Institute of Medicine to review the clinical science on omega-3s and make an authoritative statement on a recommended intake for EPA and DHA.The FDA’s proposed rule would ban nutrient content claims for products containing EPA and DHA on the basis that the IOM has made no authoritative statement that identifies a daily required or recommended nutrient level for EPA and DHA. The proposed rule was published in the November 27 2007 Federal Register (pages 66103 to 66118). “Rather than prohibiting nutrient content claims on EPA and DHA because an old review of the science set no daily requirement, we believe there should be a proper examination of the current clinical science to set a level for EPA and DHA as vital nutrients for chronic disease prevention and nutrient deficiencies,” said Adam Ismail, GOED executive director. The last review by the IOM of clinical science on EPA and DHA for the establishment of dietary reference intakes cited clinical studies and reviews through 2001. According to GOED, the PubMed database has 260 randomized, controlled clinical trials on humans and 347 reviews and meta-analyses published since 2002 that have not been assessed as part of the body of evidence for establishing a reference intake for EPA and DHA. The IOM has only considered scientific findings related to nutrient deficiencies in the general population with regard to omega-3 fatty acids; however, GOED believes the FDA should consider an approach more akin to nutrient content claims on macronutrients like fiber, where chronic disease prevention was a criterion in establishing nutrient content claims rather than just nutrient deficiencies. EPA and DHA are believed by many medical specialists to play a major role in preventing cardiovascular disease, one of the leading causes of death in the US, and a growing body of evidence indicates they may help in preventing many other chronic diseases. By allowing credible information to appear on products, the FDA will contribute to the education of consumers in making healthy dietary choices. “The market for EPA and DHA omega-3 products is very dynamic in the US, and in this case we believe the regulatory environment needs to catch up to the market,” added Ismail. According to the Nutrition Business Journal, the US market for dietary supplements with EPA and DHA has grown from $100 million in 2001 to $489 million in 2006, while Packaged Facts estimates the US market for food products fortified with EPA and DHA has grown from nothing in 2001 to $600 million in 2006. This means the industry has gone from being a small emerging industry when the science was last reviewed, to exceeding $1 billion in sales today. GOED strongly believes the best path forward, and to allow consumers to make the informed choices intended under NLEA, is for the FDA and/or the IOM make a determination about the required levels of these two vital nutrients for consumers to help prevent chronic diseases. “We believe the time is right to re-examine the science, given the growth in consumers’ and health professionals’ interest in omega-3s and the FDA’s recent request for comment on adding new nutrients to the Nutrition Facts panel,” added Ismail, “and in fact GOED has engaged the Life Sciences Research Office to hold a workshop in early 2008 that will explore the issues related to developing a recommended daily intake for EPA and DHA as a means of furthering discourse on the topic.” For more information, contact Lindsay Wright at 801/746-1413 or visit www.goedomega3.com. |
| published date: 11-29-2007 |
Natraceutical Group Acquires Viscofiber from Cevena Bioproducts Inc.EDMONTON, ALBERTA – Natraceutical Group, a biotech multinational holding company based in Europe, has agreed to purchase the assets and operations of Cevena Bioproducts Inc. Natraceutical Canada will manufacture and distribute Viscofiber, Cevena’s high-viscosity and high-concentration oat beta-glucan soluble fiber. Natraceutical Canada Inc. is a wholly owned subsidiary of Natraceutical Group. The team that manufactured and marketed Viscofiber at Cevena will remain in place at Natraceutical Canada.Beta-glucan is a natural grain-based soluble fiber mainly from oat and barley. The viscosity of beta-glucan is believed to be extremely important for its physiological efficacy. Today Viscofiber is the only viscous and high concentration beta-glucan commercially available in a multi-functional ingredient. Dietary fiber is collectively acknowledged to be one of the key factors in a health promoting diet as the link between intake of dietary fiber and the reduced risk of many diseases is established in several studies. With an enhanced concentration of soluble fiber – up to 12 times more than oat bran – Viscofiber offers a new solution for heart healthy consumers. In fact, Viscofiber® delivers a multitude of health benefits, including improved cholesterol, improved glycemic response, glucose management and increased satiety for weight loss formulations. “The need to incorporate fiber into our diets has never been higher,” said Mr. José Vicente Pons Andreu, CEO of Natraceutical Group. “Food manufacturers are scrambling to respond consumer demand for healthier, minimally processed food products. Viscofiber’s high concentration and superior viscosity is ideal for dietary supplement manufacturers, while its great flexibility in product formulations is appropriate for functional food products. The ingredient can be incorporated into breads, drinks, nutritional bars, yogurts, ice cream, soups, pasta and breakfast cereals. According to Andreu, Viscofiber also offers great potential for introduction in the beauty and pet food sectors. After the launch of soluble cocoa fiber last year, the purchase of Viscofiber® is a further step for Natraceutical Group to lead the global functional food sector by developing and manufacturing healthy ingredients and services to help their customers to achieve optimal performance in the market-place. For more information, visit www.natraceuticalgroup.com |
| published date: 11-16-2007 |
Three out of Four Physicians, Nurses Take And Recommend SupplementsWASHINGTON, D.C.— The “Life…supplemented” Healthcare Professionals (HCP) Impact Study found that 79% of physicians and 82% of nurses recommend dietary supplements to their patients. The study also showed that 72% of physicians and 89% of nurses personally use vitamin, mineral, herbal and other supplements either regularly, occasionally or seasonally. In comparison, 68% of adults regularly take nutritional or dietary supplements.The 2007 “Life…supplemented” HCP Impact Study on dietary supplements was designed to evaluate the personal attitudes and use of dietary supplements by physicians and nurses and to determine if those factors impact whether they recommend supplements for their patients. The study was sponsored by the “Life…supplemented” consumer wellness campaign, which is managed by the Council for Responsible Nutrition (CRN). “This survey, which is a first for our industry, shows that healthcare professionals believe that dietary supplements are part of a healthy lifestyle,” said Steve Mister, president and CEO, CRN. “Not only are they taking supplements for their own benefit, but they’re also recommending them to their patients. The approval of our products from reputable, respectable healthcare professionals, such as doctors and nurses, should be encouraging to consumers who already incorporate supplements into their wellness routine, and a wake-up call to those who haven’t yet started to do so.” Of the 72% of physicians who use supplements, 85% also recommend them to their patients. Of the 28% of physicians who do not use supplements, three out of five (62%) still recommend them. “It is common sense that physicians who personally take supplements also recommend them to their patients,” said Donnica Moore, M.D., president of the Sapphire Women’s Health Group and a member of the study’s physician advisor team. “It’s interesting that the majority of physicians who don’t use supplements still recognize their patients may benefit from them. Although the study doesn’t provide an explanation, it may simply be that physicians recommend supplements to their patients for specific conditions that don’t apply to the physician’s own personal health.” The number of physicians recommending dietary supplements to their patients is highest among obstetrician/gynecologists (OB/GYNs) (91%), followed by primary care physicians (84%). In addition, the study shows that almost three quarters of physicians (72%) and more than three quarters of nurses (88%) say it is a good idea for patients to take a multivitamin. The study found that almost half of physicians and nurses who take supplements most often do so for “overall health/wellness benefits,” while 41% of physicians and 62% of nurses who recommend supplements most often do so for the same reasons. Primary care physicians, OB/GYNs and nurses recommend supplements as often for “general well-being/prevention” as they do for special conditions, while other specialists recommend supplements more often for special conditions. According to Dr. Moore, “It makes sense to me that OB/GYNs are the group most likely to recommend supplements, although I am concerned that not all OB/GYNs reported they recommend them for their prenatal patients, given that women’s health—especially prenatal—is one arena where the data supporting supplement use is overwhelmingly positive.” Among the physicians surveyed, 51% use dietary supplements regularly, 19% use them occasionally and two% use them seasonally. Among nurses, 59% use them regularly, 27% use them occasionally and 3% use them seasonally. "Given the current state of the science, it is not surprising that increasing numbers of healthcare professionals are incorporating dietary supplements into their personal health routines. However, the fact that only 25% of physicians actively counsel patients regarding their dietary supplement use demonstrates an on-going and concerning problem that requires more outreach and education,” said Tieraona Low Dog, M.D, director of education, Program in Integrative Medicine, and clinical assistant professor, Department of Medicine, University of Arizona Health Sciences. Paula Gardiner, M.D., an assistant professor at Boston University Medical Center, who has conducted several surveys on the use of dietary supplements by physicians and is a member of the study’s physician advisor team, cites the need for additional research, saying: “It is critical to better understand how healthcare professionals recommend dietary supplements to their patients and how we can support educational initiatives to encourage dialogue between HCPs and their patients about the proper use of dietary supplements.” Almost three quarters of physicians (72%) and even more nurses (87%) reported they personally ask their patients about their use of dietary supplements. Also, 40% of physicians and 43% of nurses report that when discussing supplements with their patients, they, not their patients, are the ones who bring up the subject most often. Only 13% of physicians and one% of nurses agreed with the statement that “no one in my practice inquires about which dietary supplements patients are taking.” “Our industry needs to continue this type of research,” said Judy Blatman, vice president, communications, CRN. “It’s important that we use this as benchmark data, continuing to do these types of surveys to see what trends develop in the upcoming years. But in order to do that, we need more companies to step up and support the ‘Life…supplemented’ program. Healthcare professionals are an important audience for our industry and for our consumers and we must continue to be proactive in this area.” For more information, visit www.lifesupplemented.org. |
| published date: 11-16-2007 |
Acrylamide-Free Biscuits Launched in GermanyDELFT, THE NETHERLANDS—German consumers will soon be the first in Europe to be able to buy low acrylamide baked goods, according to DSM Food Specialities. A German manufacturer of Speculatius Christmas biscuits will launch the biscuits in October in time for the Christmas.The biscuits incorporate PreventASe, an enzyme that reduces acrylamide in food by up to 90% through the asparaginase process. The enzyme converts asparagine, one of the precursors of acrylamide, into asparatate, a naturally occurring amino acid. As a result, asparagine is not available for the chemical reaction that forms acrylamide when carbohydrate-containing foods, such as bread, cake, cookies, potato chips and cereals are heated. “Our enzyme has been available for a couple of months for food manufacturers and we see that actual uptake is picking up now”, said Judith Heikoop from DSM Food Specialties. “The launch in Germany is indeed a breakthrough. It is the first time that asparaginase is being applied commercially, anywhere in the world”. Frito-Lay and Procter & Gamble recently announced that they have reached agreements with DSM Food Specialities on the Intellectual Property rights to apply asparaginase in food products. Various institutions have identified asparaginase as a way to reduce acrylamide in food products. The list includes the CIAA (Acrylamide Toolbox of 29 September 2006), and the joint FAO/WAO Codex Alimentarius Commission on contaminants in Foods. In the United States, PreventASe was granted GRAS status by the FDA. In France, the enzyme’s dossier approval by the French food health safety agency (AFSSA) means the enzyme can be applied as a processing aid. France and Denmark are the only countries in the EU where such approval is needed. DSM has filed for approval in Denmark and expects a positive decision soon. For more information, visit www.dsmfoodspecialities.com |
| published date: 08-31-2007 |
Dr Edouard Brochu, A Probiotics PioneerMONTREAL –Edouard Brochu, a pioneer in probiotics and cofounder of Institut Rosell, passed away on July 25, 2007, at the age of 96.An agronomist and microbiologist born in Saint-Isidore-de-Dorchester, Quebec, Dr. Brochu dedicated his career to the development of lactic acid and probiotic bacteria, and the investigation of their health benefits. Emeritus professor for over 36 years, he taught at the Oka Agricultural Institute, the Université de Montreal, and later at Saint-Hyacinthe’s Agricultural Technology Institute. During his career, Edouard Brochu received numerous honours and distinctions, among others: Commandeur of the Ordre du Mérite Agronomique, and the Chevalier de l’Ordre National, Quebec’s highest honor.As an additional and fitting recognition of his long and brilliant career dedicated to the development and the advancement of scientific knowledge on probiotics, he received a doctorate honoris causa from Laval University. His exemplary career development, his expertise in microbiology, his numerous scientific contributions as well as his sustained commitment towards the promotion of nutrition and health gained Professor Brochu respect from his peers and recognition beyond the boundaries of Canada. In 1932, Edouard Brochu co-founded the Institut Rosell, an enterprise initially dedicated to research in lactic bacteria. Since then he never stopped devoting time and energy to the Institute, acting as its President or General Manager between 1944 and 1988. True to his reputation of exemplary commitment and perseverance, he continued to take an active part in its development after his partial retirement until his ‘full’ retirement in 2002, and even then later to follow its evolution and share his valuable experience and knowledge with his successors. The business he co-founded and nurtured, Institut Rosell, is today the Human Health and Nutrition Division of Lallemand, which has established a global reputation with active customers on all 5 continents for its probiotics and other health and nutritional yeasts and bacteria related ingredients . Dr Brochu was a remarkable man, a highly regarded scientist, a very ‘human’ businessman, teacher and mentor who has dedicated his entire professional life to the advancement of knowledge in lactic acid bacteria and particularly their use as probiotics. His insatiable curiosity, his relentless work, his perseverance, his willingness to listen and help all who called on him, his humanity, and his vision have inspired and will continue to inspire all those who have had the good fortune to have worked with him. Lallemand is immensely grateful for his contribution. |
| published date: 08-08-2007 |
FDA Issues Good Manufacturing Practices for SupplementsFDA will issue a final rule next week in the Federal Register that describes official good manufacturing practices (GMPs) for dietary supplements.The rule is intended to ensure the quality of dietary supplements and prevent them from containing contaminated, impure, or adulterated materials. The GMPs set requirements for creating quality control procedures, designing and manufacturing plants, and identity testing of both individual ingredients and finished products. The rule also imposes procedures for recordkeeping and handling consumer complaints. “The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” Robert Brackett, PhD, director of FDA’s Center for Food Safety and Applied Nutrition, said on June 22. Large companies with at least 500 employees have until June 2008 to comply with the new GMPs, while smaller companies with fewer than 500 employees will need to meet the requirements by June 2009. The GMPs will go into effect for companies with fewer than 20 employees in June 2010. Under the final GMPs, manufacturers may use a certificate of analysis for specifications other than the identity of dietary ingredients, but they must monitor in-process controls and store batch production records. Manufacturers must maintain records for at least one year beyond a product’s shelf life or expiration date when such dates are used, or for at least two years beyond the date of distribution of the last batch of supplements associated with those records. FDA will also issue a second interim rule that describes a process that manufacturers can use to request an exemption from some ingredient testing. Under the interim rule, only manufacturers that provide documentation that reduced frequency of testing would still ensure the identity of dietary ingredients would receive the exemption. FDA opened a 90-day comment period on the interim rule and will accept comments until September 24. Several dietary supplement trade associations expressed optimism about the rules but said it will take days or weeks to read through the 815-page document. “It is too soon to know how well FDA incorporated the comments submitted by industry to the 2003 proposed rule, or to completely understand the economic implications of the final rule,” said Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD). “I encourage all AHPA members to review the rule promptly and to communicate your thoughts to me at your earliest opportunity.” “We applaud FDA for bringing closure to this long, arduous process,” said Steve Mister, CEO of the Council for Responsible Nutrition (Washington, DC). “We are now eager to dive into the details of this important regulation to determine both its appropriateness for our industry and to determine how companies can best implement it.” FDA was authorized to establish the GMPs under the Dietary Supplement Health and Education Act of 1994 (DSHEA). To read the GMPs, click here. |
| published date: 06-22-2007 |
NIH-Supported Researchers Launch Nationwide Omega-3 TrialBETHESDA,MD--Researchers supported by the National Institute on Aging (NIA), part of the National Institutes of Health, will conduct a nationwide clinical trial to invesigate whether omega-3 fatty acids slows Alzeimer's disease.The study will be conducted by the Alzheimer’s Disease Cooperative Study (ADCS), a consortium of leading researchers supported by NIA and coordinated by the University of California, San Diego. The trial will take place at 51 sites across the United States and seeks 400 participants age 50 and older who have mild to moderate Alzheimer’s disease. Joseph Quinn, M.D., associate professor of neurology at Oregon Health and Science University, will direct the study. Researchers will be evaluating primarily whether the omega-3 fatty acid DHA (docosahexaenoic acid), taken over many months, slows the progression of both cognitive and functional decline in people with mild to moderate Alzheimer’s. During the 18-month clinical trial, investigators will measure the progress of the disease using standard tests for functional and cognitive change. The trial will use DHA donated by Martek Biosciences Corporation (Columbia, MD). Participants will receive either two grams of DHA per day or an inactive placebo pill. About 60 percent of participants will receive DHA, and 40 percent will get the placebo. Doctors and nurses at the 51 research clinic sites will monitor the participants in regular visits throughout the trial. To ensure unbiased results, neither the researchers conducting the trial nor the participants will know who is getting DHA and who is getting the placebo. “The evidence to date in observational and animal studies on omega-3 fatty acids and Alzheimer’s disease warrants further evaluation in a rigorous clinical trial,” says NIA Director Richard J. Hodes, M.D. “This study is one of a number we are undertaking in the next few years through the ADCS to test compounds that might play a role in preventing or delaying the symptoms of this devastating disease.” “By participating in this study, volunteers will make an invaluable contribution to Alzheimer’s disease research progress,” says Quinn, the study’s principal investigator. “We are indebted to those who graciously volunteer to participate in clinical studies.” In addition to monitoring disease progression through cognitive tests, researchers will also evaluate whether taking DHA supplements has a positive effect on physical and biological markers of Alzheimer’s, such as brain atrophy and proteins in blood and spinal fluid. To learn how to participate in the study, contact NIA’s Alzheimer’s Disease Education and Referral (ADEAR) Center at 1-800-438-4380 or by email to adear@nia.nih.gov. To view a list of the research sites, visit www.nia.nih.gov/Alzeimers. NIA leads the federal effort supporting and conducting research on aging and the medical, social and behavioral issues of older people, including Alzheimer's disease and age-related cognitive decline. For information on dementia and aging, please visit the NIA's ADEAR Center at www.nia.nih.gov/alzheimers, or call 1-800-438-4380. For more general information on research and aging, go to www.nia.nih.gov. The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit For more information, visit www.nih.gov. |
| published date: 06-06-2007 |