U.S. marshals seize supplements marketed as drugs
HILLSBORO, Wis. — At the request of the Food and Drug Administration, U.S. marshals on Thursday seized all dietary supplements manufactured by Syntec because of false claims made about the safety and effectiveness of their supplements in treating a number of diseases.
The products manufactured by Syntec are not FDA-approved and a complaint filed in the U.S. District Court for the Western District of Wisconsin alleged that several of Syntec’s products are unapproved new drugs that may not be introduced into interstate commerce and are misbranded in violation of the federal Food, Drug and Cosmetic Act.
"Marketing new drug products without FDA review or approval is dangerous because the products may cause consumers to delay or avoid legitimate treatments," FDA associate commissioner for regulatory affairs Dara Corrigan said. "The FDA is committed to protecting consumers from unapproved new drugs."
The company’s dietary supplements are sold under several brand names, including SynBio, SynOPC, BoneCare, SynBio-X, SynOPC-X, VisionCare, CardioCare, SynGevity, SynVita, SynCell, SynPhyto-K, DigestiveCare, JointCare and SynOmega.
The government alleged that the company claimed in videos and promotional materials that some of its products could be used to prevent, treat or cure such diseases as asthma, cardiovascular disease, cataracts, glaucoma and infections.
According to the complaint, the company also failed to follow the current good manufacturing practice requirements for dietary supplements, as required by federal law.
The FDA sent the company a warning letter regarding the disease claims in March 2009. During inspections in October and November 2010, June 2011 and September 2011, FDA investigators documented serious current good manufacturing practices (cGMP) violations, in addition to the company’s continued use of disease claims for some of its products.
Schiff names three members to scientific advisory board
SALT LAKE CITY — Schiff Nutrition on Thursday named three new members to its recently established scientific advisory board: Dale Bredesen, Michael Fischbach and Charles Serhan.
"These three additions strengthen and diversify the expertise from which to draw as we pursue new product development," stated Tarang Amin, Schiff president and CEO. "We look forward to the guidance of Dr. Bredesen in aging and age-associated diseases, Dr. Fischbach in probiotics and Dr. Serhan in inflammation. This is all complemented by Dr. Carmona’s background as one of the world’s leading experts in public health.”
Richard Carmona, 17th surgeon general of the United States, currently serves as chair of the scientific advisory board.
Bredesen is professor and president of the Buck Institute for Age Research, an independent research institute focused on aging and age-associated disease and adjunct professor of the Department of Neurology at University of California – San Francisco. Bredesen is a member of the National Advisory Council on Aging, the Society for Neuroscience, and the American Society for Biochemistry and Molecular Biology. He has co-authored more than 180 scientific papers and three books. He received his undergraduate degree from Caltech and his M.D. from Duke University School of Medicine.
Fischbach is an assistant professor in the Department of Bioengineering and Therapeutic Sciences at UCSF and a member of the California Institute of Quantitative Biosciences. Fischbach is a recipient of the NIH Director’s New Innovator Award, a Fellowship for Science and Engineering from the David and Lucille Packard Foundation, a Medical Research award from the W.M. Keck Foundation and the Young Investigator Grant for Probiotics Research from the Global Probiotics Council. Fischbach worked at Harvard University and spent two years as an independent fellow at Massachusetts General Hospital. Fischbach received his Ph.D. in chemistry from Harvard University.
Serhan is the Simon Gelman Professor of Anaesthesia (Biochemistry and Molecular Pharmacology) at Harvard Medical School, a professor in the Department of Oral Medicine, Infection and Immunity at Harvard School of Dental Medicine and an affiliate faculty member of MIT. Serhan was appointed to the Harvard Faculty in 1986 and has served as senior biochemist in medicine at Brigham and Women’s Hospital since 1992. An author of 346 publications, he has received a number of awards and honors, including a MERIT Award from the National Institute of General Medical Sciences and an honorary degree from Harvard University. Serhan received degrees in biochemistry from Stony Brook University, experimental pathology and medical sciences at the New York University School of Medicine, as well as post-doctoral training in physiological chemistry at the Karolinska Institute Medical University in Stockholm, Sweden.
Meta-analysis: Liquid cinnamon extract helps control blood-sugar levels
TUSTIN, Calif. — A new meta-analysis released Wednesday of eight clinical trials examining the effect of cinnamon consumption in people with Type 2 diabetes and/or prediabetes concluded cinnamon extract and/or cinnamon helps lower blood-glucose levels. The analysis was published in the Journal of Medicinal Foods.
When isolating those studies using only cinnamon extract, researchers found that "a significant overall effect on blood-glucose levels" was retained. "Consuming cinnamon, especially cinnamon extract, does produce a modest but statistically significant lowering in fasting blood glucose," said Paul Davis of the Department of Nutrition, University of California. "Using water extracts of cinnamon achieves the desired blood glucose effects while avoiding the nonpolar constituents in whole cinnamon or the cinnamon flavor components that have been linked to deleterious effects (e.g., oral lesions and mutagenicity)," he added.
Aqueous cinnamon extraction, which uses only cinnamon, water, heat and pressure, creates concentrated levels of specific procyanidins believed to be the active ingredients in promoting healthy glucose levels.