Axia3 launches Axia3 ProDigestive antacid
LOS ANGELES — Axia3 on Thursday announced the launch of its Axia3 ProDigestive antacid as a new dietary supplement that delivers relief from occasional heartburn, with a proprietary blend of potent ProDigestive enzymes to help promote healthy digestion.
"Heartburn and other digestive discomforts such as indigestion, sour stomach and bloating afflict millions of people each year," Axia3 CEO Ryan Doheny said. "In fact, more than 100 million people in the U.S. each year suffer from heartburn."
Axia3’s ProDigestive formula works by actively helping to break down protein, carbohydrates and essential fats and oils, the company stated. Axia3 currently has distribution through CVS/pharmacy, Whole Foods and Bartell Drugs at a suggested retail price of $2.99. The product is available in a number of formats including a 1.5-oz. recloseable tin of chewable minty tablets, an on-the-go roll of 12 tablets and a 45-count box of tablets.
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.