NPA testifies against illegal steroids
NEW YORK Here’s the breakdown: Two government officials representing the Food and Drug Administration and the Drug Enforcement Agency joined Travis Tygart of the U.S. Anti-Doping Agency (the body responsible for keeping performance-enhancing drugs out of U.S. Olympic athletes), Daniel Fabricant of the Natural Products Association and Richard Kingham, a litigator specialized in food/drug law, before a panel of senators — less to inform the Senate around the problem of steroids sold as dietary supplements, and more to be grilled by those senators as to why those products are actually on any market.
The senators were Sens. Orrin Hatch, R-Utah, and Arlen Specter, D-Pa., who played a sort of good cop/bad cop routine. Hatch was the good cop, at least as the dietary supplement industry goes, as he defended the legislation governing the regulation of dietary supplements that he helped draft some 15 years ago. Specter played the bad cop — questioning the regulatory priorities of the two governing bodies present, while raising the thought of adding more regulations to the FDA and/or DEA already-underutilized toolbox.
Following the hearing, dietary supplements emerged as the unwilling participants in all of this talk around performance enhancing supplements. You almost had to wonder why Fabricant was present, except to politely remind everyone that the dietary supplement manufacturers who actually distribute product through mass-channel retailers actually fought for (as in not against) such additional regulations as certified good manufacturing practices or mandated serious adverse event reports, and as such are not likely to field illegal products.
At stake in all of this is whether or not legitimate dietary supplement players ought to seek premarket approval, a condition that if ever really implemented, would decimate any future innovation in the almost $6 billion mass-channel business (according to the latest Nielsen Company figures). It’s also a condition that wouldn’t actually do much to pull those steroid drugs masquerading as supplements off the market, unless you expect those well-respected criminals to actually file an NSA (new supplement application) that contained ingredients that would not only land their consumers in the hospital, but would also land them in jail if ever actually discovered in the trunks of their cars.
The alternative, proposed by Hatch, is to place more resources behind enforcement of the laws on the book, as opposed to creating new laws that would more likely cripple legitimate manufacturers as actually inhibit outliers from selling steroids.
Study finds pre-pregnancy obesity poses increased risk of heart defects in babies
ATLANTA The largest study of obesity during pregnancy and babies with heart defects in the United States found that women who were overweight or obese before they became pregnant had an approximately 18% increased risk of having a baby with certain heart defects, compared with women who were of normal body mass index before they became pregnant, the Centers for Disease Control and Prevention announced in a press release issued Thursday.
Severely obese women had approximately a 30% increased risk, according to the CDC study, “Association Between Prepregnancy Body Mass Index and Congenital Heart Defects,” recently published in the American Journal of Obstetrics and Gynecology.
“Congenital heart defects are the most common types of birth defect, and among all birth defects, they are a leading cause of illness, death, and medical expenditures,” stated Edwin Trevathan, director of the CDC?s National Center on Birth Defects and Developmental Disabilities. “Women who are obese and who are planning a pregnancy could benefit by working with their physicians to achieve a healthy weight before pregnancy.”
The study looked at 25 types of heart defects and found associations with obesity for 10 of them. Five of these 10 types were also associated with being overweight before pregnancy. Women who were overweight but not obese had approximately a 15% increased risk of delivering a baby with certain heart defects.
“These results support previous studies, as well as provide additional evidence, that there is an association between a woman being overweight or obese before pregnancy and certain types of heart defects,” added Suzanne Gilboa, epidemiologist at CDC?s National Center on Birth Defects and Developmental Disabilities, and primary author of the study. “This provides another reason for women to maintain a healthy weight. In addition to the impact on a woman?s own health and the known pregnancy complications associated with maternal obesity, the baby?s health could be at risk.”
One important limitation of the study is that BMI was calculated based on self–reported weight and height, and weight may have been underreported by women during the study interview. Although the study found an association between overweight and obesity and the risk of certain birth defects, further study is needed to determine whether body weight is the direct cause of these birth defects, the agency noted.
The analysis included 6,440 infants with congenital heart defects and 5,673 infants without birth defects whose mothers were interviewed as part of the National Birth Defects Prevention Study. The NBDPS is funded by the CDC to collect information from mothers of children with and without birth defects in Arkansas, California, Georgia, Iowa, Massachusetts, New York, North Carolina, Texas and Utah. This study is the largest effort ever undertaken in the United States to identify risk factors for birth defects.
CRN launches collaborative program to educate consumers on dietary supplements
WASHINGTON The Council for Responsible Nutrition, creators of the consumer-wellness public relations campaign, “Life…supplemented,” on Thursday announced plans for the third consecutive year of the program upon meeting a budget goal of $1 million. The three-year, $3-million initiative encourages responsible use of dietary supplements in combination with other healthy habits, and urges consumers to assess their level of wellness by focusing on the three pillars of health: healthy diet, supplements and exercise.
“This is a collaborative program that demonstrates what an industry can do when companies work together to educate consumers who are looking for ways to take simple steps to improve their health,” stated CRN chairman Mark LeDoux. “I commend CRN for its ongoing leadership and especially thank those companies funding the program for their continued support. This program demonstrates that the industry has a commitment to urging consumers to take dietary supplements responsibly as one piece of a healthy lifestyle.”
Over the three-year campaign, 39 companies have financially supported the effort, with 25 funding companies currently signed on to support year three, including its five original Steering Committee members — NBTY, Pharmavite, Bayer HealthCare, BASF Corporation and DSM Nutritional Products.
This year, a sixth company, Wyeth Consumer Health, has increased its commitment to the Steering Committee level.
“The fact that companies continue to support ‘Life…supplemented’ year after year — particularly in this economic climate — shows that this is a sustainable campaign with responsible messages that companies can feel proud to support,” stated Judy Blatman, SVP communications, CRN, who oversees the program.
This announcement also marks the first major project coming out of the CRN Foundation, an educational affiliate of CRN. The Foundation was established earlier this year and will become the center of many of CRN’s educational activities and research projects supporting the supplement industry.
As part of the research sponsored by the “Life…Supplemented” campaign, a third annual “Life…supplemented” Healthcare Professionals Impact Study, which explores healthcare professionals’ recommendations for, and personal usage of, dietary supplements, will be supported.
This year’s study will look at registered dietitians, nurse practitioners and pharmacists. In previous years’ surveys, the campaign focused on U.S. physicians, nurses, OB/GYNs, cardiologists, dermatologists and orthopaedic specialists.
The campaign will also continue enhancements to its web site, http://lifesupplemented.org/, with emphasis on its free, interactive online tool, My Wellness Scorecard, a tool that provides consumers with a personalized wellness assessment.
The “Life…supplemented” campaign was recently awarded an honorable mention in the issue-specific web site category of the American Society of Association Executives’ 2009 Gold Circle Awards, an annual program recognizing excellence in communications. This marks the fourth award honoring the campaign, including a 2007-2008 Mercury Award win for “Web site: Health Awareness”.
“Supplement companies want to educate and celebrate the more than 150 million Americans who take their products each year; that is evident from the level of support from our funding companies and their enthusiasm for continuing the campaign,” said Judy Blatman, SVP communications for Council for Responsible Nutrition.