HEALTH

NPA testifies against illegal steroids

BY DSN STAFF

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.

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Study finds pre-pregnancy obesity poses increased risk of heart defects in babies

BY Michael Johnsen

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.

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GNC seeks competitive edge with new store format

BY DSN STAFF

NEW YORK GNC is taking its boutique-style specialty shop to a whole new level, especially as it starts folding in product lines not normally part of a specialty supplement shop’s repertoire — yoga, pet supplements, probiotics, homeopathic health remedies, natural skin care, natural oral care and a wider assortment of arguably commodity-type supplement offerings, such as multivitamins and such popular health supplements as vitamin D or fish oil.

 

You’ve got to wonder, though, how much GNC’s relationship with Rite Aid is playing a part in all of this. GNC now has some 10 years under its belt in its partnership with Rite Aid, which means some 10 years of gleaning insights on how Rite Aid has successfully positioned that GNC store-within-a-store concept as a more profitable supplement center and a true point-of-differentiation.

 

It’s also been about two years since one of the Rite Aid executives who helped develop and nurture that GNC/Rite Aid concept in the beginning has been at the helm at GNC aspresident and chief merchandising and marketing officer. “GNC has a very unique position in the market,” Beth Kaplan told Drug Store News soon after she joined GNC. “GNC’s initial DNA is built around vitamins and supplements,” she said then, not just diet aids and sports nutrition.

It’s certainly a smart play — it’s more reflective of today’s healthcare mood as politicians continue to debate how to best infuse a cost-saving well-care sentiment in healthcare reform over the sick-care model that exists today. And it de-emphasizes perhaps the two more controversial categories GNC is currently best-known for — weight loss diet aids and sport nutrition supplements. They’re not abandoning those segments of course — it’s still going to occupy half the store’s footprint after all — and nor should they. They’re legitimate businesses when marketed and merchandised responsibly. But the fact remains that both weight loss and  sports nutritionals are under greater scrutiny with today’s more-aggressive Food and Drug Administration and the controversy surrounding performance-enhancing drugs being illegally marketed as supplements — the subject, in fact, of a Congressional hearing held just last week.

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