Bodee recalls Zencore after FDA finds undeclared drugs in chemical analysis
CENTURY CITY, Calif. Bodee last month voluntarily recalled all of the company’s supplement product sold under the name Zencore Tabs after being informed by representatives of the Food and Drug Administration that lab analyses found the product contained potentially harmful, undeclared pharmaceutical ingredients.
FDA asserted that its chemical analysis revealed that one lot of Zencore Tabs contained aminotadalafil, an analog of tadalafil, the active ingredient in Eli Lilly’s Cialis erectile dysfunction medication.
FDA maintained that Aminotadalafil is close in structure to tadalafil and is expected to possess a similar pharmacological and adverse event profile. Further, FDA declared another lot of Zencore Tabs contained sildenafil, the active ingredient found in Pfizer’s Viagra, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil.
Zencore Tabs is sold in health food stores and by mail order nationwide and in Canada. The Zencore Tabs product is sold as a 2-capsule blister pack packaged in a retail booklet with five booklets in a box.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
Study shows vitamin D3 reduces risk of certain cancers
SAN DIEGO A new study looking at the relationship between vitamin D serum levels and the risk of colon and breast cancer across the globe has estimated the number of cases of cancer that could be prevented each year if vitamin D3 levels met the target proposed by researchers, the University of California, San Diego, announced last month.
Cancer prevention specialists at the Moores Cancer Center at UCSD estimate that 250,000 cases of colorectal cancer and 350,000 cases of breast cancer could be prevented worldwide by increasing intake of vitamin D3, particularly in countries north of the equator.
“For the first time, we are saying that 600,000 cases of breast and colorectal cancer could be prevented each year worldwide, including nearly 150,000 in the United States alone,” stated study co-author Cedrric Garland.
The paper, which looks at the dose-response relationship between vitamin D and cancer, was published in the August edition of the journal Nutrition Reviews.
The study combined data from surveys of serum vitamin D levels during winter from 15 countries. It is the first study to look at satellite measurements of sunshine and cloud cover in countries where actual blood serum levels of vitamin D3 had also been determined. The data were then applied to 177 countries to estimate the average serum level of a vitamin D metabolite of people living there.
The data revealed an inverse association of serum vitamin D with risk of colorectal and breast cancer. The researchers maintain that increasing vitamin D levels in populations, particularly those in northern climates, has the potential to both prevent and possibly serve as an adjunct to existing treatments for cancer.
“This could be best achieved with a combination of diet, supplements and short intervals – 10 or 15 minutes a day – in the sun,” Garland said. The serum level recommended by the study would correspond to intake of 2000 International Units per day of vitamin D3 for a meaningful reduction in colorectal cancer. The researchers recommend 2000 IU/day, plus, when weather allows, a few minutes in the sun with at least 40 percent of the skin exposed, for a meaningful reduction in breast cancer incidence, unless the individual has a history of skin cancer or a photosensitivity disease.
Vitamin Shoppe campaign to fight vitamin-A deficiency blindness
NORTH BERGEN, N.J. The Vitamin Shoppe announced Wednesday it will begin accepting cash donations on behalf of Vitamin Angels in support of that agency’s campaign, Operation 20/20, as part of the vitamin retailer’s 30th anniversary celebrations.
“With our Anniversary Sale in-store, in our catalog and on the web, we know our loyal customers will join us in supporting this important initiative to end childhood blindness caused by [vitamin-A deficiency],” stated Tony Truesdale, president and chief merchandising officer of The Vitamin Shoppe.
Vitamin Angels is committed to eliminating childhood blindness caused by vitamin-A deficiency by the year 2020. Operation 20/20 is the first major step in this global campaign, which launched this year in 15 countries.
The Vitamin Shoppe is raising funds for Vitamin Angels in store at the register. Customers can donate $1 or more to the campaign and sign a Vitamin Angels paper angel to hang in the store. Any customer who donates $5 or more will receive a special Operation 20/20 wristband as a thank you. Online customers can also donate with each purchase at www.vitaminshoppe.com.