Unsafe Levels of Selenium Found in Dietary Supplements
By Todd Neale, Staff Writer, MedPage Today
Published: April 09, 2008

ROCKVILLE, Md., April 9 -- The FDA has identified hazardous levels of selenium as the cause of 43 adverse events stemming from use of certain flavors of the dietary supplements Total Body Formula and Total Body Mega Formula.

Find this article at:

http://www.medpagetoday.com/ProductAlert/OTC/tb/9070



The distributor of the products, Total Body Essential Nutrition, of Atlanta, has recalled the Tropical Orange and Peach Nectar flavors of Total Body Formula in eight- and 32-ounce bottles and the Orange/Tangerine flavor of Total Body Mega Formula in 32-ounce containers.


An FDA analysis found that most samples contained up to 40,800 mcg of selenium, more than 200 times the amount per serving (200 mcg) indicated on the product labels.


The reports of adverse events, which included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue, have come from nine states -- Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, and Texas. The products were distributed nationwide.


The FDA is investigating how the excess selenium was added to the supplements. The agency advised throwing away any affected products.


The FDA initially warned consumers not to buy these products on March 27 following reports of adverse events in Florida and Tennessee, which prompted the voluntary recall.




Find this article at:

http://www.medpagetoday.com/ProductAlert/OTC/tb/9070