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FDA warns about excess selenium in Total Body products

4/10/2008

ROCKVILLE, Md. The Food and Drug Administration on Wednesday announced that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products “Total Body Formula” and “Total Body Mega Formula.”

The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products.

On March 27, the FDA warned consumers not to purchase or use “Total Body Formula” in flavors Tropical Orange and Peach Nectar and “Total Body Mega Formula” in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee. The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails and fatigue. 

Selenium, a naturally occurring mineral, is needed only in very small amounts for good health. Selenium can boost the immune system. Generally, normal consumption of food and water provides adequate selenium to support good health. Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin. 

Presently, FDA has 43 reports of adverse reactions including cases from Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee and Texas. 

Analyses of samples of the products by FDA laboratories have now found most of the samples contain extremely high levels of selenium—up to 40,800 micrograms per recommended serving, or more than 200 times the amount of selenium per serving (200 micrograms) indicated on the labels of the products. 

The FDA continues to investigate the matter to determine how excessive amounts of selenium were added to the products. 

Total Body Essential Nutrition, the distributor of the “Total Body Formula” and “Total Body Mega Formula” products, has voluntarily recalled the affected products. According to the company, the products were distributed nationwide. 

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