FDA Flags Megadose of Selenium Supplement

April 9, 2008 -- The FDA has found hazardous levels of the mineral selenium in samples of certain flavors of the recalled dietary supplements Total Body Formula and Total Body Mega Formula.

The FDA has received 43 reports of people in nine states -- Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, and Texas -- who experienced serious adverse reactions after using these products.

Total Body Essential Nutrition, which distributed the products, has voluntarily recalled the affected products, according to the FDA.

Selenium, a naturally occurring mineral, can boost the immune system, but it's only needed in very small amounts for good health. Generally, normal consumption of food and water provides adequate selenium to support good health.

Too much selenium is known to cause symptoms such as hair loss, muscle cramps, diarrhea, joint pain, fatigue, fingernail loss, and skin blisters.

On March 27, the FDA warned consumers not to purchase or use Total Body Formula in the Tropical Orange and Peach Nectar flavors and Total Body Mega Formula in the Orange/Tangerine flavor after receiving reports of adverse reactions in users in Florida and Tennessee.

Since then, the FDA has tested samples of the affected products and found extremely high levels of selenium -- up to 40,800 micrograms per recommended serving, or more than 200 times the amount of selenium per serving noted on the product labels.

The FDA is investigating to determine how excessive amounts of selenium were added to the products.?

The FDA has this advice for consumers:

• Call a health care professional if you've had any symptoms while using the affected products.
• Throw out the affected products.
• Report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online.

More information on selenium and its toxic effects is posted on the web site of the CDC's Agency for Toxic Substances and Disease Registry.