| U.S. Food and Drug Administration |
FDA Press Release, Apr 9, 2008
FDA Finds Hazardous Levels of Selenium in Samples of "Total Body Formula" and"Total Body Mega Formula"
Dietary supplement products linked to adverse reactions
The U.S. Food and Drug Administration announced today 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 (i.e., 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.
FDA is advising consumers to stop using "Total Body Formula" in flavors
Tropical Orange and Peach Nectar and "Total Body Mega Formula" in the
Orange/Tangerine flavor and discard them by placing them in a trash
receptacle outside of the home. "Total Body Formula" products are sold in
eight-ounce and 32-ounce plastic bottles. "Total Body Mega Formula" is sold in
32-ounce plastic bottles. Both product lines are distributed by Total Body
Essential Nutrition of Atlanta, which is listed on the products' labels.
Consumers who have been taking the products and have experienced adverse
reactions should consult their health care professional. Consumers and health
care professionals are encouraged to report adverse events to the FDA's MedWatch
program at 800-FDA-1088.
The sole 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.
This advisory was prepared by the FDA Office of Public Affairs.