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 (www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html).
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 or online
at
www.fda.gov/medwatch/how.htm.
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.
More information about selenium and its toxic effects is available
at this link to the Centers for Disease Control and Prevention's Agency
for Toxic Substances and Disease Registry:
www.atsdr.cdc.gov/tfacts92.html.
Released April 9, 2008
