Total Body Supplements Recalled for Dangerous Selenium LevelsApr 10, 2008 | Parker Waichman LLP
The U.S. Food and Drug Administration (FDA) just announced hazardous selenium levels have been found in some samples of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula"; the FDA has also received 43 reports of serious adverse reactions from these products. Consumers are warned not to purchase or consume "Total Body Formula" in the Tropical Orange and Peach Nectar flavors and the "Total Body Mega Formula" in the Orange/Tangerine flavor. The sole distributor of the "Total Body Formula" and "Total Body Mega Formula" products has voluntarily recalled the affected products. According to the company, products were distributed nationwide.
The FDA investigation over how excessive selenium amounts were added to the “Total Body” products continues. In the meantime, the FDA is advising consumers to stop using the recalled "Total Body" products and to 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.
Selenium has both beneficial and harmful effects. While low doses of selenium are needed to maintain good health, exposure to high levels can cause adverse health effects. In the short-term and via oral exposure to high concentrations of selenium, people may experience nausea, vomiting, and diarrhea. Chronic, oral exposure to high concentrations of selenium compounds can produce a disease called selenosis. The major signs of selenosis are hair loss; nail brittleness; and neurological abnormalities, which include numbness and other odd sensations in the extremities. Animal studies reveal that very high amounts of selenium can affect sperm production and the female reproductive cycle. Selenium is a naturally occurring mineral needed only in very small amounts for good health. Selenium can boost the immune system but, generally, normal consumption of food and water provides enough selenium for good health. Excessive selenium ingestion can cause significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, fingernail loss, and blistering skin.
Adverse reactions generally occurred following five to 10 days of daily ingestion of the “Total Body” products and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue. The 43 reports of adverse reactions including cases from Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, and Texas. FDA sample analyses found most samples contained extremely high levels of selenium, up to 40,800 micrograms per recommended serving, which is over 200 times the amount of selenium per serving (i.e., 200 micrograms) indicated on the products’ labels.
Consumers who have been taking the recalled “Total Body” products and have experienced adverse reactions should consult their health care professional; consumers and health care professionals are to report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.
More information about selenium and its toxic effects is available at the Centers for Disease Control and Prevention's Agency (CDC) for Toxic Substances and Disease Registry at www.atsdr.cdc.gov/tfacts92.html.