Total Body Formula
and
Total Body Mega Formula
Liquid Dietary Supplement Recalled Due to Excess Selenium and Chromium
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) are warning consumers of serious adverse reactions associated with Total Body Formula in Tropical Orange and Peach Nectar flavors, and Total Body Mega Formula in Orange/Tangerine flavor.
The distributor, Total Body Essential Nutrition, Inc. of Atlanta, GA has voluntarily recalled certain lots of the liquid dietary supplement which has been found to contain hazardous levels of the minerals selenium and chromium. Samples tested by the FDA contained 40,800 micrograms per serving of selenium (up to 200 times the amount indicated on the label) and 3,426 micrograms per serving of chromium (up to 17 times the recommended intake). The human body requires selenium and chromium in small amounts, but ingestion of large amounts of these minerals or products containing them can be harmful. Adverse reactions generally occurred after 5-10 days of daily ingestion of the product.
As of May 1, 2008 the CDC reports that the number of confirmed cases of adverse reactions in consumers using the products has climbed to at least 201 individuals in Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, Texas and Virginia.
Injuries Associated With Selenium Toxicity
· Significant hair loss
· Muscle cramps
· Diarrhea
· Joint pain
· Fatigue
· Loss of finger nails and blistering skin
Injuries Associated With Chromium Toxicity
· Renal failure
· Liver toxicity
· Thrombocytopenia
· Changes in thought processes
· Gastrointestinal disorders
· Chest pain
· Erythema/flushing/rash
· Dizziness
· Headache
· Agitation
· Rhabdomyolysis (rapid breakdown of muscle tissue)
· Interference with certain medications
Total Body Formula products are sold in 8 oz. and 32 oz. plastic bottles; Total Body Mega Formula is sold in 32 oz. plastic bottles. The products were distributed to 16 states (Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia) and sold over the Internet.
Total Body products with the following lot numbers have been recalled: Total Body Tropical Orange #4016801, 4024801, and 4031801; Total Body Peach Nectar #4016802 and 4031802; and Total Body Mega Orange/Tangerine #4031803. Consumers are advised to consult their health care professional if they have experienced any adverse reactions. Consumers and health care professionals can also report adverse events to the FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm
Resources
CDC Health Advisory:
http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00274
FDA Press Release May 1, 2008
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01831.html
FDA Press Release April 9, 2008
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01818.html
FDA Press Release March 27, 2008
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html