Warning About "Total Body" Liquid Supplements and Recall 4-4-08

The Food and Drug Administration (FDA) is advising consumers not to buy or consume the following Total Body liquid dietary supplement products because of reports received of severe adverse reactions:

• Total Body Formula in the flavors of Tropical Orange and Peach Nectar (sold in eight- and 32-ounce plastic bottles)
• Total Body Mega Formula in the Orange/Tangerine flavor (sold in 32-ounce plastic bottles)

Atlanta-based Total Body Essential Nutrition has recalled these products, which have been distributed in the following states: Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.

Adverse Reactions

The recalled products may cause the following severe adverse reactions:

• significant hair loss
• muscle cramps
• diarrhea
• joint pain
• fatigue

The Florida Department of Health has informed FDA of 23 people who experienced serious reactions from the products seven to 10 days after ingestion. FDA is also investigating a report that some people in Tennessee who used the products have experienced similar reactions.

FDA is analyzing samples to identify the cause of the reactions, including the possibility that the products contain excessive amounts of selenium, which is known to cause symptoms such as those that have been reported to the agency. Selenium, a trace mineral, is needed only in small amounts for good health.

Steps for Consumers

• Avoid using the products immediately and discard them in a trash receptacle outside of the home.
• Consult your health care professional if you have been taking the products and have experienced adverse reactions.
• Report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.
• Call FDA's toll-free Food Safety Hotline at 1-888-SAFEFOOD if you would like more information.

For More Information

FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html

Date Posted: April 1, 2008