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March 28, 2008
WASHINGTONFDA is advising consumers not to purchase or consume Total Body Formula Tropical Orange and Peach Nectar flavors, or Total Body Mega Formula Orange/Tangerine flavor, because of reports the products may cause severe adverse reactions such as significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. FDA laboratories are analyzing samples of the products 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 described in the adverse events reported to the agency.
The Florida Department of Health recently provided adverse event reports (AERs) to FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. FDA subsequently learned and is investigating a report of similar reactions in Tennessee users of the same dietary supplements.
Both products are distributed by Total Body Essential Nutrition of Atlanta and are available in 32-oz. bottles, while Total Body Formula is also sold in 8-oz. bottles. The products have been distributed in Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia. The company is the sole distributor of the products and voluntarily recalled the Total Body products in the flavors listed by FDA..
FDA is advising consumers in all states to avoid using the products immediately and to discard the products. The agency further advised consumers who have experienced adverse reactions after taking these products should consult their health care professional. 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.
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