Published March 28, 2008
The U.S. Food and Drug Administration is warning consumers in 15 states about the link between a dietary supplement and adverse side effects including "significant hair loss."
The distributor of "Total Body Formula" and "Total Body Mega Formula" has voluntarily recalled the dietary supplement products after 23 individuals suffered "serious reactions" within seven to 10 days of ingesting the liquid supplements, the FDA said in a news release.
The FDA is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue, the FDA said.
Total Body Formula products are sold in eight-ounce and 32-ounce plastic bottles, while the Total Body Mega Formula is sold only in 32-ounce plastic bottles. Both products are distributed by Total Body Essential Nutrition of Atlanta, according to the FDA.
In addition to the 23 documented cases of serious reactions, the FDA is investigating a report that some individuals in Tennessee using the same products have experienced similar reactions.
The FDA is analyzing the product and said the reactions may have stemmed from excessive amounts of selenium, which is known to cause symptoms such as those described in the adverse events reported to the agency. Selenium, a trace mineral, is needed only in small amounts for good health, the FDA said.
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 FDA is working with the Florida Department of Health in its investigation. The agency is advising consumers in all states to avoid using the products and to discard the products by placing them in a trash receptacle outside of the home.
Consumers who have been taking the products and have experienced adverse reactions 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 by clicking here.