| Warning About "Total Body" Liquid Supplements
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
- deformed fingernails
As of April 9, 2008, FDA had received 43 reports of people from 9 states who experienced adverse reactions after using the "Total Body" products. The adverse reactions generally occurred after five to 10 days of daily ingestion of the product.
Hazardous Levels of Selenium and Chromium
FDA has found hazardous levels of selenium in samples of certain flavors of Total Body Formula and Total Body Mega Formula products. Selenium is a naturally occurring mineral that can boost the immune system, but it is needed only in small amounts for good health. Generally, normal consumption of food and water provide adequate selenium to support good health. Excessive amounts of selenium are known to cause symptoms such as those reported to FDA.
FDA's final analysis of certain flavors of "Total Body" supplements also detected hazardous amounts of chromium. The samples contained up to 3,426 micrograms of chromium for the recommended serving (17 times the recommended intake). The recommended chromium intake for an adult ranges from 35 to 45 micrograms per day. Excessive consumption of chromium can cause fatigue, muscle cramps, hyperactivity, low blood sugar, kidney failure and liver toxicity. Excessive chromium intake also can interfere with certain medications.
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 (May 1, 2008)
www.fda.gov/bbs/topics/NEWS/2008/NEW01831.html
FDA Press Release (March 27, 2008)
www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html
FDA Press Release (April 10, 2008)
www.fda.gov/bbs/topics/NEWS/2008/NEW01818.html |