"Total Body Formula" and"Total Body Mega Formula" Have Hazardous Levels of Selenium.

FOR IMMEDIATE RELEASE April 9, 2008

Media Inquiries: Kimberly Rawlings, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Finds Hazardous Levels of Selenium in Samples of "Total Body Formula" and"Total Body Mega Formula"
Dietary supplement products linked to adverse reactions

The U.S. Food and Drug Administration announced today that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products.

On March 27, the FDA warned consumers not to purchase or use "Total Body Formula" in flavors Tropical Orange and Peach Nectar and "Total Body Mega Formula" in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee. The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue.

Selenium, a naturally occurring mineral, is needed only in very small amounts for good health. Selenium can boost the immune system. Generally, normal consumption of food and water provides adequate selenium to support good health. Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.

Presently, FDA has 43 reports of adverse reactions including cases from Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, and Texas.

Analyses of samples of the products by FDA laboratories have now found most of the samples contain extremely high levels of selenium--up to 40,800 micrograms per recommended serving, or more than 200 times the amount of selenium per serving (i.e., 200 micrograms) indicated on the labels of the products.

The FDA continues to investigate the matter to determine how excessive amounts of selenium were added to the products.

FDA is advising consumers to stop using "Total Body Formula" in flavors Tropical Orange and Peach Nectar and "Total Body Mega Formula" in the Orange/Tangerine flavor and discard them by placing them in a trash receptacle outside of the home. "Total Body Formula" products are sold in eight-ounce and 32-ounce plastic bottles. "Total Body Mega Formula" is sold in 32-ounce plastic bottles. Both product lines are distributed by Total Body Essential Nutrition of Atlanta, which is listed on the products' labels.

Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

The sole distributor of the "Total Body Formula" and "Total Body Mega Formula" products has voluntarily recalled the affected products. According to the company, the products were distributed nationwide.

More information about selenium and its toxic effects is available at this link to the Centers for Disease Control and Prevention's Agency for Toxic Substances and Disease Registry: www.atsdr.cdc.gov/tfacts92.html.

tag: FDA News, Suppliments, Total Body Formula, Total Body Mega Formula, Selenium, MedWatch,

Banned Steroids In Your Supplements

A study set to be released Wednesday, obtained by USA TODAY and commissioned by Informed-Choice, a non-profit coalition of U.S. supplements companies, shows 13 of 52 supplements tested between July 2006 and January 2007 at a British lab had small amounts of steroids banned by the World Anti-Doping Agency and all major sports leagues.

According to the summary of the report, 58 supplement samples were purchased from popular retail outlets and internet sites in the US and sent to HFL for analysis using HFL’s ISO 17025 accredited banned substance screen for supplements. The banned substance screen is used to detect the presence of low levels of steroid and stimulant contaminants that are considered prohibited by the World Anti-Doping Agency (WADA) in a range of supplement formulations.
Samples were extracted using a combination of liquid and solid phase extraction techniques and analysed by GCMS and LCMS using an Agilent 5973 GCMS instrument and a LCQ XP LCMS instrument.
Approximately one quarter of the samples analysed showed the presence of low levels of steroid and/or stimulant contamination that were not declared on the label.
Another test conducted between 2000 and 2002 a study was undertaken by the International Olympic Committee (IOC) accredited lab in Germany to investigate claims that many supplement products available on the market could contain steroids and prohormones that were not declared on the label (Geyer et al). Such steroid contaminants are considered prohibited by the sports regulatory authorities and professional sports people are banned from using these substances. Geyer’s research involved the purchase and analysis of 634 supplement products, bought from 13 different countries. These samples were tested for a range of steroids and prohormones - almost 15% of the products tested contained steroids and prohormones that were not declared on the label. If consumed by professional sports people, such contaminants could result in them failing a drug test.
Also according to the same USA Today report; Starting Dec. 22, supplement companies are required to report "serious" adverse effects of their products to the FDA, including resulting hospitalization, disability and death.
More stringent "good manufacturing practices" began to roll out in August "so that consumers can be confident that the products they purchase contain what is on the label," FDA Commissioner Andrew C. von Eschenbach said in a statement in June. All supplements companies must comply by June 2010.
The FDA "is always concerned about products that may put the public health at risk," spokeswoman Kimberly Rawlings said. "When FDA learns of a product that is adulterated or misbranded, including a dietary supplement, we will take the appropriate action to protect the public health."The report is available at USA Today.

Tags: Informed-Choice, supplements, steroids, World Anti-Doping Agency, GCMS, LCMS, ISO 17025