The US Food and Drug Administration (FDA) has announced that it found “hazardous levels” of selenium in certain flavours of dietary supplements marketed as “Total Body Formula” and”Total Body Mega Formula”.
Both products are distributed by Total Body Essential Nutrition of Atlanta, whose name is also on the labelling. The distributor is voluntarily recalling all the products, which it said are distributed throughout the US.
So far the agency has received over 40 reports of people from 9 different states who have experienced serious reactions including significant hair loss, deformed fingernails, diarrhea, joint pain, fatigue and muscle cramps after using these products. These symptoms are consistent with ingesting excessive amounts of selenium and occurred about 10 days after daily use.
The FDA issued a warning on 27th March asking consumers not to buy or use the Tropical Orange and Peach Nectar flavours of “Total Body Formula” and the Orange/Tangerine flavour of “Total Body Mega Formula” after receiving reports of people in Florida and Tennessee experiencing adverse reactions after using the products.
At the time of its latest update on 7th April, the FDA had received 43 adverse reaction reports affecting people in Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, and Texas.
The agency has analysed samples of the products and found that most of them contained extremely high levels of selenium, in some cases up to 200 times that indicated on the product label (40,800 micrograms instead of 200 micrograms). The FDA is continuing to look into how the excessive levels of selenium got into the products.
In the meantime consumers should stop using Tropical Orange and Peach Nectar flavoured “Total Body Formula” and Orange/Tangerine flavoured “Total Body Mega Formula” said the FDA, who said they should be thrown in “a trash receptacle outside of the home”.
“Total Body Formula” is sold in 8-ounce and 32-ounce plastic bottles.
“Total Body Mega Formula” is sold in 32-ounce plastic bottles.
If you have taken these products and have experienced adverse reactions you should see your doctor straight away.
The FDA also advises healthcare professionals and consumers to report any adverse events to the Medwatch program, either by calling 800-FDA-1088 or via the online system at www.fda.gov/medwatch/how.htm .
Selenium is a naturally occuring element that the human body needs in tiny amounts to maintain healthy cells and an effective immune system. The element is incorporated into proteins called selenoproteins, which are important antioxidants that prevent cells from damage by free radicals. A normal diet and intake of water is usually considered to contain enough selenium for good health.
In the US the most common sources of selenium are meats and bread, and some nuts (Brazil nuts have the most) are also rich in selenium.
The amount of selenium in a food depends to a certain extent on the amount of selenium in the soil where it is grown, or for meat sources, where the animal was raised. By eating a variety of food from different places people living in areas with low selenium soil overcome any danger of not getting enough in their daily diet.
The recommended daily amount of selenium for an adult is 55 micrograms a day, although women who are pregnant or breastfeeding will need between 60 and 70 a day.
Sources: FDA News, National Institutes of Health.
Written by: Catharine Paddock, PhD