FDA "Total Body" Warning Illustrates Hazards of Selenium OveruseApr 21, 2008 | Parker Waichman LLP
Earlier this month, the U.S. Food and Drug Administration (FDA) announced that hazardous selenium levels were found in samples of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula"; the FDA received 43 reports from nine states regarding possible selenium toxicity after consumers used the dietary formulas. Consumers are warned not to purchase or consume "Total Body Formula" in the Tropical Orange and Peach Nectar flavors and the "Total Body Mega Formula" in the Orange/Tangerine flavor. The sole distributor of the "Total Body Formula" and "Total Body Mega Formula" products has voluntarily recalled the affected products. According to the company, products were distributed nationwide.
An FDA analysis of samples of Total Body Formula and Total Body Mega Formula revealed drastically high levels of selenium it the Total Body products. The testing found that the samples contained—per serving—40,800 micrograms, an amount significantly higher than what was listed on the label: 200 micrograms.
Selenium is an antioxidant that can be beneficial in small amounts. The recommended daily allowance of selenium is only 50-70 micrograms for healthy adults; however, most American adults consume a diet that is adequate in selenium and require no supplements. Also, selenium deficiency is uncommon in the U.S. because selenium is found in the soil and, therefore, in many foods. Selenium is also found in tuna, turkey, eggs, Brazil nuts, walnuts, and enriched breads.
According to The Institute of Medicine of the National Academy of Sciences, adults should not consume more than 400 micrograms of selenium daily to avoid selenium toxicity. Because selenium is found in foods and supplements, consuming much more than the daily 400 micrograms is easily possible. For those individuals who show a selenium deficiency, generally due to poor diet or disease, supplemental selenium is indicated and research on its benefits for prevention or treatment of diseases such as cancer and heart disease are underway. It remains unclear if selenium can help treat or prevent these diseases.
Selenium amounts in “Total Body Formula” and “Total Body Mega Formula” samples greatly exceeded the recommended upper level of selenium and the FDA is advising consumers to discard the recalled “Total Body” 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.
In the short-term and via oral exposure to high concentrations of selenium, people may experience nausea, vomiting, and diarrhea. Chronic, oral exposure to high concentrations of selenium compounds can produce a disease called selenosis. The major signs of selenosis are hair loss; nail brittleness; and neurological abnormalities, which include numbness and other odd sensations in the extremities. Animal studies reveal that very high amounts of selenium can affect sperm production and also the female reproductive cycle. Adverse reactions generally occurred following five to 10 days of daily ingestion of the “Total Body” products.