The U.S. Food and Drug Administration’s (FDA) final analysis of certain flavors of <"https://www.yourlawyer.com/practice_areas/defective_drugs">“Total Body Formula” and “Total Body Mega Formula†have detected hazardous amounts of chromium in addition to previously reported hazardous selenium levels. The samples contained up to 3,426 micrograms of chromium for the recommended serving (17 times the recommended intake); the recommended chromium intake for adults is between 35 and 45 micrograms per day. Last month, testing also found that samples contained—per serving—drastically high levels of selenium at 40,800 micrograms, an amount significantly higher than the 200 micrograms listed.
The FDA continues to investigate how excessive amounts of selenium and chromium got into the products and consumers continue to be 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. U.S. Centers for Disease Control and Prevention (CDC) reports indicate that the number of confirmed cases of adverse reactions in consumers using Total Body products is at least 201 individuals in Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, Texas, and Virginia.
Chromium is an essential nutrient that helps the body use sugar, protein, and fat but can be toxic in large doses. Excessive consumption of chromium can interfere with certain medications and can cause fatigue, muscle cramps, stomach upsets, ulcers, convulsions, kidney and liver damage, hyperactivity, hypoglycemia, renal failure, liver toxicity, and death. Chromium is a known carcinogen and will lodge in any tissue to form cancerous growths. The World Health Organization (WHO) has determined that chromium is a human carcinogen, the Department of Health and Human Services (DHHS) has determined that certain chromium compounds are known to cause cancer in humans, and the EPA has determined that chromium in air is a human carcinogen.
Selenium is an antioxidant that can be beneficial in small amounts. 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. 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. Adverse reactions generally occurred following five to 10 days of daily ingestion of the “Total Body†products.
Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional and 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.
