<"https://www.yourlawyer.com/practice_areas/defective_drugs">“Total Body Formula” and “Total Body Mega Formula” dietary supplements were associated with a 2008 outbreak of selenium poisoning. According to a case report published in Archives of Internal Medicine, the batch of Total Body supplements responsible for the selenium poisoning contained up to 200 times the amount of selenium stated on the label.
Selenium is an antioxidant that can be beneficial in small amounts, and the recommended daily intake is set at 55 micrograms. 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. Symptoms of selenium poisoning include nausea; vomiting; nail discoloration, brittleness, and loss; hair loss; fatigue; irritability; and foul breath odor.
The outbreak of selenium poisoning linked to Total Body supplements started to surface in March 2008. Further investigation found 201 people in ten states who had been sickened by the supplement. One of the individuals sickened had to be hospitalized. According to the Archives of Internal Medicine case report, the median dose of selenium victims had consumed was nearly 42,000 micrograms per day.
The supplements responsible for the selenium poisoning outbreak was marketed as being suitable for the “entire family” to provide a balance of nutrients to “maintain energy and sustain health” and was labeled as containing 200 micrograms of selenium per fluid ounce in the form of sodium selenite. When interviewed for the case report, patients stated that they had not suspected the supplement had made them ill and never mentioned the fact they were taking it to their physicians. Some even increased the dose to try to relieve their symptoms, the article said.
The Food and Drug Administration (FDA) ultimately determined that a “human error” on the part of a supplier was behind the selenium overage. Prior to the 2008 selenium poisoning outbreak, the Total Body supplements had been on the market for 12 years with no reports of problems.
In a commentary accompanying the Archives of Internal Medicine article, Bimal H. Ashar, MD, MBA, from Johns Hopkins School of Medicine, called on lawmakers to reevaluate the Dietary Supplement Health and Education Act, which was passed in 1994. As it stands now, the law allows manufacturers to market their products without submitting proof of efficacy or safety to the FDA.
Patients have no way of distinguishing safe supplements from those that may be harmful, and the FDA is “ill equipped to expeditiously monitor, assess, and take action on potentially unsafe supplements,” Dr. Ashar wrote. Dr. Ashar also pointed out that while the evidence that dietary supplements treat or prevent disease is lacking, reports of adverse events continue to surface.