Researchers conducting a study of dietary supplements say that a lack of regulation is resulting in potentially poisonous products being sold to consumers in the United States unchecked.
The study, published in the latest issue of the Archives of Internal Medicine, was focused on an outbreak of acute selenium poisoning from Total Body Formula, which sickened 201 people in 10 states in 2008. Researchers pointed out that due to current federal regulations, Total Body Formula did not have to go through the stringent approval process required by pharmaceutical manufacturers making drugs to treat specific illnesses.
The FDA issued a recall of Total Body Formula and Total Body Mega Formula, distributed by Total Body Essential Nutrition of Atlanta, after Florida health officials reported 23 cases of selenium poisoning in 2008. Users suffered hair loss, muscle cramps, diarrhea, joint pain and fatigue. Researchers conducting the study were able to find a total of 201 people ultimately affected by the dietary supplement side effects.
The researchers found that the supplement contained 200 times the amount of concentrated selenium indicated on the label. While necessary for cellular functions at low levels, selenium becomes toxic at high doses.
Last year there were several recalls of similar dietary supplements or other homeopathic products not regulated by FDA because they were considered either herbal remedies or did not treat a specific illness. Dietary supplements in particular came under increased scrutiny by federal regulators in the wake of a Hydroxycut recall issued in May 2009, after FDA identified a number of reports where users suffered serious and potentially life-threatening liver damage. In July, the FDA warned consumers not to take dietary supplements which contained ingredients identified as steroids. The agency recommended that anyone taking dietary supplements containing steroids should immediately see a doctor if they showed signs of liver problems.
In June, the FDA issued a Zicam recall for the popular cold remedy’s nasal sprays and gels, saying that the unregulated homeopathic product was causing users to lose their sense of smell. Only after identifying the potential health concerns from post-marketing reports, was the FDA able to tell the manufacturer, Matrixx Initiatives, that they would no longer be permitted to market the products until they submit data establishing the safety and effectiveness.
In the case of the Total Body Formula recall, a number of lawsuits have been filed in federal courts against the manufacturers, which were consolidated and centralized as part of a Total Body Formula multidistrict litigation, or MDL, in the Northern District of Alabama in October 2008.
“Toxic concentrations of selenium in a liquid dietary supplement resulted in a widespread outbreak,” researchers concluded. “Had the manufacturers been held to standards used in the pharmaceutical industry, it may have been prevented.”