According to a news source, seven of the 10 dietary supplement companies that recently received Food and Drug Administration (FDA) warnings have been sued for consumer fraud in a federal court in California. See, e.g., Barkum v. iSatori Global Technologies, LLC, No. 3:12-cv-01058 (U.S. Dist. Ct., C.D. Cal., filed April 30, 2012). According to the warning letters, the dietary supplements contain an ingredient, dimethylamylamine (DMAA), that does not meet regulatory requirements for use in the United States, and thus, supplements containing the ingredient are adulterated.
FDA warns that failure to correct the violation could result in seizure of the offending products. The agency refers to DMAA’s ability to narrow blood vessels and arteries, “which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack).”
The ingredient apparently came under media scrutiny in December 2011, when the U.S. Army, concerned about the deaths of two soldiers who purportedly used products containing the ingredient, prohibited the sales of DMAA products in post exchanges. Canada reportedly classifies DMAA as a prescription drug, and the World Anti-Doping Agency added it to its list of banned substances in 2009. See Law360, May 2, 2012.