Although many people believe that dietary supplements are safe and undergo an FDA regulation process similar to drugs, many supplements contain unknown or unapproved ingredients that can be dangerous. The FDA doesn’t have to review the supplements before they’re sold, and they must undergo a lengthy scientific and legal process to ban compounds in supplements. Last month, the FDA issued a statement that declared they are using all available resources to ensure that supplements containing DMAA are no longer distributed or available for sale.
Dimethylamylamine (DMAA) is often found in products marketed to boost endurance, aid in weight loss and help build muscle. However, it can lead to a number of side effects and health complications, including high blood pressure, chest tightness, shortness of breath, and heart attacks, among other problems. Consumers may have a difficult time identifying whether their supplement contains the potentially harmful ingredient, as DMAA is known by ten different names.
As of April 11, 2013, the FDA received 86 reports of illnesses and death associated with supplements containing DMAA. The ingredient is especially dangerous when taken with caffeine, and it can lead to nervous system and psychiatric disorders, in addition to its cardiovascular side effects. Although companies often market dietary supplements as natural, dietary supplements that contain unapproved ingredients accounted for just over half of all major drug recalls.
Last year, the U.S. military removed supplements containing DMAA after two soldiers’ deaths may have been linked to the ingredient. The agency sent warning letters to 11 companies requesting to stop further production and distribution of dietary supplements containing DMAA. Although the FDA has questioned the legality of DMAA in the past, the new warning firmly states its stance: “FDA has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal.”
All but one of the companies complied with the FDA’s request. USPLabs, which makes OxyElite Pro and Jack3d, “stands behind the safety and quality of its products,” and the company sent published studies to the FDA that challenged safety claims. However, the FDA states that the studies are not sufficient enough to defend use of DMAA in dietary supplements, as the studies were each conducted with 50 or fewer participants. The FDA will send a formal response to USPLabs and will continue its efforts to get the stimulant off the market.
Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School and a general internist at Cambridge Health Alliance in Boston, notes how dietary supplements should follow the same rigorous regulation process as pharmaceutical drugs, as “the consumer is flying blind when it comes to purchasing supplements.” Consumers are urged to report any DMAA-related problems to the company or the FDA, and they should contact a health care provider if they become ill.