FDA Warns About Dangers of Dietary Ingredient

On April 11, 2013, the FDA issued a warning for consumers of workout-booster and fat-burning products containing an ingredient that could cause heart attacks and other health problems. The ingredient, dimethylamylamine, or DMAA, is most commonly found in supplements promising benefits such as weight loss, muscle-building, and performance enhancement. Instead of these benefits, DMAA can elevate blood pressure and cause cardiovascular problems, as well as shortness of breath and tightening of the chest. The FDA noted that given the known biological activity of DMAA, its use along with consumption of caffeine could be dangerous.

In many cases, the FDA has acted to remove from the market dietary supplements that were found to contain ingredients approved only for use in prescription drugs. DMAA was approved in 1948 for use as a nasal decongestant, but the approval was withdrawn in 1983. Although health regulators in at least seven countries, including Canada, have effectively banned supplements containing DMAA, the products still remained widely available at supplement stores in the United States.

As of April 11, 2013, the FDA had received 86 reports of illnesses and death associated with supplements containing DMAA. The majority of the reports are voluntary submissions from consumers and health care practitioners. The illnesses reported include heart problems and nervous system or psychiatric disorders. The FDA did note, however, that a report is not proof that the product actually caused the problem.

DMAA-containing products can be found at national retailers of dietary supplements. The FDA had previously warned companies known to be using DMAA in dietary supplements that those products containing this ingredient were illegal. Warnings afford a quick method for the FDA to attempt to halt the further distribution and sales of dietary supplements containing DMAA in the marketplace. The agency noted that all but one of the companies sent a Warning Letter agreed to stop using DMAA as an ingredient in their dietary supplements. The one company that has yet to agree to such action, USPLabs, responded to the FDA’s warning by submitting published studies that challenged the FDA’s conclusions.

The agency faces a challenge in addressing incidents involving any potentially dangerous dietary supplements. This is especially pronounced in the wake of rising dietary supplement usage in the United States. A 2011 study by the Centers for Disease Control and Prevention found that more than half of U.S. adults used a dietary supplement between 2003 and 2006, compared to 40 percent between 1988 and 1994.

The products cited in the Warning Letter to USPLabs are Oxy Elite Pro and Jack3D. These products claimed to be fat-burning and performance-enhancing supplements, respectively. While the FDA’s action in that case is pending investigation of the USPLabs reports, the agency is actively ensuring that the other companies which promised to cease using DMAA as an ingredient in their dietary supplements are actually doing so. The FDA is also looking to see if there are other dietary supplement products containing DMAA in the marketplace.