FDA Warning for DMAA

April 16, 2012 — The U.S. Food and Drug Administration (FDA) has published a new Consumer Warning about DMAA. They have determined that supplements containing DMAA are illegal and they are using “all available tools” to ensure that DMAA is no longer distributed or sold. They also warned that the stimulant can raise blood pressure and potentially cause heart attacks and other health problems.

About a year ago, the FDA sent warning letters to 10 manufacturers of DMAA supplements. All but one manufacturer complied with the warning and stopped using DMAA in their products. The manufacturer who resisted, USPLabs, also sells the two most popular DMAA supplements: Jack3d (pronounced “Jacked”) and OxyElite Pro. These products are still widely available at major supplement retailers, such as GNC.

According to the FDA, USPLabs responded to the warning letter by submitting published studies that challenge the FDA’s conclusions about DMAA. The FDDA found that that information was “insufficient to defend the use of DMAA as an ingredient in dietary supplements.”

In the past, USPLabs has defended DMAA as a natural dietary supplement that is derived from the geranium plant. However, most experts agree that the evidence supporting this claim is very weak, and DMAA is most likely a synthetic drug. In fact, DMAA was originally mass-produced as a pharmaceutical nasal spray by Eli Lilly in 1948, but it was discontinued within a few years. FDA approval for DMAA was withdrawn in 1983.

The FDA also indicated that it intends to take further steps to remove DMAA from the market. They could ban DMAA, ask USPLabs to issue a voluntary recall, issue more warning letters, or publish public safety alerts. They could also work with U.S. marshals to seize the products from the manufacturer and retailers. In the worst case scenario, the FDA could bring criminal charges. However, this type of enforcement is very rare.

The FDA also commented on the “challenge” of regulating dietary supplements. According to Daniel Fabricant, director of the FDA Division of Dietary Supplement Program:

“With dietary supplements, there is no pre-market approval, and once a product is on the market, the burden is on the FDA to prove that a product is unsafe.”

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