The FDA Cracks Down on DMAA Supps

Why is the FDA concerned now? The U.S. Federal and Drug Administration, or FDA, has reportedly received 42 adverse event reports from persons who used DMAA-containing products. The adverse events reported included shortness of breath, tightening in the chest, and nervous system disorders. There have been lawsuits filed alleging deaths due to heart attack after taking DMAA-containing products.

What actions has the FDA taken? Some sources declared that the FDA completely halted sales of DMAA. That is wrong information. What actually happened was that on April 24, 2012, the FDA sent warning letters to ten manufacturers that the safety record of DMAA is not clear.

It also has recently challenged manufacturer’s insistence that DMAA is a substance that exists in nature from the geranium plant. The FDA’s current position is that since DMAA wasn’t previously approved as a supplement, it should technically be considered a "drug” and therefore subject to more stringent oversight. Technically, it is currently a "dietary supplement” not a "drug” and did not have to be approved before appearing on shelves.

Can I still purchase DMAA-containing products? As of the writing of this blog post, both GMC and the Vitamin Shoppe are continuing to sell its DMAA-containing products. This also technically exposes them to liability, which explains the increase in very recent class action lawsuits targeting the manufacturers and retailers of the DMAA-containing products after the FDA warning letters were sent.

This will be an interesting standoff to witness. Stay tuned for updates!