CITIZENS FOR HEALTH
In April 2012 the U.S. Food and Drug Administration (FDA) issued a Warning Letter to manufacturers of products containing 1,3 dimethylamylamine, also known as DMAA, claiming that DMAA is a “new dietary ingredient,” one which would require an advance notification to the FDA before marketing. DMAA is a naturally occurring ingredient in the geranium plant that is found in the oil obtained from the steam distillation of the stems and leaves of geranium, a plant that has been consumed as a food for well over a century.
DMAA is also an ingredient in popular weight loss and fitness dietary supplements, and produces a sensation equivalent to drinking two or three cups of coffee. Most DMAA-containing dietary supplements are made with an exact, synthetically produced copy of the naturally-occurring dietary ingredient – as is the case with many widely recognized dietary supplements, such as beta-alanine, vitamin C, beta carotene, lycopene, alpha lipoic acid and various amino acids.
A Shot Across The Bow From FDA
Citizens for Health understands the FDA’s putative interest in protecting all of us from dangerous products. However, the agency is clearly overstepping its bounds in this case by using “nonbinding recommendations” (from a draft guidance document no less) to pressure dietary supplement makers into taking their products off the market with no definitive evidence of risk. The FDA is effectively denying American citizens the right to choose for themselves which products to buy.