September 13, 2012 — The U.S. Food and Drug Administration (FDA) has sent another warning letter to a dietary supplement manufacturer who uses DMAA in their product. Although DMAA is not banned in the United States, the FDA is warning that products containing DMAA pose serious health risks. Furthermore, these products cannot be sold because synthetically-produced DMAA is not a dietary ingredient, and manufacturers have never submitted a New Dietary Ingredient (NDI) notification to the FDA.
The company that received the warning letter is Regeneca Inc., which makes the product “RegeneSlim.” It is advertised as an “Appetite Control and Weight Loss Management” supplement. DMAA is listed on the product label as “dimethylamylamine.” It is also sometimes known as methylhexanamine or geranium oil/extract. The ingredient has mild stimulant properties, similar to ephedrine, but weaker.
According to the FDA,
“To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that dimethylamylamine will reasonably be expected to be safe as a dietary ingredient. In fact, dimethylamylamine narrows the blood vessels and arteries, which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack).”
The FDA also added, “synthetically produced dimethylamylamine is not a dietary ingredient.”
The FDA has asked Regeneca to immediately cease distribution of RegeneSilm and any other products containing dimethylamylamine. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary ingredients introduced after October 15, 1994 must submit a New Dietary Ingredient (NDI) notification to the FDA. Failure to do so could result in warning letters and enforcement action.
The content of this warning letter is very similar to the content in 10 other warning letters the FDA sent to other DMAA manufacturers in May 2012. Some have fought back — Nutrex responded to a warning letter by presenting evidence that DMAA is a safe, natural substance derived from the geranium plant. There is very little evidence linking DMAA to a botanical source, and most qualified experts agree that it is very unlikely that DMAA is natural.
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