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Posted September 12, 2012

Distribution of Weight Loss Product Containing DMAA Should Be Stopped Immediately, Warns FDA

On August 28, 2012, the FDA issued a warning letter to Regeneca stating that the company's RegeneSlim, which was promoted as a dietary supplement for weight loss, is adulterated with dimethylamylamine (DMAA) and that failure to immediately cease distribution of this product could result in FDA enforcement action without further notice.

Dimethylamylamine is known to narrow blood vessels and and arteries, increase blood pressure, and is associated with cardiovascular events such as heart attack and stroke. Supplements containing dimethylamylamine were pulled from store shelves in 2011 after these products were linked to two deaths. In April 2012, the FDA issued warning letters to ten manufacturers who continued to use the ingredient in their products.

According to the FDA's warning letter to Regeneca, there is no history of safe use of dimethylamylamine and "inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury."

Once thought to be a natural component of geranium oil, recent analytical testing has shown dimethylamylamine found in supplements may be synthetic.

Synthetic dimethylamylamine is not permitted as a dietary supplement ingredient, as the FDA's letter explains: "Synthetically produced dimethylamylamine is not a vitamin, mineral, amino acid, herb or other botanical. To the best of FDA's knowledge, synthetically produced dimethylamylamine is not commonly used as human food or drink; therefore, it is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, synthetically produced dimethylamylamine is not a concentrate, metabolite, constituent, extract or combination of a dietary ingredient. Therefore, synthetically produced dimethylamylamine is not a dietary ingredient as defined in section 201(ff)(1) of the Act."

RegeneSlim also contains chromium, Garcinia cambogia extract, and a proprietary blend including kola nut extract, green coffee bean extract, chlorogenic acid, synephrine HCL, guggulsterones, tyramine, hamala extract and coleus.

See's Reviews of Chromium Supplements and Weight Loss Supplements for tests of other products promoted for weight loss.

For more details regarding the FDA warning letter, use the link below.