GE Pharma recalls dietary supplement over DMAA content

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GE Pharma recalls dietary supplement over DMAA content

Related tags: Lawful dietary ingredient, Dietary supplement

GE Pharma, LLC has announced a recall of certain lots of its dietary supplement products Creafuse Powder Grape and Fruit Punch, which were found to contain DMAA (dimethylamylamine).

DMAA (also known as methyl hexaneamine (MHA) and several other names) has been a subject of controversy for several years of controversy. In April the FDA issued a Consumer Update, which stated the agency’s position that the “information [is] insufficient to defend the use of DMAA as an ingredient in dietary supplements”​.

FDA has issued over a dozen warning letters to manufacturers and distributors of supplements containing DMAA, stating that DMAA was not a lawful dietary ingredient because it lacked a New Dietary Ingredient notification, and raised the issue of whether it is a so-called synthetic botanical.

The GE Pharma recall relates to products distributed nationwide and was sold via telephone and email. They are packaged in a white, 600 gram container with an expiration date of 2/2015. The lot numbers are GE4568 (Grape) and GE4570 (Fruit Punch), said the FDA.

Related topics: Regulation

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