FDA warns supplement firms over unapproved ingredient

May 4, 2015

The FDA issued warning letters to 14 dietary supplement manufacturers because they are using an ingredient not approved for use.The ingredient in question is 4-Amino-2-Methylpentane Citrate, also known as 1,3-Dimethylbutylamine, 2-amino-4-methylpentane, AMP citrate, and 4-methyl-2-pentanamine, or DMBA.

FDA issued warning letters to 14 dietary supplement manufacturers because they are using an ingredient not approved for use.

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The ingredient in question is 4-Amino-2-Methylpentane Citrate, also known as 1,3-Dimethylbutylamine, 2-amino-4-methylpentane, AMP citrate, and 4-methyl-2-pentanamine, or DMBA. “To the best of FDA’s knowledge, there is no information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered,” the warning letters state.

The letters were sent to: 1ViZN LLC in Lehi, Utah; Beta Labs in Newark, Del.; Blackstone Labs LLC in Boca Raton, Fla.; Brand New Energy LLC in Burbank, Calif.; Core Nutritionals LLC in Arlington, Va.; DSEO LLC in Riverside, Calif.; Genomyx LLC in Riverside, Calif.; Iron Forged Nutrition (dba, TGB Supplements) in Hopwood, Penn.; Lecheek Nutrition in Harrison, Ark.; Nutrex Research Inc. in Oviedo, Fla.; Powder City LLC in York, Penn.; Prime Nutrition in Boca Raton, Fla.; RPM Nutrition LLC in Norwalk, Ct., and Vital Pharmaceuticals(dba, VPX Sports) in Weston, Fla., according to Food Safety News.

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Even if information had been submitted about DMBA to FDA, “we know of no evidence that would establish that your product is not adulterated,” according to the letters. “It contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.”

FDA also recently sent warning letters to five manufacturers of dietary supplements containing beta-methylphenethylamine, or BMPEA, which is widely used for weight loss and energy enhancement. 

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