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Posted September 27, 2013

Company Warned For Distributing Weight Loss Supplement Containing DMAA, Drug Claims

On September 6, 2013, the FDA issued a warning letter to Pure Energy Products, Inc., following a facility inspection which found that the company distributes a weight loss supplement, called obestrim, which contains dimethylamylamine, or DMAA.

DMAA, which was listed on the supplement labels as "2-amino-4-methylhexane," has been linked to a number of adverse effects and is not allowed to be sold as a dietary supplement ingredient.

In April 2012, the FDA announced that DMAA is unsafe and cannot be sold as a dietary supplement. At the time, the agency had received 86 adverse event reports on products containing DMAA, which can narrow blood vessels and arteries and potentially increase the risk of elevated blood pressure, shortness of breath and heart attack. It may also be listed on labels as dimethylamylamine, 1,3 dimethylamylamine or methylhexanamine.

Obestrim also contains Arexis Garcinia, green tea extract, Garcinia cambogia extract, L-Carnitine, Semnostachya menglaensis, lotus leaf extract, konjac root fiber and Caralluma frimbriata.

The inspection also found that statements made on product labels, promotional materials and the company's websites about other products, including sexual enhancement supplements Vivetra, Intensa, Cialafil (tiadalis) and Zirex, and weight loss supplement Phentrazine, were found to be drug claims.

Vivetra was promoted with statements such as "The Ultimate Viagra alternative," Zirex was promoted with statements such as "ZIREX is the most effective and safest natural erection producing natural drug," and Intensa was described as "Women's Viagra."

The FDA noted that the name Cialafil closely resembles the name Cialis, a prescription drug for erectile dysfunction, and that similarities in the name and packaging of this supplement to the prescription drug could be misleading to consumers.

Similarly, the agency noted that Phentrazine closely resembles the name of Phentermine, a prescription drug for appetite-suppression.

In addition, Acai Berry Blast, Intensa, RK SLIM, COLON-ES, T-SLIM 2000, Phentrazine 37.5, Zirex, obestrim, and ViaGOLD products were found to be misbranded because the labels failed to provide information required by federal regulations.

(See's Reviews of Sexual Enhancer Supplements, Weight Loss Supplements and Acai Berry Supplements for tests of related products.)

To read the FDA's warning letter, use the link below.