May 9, 2012

“Natural” Ingredients Undergoing FDA Scrutiny

Washington, D.C.—The FDA is questioning whether dimethylamylamine, more popularly known as DMAA, really is a "natural" stimulant and why safety evidence has not been presented for supplements containing it.

Warning letters were sent to 10 manufacturers of the following products: Biorhythm SSIN Juice, LeanEfx, Spirodex, PWR, Napalm, Code Red, Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, Lipo-6 Black Hers, MethylHex 4, 2, Nitric Blast, Oxy Elite Pro and Jack 3D. Here is one of the letters.

FDA has received 42 adverse event reports on products containing DMAA, alleging that the supplement caused cardiac disorders, nervous system disorders, psychiatric disorders, and death.

Dimethylamylamine, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is marketed as a natural stimulant, the FDA warning letters said, but no evidence has been presented to indicate that DMAA is safe. The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires manufacturers, marketers and distributors of dietary supplements to prove that they are marketing a safe product.

DMAA is known to narrow blood vessels and arteries, which can elevate blood pressure and potentially lead to cardiovascular events ranging in seriousness from shortness of breath and tightening in the chest to heart attack, according to the FDA letters.

"Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven't done that and that makes the products adulterated," Daniel Fabricant, PhD, director of FDA's Dietary Supplement Program, said in a statement.

The companies have 15 business days to respond to the FDA with the specific steps they will take to address the issues in the warning letters.

Controversy about the supplements was fueled last year after two soldiers died of heart attacks during fitness training, and 1,3-dimethylamylamine was found in their toxicology reports.

A number of class action lawsuits also have been filed.  

U.S. Pharmacist Social Connect