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GNC Says "No Basis" for FDA Crackdown on DMAA Supplements

The dietary supplement retailer GNC has called the U.S. Food and Drug Administration (FDA) action against DMAA “factually and legally unfounded.” In April 2012, the FDA sent 10 warning letters to manufacturers of products containing DMAA. The FDA had concluded that DMAA is a synthetically produced drug — not a dietary ingredient — and therefore an illegal ingredient in dietary supplements. GNC spokesman Greg Miller said there is “no basis for this FDA action,” and GNC is “unaware of any scientific or medical evidence which calls the safety of DMAA into question.”

The debate about the safety of DMAA was sparked after the U.S. Department of Defense banned sales of all products containing DMAA on military bases, following the deaths of two soldiers. The solders suffered severe cardiovascular events during training exercises, and they were found to have DMAA in their bloodstream. In response to these deaths, GNC stated that “no link between DMAA and the medical conditions reported by military medical providers have been validated scientifically by us,” and furthermore, “GNC believes DMAA is safe for consumer use.”

DMAA is known to cause blood vessels to constrict, which can increase blood pressure, and may lead to severe cardiovascular events including heart attack. The FDA has received 42 adverse event reports from people who have suffered cardiovascular disorders, nervous system disorders, psychiatric disorders, and death.

DMAA supplements (Jack3d, OxyElite Pro, C-4 Extreme, party pills, and more) are sold as pre-workout energy boosters and weight-loss aids. Since 2007, more than 440 million doses of the products have been sold. DMAA is often listed on the ingredient labels as “dimethylamylamine,” “methylhexanamine,” or geranium extract.

The link between DMAA and the geranium plant is weak, based on one technical report published in a non-peer-reviewed Chinese journal in 1996. No independent scientist has ever been able to produce DMAA from the geranium plant. In fact, DMAA was originally synthesized by the drug company Eli Lilly in the 1940s, used as a nasal decongestant.

The FDA has concluded that there is no link between DMAA and the geranium plant, and DMAA is a synthetic drug that is illegally marketed as a dietary supplement.

GNC said that the company “totally disagrees with FDA’s interpretation of DSHEA (1994 Dietary Supplement Health and Education Act).” Under this act, manufacturers of dietary supplements are exempt from most of the safety regulations required for food and drugs. However, DSHEA explicitly states that manufacturers selling new ingredients introduced after 1994 must provide the FDA with safety information. Manufacturers have never provided the FDA with evidence of the safety of DMAA.

Do I Have a DMAA Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in DMAA lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has suffered from severe side effects after taking DMAA, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

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