By Elaine Watson Nutra Ingredients USA
G.N.C., Cellucor Sports Nutrition and others have been accused of misleading consumers over the source, regulatory status and safety of the controversial stimulant DMAA (1,3 Dimethylamylamine) in a new class action lawsuit filed in California.
G.N.C.: 'There is also no scientific/medical evidence that demonstrates any causal link between DMAA and any adverse medical condition, let alone a death'
In a civil action filed in the US District Court, Central District of California against G.N.C., Cellucor Sports Nutrition, Woodbolt Distribution, Woodbolt Management and Woodbolt International, plaintiff Lynette Bates argues that the defendants misled shoppers by selling Cellucor's C-4 Extreme pre-workout supplement containing the “synthetic and dangerous stimulant DMAA”.
The plaintiff seeks damages on behalf of all persons in the US who purchased C-4 Extreme at any time during the past four years.
DMAA is ‘wholly synthetic, manufactured and not derived from the geranium plant’
The complaint comes hot on the heels of actions filed against BPI Sports and USP Labs for selling supplements containing DMAA alleged to be in a “synthetic form that is both illegal and dangerous”.
The US Department of Defense has also removed DMAA-containing products from stores on US army and airforce bases while it conducts a probe into the safety of DMAA following the deaths of two soldiers found to have it in their blood.
The new action, filed on February 15, alleges that during the class period, the defendants engaged in an illegal and deceptive practice of promoting, marketing, distributing and/or selling C-4 Extreme as a natural dietary supplement when, in fact, the DMAA in C-4 Extreme is “wholly synthetic, manufactured and not derived from the geranium plant”.
It adds: “It is in the defendants’ interests to maintain that DMAA is natural so that they can avoid FDA (Food and Drug Administration) scrutiny.
“Plaintiff alleges that the DMAA contained in C-4 Extreme is a synthetic product that is illegal and dangerous and has dangerous side effects.”
The action acknowledges that Cellucor may have recently reformulated its products to remove DMAA from some iterations of C-4 Extreme [DMAA is no longer listed in the C-4 ingredients list on the Cellucor website] but notes that it has been replaced with another stimulant called Synephrine HCL.
It adds: "Even if Cellucor has switched synthetic stimulants to be included in later versions of C-4 Extreme, this change has not corrected the misrepresentations to consumers identified in this complaint."
What is the source of DMAA in dietary supplements?
There is an ongoing debate about whether DMAA (also known as methylhexaneamine or MHA), which was first manufactured synthetically by drug giant Eli Lily in the 1940s, is in fact a constituent of geranium, with the consensus growing that it is not.
Health Canada has also issued a statement arguing that DMAA is not found naturally in geranium (as supplement makers using it claim) and affirming that any products containing it require a drug authorization.
No credible evidence DMAA is in geranium
There is only one study that is repeatedly referenced to show that DMAA is a naturally occurring constituent of geranium oil (Ping, Z.; Jun, Q. & Qing, L. (1996), ‘A Study on the Chemical Constituents of Geranium Oil, Journal of Guizhou Institute of Technology 25 (1): 82–85).
However, analytical testing experts contacted by NutraIngredients-USA say they are not convinced by the study.
Frank Jaksch, chief science officer at analytical testing and health ingredients firm ChromaDex, said last month he had “not seen any credible evidence that DMAA is in geranium.
“I’ve seen data from some other sources that have tried to reproduce the results [of the Ping et al study] and no one has been able to do it. Everything that we’ve seen appears to be synthetic material.”
As for what if any action was needed from the FDA, he said: “My guess is that class action lawsuits will probably purge it from the market much faster than the FDA.”
A paper recently published in the journal Drug Testing and Analysis has also added fuel to the debate by asserting that “the use of the name Geranamine for this compound appears to have been a marketing ploy.”
However, USPLabs – which insists the DMAA in its OxyELITE and Jack3d dietary supplements is derived from geranium - says it has new data from “two independent and highly respected analytical chemistry laboratories” that “further demonstrate the occurrence of DMAA in the geranium plant, Pelargonium graveolens, and its edible oil”.
Trade association views
Meanwhile, the American Herbal Products Association (AHPA) has advised members not to label DMAA as geranium oil or any part of the geranium plant – a stance supported by the United Natural Products Alliance (UNPA).
The Natural Products Association (NPA) said it has “no comment on this issue at this time”, while Council for Responsible Nutrition (CRN) vice president, scientific & regulatory affairs Duffy MacKay said last month that the CRN was still debating the issue.
American Botanical Council (ABC) executive director Mark Blumenthal said that even if it is determined that DMAA is in geranium, the sheer quantity of raw material needed to produce even small quantities of it suggested that “from a chemical engineering and economic point of view” it was highly unlikely that the DMAA used in supplements was extracted from geranium.
G.N.C.: No causal link between DMAA and any adverse medical condition
G.N.C. said it does not comment on pending litigation, while Cellucor was unavailable for comment as this article went to press.
However, G.N.C., which agreed to recall 18 products containing DMAA from stores on US military bases, said last month: “There is also no scientific/medical evidence that demonstrates any causal link between DMAA and any adverse medical condition, let alone a death.
"It’s important to remember that adverse event reports do not equate to scientific/medical evidence that demonstrates a product was the cause of the harm.”
His comments came as the FDA said it would consider whether regulatory action was required over DMAA in the wake of the army probe and the wave of class action lawsuits.