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Class Sees Dangerous Drug in Diet Supp

SAN FRANCISCO (CN) - A federal class action claims a diet supplement maker sells a powerful and dangerous stimulant banned by Major League Baseball and Canada, and makes false claims about its effectiveness.

Lead plaintiff Stephen Rush sued Nutrex Research in Federal Court.

Rush claims that Nutrex's leading products, including "Hemo Black Rage," "Hemo Black Rage Ultra Concentrate," "Lipo Black 6 Ultra Concentrate," "Lipo Black 6 Hers" and "Lipo Black 6 Hers Ultra-Concentrate" contain dangerous levels of the stimulant DMAA, also known as 1,3, dimethylamylamine, and as methylhexanamine, and as geranamine.

DMAA, whose 1944 patent claims to be derived from the oil of the geranium plant, is a dangerous central nervous system stimulant that is on the World Anti-Doping Agency and Major League Baseball lists of banned substances, according to the 37-page complaint. "DMAA is totally banned in Canada and New Zealand. Recently, DMAA has gained popularity with young people as a designer drug used in 'party pills,'" according to the complaint.

DMAA was developed by Eli Lilly and marketed as a nasal decongestant in the 1970s under the trade name Forthane, the complaint states.

Rush claims that the DMAA in Nutrex's products is purely synthetic. "Significantly, recent studies have also concluded that there is no DMAA in geranium oil at all, that DMAA cannot be extracted from geranium oil, and that all DMAA on the market is synthetic," the complaint states.

"Because DMAA is a wholly synthetic substance, it is not a 'dietary ingredient,' and Nutrex's products are therefore not 'dietary supplements' as those are terms defined by the federal Food, Drug and Cosmetic Act (FDCA) and implementing rules and regulations adopted by the US Food and Drug Administration - all of which are expressly incorporated into California's Sherman Food, Drug and Cosmetic Act."

Rush claims that because DMAA was previously patented and marketed as a drug, it cannot now be considered a dietary ingredient for supplements under the FDCA.

"Although defendants have been extremely successful with the marketing, sale and distribution of the products, their success has been based on false, misleading and deceptive labeling and advertising," the complaint states. "Nutrex sells the products through a deceptive marketing campaign claiming that they are safe, all natural dietary supplements which can be used as a pre-workout 'detonator' or as weight loss 'fat destroyer' products." (Citations to exhibits of ads omitted.)

"Defendants fail to inform consumers that the products do not meet the definition of a 'dietary supplement,' and that DMAA does not meet the FDA's definition of a 'dietary ingredient,' as those terms are defined and adopted by California's Sherman Law," the complaint states.

"The FDCA defines a dietary supplement as 'a product (other than tobacco) intended to supplement the diet' that contains one or more enumerated 'dietary ingredients,'" according to the complaint. The dietary ingredients in such 'supplements' may include a number of enumerated naturally occurring substances; such as vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates. A purely synthetic substance cannot be a dietary ingredient," the complaint says. (Parentheses in complaint, citations omitted.)


The plaintiff says all DMAA is synthetic. "NSF International, a world leader in standards development and product certification for over 65 years, and widely recognized for its scientific and technical expertise in product certification, has publicly stated that it has tested geranium oil down to a parts per billion screen, and DMAA is not derived from natural geranium oil; it is a synthetic compound and not a natural constituent of the botanical geranium," the complaint states. "Furthermore, experts in the industry have been extremely concerned that this potent stimulant drug will lead to serious health issues and even death, as was the case with ephedra before it was banned by the FDA in 2003.

"In addition, defendants make claims regarding the effects of the products on the human body structure and function that are essentially drug claims. In other words, defendants market the products as safe, over-the-counter dietary supplements, but ones which also affect the structure and function of the body in the same manner as drugs. Defendants fail to inform consumers that the product labeling and Internet advertising make 'structure/function' claims without having adequate scientific substantiation to support such claims.

"For example, the labeling for Hemo Rage Black Ultra Concentrate claims that use of the product provides 'freakish blood-engorged vascularity, tunnel-vision like mental focus and clarity, coupled with record-shattering strength gains that will help propel your physique to new heights.' "The labeling for Hemo Rage Black asserts the product '[i]nduces raging energy, expands blood volume, increases strength, hyper-activates pump effect, detonates fat, and provides serious muscle-building compounds all in one.'" (Citations omitted.)

The labeling for the Lipo 6 Black Hers Ultra Concentrate and Lipo 6 Black Unltra Concentrate calls those drugs "'the world's first one-pill-only fat destroyer that combines receptor cleansing and reprogramming agents with an ultra concentrated fat destroying complex ... [And each] cleanses and reprograms receptor sites to support maximum cell-to-cell communication ... [and] hits the fresh receptor with an ultra concentrated fat destroying complex so powerful that all you need is a single pill," the complaint states. (Ellipses and brackets in complaint)

Rush claims that under the FDCA, diet supplement labeling may include claims about the supplement's effect on the structure or function of the human body only if certain requirements are met.

"One of these requirements is that the manufacturer must have substantiation that the claims are truthful and not misleading," the complaint states. "Plaintiff is informed and believes and on that basis alleges that defendants do not have scientific substantiation to support the structure/function claims made by defendants regarding the products.

"The FDA has often warned manufacturers of 'fat burner' products like RoxyLean that claims their products 'burn fat,' are 'thermogenic,' or 'suppress appetite' are structure/function claims requiring adequate scientific substantiation (and possibly even 'disease claims' which cannot be made about dietary supplements at all, i.e. that so-called 'fat burner' products can be used to cure or treat obesity).

"Some of the 'fat burner' products which the FDA has cited in the past for making improper structure/function claims were products which also contained synthetic stimulants, much like DMAA. Like synthetic norephedrine, synthetic DMAA is not a 'dietary ingredient' as that term is defined and adopted by California's Sherman Law." (Citations omitted, parentheses in complaint.)

Rush claims that the products branded as "Ultra Concentrate" violate the FDCA and Sherman Law because most ingredients do not have established Reference Daily Intake (RDI) or Daily Reference Value (DRV), and California law allows words such as "maximum," "high potency," or "ultra concentrate" to be used only to describe nutrients present at 100 percent or greater of such values.

Rush says DMAA can have "extremely dangerous side effects."

"Significantly, Don Caitlin, preeminent anti-doping scientist, has noted in a Washington Post news article that DMAA has a chemical structure similar to amphetamine and ephedrine, and can cause increases in heart rate and blood pressure, and even death. Caitlin further states 'this substance should not be out there ... it's a dangerous material,'" the complaint states, citing the Post article.

"The safety concerns associated with DMAA have been well documented, including concerns that DMAA is a dangerous and addictive substance that can cause headache, nausea, and stroke. To make things worse, DMAA is widely used as a 'designer drug' in dangerous 'party pills.'

"Despite defendants' knowledge of the dangers associated with DMAA use, they continue to advertise and sell the products to unknowing consumers as safe, dietary supplements. Defendants have failed to warn consumers that DMAA use can potentially cause serious adverse side effects, that DMAA is considered to be a potentially dangerous, performance-enhancing stimulant in the sports world and, as such, is classified as a banned substance by MLB, WADA, and the United States Anti-Doping Agency. Numerous athletes in various sports throughout the world have been suspended or disqualified for unknowingly using products containing DMAA. However, despite having knowledge of these facts, defendants have never specifically warned consumers that DMAA is actually banned by certain sports organizations, as well as being completely banned in Canada and New Zealand, and could cause users to fail drug tests.

"Defendants not only promise consumers that the products are safe, they also assure consumers the products are effective and can produce amazing results. Defendants promise these results knowing that none of the products, nor any of the products' individual ingredients at the levels contained therein, can produce these promised results. Plaintiff is informed and believes, and on that basis alleges, that any existing efficacy studies are on individual ingredients contained within the products, and none of these studies are on healthy humans with equivalent dosing or routes of administration. Therefore, such claims are purely false advertising to induce consumers to spend their hard earned money on unproven products solely for defendants' monetary gain," the complaint states. (Citations omitted.)

Rush claims that he and his girlfriend used Nutrex's products for about a month and a half and suffered adverse effects that included "feeling jittery and anxious when using the products, having a racing pulse rate and fast heartbeat, and feeling exhausted when not using the products."

Rush also sued Nutrex's owners, Jeffrey McCarrell and Jens Ingenohl.

He wants sale of products with DMAA enjoined and class damages for violations of the Consumer Legal Remedies Act, California's Unfair Competition Act and false advertising laws, breaches of implied and express warranty, and unjust enrichment.

He is represented by Melissa Meeker Harnett and Gregory Scarlett, with Wasserman, Comden, Casselman and Esenstein, of Tarzana.

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