The case is likely to attract broader interest because konjac mannan (glucomannan) is one of only a handful of ingredients about which the European Food Safety Authority (EFSA) has issued a positive scientific opinion under article 13 of the EU Nutrition and Health Claims Regulation.
False and misleading claims
In the class action complaint, filed on January 17 in the US District Court in the Central District of California against Lipozen maker Obesity Research Institute LLC and DOES 1-25*, inclusive, however, plaintiff Martin Conde argues that claims made about Lipozene are “false and misleading” and that the “research relied upon by the defendant does not substantiate its claims”.
Drafted by law firm Newport Trial Group, which recently filed a high-profile suit against USP Labs over DMAA, the complaint alleges that claims made on the Lipozene website, printed materials, radio and TV ads are not supported by evidence.
Specifically, it says that claims including, ‘78% of each pound lost is pure body fat’…’Lipozene guarantees you will lose weight and body fat’…’Lipozene diet pills are backed by multiple clinical studies’…and ‘Reduce pounds of body fat and weight without a change in lifestyle’ are not supported by science.
Plaintiff: ‘No reliable clinical research can support the claims’
It adds: “In reality, no reliable clinical research or university testing can support the above claims. Those tests and studies purportedly relied upon by the defendant are not named or identified by the defendant nor are the universities or institutions that allegedly conducted them.”
“Defendant’s exaggerated and/or blatant misrepresentations regarding the efficacy of their products were designed to and did lead the plaintiff and others similarly situated to believe that the products were effective at providing weight loss and the reduction of fat.”
The proposed class covers any person located in the US who purchased Lipozene supplements from a store in California or over the internet after April 1, 2011 through the date of trial in this action.
Glucomannan creates a sponge-like effect
Obesity Research Institute does not refer to any published or unpublished research on the Lipozene website although it repeatedly uses the phrase “clinically proven”.
On its website, it says: “Glucomannan creates a sponge-like effect in the intestine, making you feel full and in turn reducing your caloric intake… Glucomannan assists in weight loss without the necessity for a diet or lifestyle change.”
The recommended dosage is one capsule with eight ounces of water three times a day, which “can be increased to two capsules three times daily for even more rapid results”.
According to the label, each 2-capsule serving contains 1,500mg of a proprietary blend containing Amorphophallus konjac from konjac root. The maximum daily dose of six capsules would therefore deliver 4,500mg or 4.5g of the active ingredient.
EFSA opinion: A cause and effect relationship has been established
In its 2010 opinion – which surprised some experts – EFSA concluded that “a cause and effect relationship has been established between the consumption of glucomannan and the reduction of body weight in the context of an energy-restricted diet”.
In order to obtain the claimed effect, said EFSA, “at least 3g of glucomannan should be consumed daily in three doses of at least 1g each, together with 1-2 glasses of water before meals, in the context of an energy-restricted diet.”
However, nutritionist Dr Carrie Ruxton, told our sister publication NutraIngredients.com that EFA’s position opinion was “strange”.
She added: “I would question why EFSA allowed glucomannan a weight loss claim given the balance of the evidence.”
Obesity Research Institute was unavailable for comment as this article went to press.
*The second defendant in the case is listed as “DOES 1-25, Inclusive”. Newport Trial Group says: “The true names and capacities, whether individual, corporate, associate, representative, alter ego or otherwise, of defendants and/or their alter egos named herein as DOES 1-25 inclusive are presently unknown to the plaintiff at this time, and are therefore sued by fictitious names pursuant to California code of Civil Procedure §474.”