BBB National Programs Archive

NAD Recommends Lutimax Nutraceuticals Discontinue All Challenged Claims for Supplement Marketed as Treatment for Autism Spectrum Disorders

New York, NY – May 7, 2014 – The National Advertising Division has recommended that Lutimax Nutraceuticals, LLC, discontinue all of the advertising claims for “Lutimax Pediatric Powder & Pediatric Powder with L-Theanine” identified in a challenge filed by Council for Responsible Nutrition.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

As part of NAD’s initiative with CRN to expand the review of advertising claims made for dietary supplements, NAD requested that Lutimax provide substantiation for a wide range of claims made for “Lutimax Pediatric Powder & Pediatric Powder with L-Theanine,” including:

  •  “Lutimax Pediatric Powder has been clinically shown to help improve the quality of life in children.”
  •  “It can help with speech improvement, emotional attachment, cognitive functions, coordination, behavior outbursts, attention span, intimacy, interaction, and comprehension.”
  •  “If you have a hyper-active child Lutimax Pediatric Powder with L-Theanine would be recommended as a first choice.”
  •  “Preclinical studies have shown that luteolin may possess pharmacological activities, including antioxidant, anti-inflammatory, antimicrobial, and anticancer activities.”

The advertiser’s products are formulated with the anti-inflammatory flavonoids luteolin and rutin. The advertiser relied in large part on an open-label pilot study that examined the effects of luteolin and quercetin on the behavior in children with autism spectrum disorder.

NAD had several concerns about the reliability of the study to support the challenged claims. The supplement tested during the study included an ingredient that isn’t found in the advertiser’s products, NAD noted, and the recommended dosage of luteolin differed between the supplement examined during the study and Lutimax products.

The study, NAD noted, “was fatally flawed for the purpose of claim substantiation because it had no placebo group and was not blinded.”

Further, as only forty children over a wide age range (4 to 10 years-old) completed the study, NAD also questioned its robustness.

NAD noted in its decision that “Autism Spectrum Disorder, as the name suggests, is a disorder encompassing a wide range of social and functioning skill levels, with some children having milder symptoms while others are profoundly disabled.” It wasn’t clear from the advertiser’s evidence, NAD noted, where children fell on the spectrum or what impact, if any, other therapeutic interventions may have had on the outcome.

NAD recommended that the advertiser discontinue all of the challenged claims because the study on luteolin and quercetin was not a randomized, placebo-controlled, or blinded study, and used a different formulation and dosage of ingredients than that found in the Lutimax products. In the absence of competent and reliable testing on humans, NAD further determined that the advertiser’s in vitro and animal testing on luteolin, rutin and L-theanine were insufficient to provide a reasonable basis for its claims.

NAD noted that nothing in its decision prevents the advertiser “from making carefully qualified claims based on their in vitro and animal studies as long as the claims clearly and conspicuously make it known that they are based on in vitro and animal studies and do not convey the unsupported message that the results can be extrapolated to humans.”

Lutimax Nutraceuticals, in its advertiser’s statement, said it disagreed with NAD’s conclusions, “but in support of the self-regulatory process, agree[d] to take NAD’s recommendations into account in future advertising.”