NAD Recommends Neogenesis Discontinue Certain Claims for Neo40 Dietary Supplement; Company to Appeal

New York, NY – Oct. 28, 2014 – The National Advertising Division has recommended that by Neogenesis Laboratories, LLC, maker of the Neo40 Daily dietary supplement, discontinue certain claims challenged by the Council for Responsible Nutrition (CRN). The company has said it will appeal NAD’s findings to the National Advertising Review Board (NARB).

NAD is an investigative unit of the advertising industry’s system of self-regulation and administered by the Council of Better Business Bureaus. As part of an initiative with CRN to expand the review of advertising claims for dietary supplements, NAD examined the advertiser’s evidence.

The challenger noted that some of the advertiser’s evidence pertained to the physiological function of nitric oxide (NO) in the body which, a relatively new area of physiology, and did not dispute the important role of NO.

The challenger argued that the core issue was whether the advertiser’s evidence regarding the physiology of NO in healthy individuals could be reproduced in individuals supplementing with Neo40 Daily.  CRN challenged claims that included:

  • “Nitric Oxide is involved in virtually every organ system within our body but is known primarily for maintaining normal blood pressure and blood flow to tissues.”
  • “The endothelium (inner lining) of blood vessels uses Nitric Oxide to signal the surrounding smooth muscle to relax, thus resulting in vasodilation and increasing blood flow and oxygen delivery.”
  • “Effects of Nitric Oxide are widespread throughout the body including, but not limited to, blood vessel dilation.”
  • “Neo40 Daily is proven to help the body naturally increase its nitric oxide level.”
  • “ Neo40 Daily helps maintain circulation.”
  • “Neo40 Daily helps maintain healthy blood pressure.”
  • “Neo40 Daily is proven to help the body naturally increase its nitric oxide level,

(which helps support):

  • Blood Pressure
  • Triglycerides
  • Energy Levels
  • Workout Endurance
  • Sexual Function”

The advertiser contended that NO is a well-studied molecule and noted that more than a 1,000 papers had been written on NO since its discovery in 1989. The advertiser further argued that it produced several methodologically sound studies conducted with the actual Neo40 Daily product that support of all of its performance and mechanism of action claims.

NAD determined that in the context that the advertising claims appear that the advertiser provided a reasonable basis for the following claims:

  • “Nitric Oxide is involved in virtually every organ system within our body but is known primarily for maintaining normal blood pressure and blood flow to tissues”
  • “The endothelium (inner lining) of blood vessels uses Nitric Oxide to signal the surrounding smooth muscle to relax, thus resulting in vasodilation and increasing blood flow and oxygen delivery”
  • “Effects of Nitric Oxide are widespread throughout the body including, but not limited to, blood vessel dilation.”

Regarding the remaining claims, NAD noted that while the production of NO in the body is associated with positive cardiovascular benefits, the question for NAD was whether supplementation with Neo40 Daily led to the promised health outcomes.

NAD noted in its decision that, generally speaking, health-related performance claims must be supported by competent and reliable scientific evidence – specifically human clinical trials that are methodologically sound with statistically significant results to at least the 95% confidence level. The results should also translate into meaningful benefits for consumers that relate directly to the performance attributes promised by advertising.

The advertiser submitted several studies conducted with the Neo40 Daily supplements on healthy and-at-risk-participants and also participants already diagnosed with cardiovascular disease, a case study of improved circulation in one person and a description of a study that purported to look at blood pressure and arterial stiffness in thirty-one people up to one hour after ingesting Neo40 Daily supplements. However, that evidence did not rise to the level of competent and reliable scientific evidence because of methodological flaws in the studies and/or the results from the trials did not support the advertiser’s claims.

Neogenesis Laboratories, in its advertiser’s statement, said it “initially welcomed the opportunity to participate in the self-regulatory process, as it provided an opportunity to demonstrate the depth of its clinical research in support of Neo40.”

The advertiser contended that NAD failed “to appreciate the clinical relevance of the clinical evidence provided, which includes four clinical trials, opinions from five experts in the relevant field, and a wealth of case studies and other research demonstrating the clinically relevant benefits of the product. To say the least, the company disagrees with NAD’s decision.”

Neogenesis, the company added, “appeals the decision in its entirety to the NARB.”