December 2007
RESEARCH
STANDS UP TO
INTENSE SCRUTINY




Claims made by Proctor & Gamble regarding their Metamucil product have recently undergone intense scrutiny by the NAD and other industry policing agencies.

An investigation was conducted and headed by The National Advertising Division (NAD) of the Council of Better Business Bureaus in which they demanded to see substantiation of the claims made on P & G’s Metamucil product.

In response to claim substantiation, Proctor stated “The standards for FDA approval of health claims is the highest of any claims standards.”

In 2007, Human In Vivo Clinical Trials were conducted for Proctor & Gamble by the Glycemic Research Institute (www.Glycemic.com). GRI’s clinical testing protocols are considered the strictest and most accurate in the industry.

It is a Federal offense to make illegal label and product claims, thus clinical trials are required for any product label claims. Companies that cannot produce independent clinical trials directly related to FDA 21 CFR claim substantiation, are in jeopardy of FDA and FTC intervention.

Glycemic Research Institutes (GRI) specializes in FDA and FTC claim substantiation, including clinical testing protocols that have taken the industry testing variability/error rate from 80% down to less than 2%.

GRI has conducted clinical trials for claim substantiation for the major food and Nutraceutical companies for the past 20 years, specializing in the glycemic index, adipose tissue fat-storage, and diabetes.



NUTRAINGREDIENTS.COM

Procter & Gamble's
claims are correct

12/20/2007



Following an investigation, the National Advertising Division (NAD) of the Council of Better Business Bureaus has determined that advertising claims made by Procter & Gamble concerning the cholesterol-lower capacity of its Metamucil dietary supplement are supported.

As part of its ongoing monitoring efforts, NAD had requested substantiation for the claim "Metamucil can help lower your cholesterol", made in print advertising.

The aim for NAD is to weed out companies making false or exaggerated claims, so as to protect the interests of consumers. On a similar note, the dietary supplement industry itself has been looking to self-regulate and monitor so as to enhance the credibility of its own industry.

According to NAD, the advertiser explained that Metamucil contains soluble fiber from psyllium, and that the US Food & Drug Administration (FDA) has approved health claims pertaining to this fiber source - including claims for cholesterol reduction.

To this argument, Procter & Gamble added that the standard for FDA approval of health claims is the highest of any claims standards.

FDA stipulates that to qualify for the health claim, a psyllium product must provide at least 1.7 grams of soluble fiber per reference amount and that the level of daily consumption of psyllium fiber associated with lower disease risk is seven grams per day.

Procter & Gamble answered to FDA accordingly that Metamucil contains 2.4 grams of soluble fiber per reference amount and is labeled for three doses per day.

The Council for Responsible Nutrition (CRN) has undertaken to take part in similar monitoring in order to help industry police itself.

The organization has been amassing grants destined for the NAD with the purpose of allowing it to increase by three-fold the number of dietary supplement-specific case reviews opened each year.

The Council for Responsible Nutrition will have no role in determining which advertisements NAD chooses to review or whether the claims are determined to be truthful and accurate.



PRESS RELEASE

February 2007

PROCTOR & GAMBLE CONDUCTS
CLINICAL TRIALS WITH
GLYCEMIC RESEARCH INSTITUTE®


Click for PRESS RELEASE








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