New York, New York – Feb. 9, 2011 – The National Advertising Division of the Council of Better Business Bureaus has determined that Pharmavite, LLC., can support challenged advertising claims for the company’s Nature Made GreatMind dietary supplement.

NAD, the advertising industry’s self-regulatory forum, reviewed claims that appeared in print and Internet advertising and on product packaging, pursuant to NAD’s ongoing monitoring of advertising for dietary supplements.

Claims at issue included:

• “Keep your mind great with Nature Made GreatMind!”
• “Enhances mental clarity and performance.”
• “Naturally helps improve and maintain short-term memory.”
• “Helps guard against normal cognitive decline associated with aging.”
• “Nature Made GreatMind is an easy, natural and effective way to take care of your mind so you can stay clear, sharp and active.”
• “Nature Made GreatMind has a unique, patent-pending formula that enhances mental performance, clarity and short-term memory with daily use.”
• “Nature Made GreatMind is formulated with key ingredients that your mind needs to stay healthy.” 

According to the advertiser, the product is a cognitive health supplement, based on a formulation developed and studied by Dr. Thomas B. Shea, Ph.D., and his colleagues at the University of Massachusetts, Lowell. The formulation has been studied by Dr. Shea and his colleagues in subjects with early, moderate, and later-stage Alzheimer’s disease. Those subjects showed improvement on certain cognitive and dementia rating scales, and formulation was then later studied in healthy subjects using cognitive scales to evaluate the effects.

The advertiser stated that GreatMind contains vitamin E, folic acid, vitamin B12, N-acetyl-L-cysteine (NAC), acetyl-L-carnitine hydrochloride (ALCAR), and S-adenosylmethionine (SAM-e), in the same formulation as the ingredients used in the studies conducted by Dr. Shea and his colleagues, although the amount of vitamin B12 in GreatMind was increased to 12 mcg from 6 mcg.

NAD noted in its decision that the first Shea study was a double-blind study, with 93 participants; the second, a six-month trial with the 38 subjects and no control and third, a two-week study with 43 subjects that compared treatment with the nutraceutical formulation to placebo.

NAD noted that the first Shea study was a double-blind study, with 93 participants that received either placebo or the nutraceutical formulation for a period of 3 months. The participants, both male and female, ranged from 18 to 80 years old, with no known or suspected dementia or clinical memory difficulties. At 3 months, the control subjects were switched to the nutraceutical formulation for 3 months (this group was called the “delayed start” group) while the treated subjects continued with the nutraceutical formulation for 3 more months. At the 6 month point, all participants stopped taking the product. At 9 months, a small number of the subjects from the trial were re-enlisted to start taking the product again for 3 more months, resulting in a 12 months total length. The second Shea study was a 6 month trial with 38 subjects, and no control. The third Shea study was a short-term study with 43 subjects comparing treatment with the nutraceutical formulation to placebo for 2 weeks, followed by an additional 2 week period during which all of the participants were given the nutraceutical formulation.

Following its review of the evidence in the record, NAD concluded that the results of the Shea Studies, which found statistically significant improvement in various measures of cognitive ability in those participants taking GreatMind, provided a reasonable basis for the specific claims about the supplement’s ability to improve and maintain memory and cognitive ability.   

Pharmavite, in its advertiser’s statement, said the company is a strong supporter of advertising industry self-regulation.

“Pharmavite believes consumers are best served when advertisers are held to the rigorous standards employed by NAD and appreciates the opportunity to participate in the self-regulatory process,” the company said.