New York, New York – August 11, 2009 – The National Advertising Division of the Council of Better Business Bureaus has determined that certain advertising claims made by Herbal Groups, Inc., the maker of Prostalex Plus dietary supplement, were supported by the advertiser’s evidence. However, NAD recommended that Herbal Groups, Inc., modify or discontinue certain advertising claims for the product. The advertiser voluntarily discontinued its ‘Prostate Health Blog,’ at the outset of NAD’s inquiry.

As a part of its ongoing monitoring program and in conjunction with NAD’s initiative with the Council for Responsible Nutrition to expand NAD’s review of advertising claims for dietary supplements, NAD – the advertising industry’s self-regulatory forum – reviewed Internet advertising for Prostalex. The claims at issue included the following:

• “Revolutionary new drug-free formula helps you regain your youthful prostate function so you’ll urinate less often and sleep though the night.”
• “Introducing Prostalex Plus, the amazing new all-natural supplement for men that helps solve your urination problems, improve prostate function, and boost prostate health so you won’t need to urinate as often, you’ll enhance urination function, and you’ll finally be able to sleep though the night without any trips to the bathroom!”
• “The amazing new Prostalex Plus drug-free supplement has been scientifically formulated to reduce your need to urinate by combating the natural growth of your prostate, which occurs naturally as you age and is the cause of most urination problems in men.”
• “Containing rare, high-potency, all-natural ingredients, the Prostalex Plus formula is unique because it not only stops your constant need to urinate, it also helps improve your ability to urinate (so you’ll no longer have trouble getting your stream to start), and it helps you maintain a healthy prostate.”
• “Prostalex Plus has shown in clinical studies to naturally treat the cause of urinary and sexual dysfunction issues by helping to reduce the size of an enlarged prostate, leading to long-term, lasting results.”
• “Prostalex Plus has been shown in clinical studies to reduce the size of the prostate, leading to: a reduced urge to urinate, improvement in Urinary Flow, improvement in Erectile Issues, and increased Sex Drive.”

NAD was concerned, as well, about the testimonials featured in the advertising:

• “I used to get up more than 6 times a night. Now I don’t have to get up even once!”
• “I almost had to quit my job as a truck driver, but now I can go for hours and hours without having to look for a bathroom.”
• “All my urination problems – urgency, frequency, low flow, dribble – they’re totally gone now!” 

During the course of the NAD inquiry, the advertiser voluntarily discontinued the “Prostate Health Blog.”  NAD noted in its decision that “all of the posts on the blog are posted by Prostalex Plus.” Although some posts related to prostate health in general, other posts advertised Prostalex Plus specials. NAD determined that the blog itself constituted advertising and noted its appreciation that the advertiser had discontinued the blog.

NAD examined evidence that included a 2005 study of Prostalex Plus, which was conducted on 50 men over the age of 40. As part of the study, participants blood pressure, pulse, temperature, respiration, and digital rectal exams. In addition, urine and saliva samples were collected and analyzed. The subjects were examined following the second week and fourth week of use of Prostalex Plus. 

The study concluded that the decrease in prostate inflammation at the end of the fourth week using Prostalex Plus indicated a lowered rate of 24%. A second phase of this study was conducted with 20 men over the age of 40. The second phase study researchers concluded that the decrease in prostate inflammation at the end of the eighth week using Prostalex Plus indicated a lowered rate of 38%.

NAD also examined studies on the product’s ingredients, which include Beta-Sitosterol.

Following its review of the evidence in the record, NAD determined that the Prostalex Plus study demonstrated that use of the product helped to reduce prostate size as measured by the digital rectal exam. In addition, NAD found that certain claims of improved prostate function – less frequent urination and improved urinary flow – were also supported, as long as such claims were tied to the reduction in prostate size.

NAD was concerned, however, that certain claims overstated the results of the research. NAD recommended the advertiser discontinue the claim “regain your youthful prostate function,” and modify claim the overly broad claims that the product will ““solve” urination problems and “…you’ll finally be able to sleep though the night without any trips to the bathroom.”

NAD found that that the advertiser could support its claim that the product has been “scientifically formulated to reduce your need to urinate by combating the natural growth of your prostate … .” NAD noted that the claim clearly connects the reduction of “the need to urinate” to the demonstrated effect of the product – a reduction of prostate size.

NAD found that the absolute claim that Prostalex Plus will “stop your constant need to urinate” was not supported by the research. Further, while the claim that Prostalex Plus can “improve your ability to urinate” was supported, NAD recommended the advertiser more clearly connect the claimed benefit to a reduction in prostate size.

NAD recommended that the advertiser modify the claim “no longer have trouble getting your stream to start,” to more accurately reflect that the benefit is related to a reduction in prostate size and discontinue the claim that a reduction in prostate size would lead to “improvement in Erectile Issues, and increased Sex Drive,” given the absence of evidence regarding sexual function.

NAD further recommended that that advertiser discontinue the testimonials at issue, noting that there was insufficient evidence to support them.

The company, in its advertiser’s statement, said it would comply with NAD’s recommendations.

The company noted that it will “remove the customer testimonials and, if we were to include testimonials in the future, we will attempt to use those that are representative of more common results.”