New York, NY – July 9, 2009 – The National Advertising Division of the Council of Better Business Bureaus has recommended that PatentHEALTH LLC modify or discontinue certain claims for the company’s Trigosamine Fast Acting (Trigo FA) dietary supplement, including speed of relief claims. The company has said it will appeal certain NAD findings to the National Advertising Review Board.

NAD, the advertising industry’s self-regulatory body, examined advertising for Trigo FA following a challenge by Nutramax Laboratories, Inc. Claims at issue included:

• “Mom gets rapid relief from the new joint pill that works in just 3 days.”
• “Trigosamine Fast-Acting has been clinically shown to get results in as little as 3 days. Participants continued to feel improvement throughout the 8 week trial”
• “Just released clinical study says new pill works 600% faster than Glucosamine alone.”
• “2 caplet dose for fast, all day joint relief.”
• “It’s a blend of herbal extracts that when combined with glucosamine improves absorption of nutrients and works quickly to improve mobility and flexibility.” 
• In addition, the challenger raised a concern over the format of the print advertising, which appeared as a newspaper article, and may not be understood by consumers to be an advertisement.

The advertised product is an addition to the advertiser’s line of joint-health products, and was introduced into the marketplace in 2008. In contrast to the original formula Trigosamine, which contains Glucosamine HCl, Chondroitin Sulfate, and Hyaluronic Acid,  Trigo FA contains a formula of Glucosamine Sulfate, Hyaluronic Acid and the “RapidFlex” proprietary blend, which includes trademarked Boswellin (Boswellia serrata gum resin extract), patented Curcumin C3 Complex (extract from the root of Curcuma long (turmeric), and patented Bioperine (a standardized extract of black pepper). 

As support for its performance claims, PatentHEALTH relied on a clinical study on Trigo FA that it commissioned to test the supplement’s efficacy in the management of osteoarthritis of the knee in comparison to placebo. The advertiser maintained that in the fall of 2008, its proprietary Trigo FA study was completed, and based upon the results, as well as the substantial body of scientific evidence for each of the individual ingredients in Trigo FA, PatentHEALTH developed its advertising claims for new Trigo FA. The advertiser also submitted an independent expert report and review of the study by Dr. Michael Glade, Ph.D., F.A.C.N., C.N.S. 

In addition to the study on the product, the advertiser relied on studies conducted on the individual ingredients in Trigosamine FA, including glucosamine, hyaluronic acid, boswellia, Curcumin and Bioperine. Further, NAD has reviewed advertising substantiation in several other cases involving glucosamine products. Based on all of this evidence, NAD noted in its decision that it recognizes that glucosamine supplementation provides a benefit for sufferers of osteoarthritis, but not within the short time periods advertised for this product.

The advertising featured several claims of fast relief, such as “Mom gets rapid relief from the new joint pill that works in just 3 days.” and “Trigosamine Fast-Acting has been clinically shown to get results in as little as 3 days. Participants continued to feel improvement throughout the 8 week trial” as well as the name of the product itself, Trigosamine “Fast Acting.”

These claims of “rapid relief” and “fast acting” are based on the advertiser’s Trigo FA study which found that the subjects taking Trigo FA experienced a statistically significant (albeit small) increase in the distance walked from baseline as measured by a six-minute walk test, after three days of supplementation. In contrast, the placebo group in the study experienced a decrease in distance walked in the six minute walk test at every measured interval. The advertiser maintained that this positive and statistically significant result evidences that the product can “work” for most in only three days, which is a quick result that can be referred to as a “rapid relief” and, therefore, this claim is properly substantiated.

NAD determined however, found that there was insufficient evidence to establish that the demonstrated improvement in the walk test is what consumers taking Trigo FA would expect or consider as the claimed “relief” promised in three days. NAD recommended that the advertiser discontinue using the term “rapid relief,” since there was insufficient evidence that the results achieved in the Trigo FA study would be considered by consumers to be “rapid relief.”

Further, citing concerns about the parameters of the walk test, NAD recommended that the advertiser discontinue claims based on the results of the test as measured after three days.

NAD also recommended that the advertiser discontinue the claim “2 caplet dose for fast, all day joint relief.”

NAD had two primary concerns about the truthfulness and accuracy of the comparative superiority claim that Trigosamine works 600% faster than Glucosamine alone.

First, the Trigo FA study relied upon by the advertiser did not compare Trigosamine FA with Glucosamine. Rather, the advertising relied on the results of results of its Trigosamine FA testing against a placebo, compared to the results of other studies conducted on Glucosamine alone. Making such a study-to-study comparison is not appropriate because of the different study populations, and other variables involved within each study. Given the uncontrolled variability within studies and between the studies, a claim based on such a comparison is inherently unreliable.

Further, NAD determined that the express language of the claim which reasonably implies that the “just released clinical study” specifically found that Trigo FA works 600% faster than glucosamine alone, a message which misstates the results of the study.

NAD recommended that because there is currently no testing comparing the efficacy of Trigo FA supplementation with that of Glucosamine supplementation alone, any comparative efficacy and/or performance claims of Trigo FA versus glucosamine should be discontinued.

During the course of the NAD inquiry, the advertiser notified NAD that it had voluntarily discontinued the claim “It’s a blend of herbal extracts that when combined with glucosamine improves absorption of nutrients and works quickly to improve mobility and flexibility,” action that NAD found necessary and proper action.

NAD reviewed the various news article-like advertisements for Trigo FA, which all included the word “Advertisement” on the top of the page. The advertisement is presented in news article format, with a headline, a sub-headline, an author’s name and then article text. While there are elements of an advertisement, such as the phone number and Weblink to call to order Trigo FA, overall, NAD found that the advertiser should more clearly delineate this print advertisement as an advertisement. NAD recognized that these types of advertorials are common, but still found that the advertiser should do more to make it clear that it is advertising, and not news.

The company, in its advertiser’s statement, said it would appeal NAD’s decision related to claims based on the results of the Six Minute Walk Test, measured at the three day data point, as well as NAD’s findings related to appearance of advertising.

“PatentHEALTH believes that the NAD has misunderstood the meaning of its statistical analysis and the data underlying the three-day claim, which led the NAD to reject this claim. This misunderstanding surrounding the meaning of baseline and raw data should not change the fact that credible statistical analysis proves there was a statistically significant improvement in mobility at the Day 3 data point.  Therefore, PatentHEALTH will seek the NARB’s review of this claim,” the company said.

The company said, as well, that it will comply with NAD’s recommendation regarding claims of “fast” or “rapid relief;”  “600% faster than Glucosamine” and any direct glucosamine comparison claims; and “…when combined with glucosamine, improves absorption of nutrients and works quickly to improve mobility and flexibility.”