HEALTH

NAD recommends PatentHealth modify, discontinue advertising claims for dietary supplement

BY Michael Johnsen

NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Thursday recommended that PatentHealth modify or discontinue certain claims for its Trigosamine Fast Acting dietary supplement, including speed of relief claims.

PatentHealth responded that 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. 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.”; and
  • “2 caplet dose for fast, all day joint relief,” among others.

The advertised product is an addition to the advertiser’s line of joint-health products, and was introduced into the marketplace in 2008, NAD noted. In contrast to the original formula of Trigosamine, which contains glucosamine, chondroitin sulfate, and hyaluronic acid, Trigo FA contains a formula of glucosamine sulfate, hyaluronic acid and a “RapidFlex” proprietary blend, which includes trademarked Boswellin, patented Curcumin C3 Complex 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.

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 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 also fielded 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.

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,” the dietary supplement supplier stated. “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, 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.”

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Twinlab announces its 2009 Mobile Beach Bash Celebration

BY Anna Mcgrath

GALVESTON, Texas Twinlab is kicking off its 2009 Mobile Beach Bash Celebration July 11.

The celebration will coincide with the company’s rateyourabs.com contest for a chance to win a Jeep Wrangler Unlimited. The 10-stop beach tour will begin in Galveston, Texas and continue along the Gulf and Atlantic coasts to celebrate this summer’s best beach abs.

The event will feature music, models and plenty of product sales, including Twinlab’s ultimate six-pack helper, Ripped Fuel 5x.

“Twinlab’s Ripped Fuel products are all about helping people get the lean, defined bodies they’ve always wanted, and there’s no better place to show off their success than the beach,” said Marc Stover, director of marketing, ISI Brands/Twinlab. “We ran a similar contest last year with enormous success. This year, we upped the ante and decided to take the party to some of the hottest beaches in the country to find that perfect six-pack.”

Contest entry forms and camera will also be on hand for those wishing to enter. Voting will take place at www.rateyourabs.com through September 13.

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NCPA announces new FSA service

BY Michael Johnsen

ALEXANDRIA, Va. The National Community Pharmacists Association on Wednesday announced a new service — the FSAok AutoCopay — that enables community pharmacies to continue serving patients who use flexible spending account debit cards within new IRS regulations.

As of July 1, those regulations precluded customers from using their FSA debit card at drug store retailers that had not secured an Inventory Information Approval System, a point-of-sale system that’s able to identify eligible health care FSA purchases by comparing the purchased items’ UPC or SKU number against a pre-established list of eligible items; keep a separate total for the eligible items; and charge the FSA card only for the eligible items total, and request another form of payment for any remaining items.

“We were pleased late last year when, after meeting with NCPA, the Internal Revenue Service extended the deadline [for the new requirement] from January 1 to July 1, 2009,” stated Bruce Roberts, NCPA EVP and CEO. “During that time, NCPA responded to the needs of our members by collaborating with Finpago’s FSAok AutoCopay service to offer a low-cost solution requiring no special software or POS system so that they can continue to serve their patients’ with FSA accounts with an automated copayment claims service and real time substantiation of eligible over-the counter transactions.”

For pharmacies without point of sale systems, AutoCopay makes it possible to accept payment from patients who use FSA debit cards in accordance to IRS regulations.

“The average pharmacy sells more than $60,000 per year to customers with flexible spending account debit cards,” stated Finpago CEO Fred Hawkins.

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