HEALTH

ERSP determines Swiss Labs reliable support for dietary supplement claims

BY Michael Johnsen

NEW YORK The Electronic Retailing Self-Regulation Program on Thursday determined that Swiss Labs provided reliable support for certain claims around the company’s Arthri-Zen Relief dietary supplement, but recommended the marketer modify certain claims.

ERSP examined claims in broadcast and online advertising that included:

  • “Imagine 24-HOUR JOINT RELIEF!”;
  • “Arthri-Zen eases: joint discomfort; muscle and tissue aches; sleepless nights; stiffness and swelling”;
  • “Arthri-Zen Relief is clinically proven effective in the relief of joint and muscle discomfort.”;
  • “…And natural products like Glucosamine and Chondroitin just don’t work.”; and
  • “With its unique delivery system Arthri-Zen Relief works quickly and effectively. You’ll feel a difference immediately.”

Following its review, ERSP determined that the marketer’s clinical study provided adequate support for the marketer’s claims that the product could reduce joint and muscle discomfort when used as directed. However, given that a single study was performed, ERSP recommended that the marketer discontinue any reference to “clinical studies.”

ERSP noted in its decision that the marketer’s study indicated that 53% of the trial subjects who received the Arthri-Zen formulation experienced significantly less pain by the fourth day of the trial. ERSP noted that relief following four days of treatment is not consistent with consumers’ expectations of a product that advertises “immediate” relief. The marketer asserted that it would modify the claim, “immediate relief.”

ERSP further noted that that the marketer’s “24-HOUR JOINT RELIEF” claim could be interpreted by consumers as a reference to a systematic release of the product’s primary ingredients throughout the day. ERSP recommended that the marketer modify the context of the claim to clarify for consumers its intended message that users of the product can experience relief for up to 24 hours in between dosages.

Further, ERSP determined that, based upon the evidence presented by Swiss Labs it is inaccurate to categorically conclude that glucosamine and chondroitin provide no therapeutic benefits and noted that the advertiser has asserted it will voluntarily discontinue comparative claims involving glucosamine and chondroitin. ERSP recommended the marketer not disseminate the same or similar claims in future advertising for Arthri-Zen Relief.

“While we believe that all of our advertising is fully substantiated, we have decided to accept ERSP’s recommendations in its entirety and will make the minor recommended modifications to our advertising,” Swiss Labs stated. “Swiss Labs appreciates the insight and expertise provided by this process and will take this guidance into consideration in future advertising.”

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McNeil Consumer Healthcare addresses acetaminophen concerns on Tylenol.com

BY Michael Johnsen

NEW BRUNSWICK, N.J. In the wake of the news around acetaminophen last week, McNeil Consumer Healthcare posted a public letter at www.tylenol.com to explain the news to Tylenol users.

“Recently, there have been reports about acetaminophen, the medicine in Tylenol, and the potential for liver damage if the medicine is misused or taken in overdose amounts,” the letter, signed by Edwin Kuffner, senior medical director, medical affairs at McNeil, opened. “As the makers of Tylenol, we share the FDA’s goal of helping to ensure that over-the-counter and prescription medicines are used safely and properly,” he said. “[But] Tylenol, when taken as directed, remains the safest pain reliever people can take.”

The letter goes on to explain that it’s inappropriate use of acetaminophen products, when patients consume more than the recommended dosage, that is linked to increased liver damage risk.

That message was replicated last week with full-page ads in USAToday, the New York Times and the Wall Street Journal, among other papers.

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H.D. Smith appoints two new executives

BY Alaric DeArment

SPRINGFIELD, Ill. A wholesaler that supplies OTC and prescription drugs to retail and other pharmacies has appointed two new executives.

H.D. Smith announced Thursday the appointment of Jeff Greer as VP sales and Robert Dynek Jr. as VP purchasing and trade relations, saying the appointments part of an effort to bolster its growth potential.

As VP sales, Greer will lead the company’s efforts to expand into new service areas, while Dynek will have primary responsibility for purchasing and managing inventory service levels across business segments.

“Moving Jeff and Bob into corporate headquarters will take full advantage of growth potential for the company,” chairman and CEO Dale Smith said. “Together, they bring more than 50 years of expertise in pharmacy distribution and will be influential in helping us realize our goal of becoming the preferred pharmaceutical wholesaler nationwide.”

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