HEALTH

NAD recommends InflameAway Celadrin ad claims be discontinued

BY Michael Johnsen

NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Wednesday recommended that Imagenetix discontinue certain advertising claims made for the dietary supplement InflameAway Celadrin following a challenge by Schiff Nutrition Group. InflameAway executives countered that they did not agree with the decision, but agreed to abide by NAD’s suggestions.

Imagenetix, at the outset of the NAD review, informed the bureau that the company had been revising its marketing campaign prior to the NAD challenge and had discontinued all of its comparative claims versus glucosamine/chondroitin (and other joint health products), as well as its claim that Celadrin has been “proven to work.”

NAD advised Imagenetix to also discontinue the claim that Celadrin is “clinically tested and shown to be effective for improving joint comfort” as the evidence in the record was inconsistent and insufficient to support a claim that either Celadrin, or its active ingredient, cetylated fatty acid, had been proven effective through clinical trial.

Further, NAD noted, while the patent on the ingredient is evidence of its novelty, the patent alone cannot support a “clinically shown” claim. NAD recommended that the advertiser discontinue the claim.

NAD also found that the claim that “patented InflameAway Celadrin is a medical breakthrough,” was not supported by the research on Celadrin or by the patent on the key ingredient in Celadrin and recommended that it be discontinued.

InflameAway, in its advertiser’s statement, said it is “extremely disappointed that the unrebutted opinions of two highly qualified scientific experts have been rejected in favor of the non-scientific judgment made by NAD counsel.”

However, in the spirit of cooperation, the company said it “has and will continue to voluntarily discontinue the use of all NAD challenged claims in its national advertising.”

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FDA ‘actively pursuing’ McNeil Consumer Healthcare

BY Michael Johnsen

WASHINGTON The Food and Drug Administration on Monday posted a media update to its Web page around the most recent McNeil Consumer Healthcare recall, suggesting that the entire McNeil Consumer Healthcare division has come under review.

“FDA is actively pursuing issues related to this recall,” the agency stated. “Drug safety analysts and other medical professionals at FDA have begun a comprehensive review of complaints received by the agency to determine the significance of any adverse events reported and any connection to the use of the recalled products. The FDA is conducting a company-wide investigation of McNeil Consumer Healthcare’s drug manufacturing practices to determine whether similar problems exist throughout the company and what additional steps the agency must take to ensure that these problems do not recur.”

In addition to increased regulatory scrutiny, the House Committee on Oversight and Government Reform on Friday announced it will hold a hearing addressing the latest McNeil recall on May 27 “to examine the circumstances surrounding the voluntary recall of over 40 over-the-counter variations of infant and children’s medicines produced by Johnson & Johnson/McNeil Consumer Healthcare.”

Expected to testify before that panel is Johnson & Johnson chairman and CEO Bill Weldon.

McNeil implemented a voluntary recall of its infant’s and children’s liquid drug products due to manufacturing deficiencies, which may have affected the quality, purity or potency of the drugs on April 30, the FDA noted. McNeil has also ceased production at its Fort Washington, Pa. facility. The agency also reiterated its belief that the chance of serious adverse health consequences associated with the recalled products is remote.

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Personalized monitoring

BY DSN STAFF

FORT MYERS, Fla. —The SilverCare personal monitor from SilverPlus was named by retailers attending the ECRM Home Health Care conference in March as the “hot new product” at the show.

The SilverCare monitor is a multifunctional, daily-living assistant, the company stated, with functions including a dedicated 911 button, a hands-free speaker and medication reminder in the body of a digital wristwatch. By 2011, SilverPlus hopes to launch a model that will include a motion sensor, which could trigger an alert due to a fall, for example. And by 2012, the SilverPlus vision is to fold its product line into a comprehensive and multifunctional telehealthcare tool, where remote healthcare professionals can help with disease and wellness management.

Each unit consists of a base console and wristwatch, and retails for a suggested $449, with no monthly service contract fee associated with the use of the product, the company added.

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