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Biotech / Medical : GUMM - Eliminate the Common Cold

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From: StockDung7/31/2009 2:13:02 PM
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FURTHER ZICAM VINDICATION!!->Matrixx Initiatives, Inc., Zicam Cold Remedy Products NAD Case # 5008 (May 1, 2009)

mondaq.com

Matrixx Initiatives, Inc., Zicam Cold Remedy Products NAD Case # 5008 (May 1, 2009)

In this challenge, NAD held that an advertiser must exercise care when advertising a medical product that is similar but not identical to another medical product, and may not assume that tests done on one product will apply to the other. The advertiser, Matrixx, is the maker of Zicam, a popular brand of products advertised to shorten the duration of the common cold. In 2005, in a decision that garnered unusual publicity, NAD reviewed Matrixx's advertising for Zicam nasal gel in spray form, and concluded that the studies relied upon substantiated Matrixx's claim that, when taken at the onset of a cold, Zicam nasal gel is clinically proven to shorten the duration of a cold. NAD also concluded that those studies also supported Matrixx's claims about Zicam nasal gel in swab form.

In the current challenge, a competitor, Quigley Corporation, challenged new Matrixx advertising about the efficacy of Zicam when taken orally. The new advertisements stated: "Taking Zicam Cold Remedy at the first sign of a cold: Reduces the duration of the common cold," "Numerous physicians, including ear, nose, and throat specialists, general practitioners and internists have come forward in support of the science behind Zicam cold remedy," and "Get over your cold faster with Zicam Cold Remedy!". These new claims were based on the same studies on which Matrixx relied in the 2005 challenge. Here, however, the challenger argued that none of those studies tested the efficacy of the oral version of Zicam. The challenger also contended that Matrixx's "doctors have come forward" claim was the equivalent of a "Doctors Recommend" claim which, in this case, was inadequately substantiated.

NAD sided with the challenger, concluding that a consumer viewing the advertiser's website could reasonably believe that the challenged advertising statements applied to all of the Zicam products, including the oral products. NAD also noted that even though Zicam is a homeopathic remedy, the specific performance claims about Zicam's efficacy must be supported by competent and reliable scientific evidence.

NAD concluded that Matrixx had offered no evidence to suggest that the Zicam oral products work the same way as, or are as effective as the products sprayed or dabbed in the consumer's nose, and thus the studies Matrixx relied on in the 2005 challenge did not support Matrixx's new claims. Similarly, NAD determined that an additional study of the cold-fighting efficacy of various oral zinc formulations advanced by Matrixx did not support its new claims because there was no evidence that the zinc formulations used in the study were the same as Matrixx's oral Zicam formulations.

NAD made several recommendations to change the advertising. First, NAD recommended that when making claims about the ability of the Zicam oral products to reduce the severity of cold symptoms, Matrixx should add the qualifier "may". NAD also recommended that in making any advertising in reliance on clinical studies, Matrixx should make clear which product, the oral or nasal, it is referring to. Finally, NAD concluded that the advertiser's truthful claim that numerous physicians have supported the products was not equivalent to a "Doctors Recommend" claim and therefore did not have to meet the substantiation standards for such a claim.

...

NAD press release is here:
nadreview.org

NAD® News

For Immediate Release

Contact: Linda Bean

212-705-0129

NAD REVIEWS ADVERTISING FOR ZICAM PRODUCTS

NAD Recommends Advertiser Modify Claims Related to Oral Cold Remedy Products

New York, NY – May 12, 2009 – The National Advertising Division of the Council of Better Business

Bureaus has recommended that Matrixx Initiatives, Inc., modify certain advertising claims for the

company’s oral Zicam Cold Remedy products.

NAD, the advertising industry’s self-regulatory forum, examined claims in product packaging and at

a company Website, following a challenge by Quigley Corporation. Claims at issue included:

· “Taking Zicam Cold Remedy at the first sign of a cold: Reduces the duration of the common

cold.”

· “Taking Zicam Cold Remedy at the first sign of a cold: . . . Reduces the severity of cold

symptoms.”

· “Zicam Cold Remedy is an over-the-counter homeopathic medicine that actually reduces the

duration and severity of the common cold when taken at the first sign of cold symptoms.”

· “Get over your cold faster with Zicam Cold Remedy!”

· “When taken at the first sign of a cold, within the first 24 to 48 hours, Zicam Cold Remedy

has been proven to shorten the cold’s duration and reduce its severity.”

· “However, unlike most over-the-counter and prescription cold remedies that have been

designed to temporarily suppress the symptoms of the common cold, Zicam Cold Remedy

helps reduce the duration and severity of the common cold.”

· “Unlike other over-the-counter cold medicines designed to merely relieve cold symptoms,

Zicam Cold Remedy represents a breakthrough in the treatment of the common cold.”

· “Numerous physicians, including ear, nose, and throat specialists, general practitioners and

internists have come forward in support of the science behind Zicam Cold Remedy.”

· “Zicam Cold Remedy is safe and does not cause the side effects often experienced when

taking cold relief products, such as drowsiness or grogginess, Zicam Cold Remedy is not

habit-forming.”

· “Research conducted by the Cleveland Clinic Foundation, one of the world’s largest and most

prestigious health centers, again confirms the efficacy of Zicam Cold Remedy. This clinical

study demonstrated that Zicam reduced the severity and duration of common cold symptoms

even when treatment is started as late as the second day after onset of illness.”

· “This research is important because it demonstrates that Zicam can still reduce the duration

of the common cold even when busy cold sufferers can’t or don’t start using Zicam within the

first 24 hours of illness. Previous research studies all initiated treatment within the first 24

hours of symptoms.”

NAD noted that it determined in a 2005 review of advertising for Zicam that Matrixx possessed the

necessary support for claims that Zicam nasal products shortened the duration and reduced the

severity of cold symptoms. NAD also determined in 2005 that studies conducted using the nasal gel

in a spray pump form provided reliable support for claims made for the nasal gel in a medicated

swab form.

NAD reviewed evidence for Zicam products in an oral form, including previously submitted evidence,

and determined that certain claims were supported for all Zicam products, including cold duration

reduction claims. However, because different evidence supported the nasal products and the oral

products, NAD recommended certain clarifications.

NAD recommended that Matrixx modify claims to indicate that the Zicam oral products “may” reduce

or lessen the severity of cold symptoms, as reflected by the evidence.

In considering claims referencing research on the products, NAD determined that claims referencing

the Cleveland Clinic Foundation study – which was conducted on the nasal gel product – should be

made separately from the general claims, and that Matrixx should make it clear that referenced

research was conducted on the nasal gel product. Further, NAD noted, that in any claim referencing

its scientific studies, the advertiser should make it clear to consumers which product – oral or nasal

– was studied.

NAD further determined that the claim “Numerous physicians, including ear, nose, and throat

specialists, general practitioners and internists have come forward in support of the science behind

Zicam Cold Remedy” does not rise to the level of a “doctor recommended” claim. NAD found, as

well, that the claim was supported by the evidence in the record.

The company, in its advertiser’s statement, thanked NAD for its consideration of the matter, but was

“disappointed” at NAD’s recommendation that it qualify claims related to a reduction in severity, in

connection with Zicam Cold Remedy Oral Products.

“Matrixx believes that the NAD erred in making such a recommendation given the abundant and

solid clinical literature establishing the effectiveness of oral zinc in the reduction of the duration and

severity of the common cold, in conjunction with numerous Matrixx studies establishing the

bioavailability of abundant quantities of free ionic zinc in the oral cavity, among other things.

Matrixx believes that the severity reduction claim is well supported without any additional

qualification.”

The company said, however, that it would “take under advisement” NAD’s recommendation in future

advertising.

NAD's inquiry was conducted under NAD/CARU/NARB Procedures for the Voluntary Self-Regulation of

National Advertising. Details of the initial inquiry, NAD's decision, and the advertiser's response will be

included in the next NAD/CARU Case Report.

###

About Advertising Industry Self-Regulation: The National Advertising Review Council (NARC) was formed in 1971 by the

Association of National Advertisers, Inc. (ANA), the American Association of Advertising Agencies, Inc. (AAAA), the American

Advertising Federation, Inc. (AAF), and the Council of Better Business Bureaus, Inc. (CBBB). Its purpose is to foster truth and

accuracy in national advertising through voluntary self-regulation. NARC is the body that establishes the policies and

procedures for the CBBB’s National Advertising Division (NAD) and Children’s Advertising Review Unit (CARU), as well as for

the National Advertising Review Board (NARB) and the Electronic Retailing Self-Regulation Program (ERSP).

NAD and CARU are the investigative arms of the advertising industry’s voluntary self-regulation program. Their casework

results from competitive challenges from other advertisers, and also from self-monitoring traditional and new media. The

National Advertising Review Board (NARB), the appeals body, is a peer group from which ad-hoc panels are selected to

adjudicate those cases that are not resolved at the NAD/CARU level. This unique, self-regulatory system is funded entirely by

the business community; CARU is financed by the children’s advertising industry, while NAD/NARC/NARB’s sole source of

funding is derived from membership fees paid to the CBBB. ERSP’s funding is derived from membership in the Electronic

Retailing Association. For more information about advertising self regulation, please visit www.narcpartners.org.
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