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Thursday, September 19, 2013

ERSP Finds Migralex, Inc. Provided Reasonable Basis for Advertising Claims

The Electronic Retailing Self-Regulation Program (ERSP) has determined that Migralex, Inc. can support performance and establishment claims for Migralex, an over-the-counter product intended for the treatment of headaches.

ERSP is an investigative unit of the advertising industry’s system of self-regulation and is administered by the Council of Better Business Bureaus. The marketer’s advertising came to the attention of ERSP pursuant to its ongoing monitoring program.

ERSP reviewed online advertising for Migralex and identified several claims for review, including:
  • “Patients are raving about Migralex because it works and here is why:
    • Doctor Developed
    • Unique combination of proprietary ingredients
    • Rapid release formula designed to relieve tough headaches
    • contains no caffeine, no sodium, no preservatives
    • Is gentle on the stomach”
  • “Fast acting formula designed to treat tough headaches.”
  • “Patented scientific formula”
  • “Dr. Mauskop’s Migralex, a patented, clinically proven, breakthrough formula is now available as an over-the-counter treatment for many kinds of headaches, including:
    • Tension Headaches
    • Menstrual Headaches
    • Sinus Headaches
    • Exertion Headaches
    • Stress Headaches
    • Neck Strain Headaches”
During the course of ERSP’s inquiry, the marketer asserted that it had voluntarily discontinued a number of the claims cited by ERSP and noted that several of the original claims were taken from an outdated version of the product’s website and commercial.

Migralex, Inc. explained that the key ingredient in its product is aspirin, and provided several studies to supports its performance and establishment claims. Following its review of the evidence in the record, ERSP determined that a “clinically proven” claim for the active ingredient – aspirin – is adequately supported.

With respect to the five performance attributes of the product (“doctor developed,” “unique combination of proprietary ingredients,” “rapid release formula designed to relieve tough headaches,” “contains no caffeine, no sodium, no preservatives,” and “is gentle on the stomach”), ERSP agreed that the claims truthfully describe several distinguishing characteristics of Migralex.

Further, ERSP found that claims regarding “rapid relief” and “fast acting” are appropriately disseminated in the advertising.

The company, in its marketer’s statement, said “Migralex appreciates the opportunity to participate in the ERSP self-regulatory process and is pleased that ERSP has agreed that the current claims being made for Migralex are truthful and accurate.”

ERSP Finds Farr Laboratories, Inc. Can Support Performance Claims for ‘Prosta-Q,’ Recommend Marketer Modify Certain Claims

The Electronic Retailing Self-Regulation Program (ERSP) has determined that Farr Laboratories, LLC  can support general performance claims for Prosta-Q, a dietary supplement intended to address the symptoms of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). However, ERSP recommended that certain claims be modified to more accurately communicate material information to consumers.

ERSP is an investigative unit of the advertising industry’s system of self-regulation and is administered by the Council of Better Business Bureaus. The marketer’s advertising came to the attention of ERSP pursuant to its ongoing monitoring program.

ERSP reviewed online advertising for Prosta-Q and identified several claims for review, including:

·         “… unique blend of potent supplements and all natural ingredients to provide relief from the symptoms associated with chronic prostatitis and general pelvic pain.”
·         “If you are currently suffering from symptoms associated with Dysuria, Nocturia, Chronic Pelvic Pain Syndrome (CPPS) or Prostatitis, then look no further. Taking Prosta-Q daily has been shown to be an effective remedy for the symptoms often associated with Prostatitis, while at the same time increasing sexual vitality. This powerful blend of natural and targeted ingredients is sure to ease your pelvic pain and discomfort.”
·         “The Prosta-Q complex is a proprietary combination of clinically proven ingredients including Quercetin, a bioflavonoid with anti-inflammatory and antioxidant effects, Saw Palmetto, Cranberry, Bromelain and Papain, to aid digestion, as well as zinc. Prosta-Q has been shown to be the most effective all-natural nutraceutical formulation yet tested to ‘provide significant symptomatic improvement’ in men with pelvic or genital discomfort seeking prostate health.”
·         “Prosta-Q was tested in a randomized placebo controlled clinical trial by the Institute of Male Urology (IMU) and was led by Dr. Daniel Shoskes, M.D. The study showed that 82% of males taking Prosta-Q had an ‘improvement of symptoms’ from pelvic or genital discomfort.”
·         “The #1 doctor supported and recommended prostate supplement”
·         “Recommended by physicians worldwide”

Following its receipt of ERSP’s opening letter, Farr Labs advised ERSP that the banner advertisement claiming that Prosta-Q is “The #1 doctor supported and recommended prostate supplement” was disseminated by a third party affiliate advertiser and that Farr Labs had contacted the affiliate advertiser to request that it stop running the advertisement.

Following its review of the marketer’s evidence, ERSP determined that the clinical testing provided a reasonable basis for the core claim that Prosta-Q will reduce the symptoms often associated with prostatitis.

Based upon the clinical evidence provided by the marketer, ERSP also concluded that the marketer adequately supported the establishment claims at issue. However, ERSP recommended that Farr Labs modify the claim that the ingredients in Prosta-Q have been clinically proven to aid digestion.

ERSP further recommended that the marketer modify the claim “82% of males taking Prosta-Q had an ‘improvement of symptoms’ from pelvic or genital discomfort” to more accurately describe the parameters of the clinical test.

The company, in its marketer’s statement, said “Farr Labs is pleased that ERSP determined that it provided a reasonable basis for our core claim that Prosta-Q will reduce the symptoms often associated with CP/CPPS as well as our establishment claims. Moreover, during the pendency of the inquiry, we have already taken steps to include additional information regarding the clinical study that served as our basis for the claim stating that “82% of males taking Prosta-Q had an ‘improvement of symptoms’ from pelvic or genital discomfort” to more accurately describe the parameters of the clinical test.”