HEALTH

Web-based association regulates weight-loss claims

BY Michael Johnsen

NEW YORK One week after a number of weight-loss advocacy groups and GlaxoSmithKline petitioned the Food and Drug Administration to closely regulate weight loss claims, an Internet industry association noted that it’s already reining in what it considers to be outlandish advertising claims through a self-regulation program of online advertising.

The Electronic Retailing Association created the self-regulation tool, the Electronic Retailing Self-Regulation Program, which is administered by the Council of Better Business Bureaus and overseen by the National Advertising Review Council.

The ERSP on Monday determined that Proactol, marketer of the Proactol Fat Binder, has provided a reasonable basis for certain advertising claims and announced that the company has agreed to modify other claims.

ERSP reviewed advertising claims in Internet advertising, in videos posted to the YouTube video-sharing Website, and on a MySpace Website page for the product. Claims at issue included: “Helps Decrease Your Appetite;” “Proactol has been clinically tested to bind up to 28 percent of dietary fats;” and “Medically Backed Weight Loss.”

ERSP determined that the marketer provided a reasonable basis for its general performance claims that Proactol “helps reduce” calorie intake, excess body weight, food cravings and appetite, but recommended that any representations regarding weight loss be properly qualified by indicating that the product should be used in conjunction with a low-calorie diet and a routine exercise regimen.

Proactol informed ERSP that it has removed claims from the US version of its Website and product labeling stating that the product is “clinically proven” in favor of the modified claim “clinically tested.” Further, the marketer asserted it has removed from its U.S. Website the claim that it is a “certified organic medical device.”

Following its review of the evidence, ERSP determined the marketer provided a reasonable basis that the product’s active ingredient—a fiber complex—has been “clinically tested.” However, ERSP recommended the marketer discontinue use of the claim in instances where it makes specific, quantified reference to the product’s effectiveness, to avoid suggesting to consumers that the product is “clinically proven” to effect dietary fat intake.

ERSP also determined that the statements of the two doctors read in conjunction with the general comments about the clinical testing conducted on Proactol provided a reasonable basis for the claim that the product is “medically backed.”

Further, ERSP confirmed that the claim that Proactol “Is a certified organic medical device” no longer appears on the U.S. version of the Proactol Website.

In its decision, ERSP noted that it has been advised that the marketer has had videos containing inaccurate claims removed from the Internet. ERSP has alerted the marketer to other third-party advertisements containing unsupported and/or inaccurate claims and requested the marketer use its best efforts to address these advertisements as well.

The company, in its marketer’s statement, said “Proactol has fully supported the ERSP self regulatory program’s inquiry and has appreciated the professionalism shown throughout this investigation” and “Proactol Ltd will ardently try to adhere to the comments and suggestions made within this inquiry.”

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Poll shows Advil, Aleve most popular choice to treat back pain

BY Michael Johnsen

CHICAGO Half of back pain sufferers reach for Advil or Aleve for relief, according to a poll conducted by Spine-health.com that was released Thursday.

The poll, which ran on www.spine-health.com from March to April 2008, asked 899 consumers which over-the-counter pain reliever they prefer for treating back pain or neck pain. The respondents were offered the choice of several brand name OTC pain relievers, and a write-in option.

Ibuprofen in general (Advil, Motrin and Nuprin combined) accounted for 39 percent of the responses. More than 25 percent of the respondents said Advil (ibuprofen) is their first choice for OTC pain relief, while 24 percent selected Aleve (naproxen). Tylenol (acetaminophen) was chosen by 11 percent, and aspirin was selected by 5 percent. “Other” accounted for 15 percent and responses ranged from various prescription drugs to no alternative specified.

“NSAIDs, like ibuprofen, are most often recommended for treating activity-related pain or discomfort—pain that follows sports, housework, shoveling snow, or other exertion—pain related to muscle strain in the low back, and neck stiffness related to muscle, ligament or tendon strains or damage,” stated Dr. Stephen Hochschuler, an orthopedic spine surgeon at Texas Back Institute and a medical advisor for Spine-health.com.

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FDA gives Perrigo approval for OTC nicotine gum

BY Michael Johnsen

ALLEGAN, Mich. Perrigo on Thursday announced that it has received approval from the Food and Drug Administration to market over-the-counter Nicotine Polacrilex Gum USP, 2 mg (base) and 4 mg (base) (Orange, Coated).

The FDA has determined the product to be bioequivalent to the reference listed drug, GlaxoSmithKline’s Nicorette Gum, which is an aid to smoking cessation.

“This approval of orange-flavored, coated nicotine gum extends our leading store brand position,” stated Joe Papa, Perrigo chairman and chief executive officer. “Our expanded range of smoking cessation products also includes coated mint-flavored gum, coated fruit-flavored gum, uncoated gum and lozenges.”

The overall market for OTC nicotine gum and lozenge products is estimated at approximately $750 million annually at all retail outlets, Perrigo reported.

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