HEALTH

Report: Oklahoma may reverse-switch PSE law

BY Michael Johnsen

OKLAHOMA CITY According to an Associated Press report published Thursday, Oklahoma may join California in considering the reverse-switch of pseudoephedrine, making the common decongestant available only with a doctor’s prescription, in an effort to stem methamphetamine production.

Oklahoma arrests for methamphetamine production have risen sharply over the past 18 months, peaking in April when 37 cases involving a total of 74 defendants were filed in state district court, according to the report.

Rep. Lucky Lamons, D-Tulsa, Okla., announced plans to introduce the reverse-switch legislation in  2010.

Both the Oklahoma Pharmacists Association and the Consumer Healthcare Products Association oppose the proposed measure, arguing that the are policies in place, if enforced, would effectively stem meth production while still maintaining legitimate access to the cold medicine.

Similar to California and in Missouri, CHPA has offered to fund a state-wide electronic logging system that would enable law enforcement to track people attempting to purchase more than their legal limit in PSE products in real time.

Oregon is currently the only state that requires a prescription for pseudoephedrine products.

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The Preval Group showcasing two new products

BY Michael Johnsen

PORTLAND, Maine The Preval Group is currently showcasing two new products for the retail channel — Wrecking Balm Tattoo Fade System and Quietus, a homeopathic remedy for symptoms of tinnitus.

With the tattoo fading system Wrecking Balm, available as a direct-to-consumer brand since 2006 and more recently through specialty channels (tattoo parlors), there is the potential for a new category in the drug channel. The product contains DemoMatic, approved as a Class I device by the Food and Drug Administration, and a Suffusion gel that helps exfoliate the upper layers of the skin, among other ingredients.

Current retail packaging contains between a one to two month supply of the product, but takes on average between six and eight months to fully fade the tattoo, which means return business.

Approximately 40 million Americans already have tattoos, the Preval Group, and citing the American Society of Dermatological Surgery, half of them consider removing permanent body art like tattoos at some point in their lives.

Quietus offers symptomatic relief to the symptoms of tinnitus, a ringing in the ears associated with exposure to loud noise that about 1-in-6 Americans experience in their lifetime. At greater risk to tinnitus are carpentry and construction workers, airport workers, gun enthusiasts and hunters, machine operators and night club workers and musicians.

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NAD: Bayer Healthcare ad claims for Aleve are supported

BY Michael Johnsen

NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Thursday determined that Bayer Healthcare can substantiate claims made in packaging, television, print and Internet advertising for Aleve and Aleve Liquid Gels products.

Claims at issue included:

  • “minimum daily dosing” and “minimum label dosing”;
  • “all day pain-free movement” and “stop pain all day”; and
  • “Only two Aleve can stop pain all day” and “that would take twice as many Advil.”

NAD, the advertising industry’s self-regulatory forum, reviewed the claims at issue, following a challenge by Wyeth Consumer Healthcare, manufacturer of Advil, a competing analgesic.

Wyeth also challenged a pill-count comparison graph that two Aleve caplets stacked next to four Advil caplets, with the claim “Just 2 Aleve = 4 Advil.”

 NAD noted in its decision that Bayer has, since at least 2002, made a pill-count comparison in its advertising, including the recent claim that two Aleve capsules equal four Advil capsules. The advertiser maintained, and NAD accepted, that the pill count comparison is based on the respective FDA-approved labels for Aleve and Advil.

Consistent with past decisions, NAD accepted product labels, approved by the Food and Drug Administration as reasonable support for the durational capacity of Aleve and Advil.

NAD determined that the advertiser provided a reasonable basis for its “pain-free” claim, based on its FDA-approved label. Further, NAD determined that it was unlikely that consumers who use over-the-counter analgesics would expect to experience a complete absence of any pain.  The NAD also found that the advertiser established a reasonable basis for its value calculator, based on a minimum daily dose of two Aleve pills versus four Advil tablets.

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