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Church & Dwight agrees to modify First Response ad claim

BY Michael Johnsen

NEW YORK — The National Advertising Division on Thursday recommended that Church & Dwight discontinue its claim that the company’s First Response digital ovulation test is the “first and only test to predict ovulation based on your unique LH hormone level.”

The claim, which appeared on product packaging and on the company’s website, was challenged by SPD Swiss Precision Diagnostics, the maker of the Clearblue DOT, a competing digital ovulation test product.

The claim that the product — through use of an adaptive algorithm —can predict ovulation based on woman’s own luteinizing hormone level, suggests a test that is more sensitive than a test that only compares a woman’s daily LH measurements to some fixed threshold LH value, NAD noted. The claim is of significance to women who use home ovulation tests because LH Surge (the signal for ovulation) varies from woman to woman and from cycle to cycle.

A key consideration for NAD was the mechanism of action for each product. The issue, NAD noted, was not whether First Response —through use of an adaptive algorithm — predicts ovulation based on the user’s individual level of LH hormone, but whether it is the “first” and “only” home ovulation test to do so. The accuracy of the challenged claim, NAD noted, depended not on how the advertiser’s own product works, but on the mechanism of action for Clearblue DOT, the challenger’s product.

Advertisers are required to possess a reasonable basis for their product claims. In a case involving a “first and only” claim, the advertiser’s burden necessitates that it have some amount of information regarding how other competing products operate, information that may or may not be readily available, NAD noted.

In this case, C&D maintained that it had identified through its own testing key distinctions between the products that indicated Clearblue does not use a similar adaptive algorithm, NAD reported. NAD determined that although the evidence demonstrated that the products perform using different mechanisms, the evidence failed to show that Clearblue DOT does not utilize an adaptive algorithm.

Further, C&D maintained that SPD did not, prior to 2010, claim in its own advertising or package inserts to use such an adaptive algorithm, nor was the advertiser aware of any other competitor who did.

Following its review of the evidence, NAD determined that Church & Dwight — at the time it initially made the claim — had a reasonable basis for stating that First Response was the first and only test to predict ovulation based on a user’s unique LH hormone level.

However, NAD found, absent evidence that SPD Swiss Precision Diagnostics does not also use an adaptive algorithm, the advertiser cannot continue the make the claim. NAD recommended the claim be discontinued.

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Amgen drug approved for osteoporosis in men

BY Alaric DeArment

THOUSAND OAKS, Calif. — The Food and Drug Administration has approved a new usage for an Amgen drug, the drug maker said.

The biotech manufacturer announced the FDA approval of Prolia (denosumab) to increase bone mass in men with osteoporosis who are at high risk for fracture. The drug already was approved for osteoporosis in postmenopausal women.

According to the National Institutes of Health, the number of men with osteoporosis is expected to increase as the number of men older than 70 years grows, and about one-quarter of men older than 50 years will have an osteoporosis-related fracture in their lifetime, according to the National Osteoporosis Foundation, which estimated the condition affects 2 million men, with 12 million more at risk.


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Walgreens donates 3,000 flu shots to high school students in Tennessee

BY Michael Johnsen

KNOXVILLE, Tenn. — Walgreens has donated 3,000 doses of flu vaccine to Knox County high school students, valued at $100,000, according to a report in the Knoxville News Sentinel published Thursday.

"This is just an extraordinary effort to really focus on keeping our kids healthy in school," Jim McIntyre, Knox County Schools superintendent, told the Sentinel. "We know that as we get into the winter months, making sure that our kids are healthy is an important prerequisite to having them in school and making sure that they are learning every day."

To redeem the complimentary flu shot, students participating in the program need to present a vaccination administration form to any local Walgreens pharmacy. 

According to the report, Knox County boasts one of the highest school-aged children vaccination rates in the country. 

For the full report, click here


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