HEALTH

Abbott receives regulatory approval for FreeStyle Lite test strips

BY Allison Cerra

ALAMEDA, Calif. The Food and Drug Administration approved blood-glucose test strips from Abbott.

Abbott’s new FreeStyle Lite test strips use an enzyme which is unaffected by common nonglucose sugars, such as maltose or galactose, and minimizes the potential for other interference, Abbott said. The strips also are compatible with the company’s FreeStyle Lite blood-glucose monitoring systems.

“The new FreeStyle Lite test strips represent Abbott’s latest  success in delivering innovative products for people living with  diabetes,” said Heather Mason, SVP Abbott Diabetes Care. “Abbott is delivering on what patients and healthcare professionals demand in diabetes care, especially for people who use insulin to manage their diabetes.”

FreeStyle Lite test strips will be available in July.

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NAD recommends more modifications for Mead Johnson’s Enfamil ads

BY Michael Johnsen

NEW YORK Although Mead Johnson has said it voluntarily will modify or discontinue certain advertising claims for the infant formula Enfamil Premium with triple health guard, the National Advertising Division of the Council of Better Business Bureaus has recommended additional modifications to print, Web site and broadcast advertising for the product, the division announced Thursday.

NAD, the advertising industry’s self-regulatory forum, examined advertising for the product following a challenge by Abbott Nutrition, the maker of the Similac line of infant formulas.

Claims at issue included:

  • Only new Enfamil Premium has triple health guard — clinically proven to promote growth, to improve brain and eye development, and to improve respiratory and immune system outcomes;
  • Our new triple health guard is found only in Enfamil Premium. The result of years of leading edge research, new Enfamil Premium is clinically proven to promote growth, improve brain and eye development, and improve respiratory and immune system outcomes; and
  • Only NEW immunity building Enfamil Premium has triple health guard. The formula clinically proven to benefit your baby in all three ways: Promotes healthy growth; Improves brain and eye development, helps to build immune system and supports respiratory health.

In the broadcast advertising at issue, an actor portraying a pediatrician said: “I tell Moms, be picky. Look for the baby formula proven to offer three benefits.” The “doctor” then turned to a checklist and marked a check next to the benefits “Growth,” “Brain and Eye” and “Immune System,” and repeated the three benefits as the camera panned to a baby. A bar graph depicting different levels of DHA then appeared on the screen as the actor stated, “With twice the DHA of the leading brand.” The camera then cut to a product shot followed by another shot of the baby. Simultaneously, the actor said, “only Enfamil Premium has triple health guard. It’s a formula clinically proven for your baby’s health [development.]” The commercial concluded with the following voiceover: “Enfamil Premium with triple health guard. Our triple advantage. Learn more at Enfamil.com.”

Taken all together, the challenger argued, the commercial conveys the message that Enfamil Premium is superior to Similac Advance because of its higher DHA content — and that Mead has clinical proof of this fact.

At the outset of NAD’s inquiry, Mead Johnson said that commercial would be discontinued at the end of its broadcast schedule and that any new versions of the commercial would be modified to make the disclosure under the DHA comparison chart will be clearer and more concise; remove the “triple advantage” language and remove the word “only.” The advertiser also asserted that it would modify its print advertising.

Following its review of the evidence, NAD determined that the advertising at issue conveyed the message that that the product was the only infant formula that offered the three advertised benefits, a message that was not supported by the evidence in the record.

NAD further determined that the advertiser’s three-part exclusivity claim was potentially confusing and would remain so regardless of the size and proximity of the accompanying disclosures. NAD recommended that the advertiser discontinue the exclusivity claims in print and Website advertising.

Mead Johnson, in its advertiser’s statement, said it respectfully disagrees with NAD’s determination that an “exclusivity claim incorporating all three proven benefits of Enfamil Premium as formulated in the advertising at issue was overly complicated for consumers.”

“Nonetheless, as noted by NAD in its decision, Mead Johnson already voluntarily has made modifications to its advertising. Mead Johnson continues to support the NAD self-regulatory process and will take the NAD’s recommendations into consideration in future advertising,” the company said.

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Study: Metformin may cause vitamin B12 deficiency

BY Allison Cerra

NEW YORK A commonly prescribed diabetes drug may cause a vitamin deficiency over time, a new study found.

Dutch scientists, led by Coen Stehouwer of Maastricht University Medical Center in the Netherlands, found that prolonged use of metformin  to treat diabetes may drive down vitamin B12 levels in diabetic patients.

The study, which was published in the British Medical Journal, reviewed 390 patients with Type 2 diabetes. Of the group, 196 of them were administered metformin three times a day for more than four years. The remaining 194 patients were given a placebo. Stehouwer and colleagues found that 19% of the subjects had reduced B12 vitamin levels and progressively worsened over time, compared with the placebo group, which had almost no change.

“Our study shows that it is reasonable to assume harm will eventually occur in some patients with metformin-induced low vitamin B12 levels,” Stehouwer wrote.

In related news, a recent study published late last month found that diabetic nephropathy patients that receive high-dose vitamin B therapy are more likely to have decreased kidney function and an increased risk of heart attack and stroke.

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