HEALTH

FDA warns consumers on using sexual enhancement products

BY DSN STAFF

NEW YORK This kind of news is more notable for what it doesn’t mean than what it means. And what it doesn’t mean is good news for the dietary supplement industry, because what it doesn’t mean is the industry is “unregulated,” or even “loosely regulated,” for those of you keeping track of how often reporters on some of the major dailies get it wrong.

 

Because what it doesn’t mean is that, even within the confines of its budget, the Food and Drug Administration has allowed regulation of dietary supplements to play second-fiddle to anything else. Indeed, this FDA quite possibly is the most active in regulating the supplement industry as a supplement industry than any of its predecessor administrations. And it’s only been 10 months.

 

 

There are a number of factors coming together that ought to get the blood pumping for any retailer or supplier in the industry — the FDA has been utilizing new regulatory tools to help enforce rules, such as codified good manufacturing practices or mandatory serious adverse event reporting, for example; there now is a greater recognition that even if an unscrupulous manufacturer adulterates a product with erectile dysfunction drugs, steroids or weight-loss drugs, these products are illegally marketed drug products, not supplements (in other words, calling something a supplement no longer makes it so); and finally, industry associations, the Council for Responsible Nutrition and the Natural Products Association to name two, have been becoming aggressively proactive in the past few years to help increase awareness of the need and actual regulation of the industry, as well as the need and/or benefits around supplements.

 

 

All of this will make for safer supplements going forward. But more important, it will make for the perception of safer supplements. Take that greater confidence in the product, combine it with an aging population actively looking for science-based solutions to growing old, and you have a recipe for a category that has so much more room to grow.

 

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Blacksmith Brands acquires five McNeil OTC brands, inks deal with The Emerson Group

BY Michael Johnsen

NEW YORK Blacksmith Brands on Friday announced that it had completed its acquisition of five over-the-counter consumer brands from McNeil, including Efferdent denture cleaner, Effergrip denture adhesive cream, Luden’s throat drops, Pediacare children’s cough-and-cold medicine and Gentle Vapors waterless vaporizer, and Nasalcrom, a nasal allergy relief spray.

Concurrent with this acquisition, Blacksmith Brands has announced a key business and equity partnership with The Emerson Group. The Emerson Group, a sales and marketing company located in Wayne, Pa., will provide sales and sales management services.

“We are pleased and proud to have The Emerson Group as our partner not only in the operation of our business, but as an equity partner in our new company,” stated Peter Mann, Blacksmith CEO. “We believe that the Emerson Group will be a key catalyst in our plans to grow Blacksmith Brands into a major consumer products company.

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FDA approves Arkray’s new glucose monitoring system

BY Allison Cerra

EDINA, Minn. A manufacturer of diabetes self-monitoring systems announced that it received clearance from the Food and Drug Administration for its new Glucocard Vital blood glucose monitoring system.

Arkray said its new meter and strip platform, which will be available for distribution in early December, is expected to be a significant complement to the existing Glucocard line of products, and will be ideal for the home medical equipment, durable medical equipment, mail-order and managed care markets.

“We’re very excited about the latest addition to our Glucocard brand,” said Jonathan Chapman, president of Arkray USA. “The Vital meets all of Arkray’s rigorous design and performance standards. And we can offer it at a price point that will make it an ideal solution for our customers to use in competitive bidding.”

The new Glucocard Vital meter and strip platform is highly accurate, auto-coded, requires only 0.5 microliter of blood, holds 250 dowloadable tests in its memory and has a glucose oxydase strip chemistry that is not affected by interferences that cause testing errors in other common test strips.

The Vital, along with all Glucocard brands, is backed by Arkray’s unique YouChoose wellness program, a comprehensive education and support system that includes printed tools, videos, recipes and an integrated Web site designed to help patients manage their diabetes.

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