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GMP standards will supplement the reputation of a regulated industry

BY DSN STAFF

WASHINGTON —For the first time in years, it seems that the dietary supplement industry will be better known for what it is than for what it isn’t—that is, a highly responsible and regulated industry versus the kind of unregulated collection of snakeoil salesman that its detractors claimed it to be.

Last month, the last of the deadlines requiring supplement manufacturers to comply with established good manufacturing practices passed. This alone not only will establish that the industry is regulated, but also will ensure that what manufacturers are claiming to be in the final product—by both ingredient and amount of that ingredient—actually is in the final product.

And in May, the Council for Responsible Nutrition had the opportunity to underscore all that the industry is doing to be representative of the word “responsible” before the Senate Special Committee on Aging. Also in May, Sens. Tom Harkin, D-Iowa, and Orrin Hatch, R-Utah, introduced the Dietary Supplement Full Implementation and Enforcement Act of 2010, a piece of legislation designed to provide the Food and Drug Administration with additional budgetary resources to place against enforcement of the supplement regulations.

Before the Senate, CRN president and CEO Steve Mister testified that “the dietary supplement industry is committed to manufacturing and marketing high quality, safe and beneficial products that have a valuable role in a wellness regimen.”

“This industry is likewise committed to ensuring consumers receive truthful, accurate and nonmisleading information on dietary supplements,” he added.

The supplement industry—through its five trade associations—has developed a variety of voluntary, self-regulatory programs that address issues that potentially tarnish the industry, and pointed specifically to the $1.5 million unrestricted grant provided by CRN to the National Advertising Division of the Council of Better Business Bureaus to monitor dietary supplement ads to help ensure they are truthful and not misleading.

With regard to the new legislative act, “CRN and its member companies have long advocated for more resources to help the FDA better enforce industry regulation, and this bill is a step in the right direction to making that happen,” Mister said. “Sens. Harkin and Hatch understand that the real need is to fully enforce the stringent statutes already on the books, to the full extent of the law,” added John Gay executive director and CEO of the Natural Products Association. “The way to get the bad actors out of the industry is by putting more cops on the street, plain and simple.”

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FDA advisory committee shoots down Vivus’ Qnexa

BY Alaric DeArment

MOUNTAIN VIEW, Calif. The possibility of a new drug for treating obesity suffered a setback Thursday as a Food and Drug Administration advisory committee voted against recommending its approval.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 10 to 6 against recommending approval for Vivus’ drug Qnexa (phentermine and topiramate), citing safety concerns such as the possibility of psychiatric problems and birth defects.

“We appreciate the advisory committee’s recognition of obesity as a significant health crisis and the challenges associated with the treatment of this disease,” Vivus CEO Leland Wilson said. “We are disappointed with the advisory committee’s vote.”

The company said it would attempt to address the committee’s concerns. An advisory committee vote is a recommendation, and while the FDA will take it into account when deciding whether to approve a drug, it is not bound to follow it.

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Post-it launches Shopping Genius widget

BY Allison Cerra

LONDON 3M has developed a bargain-shopping widget with the help of its Post-it brand.

Inspired by usage of the classic Post-it note as a shopping list, 3M has developed an evolution of the shopping list for the digital age called Post-it Shopping Genius. How it works: Post-it Shopping Genius sits on your computer desktop, keeping an eye on the price changes for you, locating the cheapest price, and letting you know when it changes. The customizable application enables you to choose from thousands of electricals, durables and other consumer goods, and track up to five at a time.

The application — which can be directly downloaded from http://bit.ly/Post-itGenius and is available on iGoogle, Mac OS X desktop and Windows 7 / Vista desktops — displays up-to-date prices on many thousands of products, which are searchable within the tool.

In related news, 3M announced that it is offering a monthly monetary prize of 1,000 GBP ($1,542) or the value of a user’s shopping list if less as an incentive to those who refer the Shopping Genius application to a friend.

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