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ANOTHER DAY, ANOTHER RECALL |
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By marc on
7/30/2008 10:52 AM
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Is there any end to the recalls of “sexual enhancement” supplements in sight? Isn't it about time to put a stop to this.
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BAYER THROWS DOWN A GAUNTLET, WHAT WILL FDA DO? |
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By marc on
5/20/2008 3:37 PM
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On October 16, 2001 FDA sent Warning Letters to two companies marketing combination dietary supplement/OTC drug products, stating that those products were “unapproved new drugs” and requesting “corrective action” within 15 days. Pharmaceutical giant Bayer Healthcare, LLC has recently launched a combination aspirin phytosterol product. Have the rules changed?
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WHO NEEDS COMPETITION ANYWAY? |
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By marc on
5/9/2008 2:03 PM
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On May 2nd, a United States District Court judge certified a class action against Glaxo Smith Klein (“GSK”). That case has something in common with GSK’s recent Citizen’s Petition aimed at forcing weight loss dietary supplements of the market.
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Havoc looms in patent and trademark law |
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By marc on
5/6/2008 1:59 PM
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An article in this morning's New York Times suggested that almost every patent decision (the same issue applies to trademark disputes) that had been in dispute at the US Patent and Trademark Office may be unconstitutional. It seems that a minor change in the law in 1999 may wreak havoc with your intellectual property.
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WHAT’S THE WORST THING THAT WILL HAPPEN TO ME, A WARNING LETTER? |
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By marc on
2/29/2008 3:50 PM
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A common misconception seems to be that the strongest regulatory action the Food and Drug Administration will take against companies that market dietary supplements with blatant drug claims will be to issue a Warning Letter. A 33-count indictment handed down by a federal grand jury this week suggests otherwise.
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IF YOU WANT TO MARKET A NEW INGREDIENT OR TRANSITION FROM SUPPLEMENT TO FOOD, THERE’S SOMETHING YOU NEED TO KNOW |
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By marc on
2/28/2008 3:00 PM
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On September 27, 2007 President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA). Ostensibly designed to strengthen FDA’s authority over a variety of regulated areas such as food safety and post-market surveillance of drug products, the law contains a provision that has the potential to greatly restrict the entry crossover of dietary supplement ingredients to food and the introduction of dietary supplement ingredients into the marketplace.
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UNREGULATED SUPPLEMENTS AND JOURNALISTIC ETHICS |
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By marc on
1/16/2008 4:19 PM
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Last Friday, January 11, CNN ran a story telling its viewers that dietary supplements are “unregulated”. The story along with a video were also posted on its website. After being told that this statement was wrong, CNN edited the story and removed the erroneous material. No notice of correction was issued and no notation of an update appears on the web.
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Supplements/Steroids for Sports Redux |
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By marc on
12/10/2007 12:03 PM
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Last week Len Monheit commented on the plethora of media coverage that followed a press release issued by a group called itself Informed Choice that purported to have data demonstrating that up to 25% of dietary supplements are contaminated with steroids. This week, that story continues to have legs.
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A Visit to the Doctor |
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By marc on
11/13/2007 4:53 PM
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Last week I had the misfortune of hearing the words “periodontist,” “gum,” and “cut” in the same sentence when I visited my dentist for treatment of what I thought was a simple problem with an old filling. As it turned out, my tooth problem was far from simple and the resolution involved providing my medical history to an oral surgeon. My response to his question about the medications I was using should be an object lesson to us all.
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MIXED MESSAGES |
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By marc on
10/11/2007 2:10 PM
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Congress enacts a law directing the FDA to issue a guidance document to regulated industry within 270 days after the law passes, and the Agency fails to do so. A well know company promotes its new product with the outrageous claim “Eat all you want and still lose weight . . . “ and the FTC fails to act. The Council for Responsible Nutrition issues a press release announcing a self regulatory initiative in conjunction with the National Advertising Division (“NAD”) of the Better Business Bureau and vows that it will not have any role in what claims the NAD will review (CRN also repeats this claims in numerous advertisements touting the NAD initiative). Despite this, CRN files claims in its own name as well as on behalf of all of its members against non-CRN member advertisers.
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