<img src="http://www.npicenter.com/images/MarcUllman.gif" border="0" align="left">Mr. Ullman speaks frequently on various regulatory matters at various events, including Virgo Publications' Natural Products Industry Supply Side West Trade Shows and the National Nutritional Foods Association's annual MarketPlace Convention. He also manages the FYI Newsletter highlighting legal and regulatory issues concerning the Natural Product Industry. <br><br>Marc is a partner in New York City based Ullman, Shapiro & Ullman, <a href="http://www.usulaw.com">www.usulaw.com</a>. You can contact him at Marc[at]usulaw.com<br><br><i>Please note that blog is not intended to provide or serve as legal advice of any kind, and that the reader should not rely on it for such advice.</i> http://npicommunity.com/Blogs/tabid/53/BlogId/1/Default.aspx en-US marc@usulaw.com sa@sa.sa Fri, 03 Jul 2009 18:07:28 GMT Fri, 03 Jul 2009 18:07:28 GMT http://backend.userland.com/rss Blog RSS Generator Version 3.1.20.17153 I'm a little concerned about what I found while working on an article trying to predict what dietary supplement regulation might look like under the Obama Administration. http://npicommunity.com/Blogs/tabid/53/EntryID/119/Default.aspx marc@usulaw.com http://npicommunity.com/Blogs/tabid/53/EntryID/119/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=119 Mon, 26 Jan 2009 20:46:00 GMT 0 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=119 Is there any end to the recalls of “sexual enhancement” supplements in sight? Isn't it about time to put a stop to this. http://npicommunity.com/Blogs/tabid/53/EntryID/116/Default.aspx marc@usulaw.com http://npicommunity.com/Blogs/tabid/53/EntryID/116/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=116 Wed, 30 Jul 2008 15:52:00 GMT 1 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=116 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? http://npicommunity.com/Blogs/tabid/53/EntryID/114/Default.aspx marc@usulaw.com http://npicommunity.com/Blogs/tabid/53/EntryID/114/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=114 Tue, 20 May 2008 20:37:00 GMT 3 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=114 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. http://npicommunity.com/Blogs/tabid/53/EntryID/112/Default.aspx marc@usulaw.com http://npicommunity.com/Blogs/tabid/53/EntryID/112/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=112 Fri, 09 May 2008 19:03:00 GMT 0 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=112 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. http://npicommunity.com/Blogs/tabid/53/EntryID/111/Default.aspx marc@usulaw.com http://npicommunity.com/Blogs/tabid/53/EntryID/111/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=111 Tue, 06 May 2008 18:59:00 GMT 0 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=111 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. http://npicommunity.com/Blogs/tabid/53/EntryID/105/Default.aspx marc@usulaw.com http://npicommunity.com/Blogs/tabid/53/EntryID/105/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=105 Fri, 29 Feb 2008 20:50:00 GMT 0 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=105 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. http://npicommunity.com/Blogs/tabid/53/EntryID/103/Default.aspx marc@usulaw.com http://npicommunity.com/Blogs/tabid/53/EntryID/103/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=103 Thu, 28 Feb 2008 20:00:00 GMT 1 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=103 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. http://npicommunity.com/Blogs/tabid/53/EntryID/100/Default.aspx marc@usulaw.com http://npicommunity.com/Blogs/tabid/53/EntryID/100/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=100 Wed, 16 Jan 2008 21:19:00 GMT 0 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=100 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. http://npicommunity.com/Blogs/tabid/53/EntryID/99/Default.aspx marc@usulaw.com http://npicommunity.com/Blogs/tabid/53/EntryID/99/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=99 Mon, 10 Dec 2007 17:03:00 GMT 1 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=99 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. http://npicommunity.com/Blogs/tabid/53/EntryID/96/Default.aspx marc@usulaw.com http://npicommunity.com/Blogs/tabid/53/EntryID/96/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=96 Tue, 13 Nov 2007 21:53:00 GMT 0 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=96