Monday, January 14, 2008

CNN: false report on dietary supplement regulation

CNN’s erroneous report on dietary supplement regulation was corrected after my complaint and correction By Neil E. Levin, CCN, DANLA A recent CNN text report and the accompanying video posted on its webpage asserted that dietary supplements are “unregulated” and that label and ad claims are made without any government supervision. 1 The video was shown on the CNN television network. Of course, one need only go to the FDA's own web site to find out that this is false. Even the claim that dietary supplements are "unregulated" compared to other food categories is preposterous. The FDA says that (I have bolded certain words in these quotes to emphasize that these are mandatory rules, or regulation): "FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter)." The agency explains the scope of those regulations: "FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting [Neil's note: this has been superceded by mandatory adverse event reporting passed into law December 2006.] , and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising...Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register their facility with the FDA." Regarding the regulation of claims and labels, the agency says: "Claims that can be used on food and dietary supplement labels fall into three categories: health claims, nutrient content claims, and structure/function claims. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, or, in the case of advertising, with the Federal Trade Commission...Manufacturers of dietary supplements that make structure/function claims on labels or in labeling must submit a notification to FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim." "The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws. For more information on FTC, go to: http://www Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service." Regarding new ingredients, the agency says, "The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply." This rule does not apply to other food categories. Additionally, serious adverse event reporting (SAERs) is no longer voluntary. Manufacturers are required to report SAERs to the FDA within 15 business days of receipt, another distinction between dietary supplement regulation and rules for other regulated food categories. And the FDA, as authorized by DSHEA, is phasing in mandatory cGMPs (current Good Manufacturing Practices) for all dietary supplement manufacturers, focusing on assuring safety and proper identification of ingredients by setting strict rules for manufacturing procedures. This is another important regulatory distinction between dietary supplements and other food categories. POSTSCRIPT: I sent a short version of this correction to CNN on Monday, 1/14/08, and posted a long version on my blog. To their credit, CNN has now (1/17/08) posted a link to my blog entry (1) that had complained about the accuracy of its original report, has revised its text version on the CNN webpage to remove the errors that I pointed out to them and insert accurate quotes from the FDA website, and has pulled the video of that original report from the CNN webpage. (2) I acknowledge CNN’s corrections as responsible and applaud its efforts to quickly correct these errors when informed of them. My hope is that CNN will now be more vigilant in recognizing and challenging the common misperception that “dietary supplements are unregulated”, since even a quick fact check reveals that this is quite untrue. Even when those making these false claims are authorities, “experts” or health professionals, it would be helpful if journalists learn that such blanket condemnations are ‘red flags’ indicating that sources may be spouting personal opinions that may be inaccurate, biased, inflammatory, or even potentially libelous; and hopefully triggering a healthy skepticism instead of a mere echo. Links: 1. 2.

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