CNN: Corrects errors in report after my complaint

To their credit, CNN revised their report to remove the errors that I pointed out to them (see my entry on 1/14/08) and pulled the video of that original report from their webpage. They also added a link to my blog entry of 1/14/08 (see link below). I acknowledge their corrections as responsible and applaud their efforts to quickly correct these errors. http://www.cnn.com/2008/HEALTH/diet.fitness/01/11/hfh.supplements/index.html http://honestnutrition.blogspot.com/2008/01/cnn-false-report-on-dietary-supplement.html

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 www.honestnutrition.com 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include monitoring safety, e.g. voluntary dietary supplement adverse event reporting [Neil's note: this has been superceded by mandatory adverse event reporting passed into law December 2006.]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 .ftc.gov/bcp/menu-health.htm. 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. http://honestnutrition.blogspot.com/2008/01/cnn-false-report-on-dietary-supplement.html 2. http://www.cnn.com/2008/HEALTH/diet.fitness/01/11/hfh.supplements/index.html

Selective facts produce poor journalism (or science).

Selective facts produce poor journalism (or science). For example, the Women's Health Study had a 7% reduction in major cardiovascular events with vitamin E, a number that was not significant. But there was a significant 24% reduction in cardiovascular death in the vitamin E group. Would you characterize that as a failure for vitamin E? The media did. Yet, the authors of the study admitted that, "This was largely attributable to fewer sudden deaths in the vitamin E group (38 vs 51 among women assigned to placebo) and fewer deaths from other cardiovascular disease (ie, deaths due to cardiovascular diseases other than ischemic heart disease and cerebrovascular disease, 20 vs 34, respectively)." The Williams College ginkgo study in JAMA allowed participants to miss up to 6 daily doses over a 2-week period (nearly 50%!) before they were eliminated for non-compliance. It also tested only one brand of ginkgo (Ginkoba) on healthy volunteers for only six weeks, with results (by convention) not applicable to other brands. This was an obvious attempt to see whether a quick, drug-like effect could be obtained from a short course of supplementation. Longer term studies are more authoritative, especially if compliance is better. The CoQ10 statement is laughably wrong: "Coenzyme Q10 has not been carefully tested to see if it is safe and effective. Because coenzyme Q10 is sold as a dietary supplement rather than a drug, it is not regulated by the US Food and Drug Administration." This is a complaint that the FDA does not test individual dietary supplement products for potency or approve individual label claims. The agency does have the longstanding right to veto dietary supplement label claims and to remove any mislabeled or adulterated product from the national market. This contrasts with the FDA's explicit approval of drugs and drug claims, though the agency doesn't test individual pharmaceuticals for potency or safety, either. Of course, the FDA would take issue with their supposed inability to regulate dietary supplements. They even claim the opposite on their web page. Note the first 4 words: "FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading. FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising." regarding the CNN report: http://www.cnn.com/2007/HEALTH/04/09/chasing.supplements/index.html