Thursday, October 12, 2006

Wrong TIME

Wrong TIME By Neil E. Levin, CCN, DANLA The Time article “State of Reliefs: HOW THE CONTROVERSIAL YET POPULAR SUPPLEMENT BUSINESS EMERGED IN UTAH” (10/1/06) mostly deals with MLMs (multi-level marketers) rather than other types of dietary supplement companies, but there are a few problems with the reporting. Time relies on quotes from notorious anti-supplement partisans who do not often admit to the peer-reviewed science of supplements: the Mayo Clinic and Dan Hurley. It is not even possible that Mr. Hurley's claim could be true ("the vast majority of supplements taken by Americans have been proven to be unsafe, ineffective or both"). If so, the FDA and the majority of companies that really do care about consumers' health would have already voluntarily or forcibly pulled them off the market. The mainstream dietary supplement industry's primary motivation is to provide safe, effective natural products, not to hurt or scam people. Most dietary supplement companies are science-driven and their labels and claims are scrutinized for accuracy and compliance with federal laws, such as the law (DSHEA) that the article falsely accuses of reducing FDA authority. Even the FDA itself denies this on their own website, as well as in the Congressional testimony of several FDA commissioners. DSHEA disallows any dietary supplement claims related to disease, so companies only offer documented structure-function claims as to how the supplements may affect the individual. These claims are submitted to the FDA for scrutiny and the agency has the power to ask for changes to these claims. The law also provides that any ingredient introduced to the market after October of 1994 must have a New Dietary Ingredient packet submitted to the FDA with evidence of safety, as well as allowing the FDA to set rules for good manufacturing practices, so the article's claim that DSHEA "released manufacturers from demonstrating that products were safe before being sold" is not quite accurate. In my personal opinion, Ephedra was only banned because of the FDA's misrepresentation of this herb’s safety record and an arbitrary dismissal of all of its proven benefits to produce a slightly negative risk/benefit ratio. (1,2) Rand Corporation researchers actually reported that up to 155 reported deaths possibly linked to Ephedra were contradicted by its own review of published Ephedra studies that found no deaths, strokes or any serious side effects reported from using the herb, yet the Time report only reports the association of Ephedra to these deaths, despite a complete lack of evidence of cause and effect. (3) The Rand report also stated that Ephedra, with or without caffeine, provided a statistically significant increase in short-term weight loss compared to placebo: about 2 pounds per month for up to 6 months, which contradicts the FDA's decision that Ephedra has only risks and no benefits. Several other review studies have also concluded that Ephedra is safe when properly used. (4,5) And while the Time article implies that an appeals court rejected the safety record of Ephedra ("Utah company Neutraceutical Corp. [sic] is still arguing that lower doses are safe, but in August the firm was overruled by an appeals court"). But the court did not really rule on whether or not the herb is safe because it was narrowly focused on the FDA's authority to implement DSHEA. To read the original Time article, click on this link:,9171,1541294-2,00.html REFERENCES: 1. 21 C.F.R. Pt. 119, Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (Published February 11, 2004) (Effective April 12, 2004) available at 2. Federal Register: February 11, 2004 (Volume 69, Number 28). 3. Shekelle PG, et al. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis. JAMA. 2003 Mar 26;289(12):1537-45. Epub 2003 Mar 10. PMID: 12672771 4. Morgenstern LB. Use of Ephedra-containing products and risk for hemorrhagic stroke. Neurology. 2003 Jan 4;60(1):132-5. Erratum in: Neurology. 2003 Mar 25;60(6):1055. PMID: 12525737 5. Soni MG, Carabin IG, Griffiths JC, Burdock GA. Safety of ephedra: lessons learned. Toxicol Lett. 2004 Apr 15;150(1):97-110. Review. PMID: 15068827

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