Natural Causes is cause for concern about journalism

Natural Causes To those deciding whether this book is worthy of purchasing, I find that many of the author's claims are overblown. Some are demonstrably untrue. Mr. Hurley's inflammatory rhetoric is apparently at odds with official FDA statements, because on its website and in Congressional testimony the agency has repeatedly stated that it has adequate power to regulate dietary supplement safety and quality, which the author denies is true. DSHEA (the Dietary Supplement Health and Education Act) is NOT a deregulation bill. It took a misunderstood food category and elevated its regulation to almost that of pharmaceuticals, allowing the FDA to ban drug and disease claims, control manufacturing quality through mandatory Good Manufacturing Practices (GMP), have veto power over label claims, and make manufacturers bear responsibility for mislabeled, adulterated or unsafe products. What was stopped by DSHEA was inexplicable FDA harassment of supplements, stopped only by outraged federal judges. DSHEA was the compromise bill that gave more power to the FDA while preventing the grossest abuses of its power. Dietary supplement plants are FDA inspected, while also under the sanitation and health laws of local and state governments. Other quality inspectors keep manufacturers honest; for example, GMP, organic and kosher certifiers. A documented paper trail is required for every step in the production of products. The FTC also regulates dietary supplement advertising, including monitoring Internet websites. The dietary supplement industry strongly supported the recent Adverse Event Reporting Act that requires manufacturers to report all serious adverse events to the FDA. Some manufacturers have already been doing this voluntarily, but have received very few, to date. This evidences their commitment to safety. Dietary supplement industry associations have quality programs that require registration and random testing for active ingredients in products, so member companies are of a significantly higher level of quality assurance than other manufacturers. Of course, not all natural products are 100% safe or 100% effective for every person. But, checking poisoning death figures from the American Association of Poison Control Centers, I see that supplements are safer than most other products: there were only 5 accidental deaths linked (reported as possibly due) to dietary supplements over a 3-year period. In the same 3-year reporting period, there were 67 deaths from plain aspirin, 50 from aspirin combinations, 48 from pesticides, 7 from cosmetics, 66 from household cleaners, 171 from plain acetaminophen, and 446 from acetaminophen combinations. The medical journal JAMA reports that there are over 100,000 deaths a year from pharmaceutical drugs that are used as directed, and many more from misperceived drugs. How many dies from the FDA-approved drug Vioxx? How many from mood altering and cholesterol lowering drugs? How many from cardiovascular disease aggravated by synthetic hormone replacement therapy? The tryptophan that caused deaths in the late 1980's was reportedly produced by a pharmaceutical company using a prototype/unproven genetically engineered bacteria for the first time to produce the amino acid, which was then prescribed by a physician. How do dietary supplement companies get all the blame for this? While Mr. Hurley is correct that, normally, food is the best source of nutrients, there are some that are shown to be better absorbed from supplements than food, such as certain B vitamins. Compared with the admitted shortage of essential nutrients in the American diet and the dangers of prescribed and OTC drugs, most people feel better about the relative safety and utility of dietary supplements. Greater than RDA levels of vitamins are NOT toxic. Safe upper levels exist and are often far higher. Medical professionals frequently use mega-doses of Vitamin C, biotin, folic acid, vitamin B-12 and vitamin D with no serious adverse effects. Natural products companies exist because of a strong commitment to natural health, including product safety. Most natural products manufacturers would rather go out of business than harm their customers. Many people believe that natural products are more health promoting than synthetic drugs because the nutrients and gentler therapeutic agents are better tolerated by the body and encourage healing; not merely controlling symptoms like so many toxic drugs. And, yes, dietary supplements are backed by tens of thousands of published research papers showing their safety and efficacy. I read them daily. Perhaps Mr. Hurley just didn't pay enough attention in science class and is too focused on muckraking to notice his many errors. I give this book an "F". Neil E. Levin, CCN, DANLA board certified clinical nutritionist with diplomate in advanced nutritional laboratory assessment http://www.honestnutrition.com/

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: http://www.time.com/time/insidebiz/article/0,9171,1541294-2,00.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 http://www.fda.gov/ohrms/dockets/98fr/1995n-0304-nfr0001.pdf 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