Consumer Reports Wrong on Dietary Supplements

CR Wrong on Dietary Supplements By Neil E. Levin, CCN, DANLA Consumer Reports published an article on dietary supplements in January 2008, titled, “Risky Pills – Supplements to avoid”. Unfortunately, CR may have failed to live up to its reputation as an impartial arbiter of quality, apparently relying on its medical and research consultants’ opinions instead of actually testing products. How informed and impartial are these sources on this particular topic? Of course, there is no excuse for companies that blatantly break the law by illegally and knowingly adulterating dietary supplements with drugs or banned substances. The dietary supplement industry asks the FDA and FTC to throw the book at those bad apples pretending to be legitimate businesses. In fact, manufacturers overwhelmingly supported recent legislation – now the law of the land – to put teeth into FDA enforcement powers by banning steroid precursors, regulating manufacturing requirements (cGMPs, current good manufacturing practices) and instituting mandatory reporting of serious adverse events. The supposed burden on the FDA “to prove that a supplement creates “a significant or unreasonable risk” before it can demand its removal” is actually a very low bar, now that the US Supreme Court has allowed a ban on the herb Ephedra without requiring proof that the agency had followed the law, or even its own regulations, in the process. In the CR report, several dietary supplements are singled out for criticism, but with some startling omissions of fact. Androstenedione products (anabolic steroid precursors) have already been outlawed, with the explicit support of the dietary supplement industry. Only rogue manufacturers carry them because they are clearly illegal. Chaparral is mentioned as a present danger, but reputable manufacturers voluntarily withdrew the herb after an FDA warning – back in 1992. Organ and glandular tissues are singled out for risk of Mad Cow disease, but only certain ones are vulnerable and these have largely disappeared from the marketplace. Most glandular tissues are carefully obtained from range-fed animals in New Zealand or Argentina, from areas with no reported cases of this disease. The alkaloid synephrine from Bitter Orange (Citrus aurantium) often gets accused of causing “high blood pressure, heart arrhythmias, heart attack, stroke”. Yet the FDA Medwatch program’s web page does not list a single substantiated complaint of the herb causing these symptoms. Most Bitter Orange is used in formulations along with caffeine and other legal stimulants. In fact, there is evidence that Bitter Orange is not responsible for some of these products’ side effects: “Ephedra-free weight loss supplements have significant cardiovascular stimulant actions, similar to ephedra. These effects are not likely caused by C. aurantium alone, because an eightfold higher dose of synephrine … had no effect on blood pressure, but may be attributable to caffeine and other stimulants in the multi-component formulation.” (The American Journal of Medicine (2005) 118, 998-1003). In 2004, attorney Marc Ullman requested FDA records on Bitter Orange adverse events from the FDA under the Freedom of Information Act. Scrutinizing these files, he found that many so-called adverse events supposedly related to Bitter Orange were actually for unrelated products, combination formulas, pre-existing conditions etc; reporting that, “In its response to the April 14 FOIA, FDA disclosed it had conducted no research whatsoever concerning either the safety or efficacy of Citrus aurantium.” (Natural Products Insider) The American Herbal Products Association also reviewed every adverse event report on Bitter Orange disclosed under another FOIA request and, after eliminating products also containing ephedra and/or caffeine, found only one minor adverse event (weakness, leg swelling) remaining in the FDA archives, which involved a woman also being medicated for osteoarthritis, hypertension, and diabetes. (HerbalGram. 2006;69:52-55) Another study reported that, looking at formulations including Bitter Orange and caffeine with other herbs, “Laboratory testing (including vital signs, serum chemistries, CBC with differential, urinalysis, and electrocardiography) revealed no significant changes.” (Curr. Ther. Res., 60, 145 - 153.) And in another report, “Bitter orange dried-fruit extract did not significantly alter the [heart rate] or blood pressure after a single dose was administered.” (Pharmacotherapy, Dec. 2005) Yet another study reported that bitter orange had no significant effects on any of the cardiovascular variables measured. (Journal of Clinical Pharmacology, 2001;41:1059-63) Another small study reported small increases in these measures, but the point is that strong cautions are premature, at best. One expert has stated that synephrine works differently if synthesized or injected, rather than orally taking the natural herbal extract. (Experimental Biology and Medicine (vol. 229) and Washington Post 9/7/05). There is still reasonable doubt that Bitter Orange supplements have caused any serious adverse events. The herb kava is also the subject of a caution. I personally use this herb, and have looked at the few, unverified reports relating to liver problems and concluded that they are anecdotal and probably unrelated to use of the herb. Some toxicology experts note that the vast majority of such reports are unverified and that “kava extracts continue to demonstrate a far better risk-to-benefit ratio [than medical options].” (Toxicology Letters, Volume 150, Issue 1, 15 April 2004) My routine liver function tests remain optimal. I was surprised that CR touts the “USP Verified” mark, a certification that is not even as stringent and broad-based as the new federal cGMPs, which are mandatory. This explicit endorsement of a commercial testing program that does not yet meet the new national standard seems misplaced, and is also unfair to imply that GMP-certified manufacturers audited by competing certifying agencies have lesser quality controls. I believe that CR has missed the mark in portraying dietary supplements as dangerous and unregulated by using inconclusive, outdated and unrepresentative data. Why doesn’t the magazine to raise its coverage of these issues to the same high standard as its other reporting? Scaring consumers into using more dangerous medical treatments by such methods may sell magazines and gain media exposure, but at the cost of CR’s credibility, consumers’ wallets and real lives lost. Reactions to properly prescribed pharmaceutical drugs reportedly cause over 100,000 deaths per year and may be the fourth leading cause of death in the US; even ignoring medical errors and overdoses. (JAMA, Apr 1998; 279: 1200 - 1205.) Positioning herbs and other dietary supplements as dangerous, when they are rarely life-threatening, is irresponsible and completely disproportional to their relative safety.

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/