Sunday, October 19, 2008

Nocturnal leg cramps: quinine vs nutrients

Quinine is kind of dangerous (real risk of multiple organ failure). It's basically an old folk remedy lacking validity. In fact, the FDA banned the marketing of quinine in 1994 due to its toxicity and lack of evidence that it even helps with nocturnal leg cramps. (Procedings of Baylor University Medical Center, 2003 January; 16(1): 21–26. PMCID: PMC1200805) Since 2007, the Food and Drug Administration has recommended that quinine be prescribed only for the prevention and treatment of malaria. For nocturnal leg cramps, "better to rely instead on stretching exercises to flex the legs before bedtime," according to the Mayo Clinic, which also recommends drinking plenty of fluids and eating foods high in potassium. (NY Times 8/5/08) There are certainly much safer and more convincingly effective things to take for leg cramps. Giving elderly patients a vitamin B supplement providing 250 micrograms of B-12, 30 mg of B-6, 5 mg of riboflavin (B-2), and 50 mg of thiamine (B-1) for three months, doctors found that 86 per cent of their patients who took vitamin B complex vitamins enjoyed complete remission for noctural leg cramping. The researchers reported that, in their view, safe and effective vitamin B should be the treatment of choice for nighttime leg pain in older people. (Chan P, Huang TY, Chen YJ, Huang WP, Liu YC. Randomized, double-blind, placebo-controlled study of the safety and efficacy of vitamin B complex in the treatment of nocturnal leg cramps in elderly patients with hypertension. J Clin Pharmacol. 1998 Dec;38(12):1151-4.) [The B vitamins will be found in multiple vitamins and B-Complex vitamins, but some are far weaker than these amounts.] Vitamin E may also be helpful (about 400 IU minimum). (Robert F. Cathcart, III, M.D. The Journal of the American Medical Association, Vol. 219, No. 2.) http://naturalsolutionsradio.com/articles/article.html?id=6614 And another study showed that calcium, magnesium, and B Vitamins were all effective at dramatically reducing or eliminating noctornal leg cramps. (Int J Gynecol Obstet 2006 Aug 17 [e-pub ahead of print]) http://bastyrcenter.org/content/view/1131/ Some people may simply require more than normal of some specific nutrients...probably due to recent medical history, such as GI problems. Muscle cramps can be aggravated by some drugs, but rarely remedied by any drug. After all, all drugs are "controlled substances" precisely because of their known toxicities and side effects.

Monday, September 29, 2008

Science Sins and Media Mistakes

Science Sins and Media Mistakes What You Should Know About Dietary Supplement News Reporting By Neil E. Levin, CCN, DANLA Are male smokers taking beta-carotene really at increased risk of cancer? Are high dosages of Vitamin E really hazardous to your health? Is ephedra, an herb with demonstrated weight loss benefits, really a “killer” that merits its banned status by the U.S. Food and Drug Administration? Natural health remedies have a long history of promoting health and wellness, dating back thousands of years. But sloppy science and sensationalist health reporting by the news media make this increasingly hard to believe. And misleading and contradictory information about the safety of nutritional supplements may cause consumers to make poor health choices – or to avoid making any choices at all. The result: Many miss out on the myriad health benefits supplementation can bring about. Understanding the common sins of commission and omission on the part of science and the press arms the public with the ability to make better decisions – if not to apply a liberal grain of sea salt to what they’re reading and seeing. Beta Carotene: Myth vs. Fact There have been several instances where the reputation of a dietary supplement or herb has been tarnished due to poor science combined with the media’s inertia. The association of cancer risk with the use of the anti-oxidant beta-carotene is a prime example. In 1994, an antioxidant study being conducted in Finland was halted as a result of a report noting an increase in cancer rates among male smokers taking beta-carotene. Headlines roared: Beta-carotene connected with cancer risk. Doctors told patients to avoid this nutrient and sales dropped. Yet ten years later, the data was re-analyzed, this time taking into the account the smoker’s total antioxidant intake – not just beta-carotene. The results were clear: a combination of antioxidants – including beta-carotene – actually lowered lung cancer risk in male smokers. Supplementing beta-carotene to people with low antioxidant status was simply a matter of too little, too late. The antioxidant itself was not to blame; the lack of other antioxidants was. Science Sin: Poor science did not originally eliminate additional dietary antioxidants as variables or look at how antioxidants interact and support each other. Adding one antioxidant does not make up for the lack of others. Nutrients are not drugs, and supplementing a single nutrient is actually a model of a drug study, not a nutrient study. Media Mistake: Failing to fact check. In the original report, the researchers stated that the slightly increased risk was possibly due to chance and that there was no known mechanism as to how this could happen. Yet the news media and others, including a National Institute of Health (NIH) scientific panel, stubbornly continue to refer to beta-carotene as potentially harmful even though credible scientists actually revised those findings years ago and high blood levels of beta-carotene are shown to be consistently protective to populations at risk for cancer. Sloppy Science and Vitamin E One of the strongest examples of sloppy science is the controversy over Vitamin E. In 2004, warnings were issued by authors of a study published in Annals of Internal Medicine about taking 400 IU or more of Vitamin E per day. This warning was based on a “meta-analysis” report that was generated by statisticians who mathematically integrated the results collected from 19 individual studies, selected partly on the basis of at least ten deaths occurring - from any cause - in the course of each study. Sales of this essential vitamin dropped dramatically. This was a major national news event. But when leading antioxidant researchers re-reviewed the same individual datasets more carefully for the American Journal of Clinical Nutrition, they found that daily doses of Vitamin E up to 2,000 IU were actually safe in the same study populations. It seems that the Annals report did not properly segregate doses and forms, such as taking into account other supplements taken. Nor did it find a dose-dependent relationship between vitamin E and death risk, which is a normal toxicological rationale for determining risk. Apparently, it was simply sloppy work that was not able to be replicated using more accurate statistical models that properly accounted for more variables. Similarly, the Institute of Medicine sets the safe upper level of Vitamin E at 1,500 IU per day. And a recent SENECA study of 90,000 nurses showed a 30% to 40% lower incidence of heart disease among those who take in the highest amounts of Vitamin E from diet and supplements, indicating that the Annals report may have scared a lot of people from taking a life-saving essential vitamin. Science Sin: Mistaking unverified statistics for proven science. The straight mathematical integration of data from different selected scientific studies – and the interpretation of the results – were left largely to statisticians whose methods were heavily criticized in comments by other researchers published by the same journal. Consequently, apples were compared to oranges and the reputation of Vitamin E among consumers continues to feel the squeeze. The researchers have never adequately addressed the criticism or the reanalysis that produced vastly different results. Media Mistake: Making a mountain out of a molehill. The outcome of the original study was interpreted by the press to be more meaningful than it really was, as if one study negated all others, and no follow-up was done to report the reanalysis or to mention the myriad of studies showing the proven protective effects of vitamin E. To this day, journalists continue to cite the flawed report – even though Vitamin E has been proven safe and beneficial. Ephedra’s Bad Rap But it’s Ephedra – an herb most commonly used to assist with gentle weight loss and easing breathing difficulties – that will go down in history as the most pilloried dietary supplement ever. The FDA banned Ephedra in 2004 based on a series of unproven Adverse Event Reports (AERs.) AERs are by definition preliminary, unscreened and unverified reports of possible associations of a substance with a side effect. In banning Ephedra, the FDA said that evidence proving that the product has caused actual harm to someone is not required; all that is required is scientific evidence that supports the existence of some theoretical risk. Ironically, after closer examination of the claims, the FDA eliminated virtually all of the Ephedra AERs from consideration. It also admitted that a total ban on the herb would possibly prevent only one estimated death per year out of 3 billion doses taken by 20 million consumers. In comparison, about 100 out of 11 million people with true food allergies die each year. Yet tree nuts, fish and dairy (the most common food allergens) are still legal. Science Sin: Considering AERs to behard evidence. AERs are unverified and thus cannot be considered scientific evidence as proof of toxicity. Government and medical authorities falsely and cynically assumed that most dietary supplement AERs are true, while drugs that have received far more numerous AERs outlining severe side effects (including death) continue to be widely prescribed. More than 100 years of scientific studies were arbitrarily ignored by the FDA in ruling that ephedra had no benefits and no safe level of use; and the agency likewise ignored its own scientific panels that found no smoking gun. Supplements containing large doses of caffeine and other stimulants were lumped in as “ephedra-related” AERs because they also happened to contain ephedra; or more likely, synthetic ephedra alkaloids. Ironically, ephedrine alkaloids are still universally available as OTC drugs for allergies in doses considered too dangerous to sell in a dietary supplement label. However, they are usually sold behind the counter at pharmacies because of the risk of people making crystal meth from these drugs. Ironically, the ephedra herb is too dilute to economically make meth from. I assume that ephedra was axed as an innocent bystander in the drug war to avoid it competing with products which had to be locked up behind the counter. The coincidental timing of the supplement ban and access to the competing drug is very suspicious. Media Mistake: Not getting the whole story; scaring people unnecessarily. Journalists did not bother to research the whole story when it when it came to reporting on this controversial herb. The media made the all-too common assumption that press releases issued by researchers or governmental offices are true. With a little digging, the “real” story might have been reported. But the media was largely content to focus on the sensational “killer herb” rather than to investigate the facts and find out the truth. When controversy arises around dietary supplement or herb, an unproven AER is often at its root. AERs are intended to be an early warning system to allow experts to try to look for and hopefully isolate a dose-related cause and effect. But most, if not all, AERs involving dietary supplements actually involve a combination of substances and issues that include the supplement as well as prescription drugs or other substances along with pre-existing conditions. And many “adverse effects” attributed to supplements are known side effects of prescription drugs. It’s dubious that either science or the media will admit fault or repent. But with a little effort, consumers can get the most accurate and up-to-date information to ensure they can make informed and beneficial decisions when it comes to their most important asset: our families’ health.

Tuesday, September 09, 2008

Neil has contributed to a new textbook on vitamin E

Neil contributed Chapter Two of the technical book "Tocotrienols: Vitamin E Beyond Tocopherols" by the American Oil Chemists Society (AOCS), with help from a colleague to format my lecture notes into a book chapter format. That chapter is titled, "Tocotrienols in Vitamin E: Hype or Science?" 2008. Hardbound. 423 Pages. $155 SRP CRC Press, Taylor & Francis Group "This volume goes far beyond the usual considerations of vitamin E to focus on tocotrienols, which, along with tocopherols constitute the bioactive ingredients of vitamin E. Recognized as potent antioxidants, tocotrienols are associated with cholesterol reduction, tumor suppression, and protecting the heart against oxidative stress. Compiling contributions from leading researchers, this book builds upon a recent symposium sponsored by the AOCS. It examines sources, discusses isolation, and delves into the biochemistry and chemistry of tocotrienols. The book then takes a comprehensive look at their role in health and disease, with a special focus on heart disease." ISBN: 978-1-420080-37-7 https://www.aocs.org/catalog/product.asp?ID=w225&dept=10

Sunday, August 24, 2008

Neil wins prestigious national award!

On July 17, 2008, the Natural Products Association awarded Neil the prestigious Industry Champion Award. This award is given to people who have made notable individual contributions to industry above and beyond what is expected to achieve commercial success.
Neil is a Truth Advocate recognized by the industry. He responds to negative stories - both in the media and in scientific/medical journals - that are biased or flawed.
NPA President Debra Short presented the award at the association's annual business meeting. Neil's brief off-the-cuff comments from the podium at the national meeting are on the accompanying video.

video

Tuesday, July 22, 2008

Beta-carotene risks still unproven!

A recent journal article pointed out the widely-reported danger of smokers using beta-carotene, a natural source (provitamin) of vitamin A, as part of their multivitamins. 1 In this meta-analysis (as in common in such analyses) the researchers have neglected to consider pre-existing dietary and serum levels of this nutrient, making their claim to control by placebo inadequate to properly isolate this variable. In fact, this failure to determine the effects of beta-carotene at a dose-dependent plasma level – and by neglecting to measure total beta-carotene intake along with the relevant synergistic antioxidants associated with it, as opposed to simply measuring supplemental intake - raises serious questions about the validity of these results. 2 There is also legitimate scientific debate over the use of trans versus cis forms of this provitamin that may affect the way it is used by our bodies in vivo that dispute whether all forms are equal, which most studies simply do not address (including this meta-analysis). 3 Regarding beta-carotene safety little has been satisfactorily resolved, and the negative studies have been vigorously disputed for these and other reasons. For example, researchers have previously noted in the Journal of the National Cancer Institute that beta-carotene has been shown to not affect the risk of oxidative DNA damage in male smokers, despite its reputation as an antioxidant. But neither did the provitamin A prove to cause oxidative DNA damage. 4 It has become apparent to numerous observers that simply measuring supplementation of beta-carotene is not a good predictor of serum levels or of risk, and that a low level of total antioxidant intake may be a more valid marker in this regard. In fact, the dietary level of several antioxidants has been shown to be an independent predictor of plasma beta-carotene, especially in moderate alcohol drinkers. A recent study reports, "This may explain, at least in part, the inverse relationship observed between plasma beta-carotene and risk of chronic diseases associated to high levels of oxidative stress (i.e., diabetes and CVD), as well as the failure of beta-carotene supplements alone in reducing such risk." 2 As the authors (Tanvetyanon, et al) of this current analysis have themselves noted, the Physicians Health Study compared the effects of taking 50 mg of supplemental beta-carotene (over 83,000 IU) every other day to a placebo in 22,071 US male physicians aged 40-84 and found no adverse health effects over a 12-year study period. 5 Likewise, the Women’s Health Study of 39,876 health professionals found no significant difference on lung cancer rates when looking at the effects of 50 mg of beta-carotene administered on alternate days over 2+ years plus a 4-year follow up period, using forms and dosing similar to the Physician’s Health Study to achieve very high serum levels of beta-carotene. 6 In a third study used in the current meta-analysis, The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group (ATBC), an antioxidant study in Finland was halted early because of a widely reported small increase in cancer rates among male smokers taking beta-carotene that were only possibly linked to that nutrient. 7 Headlines associated this supplement with cancer risk. Despite objections that the study was flawed, beta-carotene use dropped. This study continues to be widely cited and believed, despite the researchers’ own statements that the results were most likely due to chance. A later analysis published in July 2004 took another look at that same Finnish smokers study’s data, but now taking into account total antioxidant intake, which should have cleared away some of the scientific controversy over beta-carotene safety. The smokers’ risk of getting lung cancer was inversely associated with total antioxidants in the diet, with more total antioxidants resulting in fewer cancers. 8 In this study a composite antioxidant index was generated for each of the 27,000 men over 14 years. The calculated amounts of carotenoids, flavonoids, vitamin E, selenium and Vitamin C were compared to actual lung cancer rates, with a clear result: a combination of antioxidants lowered lung cancer risk in male smokers. Properly reviewed, beta-carotene was not the culprit; low antioxidant status was the more relevant factor affecting cancer rates, and supplementation with a single antioxidant supplement simply failed to create enough improvement to avert deaths related to oxidative factors. Perhaps the supplementation with beta-carotene was simply a case of "too little, too late", rather than a root cause of a slightly higher lung cancer rate in those smokers. It is notable that Tanvetyanon et al included the ATBC study but failed to even reference the later Wright et al study that largely refuted the alleged harms of beta-carotene shown in ATBC, which were shown to be more likely due to low levels of total antioxidant intake than to excessive beta-carotene intake. This later review of ATBC should be a cautionary tale concerning the lack of proper controls in nutrient studies, especially as compounded by the use of meta-analysis, and should have alerted the current authors to that all-too-common mistake in nutrient study design. Indeed, another large study has noted that high carotenoid intake, confirmed by measures of plasma, was associated with lower mortality rates among the elderly over a ten year period. 9 This model measured results of consuming both supplements and foods, not solely supplement input, and when combined with plasma levels should therefore be regarded as a far more robust type of science for measuring vitamin effects than a meta-analysis of simply supplementation. As in the long-term Physicians Health Study, there was no observable risk of lung cancer noted in this report. The fourth study used in the current meta-analysis used very high doses of both beta-carotene (30 mg, equal to 50,000 IU) plus 25,000 IU of pre-formed vitamin A. 10 These amounts are extremely high; the Upper Limit for vitamin A is 10,000 IU, though there is no official Upper Limit for beta-carotene because of its historic safety record. The amounts of beta-carotene used in the eye vitamins were high only because the authors selected solely formulas designed for eye health that typically provide more beta-carotene than ordinary multivitamins. This distinction is not clear in their calling such formulas "multivitamins", because that name is typically given to full-spectrum formulas containing a full range of the essential vitamins with minerals, not system-specific formulas like those sold for eye health. Such formulas have proved to be beneficial in maintaining eye health and the combination of antioxidants have been stronger antioxidants than beta-carotene, which is potentially a pro-oxidant at times and could thus be used more safely – and effectively - in combination with other antioxidants. 11 That being said, eye formulas with more milligrams of lutein than beta-carotene are probably better formulated than ones with very high beta-carotene because of their competition for absorption. Most importantly, the authors have not shown why they assume that "multivitamin" use would be associated with the supposed risks of beta-carotene used singly, even if those risks for the solo provitamin are assumed to be true. Nor have they adequately demonstrated the alleged dangers of taking eye formula supplements, or even the danger of lung cancer rates increasing in those taking mixtures of beta-carotene combined with other antioxidant nutrients. In the case of multivitamins most studies have shown overwhelmingly positive effects, such as one report evidencing reduced infections in nursing homes with vitamins over placebo (73% vs. 43%). Intervention was with a multivitamin containing beta-carotene. Infection-related absenteeism was higher in the placebo group than in the treatment group (57% vs. 21%). Perhaps most importantly, 93% of participants with diabetes mellitus reported an infection versus only 17% of those receiving supplements. 12 These huge reductions in potentially serious infections among our elderly citizens should be measured against the relatively slight and mostly theoretical risk of increased lung cancer rates associated with beta-carotene supplementation. A study reported in the Journal of the National Cancer Institute looked at death rates in a population given multivitamins or other nutrients. 13 After supplements were given for 5.25 years in the general population trial of 30,000 people, significant reductions in total [relative risk (RR) = 0.91] and cancer (RR = 0.87) mortality were observed in subjects receiving beta-carotene, alpha-tocopherol, and selenium combined. The same researchers reported on a subgroup of 3,318 persons with esophageal Dysplasia (a precursor to esophageal cancer) that was given either a multiple vitamin-and-mineral supplement or a placebo for 6 years. In this portion of the trial, small reductions in total (RR 0.93) and cancer (RR = 0.96) mortality were observed but were not significant. In any case, no increase in cancer rates was noted in the group taking multivitamins; there was actually a possible small benefit in terms of reducing this risk. The participants getting the multivitamin took a daily beta-carotene capsule along with two multivitamin tablets. This was a group of subjects at high risk of getting throat cancer. 14-15 It is a leap of faith to assume that a single nutrient would have identical effects to a combination of nutrients without substantial supporting evidence, which is still lacking; confounded by conflicting evidence and multiplying variables in meta-analyses. Since nutrients are both synergistic and present in the diet, it is important to factor those known variables into a proper study design. All too often, researchers do not consider this fundamental difference between drug and nutrient research and unwittingly introduce extra variables that undermine their conclusions. 16

This current meta-analysis of 4 studies - only one of which unquestionably shows a slight increase in lung cancer risk but does not actually measure isolated beta-carotene risk; two others are well-designed and robust studies looking at serum levels of those taking a high dose of beta-carotene but show no increased risk in lung cancer rates, and the fourth has been largely shown to be moot by a later and more complete re-analysis of the data - does not support the hypothesis that beta-carotene increases rates of lung cancer and that multivitamins are therefore dangerous. Thus, there is no sound basis in the current review for suggesting that warning labels may be needed for multivitamins or eye health supplements containing beta-carotene along with other nutrients that have been shown in well-designed studies to help protect the eyesight – and independence - of our aging population. REFERENCES:

  1. Tanvetyanon T, Bepler G. Beta-carotene in multivitamins and the possible risk of lung cancer among smokers versus former smokers: a meta-analysis and evaluation of national brands. Cancer. 2008 Jul 1;113(1):150-7. PMID: 18429004
  2. Valtueña S, et al. The total antioxidant capacity of the diet is an independent predictor of plasma beta-carotene. Eur J Clin Nutr. 2007 Jan;61(1):69-76. Epub 2006 Jul 12. PMID: 16835597 [Supported by the European Community IST-2001–33204 'Healthy Market', the Italian Ministry of University and Research COFIN 2001 and the National Research Council CU01.00923.CT26 research projects.]
  3. Andreas Schieber, Reinhold Carle. Occurrence of carotenoid cis-isomers in food: Technological, analytical, and nutritional implications. Trends in Food Science & Technology, Volume 16, Issue 9, September 2005, Pages 416-422
  4. van Poppel G, Poulsen H, Loft S, Verhagen H. No influence of beta carotene on oxidative DNA damage in male smokers. J Natl Cancer Inst. 1995 Feb 15;87(4):310-1. PMID: 7707423
  5. Hennekens CH, Buring JE, Manson JE, et al. Lack of effect of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease. N Engl J Med. 1996 May 2;334(18):1145-9. PMID: 8602179
  6. Lee IM, Cook NR, Manson JE, Buring JE, Hennekens CH. Beta-carotene supplementation and incidence of cancer and cardiovascular disease: the Women's Health Study. J Natl Cancer Inst. 1999 Dec 15;91(24):2102-6. PMID: 10601381
  7. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group. N Engl J Med. 1994 Apr 14;330(15):1029-35. PMID: 8127329
  8. Wright ME, et al. Development of a comprehensive dietary antioxidant index and application to lung cancer risk in a cohort of male smokers. Am J Epidemiol. 2004 Jul 1;160(1):68-76. PMID: 15229119
  9. Buijsse B, et al. Plasma carotene and alpha-tocopherol in relation to 10-y all-cause and cause-specific mortality in European elderly: the Survey in Europe on Nutrition and the Elderly, a Concerted Action (SENECA). Am J Clin Nutr. 2005 Oct;82(4):879-86. PMID: 16210720
  10. Omenn GS, Goodman GE, Thornquist MD, et al. Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. N Engl J Med. 1996;334:1150–1155.
  11. Bartlett H, Eperjesi F. Age-related macular degeneration and nutritional supplementation: a review of randomised controlled trials. Ophthalmic Physiol Opt. 2003 Sep;23(5):383-99. Review. PMID: 12950886
  12. Liu BA, et al. Effect of multivitamin and mineral supplementation on episodes of infection in nursing home residents: a randomized, placebo-controlled study. J Am Geriatr Soc. 2007 Jan;55(1):35-42. Erratum in: J Am Geriatr Soc. 2007 Mar;55(3):478. PMID: 17233683
  13. Blot WI, Li IY, Taylor PR, et al. Nutrition intervention trials in Linxian, China: supplementation with specific vitamin/mineral combinations, cancer incidence, and disease-specific mortality in the general population. J Natl Cancer Inst 1993:8ı:1483-92
  14. Li JY, Taylor PR, et al. Nutrition intervention trials in Linxian, China: multiple vitamin/mineral supplementation, cancer incidence, and disease-specific mortality among adults with esophageal dysplasia. J Natl Cancer Inst. 1993 Sep 15;85(18):1492-8. PMID: 8360932
  15. Blot WI, et al. The Linxian trials: mortality rates by vitamin-mineral intervention group. Am J Clin Nutr. 1995 Dec;62(6 Suppl):1424S-1426S. PMID: 7495242
  16. Levin, N. Land of Confusion: How Poor Science and Misleading Media Coverage Create Public Confusion About How Dietary Supplements Affect Health. J App Nutr, Vol 55, No. 1, 2005 8-15

Wednesday, July 09, 2008

Memory and Age

Memory and Age By Neil E. Levin, CCN, DANLA The most important things for an older person to consider in protecting against minor memory loss – often attributed to “aging” – include: · Maintain at least a nominal physical activity level to keep circulation and body functions at optimal levels. · Take a good multivitamin to assure minimal levels of essential nutrients. Too many elders fail to eat properly or to get adequate levels of B vitamins and other key nutrients associated with proper cognitive function. Also, the elderly don’t absorb nutrients from food as efficiently, making supplementation even more important. · Don’t forget to eat meals. Often, single, divorced or widowed seniors fail to eat regular meals on schedule. This creates nutrient deficiencies that complicate their ability to maintain physical and mental health. · Don’t overeat on processed, high fat, high sodium foods such as fast foods to “compensate” for poor eating habits. · Take foods and supplements that are rich in antioxidants. Oxidative damage is clearly associated with many of the conditions that affect mental, as well as physical, capabilities in older people. This includes negative changes to the brain itself; and also the nervous system, the eyes and joints. · Use vitamin D, which may be in your multivitamin or calcium supplement, to compensate for the lack of direct sunlight on skin. This essential vitamin also helps with immunity, cardiovascular health and bone health. · If your dietary habits are reasonably good and you still want some more natural aids for brain and memory function, consider a brain nutrient formula. Of course, college age is a time when many students want to use brain nutrients to maximize their learning and recall, especially for tests. Many adults then coast through adulthood until they reach their 40’s or 50’s and start to get a little forgetful. By then, they should already be examining their diet, lifestyle and stress levels to consider whether they may need additional nutritional support for their mental functions. If they wait until things get bad - in their 60’s, 70’s or later - it may be too late to preserve their memories and mental acuity. Basic brain nutrients are multivitamins, lecithin and fish oil. Antioxidants will protect the brain’s structures and functions throughout adulthood. Magnesium, an essential mineral that is deficient in 90% of Americans, helps to reduce toxic effects of chemicals on neurons; as do antioxidants such as vitamin E, tocotrienols, and vitamin C. People will usually hint at the need, or ask about Ginkgo or look at the section. We’re not the family, friends or work colleagues that people try to hide symptoms from…after all; we are the ones that perfect strangers often disclose their bowel habits and other normally hidden quirks to. Speaking in user-friendly but technical structure-function language will often make the discussion less personal and more scientific, removing much of the emotional content of the health issue. Phosphatidyl Serine is a phospolipid compound derived from soy lecithin that plays an essential role in cell membrane composition and intercellular communication. Phosphatidyl Serine is a major structural component of neural membranes where it assists in the conduction of electrical impulses and facilitates the activity of neurotransmitters involved in learning, memory and mood. These properties make Phosphatidyl Serine formulas ideal basic supplements for the support of cognitive function. There is enough evidence of the safety and efficacy of PS for the FDA to have issued a qualified health claim for it. DMAE is known primarily as a precursor to choline and acetylcholine (chemicals in the brain responsible for nerve transmissions and cognitive function), and has been used most predominantly to improve memory and focus while stimulating neural activity. Many researchers believe that it may serve an anti-aging function by increasing the body’s capacity to produce acetylcholine – a deficiency commonly associated with memory loss. Scientific research has demonstrated that Ginkgo Biloba Extract has antioxidant activity in in vitro studies and thus may aid in maintaining healthy brain and memory function. The insulating myelin sheaths that protect the brain, spine and thousands of miles of nerves in the human body are almost two-thirds Lecithin. Lecithin is composed of many different components, including Choline, Inositol, Linoleic Acid, Phosphatidyl serine, fatty acids and triglycerides. These valuable constituents of Lecithin are vital for the proper functioning of many metabolic processes. And let’s not forget the benefit of DHA and fish oil. Fish oils are typically molecularly distilled and tested to be free of screened for the absence of potentially harmful levels of contaminants (i.e. mercury, heavy metals, PCB's, dioxins, and other contaminants). DHA is utilized in forming the brain and nerves. And last but not least, antioxidants and magnesium are very helpful in protecting brain structures and may be useful in preventing some of the feared declines associated with aging brains. For example, vitamin C actually pumps glutamates out of neurons.

Sunday, June 29, 2008

Detoxification

Detoxification By Neil E. Levin, CCN, DANLA The EPA tracks about 650 toxic chemicals used in 23,600 facilities in the US. The agency reports that about half of the 4.24 billion pounds of these toxic chemicals are annually released into the air, ground or water. These include chemicals from the mining, smelting and power generation industries, paper production, electronic equipment manufacturing, plastics, pesticides, etc. While the highest release of chemicals is associated with mining and power production, other industries release problematic chemicals into the environment on a daily basis, all over our country. Certain groups are most at risk (e.g., children, pregnant and nursing women, the elderly). I would also add that people with multiple chemical exposures or even a single toxic level of exposure can develop a hyper-sensitivity to chemicals that can be debilitating. This condition is often called multiple chemical sensitivity. Of course, there is an increase in exposures as our exposure to so many chemicals uses up key nutrients and can overload the body’s ability to detoxify these toxic “insults” to the liver and other body systems. As our need for key nutrients and optimal detoxification processes grows during repeated, chronic exposures, our bodies may fail to keep pace and the levels of toxins can accumulate in our body. The results can be subtle (acne, headaches, persistent “colds”) or extreme (hair or tooth loss, chronic fatigue, pain). We see inflammatory-related conditions increasing, such as liver problems, cardiovascular issues, joint degradation and brain degeneration. While it is true that these conditions are associated with aging, it is also true that aging relates to the body’s inability to properly remove toxins and distribute nutrients to all of its tissues. Inflammatory chemicals can be either the original chemical or a biochemical metabolite that is produced in the body as a temporary step in neutralizing and removing the chemical. If inadequate nutrient stores do not allow the detoxification to complete - and often heroic levels of nutrients far above the RDI’s are required in these situations – then the body still will have a burden of toxic, inflammatory chemicals to contend with. The old adage is to reduce the exposure and increase the nutrients in order to allow the body to clear these toxins in its usual manner. Everything that lowers exposure, even removing shoes when entering a house or using appropriate filters for air ducts, may be helpful in reducing airborne toxins. But it is also important to reduce exposures through varied sources such as medications, non-organic food and the environment as best we can. Antioxidants, including sulfur-containing substances, are the key to detoxification. Methylation, sulfation and antioxidant reduction are some detoxification techniques used by the liver, especially. The liver utilizes these methods to render toxins inert enough to allow removal through the bile or the urine. Methylation can be enhanced by methyl donor nutrients, such as choline, TMG, DMG and SAMe. Sulfation is done with MSM, sulfur from plants (garlic, onions, broccoli, kale) or sulfur-containing proteins (methionine, cysteine, glutathione). Antioxidants include Vitamin C, alpha lipoic acid, etc. Any sources of these nutrients would be beneficial to aiding the body’s natural detoxification systems. One problem is that people often fear to use adequate, high levels of these nutrients, such as taking Vitamin C up to bowel tolerance levels. Some natural substances that enhance/support detoxification include Zinc, Selenium, Copper, Manganese, Sodium Alginate, Chlorella, Bladderwrack, MSM, Beet Root, Red Clover, Dandelion Root, Oregon Grape Root, and Milk Thistle Extract. Another new product is a broccoli seed concentrate called “sgs™”, which is backed by numerous clinical studies at Johns Hopkins regarding its ability to enhance natural detoxification. Adequate fiber is also important in moving the waste quickly through the colon to help remove toxins while avoiding exposure to toxins from the waste or from inappropriate microbes that fester in an unhealthy colon. Probiotics are important, especially bifidobacteria (Bifidus). Drinking adequate amounts of clean, filtered water is another must. Eating organic whenever possible is important, avoiding non-organic fruits and vegetables prone to heavy chemical exposure. Detoxification is a normal bodily function, so claiming that a dietary supplement can support this function would be a legitimate “structure-function statement” authorized by federal law if the clinical documentation is available. Neil E. Levin, CCN, DANLA is a nationally certified clinical nutritionist with a Diplomate in Advanced Nutritional Laboratory Assessment. He is a professional member of the International & American Associations of Clinical Nutritionists. Neil is the nutrition education manager and a product formulator for NOW Foods, a natural food and dietary supplement manufacturer in Bloomingdale, Illinois. Neil is a member of the Scientific Council of the national Clinical Nutrition Certification Board and serves on the board of directors of the Mid-American Health Organization (MAHO), the Midwest regional affiliate of the National Products Association (formerly NNFA). Neil is routinely interviewed for articles in trade magazines serving the natural products industry and has published articles in magazines and newspapers, contributed to scientific journals and has been a guest on numerous radio shows. He has been interviewed for television news reports many times over a 33-year career. You can read some of Neil’s recent articles at his non-commercial website: http://www.honestnutrition.com/

Cardiovascular Health

Cardiovascular Health By Neil E. Levin, CCN, DANLA For a healthy cardiovascular system it is important to get plenty of nutrients over the whole range. B-Vitamins, for example, help to produce energy and to control metabolic processing, including the one that results in excessive levels of the inflammatory compound homocysteine. Homocysteine is a greater risk factor for cardiovascular risk than total cholesterol level. Antioxidants support each other, and clinical research indicates that total antioxidant status is more important than a single level of a single antioxidant nutrient. Antioxidants protect cholesterol from oxidizing, and also protect arterial surfaces from being damaged, leading to plaque formation and cholesterol “patches”. Minerals are also useful for cholesterol metabolism - especially chromium - also calcium, copper, and possibly magnesium and selenium. With the recent stories about obese children – some with Type-2 “adult-onset” diabetes - and with kids getting heart attacks in their teens, there is a growing awareness that cardiovascular health issues are not limited to middle aged men. Recent reports also point to the increased risk for women after menopause or who are on hormone replacement drugs, hammering the point home that age and gender are no longer rigid dividers of people into cardiovascular risk groups. That’s not to say that everyone is aware of these cardiovascular risk factors, but the risk categories in terms of age have certainly broadened dramatically in recent years. We have seen an increasing number of college-aged young men be afflicted by cardiac events at sports or training events, with some dying. Still, the risks do not seem as immediate to young adults with their heightened sense of immortality, especially young men. By the time men hit their 40s, there is an increased awareness of cardiac risks that keeps increasing throughout their lives. The young are mostly oblivious to health risks unless some event creates the beginnings of awareness that they may be at risk, such as a close relative suffering a cardiac event at an early age or a health scare. Unfortunately, these events seem to be increasing. Genetics, sedentary lifestyles, poor diet and obesity all make people susceptible to vascular problems. The emergence of hemorrhoids or any hint of varicose veins should be obvious indications of cardiovascular weakness at any age. Obesity and lack of stamina are also good indicators. Family health history is another consideration that should affect awareness. Circulation depends on body movement/exercise and requires an unobstructed blood flow through flexible blood vessels that have structural integrity. Collagen, elastin and supporting nutrients (proline, lysine, Vitamin C, Pycnogenol®, rutin) help to strengthen these tissues, while certain herbs (cayenne, garlic, horse chestnut, prickly ash extract, hawthorn extract) help to improve blood flow. Smoking and stress narrow the blood vessels, increasing the risk of forming clots or obstructions. Certain amino acids in the diet (arginine, citrulline) support NO (nitric oxide) formation that dilates blood vessels to reduce blood pressure and enhance blood flow to the peripheries. The presence of these components and modulators in the diet help to maintain cardiovascular health and vascular integrity. People should be eating a variety of fruits and vegetables, along with whole grains, in order to provide nutrients essential to the integrity of blood vessels. Products in the Cholesterol/Cardiovascular Support category include plant sterols (containing beta sistosterol), ascorbyl palmitate, Vitamin E, chromium, garlic, guar gum, Guggul extract, tocotrienols, policosanol, B1, B6, folate, B12, iodine, magnesium, selenium, potassium, garlic, carnitine, ginger, cayenne, hawthorn extract, CoQ10, alpha lipoic acid, TMG, Red Yeast Rice Extract, prickly ash extract, horse chestnut extract, butcher’s broom extract, grape seed extract rutin, nattokinase (fibrin enzyme for supporting the body’s control of clotting), fish oil, lecithin, Pycnogenol®, as well as hawthorn leaf and flower extract. Remember, you must take care of your heart and cardiovascular system if you expect them to take care of you for a lifetime! Neil E. Levin, CCN, DANLA is a nationally certified clinical nutritionist with a Diplomate in Advanced Nutritional Laboratory Assessment. He is a professional member of the International & American Associations of Clinical Nutritionists. Neil is the nutrition education manager and a product formulator. Neil is a member of the Scientific Council of the national Clinical Nutrition Certification Board and serves on the board of directors of the Mid-American Health Organization (MAHO), the Midwest regional affiliate of the National Products Association (formerly NNFA). Neil is routinely interviewed for articles in trade magazines serving the natural products industry and has published articles in magazines and newspapers, contributed to scientific journals and has been a guest on numerous radio shows. He has been interviewed for television news reports many times over a 36-year period. You can read some of Neil’s recent articles at his non-commercial website: http://www.honestnutrition.com/

Thursday, April 24, 2008

Myths about stearate "risks"


There are some common myths about stearates. Please allow me to describe the stearates that are utilized in making nutritional supplements, and how they are used, and other pertinent information on their safety and use in dietary supplements and foods.

Stearic acid is converted into oleic acid in vivo, so becomes a similar fat as is found in olive oil. In fact, one jumbo olive is estimated to contain 13 milligrams (.013 g) of stearic acid (C 18:0), many times more than is used in any pills or capsules. http://www.oliveoilsource.com/olivechemistry.htm

“Stearic acid is well absorbed by the gut and is transported in chylomicrons and remnant particles before being picked up by the liver. Once there, an interesting paradox occurs in that excess stearic acid is simply converted to the 18-carbon monounsaturated oleic acid via a desaturase enzyme in the liver (3) and then recirculates in lipoprotein complexes as oleic acid, which is not hypercholesterolemic. Thus, conversion to oleic acid may explain why stearic acid does not elevate plasma cholesterol concentrations.”

Supplement manufacturers rarely use more than 2% and usually far less or none at all, even though common foods contain much more (beef fat is 19% stearates; cocoa butter is 30%) and stearates are Generally Recognized As Safe (GRAS). It is unusual that they would use more than1-2% in a product, and when they do use them it is typically used in microgram amounts to help process only sticky or non-flowing materials.

The hydrogenation process is not used for the stearic acid in the magnesium stearate. It is possible to convert oleic acid to stearic acid by hydrogenation, but that is not necessary (or desirable) with sources that are already high in stearic acid and low in oleic acid. Lipase-catalyzed interesterification is a viable alternative to hydrogenation these days, for example, if one were to want to convert oleic acid to stearic acid.

No consumer should be inhaling stearates, so the issue of being hazardous is also a bogus one that should be relegated to producers and manufacturers. You can actually say far worse about the hazards of inhaled enzymes, for example. Most supplement materials have MSDS handling sheets that mention the dangers of inhalation. There are no known significant dangers from normal oral consumption or skin contact.

The reason dietary stearic acid is considered benign is based on its failure to elevate plasma cholesterol concentrations (1, 2). Foods naturally rich in stearic acid and other saturated fats include: Red meat (beef, pork, or lamb) High-fat dairy products (whole milk, cheese, butter, and ice cream) Chocolate, Lard, Coconut oil.

For more on stearates, please see: http://www.nowfoods.com/index.php?action=itemdetail&item_id=93528.

Also, the accompanying chart has the percentages of stearic acid in common foods (4). As you can see, stearic acid is far more abundant in olive oil, butter and lard than in dietary supplements as a percentage, with grams in foods and micrograms (possible low milligram levels) in only certain dietary supplements:

A common reference is to a 1990 study in the journal Immunology, but the reference is hardly satisfactory as a demonstration of the alleged harm of stearic acid. This was a test tube study that has not been replicated in living beings, with an artificial situation providing high concentrations of stearic acid exposed to isolated immune cells for hours at a time. It was actually done as a way to investigate whether prolonged high dose stearic acid administration could possibly be used to suppress the immune system for an autoimmune disease treatment. (5) It was definitely NOT a demonstration that this would work the same way with dietary supplements or with foods containing stearic acid. The effect was dose- and time- dependent; with a sustained, prolonged exposure over an 8-hour period that is impossible to replicate in the living human body. For a test tube study, it would first have to be shown that the mechanism was valid in vivo before it could be considered reasonable to extrapolate it to actual living organsms. This study did not do that; nor has any other, to date.

In conclusion, since this mechanism has not been proven in humans or had additional verifying studies, since humans have much more complex metabolic activities, since stearic acid is easily absorbed from the gut and then readily converted to oleic acid in the liver (in vivo), since manufacturers use far less than this study gave and with only a brief exposure, and since people get stearic acid in many common oil-containing foods in far greater amounts than are used in dietary supplements, I conclude that the fears about the use of stearates in dietary supplements are unproven and speculative at best, slanderous and unscientific at worst.

For a second opinion, please see the website of Ray Sahelian, M.D. at http://www.raysahelian.com/magnesiumstearate.html

REFERENCES
1. Yu S, Derr J, Etherton TD, Kris-Etherton PM. Plasma cholesterolpredictive equations demonstrate that stearic acid is neutral and monounsaturated fatty acids are hypocholesterolemic. Am J Clin Nutr 1995;61:1129–39.
2. Aro A, Jauhiainen M, Partanen R, Salminen I, Mutanen M. Stearic acid, trans fatty acids, and dairy fat: effects on serum and lipoprotein lipids, apolipoproteins, lipoprotein(a), and lipid transfer proteins in healthy subjects. Am J Clin Nutr 1997;65:1419–26.
3. Lin DS, Connor WE, Spenler CW. Are dietary saturated, monounsaturated, and polyunsaturated fatty acids deposited to the same extent in adipose tissue of rabbits? Am J Clin Nutr 1993;58:174–9.
4. http://www.nebeef.org/post/lfu/Stearic_Acid.pdf
5. Tebby PW, Buttke TM. Molecular Basis for the Immunosuppresive Action of stearic acid on T Cells. Immunology. 1990;70:379-384.

Wednesday, April 02, 2008

The Relative Safety of Natural Products

Some have stated that the dietary supplement industry is largely “unregulated”. My response: This is not really a fair statement considering that recent regulatory efforts – supported by that same industry – have clamped down on the industry’s freedom to operate outside the regulatory system. Drug and dietary supplement regulation are becoming more and more similar, though the safety records of the two types of products are remarkably distinct. The dietary supplement industry is now largely regulated, with more and more regulations closing the gaps. Indeed, the industry strongly supported the law to ban steroid precursors from being sold as dietary supplements, making all such products illegal drugs. And the 2006 passage of a law to require all serious adverse events to be reported to MedWatch within 3 weeks – now in effect - is an appropriate method of monitoring safety and determining problem areas needing increased monitoring or official action; though we should not confuse raw AERs with actual evidence of causes-and-effects. The implementation of the long-delayed current good manufacturing practices (cGMP) regulations (that were actually authorized by the oft-maligned DSHEA law in 1994) now requires all supplement manufacturers to be cGMP compliant over the next two years, but with the largest manufacturers required to follow that standard no later than this coming June (2008). cGMP regulations are forcing manufacturers to have quality controls on raw materials and finished goods throughout the manufacturing process, including identity and safety testing. The FDA already prohibits all adulterated products, and has in fact used its authority to act against known offenders, as noted by the agency itself. 2. There are claims that “the Institute of Medicine and the Food and Drug Administration have found that supplement health claims are largely unsupported”. My response: The FDA clearly regulates supplement label claims and requires manufacturers to submit all label claims and maintain proper documentation. The agency apparently does not review this information unless there is a problem; meanwhile making manufacturers submit such information to it while requiring a contradictory label disclaimer that the FDA has not reviewed the claims. I guess that’s what’s called “plausible deniability”. However, the vast majority of responsible manufacturers are careful to present adequate documentation to the FDA, and the cGMP regulations require well-documented justification of all processes, including the writing of label claims. DSHEA requires preapproval of all new dietary supplement ingredients with an eye to proving safety, though manufacturers are allowed to use existing ingredients if they first submit their new label claims to the agency. All new drugs need pre-approval, as do all new supplement ingredients, but drugs are approved for specific uses (though often used for other unapproved “off label” conditions) while supplements are not allowed to make any disease claims, with very few exceptions for FDA-approved health claims. (http://www.cfsan.fda.gov/~dms/supplmnt.html) 3. Some physicians warn that “supplement use can be associated with death”. My response: Supplements, foods and drugs are all associated with death risks, with supplements statistically being the safest of them all, by far. Some have chosen to focus on a very few cases of dietary supplements possibly linked to deaths, but other readers have mentioned the very large death toll from both properly prescribed drugs and drug errors as a way to counter the thinking that drugs are somehow more tightly regulated, and thus presumably safer, than dietary supplements. I agree. In the annals of our peer-reviewed literature, dietary supplements are rarely responsible for accidental deaths other than by illegal adulteration, making this class of products far safer than less-regulated foods or even more regulated drugs. And, just as in the case of prescription drugs, the FDA does not test for purity and safety. Regulators routinely require industries to have quality controls in place to do such testing themselves, with penalties for non-compliant products that come to the attention of the regulatory agencies. And it is appropriate that regulators focus on the products with the most potential to cause injuries, illnesses and deaths. The routine collection of serious AERs will serve to focus the regulators on problem areas. (For more discussion and literature citations, see #6 below.) 4. There are claims that “We cannot easily know” what’s really in supplements. My response: cGMP manufacturers must test their ingredients, so responsible manufacturers do not allow the use of adulterated ingredients and have means to avoid them. It is likely that the adulterant in this case was deliberately added to ensure a noticeable effect. By definition, an adulterated supplement actually becomes an unlabeled illegal drug, not a dietary supplement. There are already penalties for such adulteration under current regulations, and the FDA has forcefully removed these products from the market. The solution is for cautious consumers to purchase their dietary supplements from responsible brands that have third-party quality certifications, and it is likely that only those individuals seeking foolish shortcuts will be involved with mail order brands of questionable integrity. The vast majority of supplement manufacturers wish to promote natural health and will not risk their companies on such questionable unlawful schemes. 5. Regarding the relative use of pharmaceutical drugs (OTC and prescription) versus dietary supplements, related to a comment that fewer people use supplements and that explains their apparently greater safety compared with drugs: My response: A recent survey reports that, “43 percent of Americans say they take a daily multi-vitamin for cancer protection. 21 percent take some other form of nutritional or dietary supplement.” (http://www.icrsurvey.com/Study.aspx?f=Supplement_survey_release.html) This indicates that a majority of Americans, about 2/3, take dietary supplements. In the case of prescription drugs, about 45% of Americans take a prescription, with the percentage rising sharply with age. (http://www.cdc.gov/nchs/fastats/drugs.htm) And Americans also take non-prescription OTC drugs, with a combined rate of drug use estimated at about 2/3 of all Americans...about the same percentage of the population as uses dietary supplements. So the argument that the use rates are sharply different is not substantiated by the data, meaning that the dramatically lower death and adverse event rates for dietary supplements are indeed a valid testimony to their relative safety versus drugs. 6. Some have commented that just because something is "natural" doesn't mean it's safe. My response: There are no foods or dietary supplements that are unregulated by the FDA, and most natural products are far safer than artificial ones. Most synthetic substances, including drugs, have a far greater risk of side effects and deaths in the clinical literature. Still, we make choices every day and do not stop consuming most foods, drugs or supplements because most have such a tremendous reward-to-risk ratio. We obviously can’t stop eating. And since our diets are known to be deficient in essential nutrients, dietary supplements do have an important role to play in ensuring adequate nutrition. (Nutrition and Your Health: Dietary Guidelines for Americans. USDA. 2005. also Fairfield KM, Fletcher RH. Vitamins for chronic disease prevention in adults: scientific review. JAMA. 2002 Jun 19;287(23):3116-26. Review. Erratum in: JAMA 2002 Oct 9;288(14):1720. PMID: 12069675) It was reported in JAMA that, “Most people do not consume an optimal amount of all vitamins by diet alone. Pending strong evidence of effectiveness from randomized trials, it appears prudent for all adults to take vitamin supplements.” (Fairfield KM, Fletcher RH. Vitamins for Chronic Disease Prevention in Adults: clinical applications. JAMA. 2002;287:3127-3129.) Regarding food safety, a medical journal report concluded that, “We estimate that foodborne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year.” (Mead PS, et al. Food-related illness and death in the United States. Emerg Infect Dis. 1999 Sep-Oct;5(5):607-25. Review. PMID: 10511517). This indicates that eating food is a far riskier activity than taking dietary supplements, since the risk for the 2/3 of food eaters that are also supplement takers is literally orders of magnitude lower than 2/3 of the known risk of eating food (which everyone does). There are few human activities with lower odds of causing death or serious illness than taking dietary supplements. In fact, even lipsticks and cosmetics are typically responsible for more annual accidental deaths than vitamins. Looking at the categories of deaths reported by the American Association of Poison Control Centers from 2002-2004, only 5 accidental deaths were reported linked to dietary supplements, 7 from cosmetics and personal care items, over 600 related to acetaminophen use, 117 related to aspirin use, and 66 from ordinary household cleaners. By far, dietary supplements are probably the safest category of products that we put into our mouths, and are demonstrably getting safer with the new regulations now being implemented. 7. Let’s talk about the real dangers of drugs, which exceed the risks of supplementation by mind-boggling amounts. That is the main reason why drugs are controlled substances. A JAMA report documented the large death toll for properly prescribed drugs: “We estimated that in 1994 overall 2,216,000 (1,721,000-2,711,000) hospitalized patients had serious ADRs and 106,000 (76,000-137,000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death.” (Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998 Apr 15;279(15):1200-5. PMID: 9555760) Also, the Washington Post reported in its 7/21/06 edition on an Institute of Medicine study released a day earlier on the toll of improperly prescribed drugs: "At least 1.5 million Americans are sickened, injured or killed each year by errors in prescribing, dispensing and taking medications, the influential Institute of Medicine concluded in a major report released yesterday. Mistakes in giving drugs are so prevalent in hospitals that, on average, a patient will be subjected to a medication error each day he or she occupies a hospital bed, the report by a panel of experts said. Following up on its influential 2000 report on medical errors of all kinds, the institute, a branch of the National Academies, undertook the most extensive study ever of medication errors in response to a request made by Congress in 2003 when it passed the Medicare Modernization Act. The report found errors to be not only harmful and widespread, but very costly as well. The extra expense of treating drug-related injuries occurring in hospitals alone was estimated conservatively to be $3.5 billion a year." Prescription drugs were named as one of the largest causes of American deaths, perhaps the second largest, as noted in another report by CDC, also published in JAMA: "IN 2004, POISONING WAS SECOND ONLY to motor-vehicle rashes as a cause of death from unintentional injury in the United States. Nearly all poisoning deaths in the United States are attributed to drugs, and most drug poisonings result from the abuse of prescription and illegal drugs. Previous reports have indicated a substantial increase in unintentional poisoning mortality during the 1980s and 1990s. To further examine this trend, CDC analyzed the most current data from the National Vital Statistics System. This report summarizes the results of that analysis, which determined that poisoning mortality rates in the United States increased each year from 1999 to 2004, rising 62.5% during the 5-year period." (FROM THE CENTERS FOR DISEASE CONTROL AND PREVENTION: Unintentional Poisoning Deaths—United States, 1999-2004. JAMA, March 28, 2007; 297: 1309 - 1311.) As you see, the fuss about dietary supplement safety is in reality a tempest in a teapot, as the risks of eating normal foods and using pharmaceuticals are each far more dangerous, in turn. This is not to minimize the need for strict controls of dietary supplements…but to a large degree, these controls already exist or are currently being implemented. Enforcement has been slowly tightening over the past 15 years. But, looking at these authoritative death and injury statistics, is anyone really surprised that the FDA properly chooses to focus its enforcement actions on products that are proven to be dramatically more dangerous to public health than dietary supplements? Some form of triage is appropriate, given the large number of deaths and injuries from food and drugs. But dietary supplements generally do not significantly contribute to these risks, and therefore do not deserve to be singled out as especially dangerous when they are comparatively very safe. Neil E. Levin, CCN, DANLA

Friday, March 14, 2008

What is pharmaceutical grade (USP)?

The US Pharmacopeia (USP) publishes official monographs for certain substances. These monographs include specific assay methods and product specifications to assure identity and potency. Material that is tested by these methods to meet those specifications is then eligible to be called pharmaceutical grade, or USP. The key concept is "standards and verification" http://www.usp.org/aboutUSP/ Many natural ingredients do not have published USP monographs, so cannot be called USP grade (as there are no USP specifications or standards to test against). Also, the testing is often a bit imprecise, so a test result for purity may be acceptable within a narrow range (from 98% - 101% of label potency, for example) and still be considered good. Another standard monograph is that found in the Food Chemicals Codex, desribing FCC food grade materials. A product with an FCC monograph can be tested to meet the food grade specifications that are typically less rigorous than those in a pharmaceutical monograph, but do provide standards for purity and identity. http://www.usp.org/fcc/ Some substances have both USP and FCC monographs and can claim both grades. For example, the amino acid l-arginine has monographs in both compendia, as do some other aminos.

Friday, February 22, 2008

Should cancer patients take vitamins?

Regarding the article “Should cancer survivors take supplements?” (14:34 ET, Thu 21 Feb 2008, http://features.us.reuters.com/wellbeing/news/FA7141DA-E0B3-11DC-91C7-1D7C8A14.html), I had written a rebuttal to a letter in CA: the Journal of the American Cancer Society, addressing these issues. (1) It is available on the journal’s web page, posted after editorial review. I cite numerous studies in which dietary supplements were used with cancer therapies, with no apparent problems. Additionally, since 40% of cancer patients actually die of malnutrition, please consider that it is wise to try to devise strategies to nourish the patients…they can’t live solely on chemotherapy and radiation, or surgery. Soon after, a review article addressed the same issue, reaching a similar conclusion: it is possible to mix dietary supplements with cancer therapies, in many cases improving results, though the timing is important. “CONCLUSION: None of the trials reported evidence of significant decreases in efficacy from antioxidant supplementation during chemotherapy. Many of the studies indicated that antioxidant supplementation resulted in either increased survival times, increased tumor responses, or both, as well as fewer toxicities than controls; however, lack of adequate statistical power was a consistent limitation.” (2) Science Daily reported that, “There is no evidence that antioxidant supplements interfere with the therapeutic effects of chemotherapy agents, according to a recent systematic review of the use of antioxidants during chemotherapy, available in the May, 2007 issue of the peer-reviewed journal Cancer Treatment Reviews. In fact, they may help increase survival rates, tumor response, and the patient’s ability to tolerate treatment.” (3) REFERENCES: 1. Cancer patients may very well tolerate the use of certain dietary supplements http://caonline.amcancersoc.org/cgi/eletters/55/5/319#176 2. Block KI, et al. Impact of antioxidant supplementation on chemotherapeutic efficacy: a systematic review of the evidence from randomized controlled trials. Cancer Treat Rev. 2007 Aug;33(5):407-18. Epub 2007 Mar 23. Review. PMID: 17367938 [PubMed - indexed for MEDLINE] 3. Antioxidants May Aid Chemotherapy Patients. ScienceDaily. Retrieved February 22, 2008, from http://www.sciencedaily.com/releases/2007/04/070426132954.htm Neil E. Levin, CCN, DANLA http://www.honestnutrition.com/

Monday, February 18, 2008

Response to inquiries about my credentials and independence

A couple of people have asked me to comment on other sites, or to refer to other sites, which I generally will not do. After all, this blog is an archive of my non-commercial writings, which are heavily referenced; so you may analyze and determine whether or not you think my scholarship and logic are valid, or not. I do not wish to comment on other people's sites; it is beyond the scope of my purpose. I think for myself and you can, too. Don't let self-appointed experts tell you what to think, unless you respect their scholarship, not just their arguments. That goes for believing me, as well! One writer has pointed out that the FDA does not approve supplements and pointed me to the agency's site, implying ignorance. If my blog entries were inspected more carefully, many references to the FDA's web site exist and in quite a bit more detail than the writer gave. Apparently the writer did not carefully consider my nuances of meaning while asserting that he/she was the expert. In fact, the agency requires all label claims ("structure-function" claims) to be submitted to them, allowing it to deny those claims, and then paradoxically requires all labels to say that the agency hasn't evaluated the claims. Kind of makes you think, no? It should! The agency also has to receive safety documentation for all new ingredients before they are sold on the market, but again does not explicitly approve them, though the absence of action to stop them does ring loud and clear. Again, the agency has plausible deniability, while retaining control. Yes, I do understand how the FDA works. Do you? One writer has persisted in questioning whether I work for and profit from vitamin companies. I do state in my bio that I am a vitamin formulator. But, you may notice that I scrupulously avoid mentioning any company names or endorsing them. If I were to post the comment, it would name names and could promote products. I am trying to maintain a professional detachment and tell the truth, as I see it. If I involve my clients/employers, I would not be able to have the freedom and independence necessary to "speak truth to power". But I write from the heart and do my own research. I formulate my own opinions as to the validity and accuracy of scientific and news reports, which I have done for decades. If you want to debate my conclusions and references, fine. But I assure you that my references are much more scrupulous and to the point than those of many of the published research I critique! THIS IS MY PERSONAL BLOG AND I WRITE PROFESSIONAL, WELL-REFERENCED TEXT ABOUT NUTRITION. NO ONE TELLS ME WHAT TO WRITE OR NOT WRITE. THIS IS NOT ABOUT PROFIT, "For what shall it profit a man, if he shall gain the whole world, and lose his own soul?" But my credentials and reputation do not substitute for you carefully dissecting my writings and my arguments. That is why I don't belabor their defense. The point is that people should realize that there are second opinions and not to rely on experts and authorities to tell us what to think. Yet I point out that the emperor has no clothes, and someone wants to know my tailoring credentials...seems like they kind of missed the point, doesn't it?

Unbalanced Fox news report misleads about vitamin-mineral safety

Unbalanced Fox news report misleads about vitamin-mineral safety By Neil E. Levin, CCN, DANLA I watched the special health report on vitamins and minerals on FOX-32 (How Do Vitamins and Minerals Really Affect Your Body? on 2/12/08, see link below), but was disappointed that the report exaggerated the risks of vitamins and minerals and minimized their benefits without any mention of the common deficiencies that exist in the American population. For example, the report cautioned about vitamin E causing blood thinning, but the Food and Nutrition Board of the Institute of Medicine has set an upper tolerable intake level (UL) for vitamin E (alpha-tocopherol) at 1,500 IU per day, which “is the highest dose unlikely to result in bleeding problems;” though the Institute has also said that the danger of the vitamin inhibiting clotting was not convincing. In other words, taking about four times the most common strength of even a hi-potency vitamin E capsule might be a problem in terms of affecting clotting, but this potency is higher than is available as a dietary supplement and one that people are unlikely to try without specific medical advice. Yet, somehow, the far more common danger of a vitamin E deficiency was completely ignored. This, despite the fact that, according to dietary data from the National Health and Nutrition Examination Surveys, ninety percent or more of the adults studied had usual intakes below the current Estimated Average Requirement. Why is a theoretical overdose problem even mentioned in the report, especially with no balancing mention of known deficiencies and benefits? What happened to fair and balanced reporting? And what are the benefits of vitamin E supplementation? An NIH-supported USDA -Tufts University study published in the medical journal JAMA reported, “…we observed a protective effect of vitamin E supplementation on upper respiratory tract infections, particularly the common cold,” for nursing home patients taking 200 IU of vitamin E daily. And Annals of the New York Academy of Sciences reported that, “The results of this clinical trial show that vitamin E supplementation significantly reduces the incidence rate of common colds and the number of subjects who acquire a cold among elderly nursing home residents.” Zinc was also mentioned in the FOX report as a possible overdose candidate, but levels required to reach the negative side effects mentioned are between 150-450 mg per day, again requiring a consumer to take several capsules to achieve this. The highest potency I have ever seen (in 35 years) was 75 mg, though 15-50 mg products are relatively common. Yet the median intake among American adults is just over 2/3 of the Daily Value, making deficiencies far more common than overdoses. Again, the FOX report ignored the common, greater danger in favor of sensationalizing a remote possibility of overdosing. Zinc is essential for many biochemical reactions in the body, and is most notably associated with immune function and wound healing. Yet isn’t FOX essentially warning people against taking zinc, hinting that they may be in danger but without any hint of the true risks and benefits? A dietician in the report stated that there is no proof that taking extra vitamin C shortens or prevents colds. That should come as news to the researchers at the University of Pittsburgh Medical Center. Publishing results of a Review Study in the medical journal American Family Physician in February 2007, these physicians reported that, “Thirty trials involving 9,676 cold episodes showed a statistically significant decrease in illness duration with vitamin C taken before onset of symptoms…. Likewise, 15 trials involving 7,045 cold episodes demonstrated a decrease in severity scores and in days confined to the home.” While there is some little evidence (not none) that vitamin C can prevent the incidence of colds, there is significant evidence that it can shorten the duration and severity of colds. Don’t you think that the FOX report is irresponsible by highlighting rare nutrient overdoses while ignoring common deficiencies? Also, why would one person’s opinion that vitamin C is worthless against colds trump the collective evidence of 30 clinical studies that met the strict criteria of a review study? Given these gross errors, I suggest that FOX assigns fact-checkers to review all medical and health reports. Let’s put an end to the flawed practice of naively taking the word of health professionals who appear not be up-to-date on what’s published in the medical literature. This is most important when demonstrably false blanket statements are made that inappropriately dismiss the safety and efficacy of essential nutrients that are known to be deficient in most Americans’ diets. REFERENCES: http://www.myfoxchicago.com/myfox/pages/Home/Detail;jsessionid=BF06BF0BCA71AE327C05A6BA65DEB517?contentId=5757535&version=2&locale=EN-US&layoutCode=VSTY&pageId=1.1.1&sflg=1 Vitamin E Fact Sheet NIH Office of Dietary Supplements Zinc Fact Sheet NIH Office of Dietary Supplements “Thirty trials involving 9,676 cold episodes showed a statistically significant decrease in illness duration with vitamin C taken before onset of symptoms: an 8 percent decrease (95% confidence interval [CI], 3 to 13 percent) in adults and a 13.5 percent decrease (95% CI, 5 to 21 percent) in children. Likewise, 15 trials involving 7,045 cold episodes demonstrated a decrease in severity scores and in days confined to the home. Vitamin C did not decrease the incidence of cold in the general population. However, a subgroup of six trials involving runners, skiers, and soldiers participating in subarctic exercises demonstrated a 50 percent relative reduction in the risk of developing a cold (95% CI, 32 to 62 percent).” Simasek M, Blandino DA. Treatment of the common cold. Am Fam Physician. 2007 Feb 15;75(4):515-20. Review. PMID: 17323712 [PubMed - indexed for MEDLINE]. Hathcock JN, et al. Vitamins E and C are safe across a broad range of intakes. Am J Clin Nutr. 2005 Apr;81(4):736-45. Review. PMID: 15817846 [PubMed - indexed for MEDLINE] Dial S, Eitenmiller RR. 1995. Tocopherols and tocotrienols in key foods in the U.S. diet. In: Ong ASH, Niki E, Packer L, eds. Nutrition, Lipids, Health, and Disease. Champaign, IL: AOCS Press. Pp. 327–342. Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids (2000). Institute of Medicine JASPREET K.C. AHUJA, JOSEPH D. GOLDMAN, and ALANNA J. MOSHFEGH. Current Status of Vitamin E Nutriture. Ann NY Acad Sci 2004 1031: 387-390. Erwin RB, et al. Dietary intake of selected minerals for the United States population: 1999-2000. Adv Data. 2004 Apr 27;(341):1-5. PMID: 15114720 [PubMed - indexed for MEDLINE] Meydani SN, et al. Vitamin E and respiratory tract infections in elderly nursing home residents: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):828-36. Erratum in: JAMA. 2004 Sep 15;292(11):1305. JAMA. 2007 May 2;297(17):1882. PMID: 15315997 [PubMed - indexed for MEDLINE] Meydani SN, Han SN, Hamer DH. Vitamin E and respiratory infection in the elderly. Ann N Y Acad Sci. 2004 Dec;1031:214-22. Review. PMID: 15753147 [PubMed - indexed for MEDLINE]

Wednesday, February 06, 2008

More about steroids and DSHEA

The fact that CNN removed the video and corrected its text report on DSHEA by substituting some of the original quotes with quotes from US regulatory agencies adequately confirms that my original criticism was both factual and confirmable. Make no mistake; it is currently illegal - under DSHEA - to put undeclared ingredients like steroids and steroid precursors in a dietary supplement. The fact that some outlaws have made supplements containing illegal drugs - without declaring them on their labels - is not a reflection on the legally operating dietary supplement industry; any more than a drug smuggler hiding contraband in a teddy bear is representative of all teddy bear manufacturers or a hollowed-out book is representative of all publishers. My contention is that steroids are often being deliberately and illegally added to “spike” certain dietary supplements, which are not "contaminated" in the sense that the substance was not accidently added. The addition of an undeclared active ingredient is "adulteration" under DSHEA, whether deliberate or accidental, and adulteration is quite clearly illegal. The FDA has full power to remove adulterated substances from the market under DSHEA and other laws; there is absolutely no legal protection for these unlawful “supplements”. It’s not a law’s fault if a government regulatory agency fails to vigorously enforce it, despite having clear authority in that area to act. Yet that’s precisely the kind of misdirected criticism that some critics of the industry propose: blaming weak enforcement on a perceived legal emasculation which simply isn’t there. This, despite the fact that the dietary supplement industry’s legislative allies have introduced bills to add funding to the FDA specifically so the agency could enforce DSHEA more strictly; which is additional proof that the industry does not avoid reasonable regulation and in fact prefers it to false claims of being “unregulated”. The Dietary Supplement and Nonprescription Drug Consumer Protection Act now requires all serious adverse events to be reported to the FDA within 15 business days. The supplement industry also supported this Act, knowing that it had to prove the safety of its products and show responsibility to the public and to lawmakers. The fact that supplement manufacturers supported the Anabolic Steroid Control Act of 2004 (HR 3886), banning androstene-type substances, should also reflect favorably on their commitment to responsible regulation and a desire to protect the public health. Even that has not quieted some critics. It is precisely an industry revulsion to outlaws posing as legitimate manufacturers that has repeatedly prompted industry support for additional government regulation. Industries do not typically request more regulation, so this stance should be more notable. Still, in my opinion it is illogical to blame a law for the actions of outlaws. Outlaws fill a perceived need at a high price, just like other drug dealers, but to consider their products to be accidentally “contaminated” is naïve, at best. Under authority granted to it by DSHEA, and after years of industry prodding, the FDA has only recently rolled out mandatory current good manufacturing practices (cGMPs), requiring safety and identity testing. There are a number of manufacturers already certified as operating under independently certified GMPs, giving consumers a high assurance against inadvertent contamination. Steroids and anabolic steroid precursors are currently regulated as prescription drugs. So no dietary supplement manufacturer has any legitimate, legal reason to use these controlled substances in any of their products, whether on or off the label, making accidental contamination quite implausible. The FDA has not claimed that DSHEA blocked its ability to regulate dietary supplements. Actually, several FDA commissioners have testified to Congress that they already had adequate enforcement powers under DSHEA; and that was before the introduction of additional regulation such as cGMPs, adverse event reporting, the anabolic steroid precursor ban, etc. It is irresponsible to continue to echo allegations that have already been disproved, taking on faith the word of cheaters who have been revealed and are trying to point the blame elsewhere. It’s ludicrous to try to shift blame on a law passed some 13 years ago, a law that specifically prohibits adulterated products. I think that the baseball player’s union leader successfully did just that, knowing that he had a receptive audience in a leading DSHEA critic. But the resulting publicity, repeating the tired old complaint of supplements being “unregulated”, does not constitute any form of real evidence, flying in the face of so many contrary facts. If you are still in doubt, don’t take my word for it. Please read the various pieces of legislation or check the websites of the regulating agencies and see for yourself. I have done both and base my writings solely on these demonstrable facts and reputable references, including official government agencies.

Thursday, January 24, 2008

Steroids in Baseball Blamed on Dietary Supplements

  1. Say It Ain’t So, Donald Steroids in Baseball Blamed on Dietary Supplements In the latest twist in the baseball players’ steroid use scandal, congressional hearings following the release of the Mitchell Report have generated a new controversy: MLB players union chief Donald Fehr has apparently tried to shift part of the blame to poor regulation of dietary supplements, suggesting that players may have accidentally ingested banned drugs due to poor manufacturing practices in an industry deregulated by the Dietary Supplement Health and Education Act of 1994 (DSHEA). Let me be blunt: What a bunch of bull! First of all, it is ridiculous to try to point the blame at dietary supplements as the cause of professional athletes’ steroid use, implying that the players were doped against their will. I can’t believe for a minute that world-class athletes don’t have their expert trainers carefully scrutinize products before using them, and then only as part of a complete nutritional program. Either the players or their trainers know, or should know, what they’re taking. Does anyone really believe that players are impulsively buying crappy supplements in gas stations? Please! In fact, DSHEA does not allow steroids to be used in dietary supplements. DSHEA actually makes it illegal to sell dietary supplements containing any undisclosed ingredients, making them by definition “adulterated” and subject to strict FDA action. DSHEA also requires that all health claims be submitted to the FDA, and prohibits any new dietary ingredients without first registering safety information with the agency. The Bioterrorism Act also requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA. Please check the FDA website and see it all for yourself. (3) It is plainly illegal to sell any restricted substances - drugs - without OTC status or a physician's prescription, and all drugs require specific labeling. It is also illegal to sell anabolic steroid precursors like androstene in this country because of another law that was strongly supported by the dietary supplement manufacturers. A New York Daily News article (2) uncritically echoed the unbelievable argument that supplements are now unregulated because of DSHEA and reprinted an outrageous quote by someone who should know better, alleging that “DSHEA was created in order to give the supplement manufacturers a huge shield so they could distribute steroids”, despite the obvious restrictions and regulations that the law imposes. Mr. Fehr’s questionable allegations were featured on AOL, CNN, ESPN, and news feeds that went around the world; sometimes with sympathetic journalists adding similar sentiments and supporting quotes. But we can see the facts for ourselves on the FDA’s own website, proving it ain’t so. (1) Dietary supplement manufacturers also supported FDA’s dramatically increased regulation of supplement manufacturing (cGMPs, or current Good Manufacturing Practices); which was authorized by DSHEA, by the way. The industry even supported mandatory reporting of serious adverse events linked (possibly related) to their products, which is now in effect. It is clear by the record that the dietary supplement industry has consistently supported increased regulation of its own operations and products as a good faith effort to protect its customers, an estimated 2/3 of American adults, even though DSHEA has obviously given the FDA additional regulatory authority over a number of areas. The industry has even lobbied Congress for additional FDA funding to improve the agency’s enforcement of dietary supplement regulations, an incredible effort by an industry to increase government regulation of that same industry. This support should come as no surprise, since the industry is focused on the scientific use of nutrition as a means to offer healthy alternatives for people trying to avoid the use of drugs in the first place. Drugs are dangerous controlled substances, by definition, and nutrients are regulated as a special food category. In this case, Rep. Waxman seemed quite willing to believe the hype, but his history evidences his unwavering belief that the dietary supplement industry is under-regulated, even as more and more layers of regulation are added. Could it be that Mr. Fehr simply, and successfully, gambled that he could distract his inquisitor by providing another target that might be welcomed by such a prominent industry critic? In my opinion, this whole baseball doping controversy really has nothing to do with sloppy supplement manufacturing or poor regulation of the dietary supplement industry, which I consider slanderously false accusations, and everything to do with deliberate illegal drug dealing and steroid use by those who are now desperately trying to find a scapegoat. 1. http://www.cfsan.fda.gov/~dms/ds-ind.html 2. http://www.nydailynews.com/sports/baseball/2008/01/16/2008-01-16_donald_fehr_admits_mlb_players_union_res.html?page=0 3. http://www.cfsan.fda.gov/~dms/supplmnt.html

Thursday, January 17, 2008

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

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 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