The critical condition of patients admitted to the ICU is associated with worsening oxidative stress.

The critical condition of patients admitted to the ICU is associated with worsening oxidative stress, according to a medical journal article. "A major finding of the study was that administration of antioxidant vitamins at between 66% and 100% of RDA can reduce the risk for oxidative stress by 94%..." "...dietary enteral supplementation with vitamins C and E for 10 days prevented lipid peroxidation and oxidative stress in critical care patients and significantly influenced their clinical outcome at 28 days." "Greater depletion of antioxidants has been related to a greater severity of trauma, systemic inflammatory response syndrome, or sepsis." full article is available at: http://ccforum.com/content/10/5/R146

Natural Health: Ten Predictions for the Year 2008

Natural Health: Ten Predictions for the Year 2008 By Neil E. Levin, CCN, DANLA 12/10/2007 The New Year will bring more proof of antioxidant benefits for human health. Recent research shows that antioxidants help to maintain healthy brain functions during aging, protect brain and nerve cells, and prevent hormones and cholesterol fractions from oxidizing to become more harmful forms. Look for an expanded understanding of the benefits of these synergistic nutrients in 2008. 2008 will provide more proof of omega-3 fatty acids’ benefits. For example, DHA helps to maintain healthy balances of cholesterol fractions and protects the brain and nerves. EPA helps normalize cell membranes and cellular health. These essential fats are typically very low in the American diet, so dramatic results could occur in clinical trials providing these nutrients to participants. There will be more safety scares regarding popular prescription and Over-The-Counter drugs, creating new safety warnings and label cautions. Since the most popular medications are typically blocking or inhibiting natural body functions (calcium channel blockers, cholesterol production inhibitors, serotonin re-uptake inhibitors, stomach acid production inhibitors, etc.) rather than dealing holistically with the causes of problems that create body imbalances (lack of optimal levels of nutrients, environmental chemicals and metals, chronic stress - lack of deep sleep, low fiber - high carbohydrate diets, etc.), major side effects from such drugs are inevitable. Side effects from pain medications will become more evident, increasing the number of people looking for safer alternatives. Herbs and spices are the major natural alternatives with some scientific evidence of efficacy. The market for organic and local foods will continue to grow at amazing levels. This will put pressure on the regulatory, farm and grocery industries to manage these products and segregate them to maintain their integrity. That contrasts with the increased reliance on genetically engineered corn to produce ethanol that raises food costs and increases the use of farm chemicals. And there is much evidence that non-genetically engineered foods are both environmentally and nutritionally superior to their modified cousins, while natural farming techniques are proving superior to chemical and genetically engineered farming in terms of managing fuel and seed costs, water use, improving both crop yields and selling prices, etc. Millions of farmers around the world have already weaned themselves from the chemical-genetic “green revolution” to use appropriate local farming techniques and have actually been more successful as a direct result of truly “green” practices. America has begun to awaken to the benefits of local and organic foods in terms of freshness, reducing the use of fossil fuels for transportation and demonstrable benefits to local economies. Watch for these trends to accelerate in 2008. Blood pressure and blood sugar concerns will continue to grow, along with a medical backlash attacking natural strategies to manage these concerns. However, science will also continue to amass evidencing the positive health benefits of natural products to help people maintain already healthy blood levels, in contrast with the poor symptom management that is a characteristic of pharmaceutical or surgical interventions used to “correct” chronic biological imbalances. These issues dovetail with current obesity and cardiovascular concerns and are part of the same syndrome related to chronic stress and poor diets. Positive reports of the benefits of higher levels of vitamin D will continue to proliferate, though with some bias against the synthesized vegetarian/vegan form of vitamin D2 versus D3 from fish oil or sheep lanolin. Health authorities will be pressured to raise both the recommended Daily Value and the Upper Limit of vitamin D to five times the current levels. Research will continue to accumulate regarding the health benefits of whole grains and whole foods, as will reports of people allergic or sensitive to gluten, corn, and other grains. More mainstream processed groceries will have whole food options in 2008. This is a good trend, though with cautions for the sensitive minority. There will be continuing claims that “dietary supplements” are illegally contaminated with steroids or other pharmaceutical drugs. These claims will typically be self-serving and defensive, made primarily by athletes accused of cheating by using banned substances. Beyond the obvious fact that legitimate supplement manufacturers do not have illegal substances on hand and that GMP (Good Manufacturing Practices certification) quality manufacturing protocols would avoid inadvertent contamination, these accusations are a barometer of how “unregulated” the mainstream media and the public thinks dietary supplements are. While there are plenty of regulations written specifically to regulate supplements, and even the FDA claims that it has adequate regulatory authority, somehow certain medical authorities and journalists like to pretend otherwise; perhaps to have a handy punching bag to deflect attention from the well-documented hundreds of thousands of deaths caused annually from pharmaceuticals and medical errors. In any case, expect more of this blame game in 2008. With a presidential election campaign under full swing, no meaningful legislation regarding health care or Medicare will be passed in 2008. There will be a narrow window of opportunity for such measures in 2009 with a new Congress and Administration. Natural health advocates will continue to press for meaningful use of nutrition to combat the major causes of disease and illness in America, with probably little impact against the lobbying might of the medical and pharmaceutical interests. The wild card is if, by some miracle, the insurance industry finally notices that their costs could be contained by the use of targeted nutrition such as the use of calcium and vitamin D to prevent osteoporosis, antioxidants to prevent age-related macular degeneration and oxidative-related glaucoma that affect vision and impact seniors’ independence, omega-3 fats to prevent coronary heart disease, the use of fiber to manage healthy cholesterol levels, etc. That could swing the pendulum towards the use of natural products to control healthcare costs. But I’m not betting on it happening in 2008, though I hope that they wise up soon enough to manage the recently overactive increases in medical costs. There will be additional, unjustified health scares about essential nutrients in 2008. Especially beware of “meta-analyses” that mix unrelated studies and magnify the number of variables using often-flawed statistical models. Some probable targets: · Kava (a few unrelated, anecdotal reports of liver problems) · Folic acid (a few reports of higher cancer levels despite a lot of cellular data indicating the opposite, creating a backlash against re-fortification of refined foods) · Vitamin E (continued championing/publicity of questionable meta-analyses over more rigorous blood-level studies will continue the inexplicable controversy over the safety of this essential nutrient that most Americans are reportedly deficient in.) · Beta-Carotene (again, blood level studies and total antioxidant studies repeatedly show its safety, but studies measuring only administration of certain doses to sick populations that may be deficient in antioxidants create a conflicting picture.) · DHEA (this adrenal hormone has been vilified as a “steroid”, but is no more so than vitamin D. No less an authority than physician and US Senator Tom Coburn has sent a letter to his colleagues informing them that he has reviewed the issues and urging them to avoid a ban of this natural product, which is useful in anti-aging strategies but not for bodybuilders. Efforts by leading senators (including presidential candidates Clinton and McCain) to ban DHEA are ongoing.

My second letter to Reader's Digest about vitamins

Subject: Re: Vitamin Hoax Thank you for your reply. But your statement that "supplements are unregulated" is completely untrue, and is contradicted by the FDA itself on its own official Web page [“FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter).”]. Are your experts completely unfamiliar with the Dietary Supplement Health and Education Act prohibiting new dietary ingredients without FDA pre-approval and regulating adulterated products and label claims, the Serious Adverse Event reporting act passed last year, the mandatory federal current Good Manufacturing Practices (cGMP) that are now being implemented requiring quality controls and identity testing of ingredients, and currently operational GMP-audited manufacturers? That inflammatory falsehood is exactly the kind of media myth that evidences bias or abject misunderstanding. You have represented a misguided opinion as fact, when it is clearly contradicted by official records of the FDA, FTC and the Congressional Record in both law and regulations. As a watchdog for clinical studies that are misrepresented or poorly done, it is obvious to me that your writers cherry-picked negative studies that were heavily criticized, some contradicted by more robust data or not able to be replicated, and some done with very sick people where the results were admittedly not applicable to healthy populations. Many scientists simply fail to understand the topic of nutrition, thinking that nutrients should be taken just like drugs: in isolation and in high potencies to treat disease in their studies. That is pharmaceutical medicine, not basic human nutrition, which is an all-too-common mistake that creates a lot of confusion when applied to the moderate dietary supplements used by ordinary people to enhance their vitamin-starved modern diets. Using examples of potential side effects from taking amounts far above commonly available supplement potencies as the main reason to avoid taking them entirely is intellectually dishonest, in my opinion, when no one was actually suggesting that everyone take those mega dose amounts in the first place. When you say that, “Food (especially locally farmed food) is the only way to get your vitamins that's absolutely proven to be safe and effective”, you are only partially right. I am a nominee to the Illinois Local and Organic Food Task Force, on a slate approved by the state Department of Agriculture, so I do understand your point and empathize. But you forget the tens of thousands of people affected annually by food poisoning. This makes vitamins orders of magnitude safer than food, especially fresh foods, and are thus more deserving of your praise for safety and efficacy. You also seem to forget that vitamins are regulated as a special, highly regulated food category by the federal government (by law), and not as drugs. If it is so 'easy' to "get what you need from food" then why does your own report admit that only 3% of us get the minimal nutrient levels from our diet? That really disproves this tired old mantra, doesn't it? It is pure institutional bias that prevents the NIH from recommending multiple vitamins, when even the mainstream medical journal JAMA has done so years ago. If you remember (I do), it took the federal government 20+ years to endorse the use of folic acid to fortify foods denatured of that essential vitamin, during which entire time the evidence was already strong that it could prevent birth defects; with a request in to the Nixon administration that it was time to take action. The March of Dimes recommended this fortification long before the government finally caved in (during the Clinton administration!), but meanwhile thousands of children were born each year with potentially preventable and predictable birth defects while waiting for the perpetually elusive 'more conclusive evidence'. But there never seems to be enough evidence when we're talking about dietary supplements. Even a multiple vitamin taken by the mothers should have been enough to spare these children, but the government still to this day won't fully act to protect people's health by recommending that the 97% of us not eating even minimally right take a simple and safe daily multivitamin, as many doctors already recommend. Are we so set on forcing people to eat right, when they clearly won't, that we should all just pretend that taking a multivitamin as nutritional 'insurance' is somehow fundamentally wrong? In good conscience, I can't do that. I know better. And so do most Americans, who have opted to take vitamins and do so without much risk. Perhaps you haven’t noticed the reports that our food supply has dramatically dropped in nutritional value over the past half century due to factors such as chemical farming, less nutritious plant varieties, changes in storage and handling, etc? The nutritional content of U.S. fruits and vegetables has declined over the past 50 years, according to a researcher at the University of Texas. Cited in an article by Scripps Howard News Service, biochemist Donald Davis said that of 13 major nutrients in fruits and vegetables tracked by the Agriculture Department from 1950 to 1999, six (protein, calcium, phosphorus, iron, riboflavin and vitamin C) all showed noticeable declines. Declines ranged from 6% for protein, 20% for vitamin C, and 38% for riboflavin. [February 2006, official meeting of the American Association for the Advancement of Science in St. Louis, MO] Data from the Department for the Environment, Food and Rural Affairs (DEFRA) showed that, between 1940 and 1991, trace minerals in UK fruits and vegetables fell by up to 76 per cent, and United States Department of Agriculture (USDA) figures showed similar declines. [McCance and Widdowson 1940–1991, The Composition of Foods, 1st to 5th editions, published by MAFF/RSC] [Mayer AM, 1997, ‘Historical changes in the mineral content of fruits and vegetables’, in Lockeretz W (ed.), Agricultural Production and Nutrition, Tufts University School of Nutrition Science and Policy, Boston, MA, p 69–77. See also British Food Journal 99(6), p207–211] [Bergner P, 1997, The Healing Power of Minerals, Special Nutrients and Trace Elements, Prima Publishing, Rocklin, CA, p 312] Neil E. Levin, CCN, DANLA www.honestnutrition.com

A Tale of Two Studies: Vitamin E - Food vs Supplements

Vitamin E: Food vs Supplements Here is an illustration of the apparent contradiction between whether food sources of vitamin E are better to prevent prostate cancer than supplemental vitamin E sources: Two large studies, both published in the same technical journal at the same time, seem to reach contradictory results as to whether supplemental vitamin E is valuable in relation to prostate cancer. But are they both equal and contradictory? Actually, one is far more rigorous, and thus presumably more valid, than the other. In the first one (Serum and Dietary Vitamin E in Relation to Prostate Cancer Risk <1>), definite and large benefits were shown for supplemental alpha-tocopherol vitamin E, but not for food sources (containing mostly gamma-tocopherol). In the second one (Supplemental and Dietary Vitamin E Intakes and Risk of Prostate Cancer in a Large Prospective Study <2>), only food sources containing gamma-tocopherol were effective, but not supplemental vitamin E as alpha-tocopherol. A closer look reveals that the first study responsibly looked at serum levels and food plus supplemental vitamin E intake, then related that data to prostate cancer rates over up to 19 years afterward. This study's conclusion was that, "In summary, higher prediagnostic serum concentrations of alpha-tocopherol, but not dietary vitamin E, was associated with lower risk of developing prostate cancer, particularly advanced prostate cancer." The second study looked only at questionnaires related to subjects' intake of vitamin E from food and supplements at the start of the 5-year study, then compared the number of cancers over a 5-year period to data obtained from that questionnaire. The incubation period for cancers is estimated to be in the decades, rarely a period of 5 years or less. That, along with the lack of any data on serum antioxidant status and the use of a questionably reliable survey to determine intake of vitamin E from food or supplements, makes the second report far less meaningful than the first one. Don’t get me wrong, I am not against food sources of nutrients and routinely recommend vitamin E sources containing gamma-tocopherol, along with the full range of tocopherols and tocotrienols. But when preliminary or sketchy science is all-too-often reported as if it’s definitive when it’s really not, and when it is contradicted by better science, I am compelled to put things into a more realistic perspective. The measurement of serum levels in the body, along with careful reporting of a nutrient’s intake from various sources, is much more compelling than relying on a questionnaire that may be done by memory. It is well-known among nutritionists that daily food diaries are notoriously different than weekly food surveys done by memory recall, which almost always seem to conveniently forget the junk food, snacks and extra calories. A cancer study lasting nearly 4 times as long is also far more compelling than a shorter one because it will be more likely to encompass the cancer’s incubation period and allow for the development of symptoms that will allow detection. As the National Cancer Institute reports: “Prostate cancer often does not cause symptoms for many years.” <3> The use of supplemental alpha-tocopherol is supported by other reputable studies. For example, The Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study demonstrated a 32% reduction in prostate cancer incidence in response to daily alpha-tocopherol supplementation. <4> Levels of Vitamin E above 100 IU daily are associated with decreased risk of coronary heart disease and certain types of cancer, as well as enhancement of immune function. These increased vitamin E intakes (100 I.U. and above) are considerably above levels obtainable from diet alone. <5-7> In the case of supplemental vitamin E, the results for prostate cancer in the more rigorous, better designed and better implemented study shows that it is more beneficial for prostate health than only food sources of vitamin E, which also tend to be much weaker amounts (often far below 100 IU daily, with Americans’ typical intake being only around 9.5 IU (6.4 mg) of alpha-tocopherol, below the RDA of 22.5 IU (15 mg). <8-9> This indicates our general need for supplemental vitamin E, unless by some miracle we all suddenly decide to eat wholesome natural foods containing a lot more vitamin E. But in the meantime, it would be nice if these studies were put into perspective so we could accurately assess their value to our health habits. Unfortunately, media coverage of negative reports, especially regarding vitamins, tends to drown out the positive ones, even when the good news is backed by studies with better design and implementation. In this case, supplemental vitamin E was the clear winner over the abysmal amounts in our diet, which ideally should be increased to healthy levels. REFERENCES: 1. Weinstein, SJ, et al. Serum and Dietary Vitamin E in Relation to Prostate Cancer Risk. Cancer Epidemiol Biomarkers Prev 2007 16: p. 1253-1259 http://cebp.aacrjournals.org/cgi/content/abstract/16/6/1253?ct 2. Wright, ME, et al. Supplemental and Dietary Vitamin E Intakes and Risk of Prostate Cancer in a Large Prospective Study. Cancer Epidemiol Biomarkers Prev 2007 16: p. 1128-1135 http://cebp.aacrjournals.org/cgi/content/abstract/16/6/1128?ct 3. National Cancer Institute’s Web site http://www.cancer.gov/cancertopics/factsheet/Detection/early-prostate 4. Weinstein SJ, et al. Serum alpha-tocopherol and gamma-tocopherol in relation to prostate cancer risk in a prospective study. J Natl Cancer Inst. 2005 Mar 2;97(5):396-9. PMID: 15741576 5. Bauernfeind, J. Tocopherols in Foods. In: Vitamin E: A Comprehensive Treatise. Marcel Dekker, Inc., New York and Basel, pp. 99-167, 1980 6. Horwitt, M.K. The Promotion of Vitamin E. J. Nutr. 116:1371-1377, 1986 7. Weber, P., Bendich, A. and Machlin, L.J. Vitamin E and Human Health: Rationale for Determining Recommended Intake Levels. Nutrition 13:450-460, 1997 8. Ervin RB, Wright JD, Wang CY, Kennedy-Stephenson J. Dietary intake of selected vitamins for the United States Population: 1999–2000. Advance data from vital and health statistics; no 339. Hyattsville, Maryland: National Center for Health Statistics. 2004 9. Vitamin E, Office of Dietary Supplements • NIH Clinical Center • National Institutes of Health http://ods.od.nih.gov/factsheets/vitamine.asp

Natural Controversies

On Thursday, November 8, 2007 I began writing the book, "Natural Controversies". The intention is a consumer-friendly referenced guide with specific examples of how to navigate sensational reports and conflicting claims about natural products and therapies. On November 15, I registered that title as a website name, temporarily pointing it to this blog (until the book is finished and the webpage can properly showcase it).

Letter sent to Reader's Digest in response to The Vitamin Myth (11/07)

Myths about Vitamin Dangers While “The Vitamin Myth” did responsibly quote experts refuting some negative reports emphasized in the article, the overall tone was sensationalist and negative, greatly exaggerating supposed risks. Vitamins may be among the safest substances known, typically causing no deaths in any given year. The article emphasized heavily-criticized single reports in preference to more rigorous published research contradicting the alleged dangers (for example, of vitamin E), a common media error. Megadoses far above levels commonly consumed were highlighted as reasons why we should not take vitamins, with confusing potencies listed for oil-soluble vitamins by weight rather than by the consumer-friendly IU measurements. The lack of specific disease benefits was presented as the only reason not to take certain vitamins (“Vitamin C: There’s no conclusive evidence that it prevents colds, heart disease, cataracts or cancer.”), reflecting an expectation and bias not shared by many nutrition experts. Any such disease claims are regulated as “drug claims”, which are prohibited for vitamins. Were you really that hard up to find 10 reasons not to take vitamins? Nutrients are not drugs, may require synergies with other nutrients for best effect, and may be misrepresented by the conclusions of review studies that combine dissimilar protocols. Even your article admits that only 3% of us get the minimal amounts of vitamins and minerals from our diet, making supplementation essential for virtually every American. http://www.rd.com/content/are-vitamins-really-that-good-for-you-/

The Pitfalls of Meta-Analysis Should be More Widely Recognized and Acknowledged.

The Pitfalls of Meta-Analysis Should be More Widely Recognized and Acknowledged. (from a US government report) Our evidence report draws heavily on six study-level meta-analyses of glucosamine/chondroitin and five of viscosupplementation. While we used a validated instrument to appraise the quality of the systematic reviews, the instrument does not address the question of when meta-analysis is appropriate to a systematic review. Meta-analysis is a technique with underlying assumptions that may or may not hold when a particular collection of results are pooled. Furthermore, metaanalyses may fail to convey the real uncertainty and potential bias accompanying pooled estimates. Uncertainty in the magnitude of effects pooled is influenced by factors intrinsic to the underlying trials. Among these are variable patient characteristics, trial characteristics, and the indication that a few trial results were outliers and influential on pooled estimates. The metaanalyses frequently reported high inter-trial heterogeneity. Random effects models were used in the face of high heterogeneity, but a consequence is to increase the influence of smaller trials on the pooled results. The meta-analyses did not address a threshold question, one that has not been clearly resolved by practitioners of meta-analysis: when is heterogeneity too high to justify pooling trial results. A related concern is the practice of reporting on multiple outcome measures and time intervals, which may be represented by a small portion of studies, thus potentially introducing bias. Evidence Report/Technology Assessment Number 157 Treatment of Primary and Secondary Osteoarthritis of the Knee Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road, Rockville, MD 20850 www.ahrq.gov Contract No. 290-02-0026 Prepared by: Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center Chicago, Illinois Investigators David J. Samson, M.S. Mark D. Grant, M.D., M.P.H. Thomas A. Ratko, Ph.D. Claudia J. Bonnell, B.S.N., M.L.S. Kathleen M. Ziegler, Pharm.D. Naomi Aronson, Ph.D. AHRQ Publication No. 07-E012 September 2007

Nutrients for Joint Health

Nutrients for Joint Health By Neil E. Levin, CCN, DANLA Most people know that glucosamine sulfate and chondroitin sulfate are important components of joint health. They help to form spongy tissues (like articular cartilage) that hold moisture and cushion the body’s joints, protecting them from excessive wear and tear. But this takes time. Some people notice a change in joint function within days, but more typically over several weeks. Studies show that these substances help to maintain distances between joint structures over many months, a key measure of joint integrity as these structural components may slowly collapse if not nourished. This particular effect has been accepted as evidence-based by conventional physicians at a medical joint health center associated with a major university hospital. People with osteoarthritis typically may have low levels of glucosamine and chondroitin sulfates, as well as MSM, and may benefit by supplementing to restore normal levels of these soft tissue nutrients. MSM is a safe form of the mineral sulfur that may preserve joint function and structures. In order to affect joint health on a short-term basis, it may be useful to supplement the diet with herbs that inhibit the activity of the enzymes that are involved in normal inflammatory processes. These herbs may mediate COX-2 or 5-LOX enzymes. COX-2 is also the target of some widely used drugs. Some of these herbs are safe, common spices like turmeric, ginger, cayenne and the enzyme bromelain. While drugs may offer similar yet faster COX-2 inhibition, herbs can also modulate 5-LOX activity. The safety profiles and beneficial side effects associated with nutrients and herbs can be preferable to the known side effects of drugs. The antioxidant components in the herbs also improve the body's ability to repair tissues by stimulating collagen formation. A diet high in animal fat is implicated in joint problems, and experts frequently recommend that sufferers reduce their intake of most animal fats. It is important to take natural healthy essential fats, especially Omega-3 fats (cold water fatty fish, fish oil, flax seeds, flax oil) and Omega-6 fats CLA and GLA from vegetable oils. All fish oils are well-filtered and/or molecularly distilled to remove environmental contaminants and heavy metals. A low-fat, gluten-free vegetarian diet has been helpful if maintained for several months, but does not produce fast results and is best combined with other approaches, such as supplementation. Wheat and milk are often implicated in immune reactions, and it is sometimes best to avoid them, at least while addressing the problems. Joint problems have also been linked to leaky gut and maldigestion of food, leading to the body’s immune cells attacking undigested proteins. This trains immune cells to recognize food proteins as invasive organisms and respond to them aggressively, leading to food sensitivities that are not classic allergies. Since some undigested or partially digested proteins may be similar to body tissues, maldigestion could partially explain why the body sometimes attacks its own tissues. If so, there are aids to proper digestion that should be considered. Good digestion is a tool to prevent immune reactions to food and the human gut should serve as an immune barrier to pathogens in food. Take time to smell and think about your food before you eat. Avoid stress or distractions during meals. Carefully chew food to a liquid before swallowing, and even chew liquids to enhance contact with digestive enzymes in saliva. If necessary, take a high quality plant enzyme or a milk-digestive enzyme. In some cases, more stomach acid is needed to digest proteins (and minerals). HCl and Pepsin supplements do this, but sometimes much larger amounts of acid than normal are recommended by health professionals (600-2400 mg), which do have risks if you don’t need that much acid, so these high doses must be taken under medical supervision. A traditional home test to determine whether more acid would help digestion is to mix a tablespoon of (preferably raw and organic) apple cider vinegar into a glass of (pure) water and drink with a meal. If it helps digestion, you may need more acid. It may not noticeably help if you require very much acid, though. A tablespoon of raw honey can also be added to this beverage to enhance digestion, also making it taste more like apple juice. If it helps, this can be taken daily with meals. Some digestive enzymes like Bromelain and Serrazimes (serratopeptidase) can be taken between meals to help control substances associated with temporary joint discomfort. A protective layer of probiotics - acidophilus, bifidus and other “friendly bacteria” - actually lines healthy GI tracts like chain mail, preventing leakage of undigested food remnants from the gut that provoke immune responses. It is wise to supplement with healthy bacterial supplements such probiotic products. Fairly high doses of Vitamin E have been shown to help maintain joint health, but I recommend taking the full Vitamin E Complex containing eight forms of natural Vitamin E compounds, not just the alpha tocopherol. Other antioxidants are important to maintain joint health. These include the minerals selenium and zinc, vitamins A, C, E and many plant compounds. GliSODin® raises body levels of key antioxidant enzymes, such as SOD and glutathione. Celadrin® products may help to maintain joint mobility, taken orally or topically applied, and contain acetylated fatty acids from beef fat. MicroLactin™ is a milk protein fraction that helps prevent certain immune cells (cytokines) from overwhelming an area and maintaining a prolonged reaction. Time and patience may be required to find a program that works for any individual’s joint health. Many supplements work best over weeks, months or years. Stretching and gentle exercise often help people, so should be part of any comprehensive program. Yoga and Tai Chi, and variants such as water Ai Chi, are low-impact activities that aid posture and build muscle strength. Glucosamine, Chondroitin and MSM (methylsulphonylmethane, an organic form of sulfur found in all living organisms) are three of the most popular and effective nutrients for supporting joint health. There are other formulations of Glucosamine, including a vegetarian version from fungal fermentation. Studies have shown that these nutrients provide dietary components that support healthy joint structure and function. Look for substances, forms and potencies successfully used in clinical studies. REFERENCES: Chan PS, Caron JP, Orth MW. Effect of glucosamine and chondroitin sulfate on regulation of gene expression of proteolytic enzymes and their inhibitors in interleukin-1-challenged bovine articular cartilage explants. Am J Vet Res. 2005 Nov;66(11):1870-6. Chan PS, Caron JP, Rosa GJ, Orth MW. Glucosamine and chondroitin sulfate regulate gene expression and synthesis of nitric oxide and prostaglandin E(2) in articular cartilage explants. Osteoarthritis Cartilage. 2005 May;13(5):387-94. Deal CL, Moskowitz RW. Nutraceuticals as therapeutic agents in osteoarthritis. The role of glucosamine, chondroitin sulfate, and collagen hydrolysate. Rheum Dis Clin North Am. 1999 May;25(2):379-95. Kelly GS. The role of glucosamine sulfate and chondroitin sulfates in the treatment of degenerative joint disease. Altern Med Rev. 1998 Feb;3(1):27-39. Bijlsma JW. [Glucosamine and chondroitin sulfate as a possible treatment for osteoarthritis] Ned Tijdschr Geneeskd. 2002 Sep 28;146(39):1819-23. Ameye LG, Chee WS. Osteoarthritis and nutrition. From nutraceuticals to functional foods: a systematic review of the scientific evidence. Arthritis Res Ther. 2006;8(4):R127. Kim LS, Axelrod LJ, Howard P, Buratovich N, Waters RF. Efficacy of methylsulfonylmethane (MSM) in osteoarthritis pain of the knee: a pilot clinical trial. Osteoarthritis Cartilage. 2006 Mar;14(3):286-94. Ebisuzaki K. Aspirin and methylsulfonylmethane (MSM): a search for common mechanisms, with implications for cancer prevention. Anticancer Res. 2003 Jan-Feb;23(1A):453-8. Parcell S. Sulfur in human nutrition and applications in medicine. Altern Med Rev. 2002 Feb;7(1):22-44. Bruyere O, Pavelka K, Rovati LC,et al. Glucosamine sulfate reduces osteoarthritis progression in postmenopausal women with knee osteoarthritis: evidence from two 3-year studies. Menopause. 2004 Mar-Apr;11(2):138-43.

Selenium Safety

Selenium Safety By Neil E. Levin, CCN, DANLA 9/21/07 My comments refer to “Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. A randomized controlled trial. Nutritional Prevention of Cancer Study Group” 1 Giving high doses of a single antioxidant is contrary to the realities biology and nutrition. It is unfortunate that synergistic nutrients are tested individually, like drugs. This is a pharmaceutical practice, not human nutrition, and also shouldn’t imply that comprehensive mixtures of nutrients (like a multivitamin) would have the same effects. Additionally, giving these doses to sick patient populations typically results in the authors’ cautions that their results are not applicable to the general population. Still, this disclaimer is routinely ignored in the significant portion of the media that tends to sensationalize the results in headlines or brief televised “health segments”. Antioxidants are synergistic and simply don’t work in isolation. In fact, high doses of single antioxidants have been shown to create imbalances, in vivo, and may even backfire. I consider these cases to be a fault of the study design and a lack of understanding of the scientific field, not a defect of the nutrient being studied. This report was primarily a study of patients with skin cancers, with a increase in self-reported Type 2 diabetes found during a “secondary analysis”. This means that strict elimination of various factors and strict screening of patients was not completed in relation to this unexpected outcome, and that researchers relied primarily on patients’ anecdoctal reports of being diagnosed with diabetes during the trial. This raises issues of undiagnosed cases of diabetes at the start of or during the trial, since even a few missed diagnoses could have (admittedly) reduced or eliminated the significance of the results. Admittedly, “detailed information on unmeasured risk factors at baseline, such as family history of diabetes, body fat distribution, and physical activity, are lacking.” This expands the variables far beyond those accounted for in the study design, which was really looking at cancer recurrences. (More on that later.) Other concerns with this report: • Only Caucasians were included in the patient population; almost all participants in the NPC trial were non-Hispanic white persons. Three-quarters of participants were men. • Patient compliance was also self-reported, limiting validity of the data. • Selenium is not an antioxidant commonly associated with glucose metabolism, so its selection is a bit odd, though in some past studies the mineral has given some indications that it may be useful. However, its close association with vitamin E, and the lack of data on coinciding use of that and other antioxidants, raises more questions than answers. Selenium was used in a study primarily looking at its effect on cancer, with good reason based on past science, and with self-reported diabetes only noticed as varying between the groups incidentally. • The “risk for type 2 diabetes did not differ between treatment groups within the top tertile of BMI” (Body Mass Index, indicating the most overweight people). This strongly indicates another possible variable and alternative explanation, reducing the validity of the implication that selenium alone was the cause of the increased diabetes self-reports. • A well known, name-brand selenium supplement was changed for a different one late in the study, without explanation. • High-selenium yeast products may not work the same as selenomethionine, the most popular type of selenium supplement currently sold. And yeast itself is considered to be a good dietary source of selenium and other nutrients, yet yeast was the placebo. • The population was consuming more than the Daily Value of selenium in their diet, so this was not a particularly selenium-deficient group before supplementation. And since they had all had previously diagnosed skin cancer, it appears that significant other factors, especially antioxidant synergies, were lacking in this patient group. The researchers admit that, “we cannot rule out the role of chance in our findings.” In other words, they admit that their report doesn’t really prove anything. In fact, in the original trial, the focus was on selenium and cancer. What were those results? Selenium alone so successfully reduced cancer incidences and cancer mortality that the study was halted early because a lack of selenium was so clearly associated with higher incidences and deaths from cancer. “Primarily because of the apparent reductions in total cancer mortality and total cancer incidence in the selenium group, the blinded phase of the trial was stopped early. No cases of selenium toxicity occurred. CONCLUSIONS: Selenium treatment did not protect against development of basal or squamous cell carcinomas of the skin. However, results from secondary end-point analyses support the hypothesis that supplemental selenium may reduce the incidence of, and mortality from, carcinomas of several sites.” 2, 12 Regarding the editorial about selenium and diabetes published in the same edition of the journal Annals of Internal Medicine, negative comments were made about the general safety of antioxidant supplements. 3 I dispute that “randomized, controlled clinical trials have shown that ß-carotene and vitamin E supplements, which were widely believed to be safe, increase mortality and morbidity”. The choices, increasing variables, and manipulation by statistical models in meta-analyses are often questionable. In this report, prediabetic symptoms were not even considered as a variable. Buijsse noted that high carotenoid intake, confirmed by measures of blood levels, was associated with lower mortality rates among the elderly over a ten-year period, countering the claim that ß-carotene dangers are proven. 5 The Miller meta-analysis 9, cited as proof of vitamin E’s dangers, was heavily criticized in published responses, and its conclusions were NOT replicated when the same data was re-analyzed (Hathcock) 7. It should therefore not be cited as proof of the vitamin’s danger. Another meta-analysis cited reported that antioxidant vitamins may increase death rates. But the authors did not determine a dose-dependent or cause-and-effect relationship between antioxidants and deaths (from all causes) of study participants. The researchers pooled 68 published trials, excluding 405 published studies with no deaths reported. Too wide a range of potencies (Vitamin A 1333 IU - 200,000 IU, vitamin E 10 IU to 1000 IU), and durations (28 days to 12 years) were lumped together. 4 The editorial statement, “No dietary supplement, including selenium, has proven useful so far for the prevention of cardiovascular disease or cancer in the general U.S. population,” is questionable. The Alpha-Tocopherol, Beta- Carotene Cancer Prevention (ATBC) Study published by the National Cancer Institute demonstrated a 32% reduction in prostate cancer incidence in response to daily alpha-tocopherol supplementation. 8, 10 The Women’s Health Study (JAMA) reported a significant 24% reduction in cardiovascular death with supplemental vitamin E. 11 The NIH reports, “Taking a daily supplement containing 200 mcg of selenium … significantly reduced the occurrence and death from total cancers. The incidence of prostate cancer, colorectal cancer, and lung cancer was notably lower in the group given selenium supplements.” 13 Yet the Annals editorial suggests lowering consumption below the Daily Value (70 mcg) used in multivitamins, far below the current official upper limit of 400 mcg. 13 On the contrary, the Lewin Group reports that the use of antioxidants could save the vision and independence of many senior citizens, saving billions of dollars in healthcare costs. 6 REFERENCES: 1. Stranges S, et al. Effects of long-term selenium supplementation on the incidence of type 2 diabetes: a randomized trial. Ann Intern Med. 2007 Aug 21;147(4):217-23. Epub 2007 Jul 9. Summary for patients in: Ann Intern Med. 2007 Aug 21;147(4):I14. PMID: 17620655 [PubMed - indexed for MEDLINE] 2. Clark LC, Combs GF Jr, Turnbull BW, Slate EH, Chalker DK, Chow J, et al. Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. A randomized controlled trial. Nutritional Prevention of Cancer Study Group. JAMA. 1996;276:1957-63. 3. J. Bleys, A. Navas-Acien, and E. Guallar. Selenium and Diabetes: More Bad News for Supplements. Ann Intern Med, August 21, 2007; 147(4): 271 - 272. 4. Bjelakovic G, et.al. Mortality in Randomized Trials of Antioxidant Supplements for Primary and Secondary Prevention: Systematic Review and Meta-analysis. JAMA 2007. 297(8):842-857 5. 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;82:879–886. 6. DaVanzo JE, et al. An Evidence-Based Study of the Role of Dietary Supplements in Helping Seniors Maintain their Independence. The Lewin Group Inc. January 20, 2006 7. 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 8. Weinstein SJ, et al. Serum alpha -Tocopherol and gamma-Tocopherol in Relation to Prostate Cancer Risk in a Prospective Study. J. Natl. Cancer Inst. 2005 97: 396-399; doi:10.1093/jnci/dji045 9. Edgar R. Miller, III, MD, PhD; et al. High-dose vitamin E supplementation may increase all-cause mortality, a dose response meta-analysis of randomized trials. Annals of Internal Medicine. 4 January 2005 | Volume 142 Issue 1 10. Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study Group. The effect of vitamin E and beta-carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med 1994;330:1029 –35. 11. Lee IM, et al. Vitamin E in the primary prevention of cardiovascular disease and cancer: the Women's Health Study: a randomized controlled trial. JAMA. 2005 Jul 6;294(1):56-65. PMID: 15998891 12. Combs GF Jr, Clark LC, Turnbull BW. Reduction of cancer risk with an oral supplement of selenium. Biomed Environ Sci. 1997 Sep;10(2-3):227-34. PMID: 9315315 13. Dietary Supplement Fact Sheet: Selenium. Office of Dietary Supplements • NIH Clinical Center • National Institutes of Health. http://ods.od.nih.gov/factsheets/selenium.asp

Are antioxidants worthless against heart disease?

Are antioxidants worthless against heart disease? By Neil E. Levin, CCN, DANLA 8/15/07 In a published report, A Randomized Factorial Trial of Vitamins C and E and Beta Carotene in the Secondary Prevention of Cardiovascular Events in Women (Results From the Women’s Antioxidant Cardiovascular Study), researchers concluded that, “There were no overall effects of ascorbic acid (vitamin C), vitamin E, or beta carotene on cardiovascular events among women at high risk for CVD.” (1) This is simply untrue. In order to reach that conclusion, the researchers had to count non-compliant subjects as taking vitamin E, even when it was obvious that they weren’t following the study protocol. Is that intellectually honest? I would have given the opposite conclusion. When subjects assigned to take vitamin E actually took their vitamin E, the results were significant and proved that the vitamin had benefits: “Censoring participants on noncompliance led to a significant 13% reduction in the primary end point…Reductions in secondary study end points were also stronger, with a 22% reduction in MI … a 27% reduction in stroke … and a 9% reduction in CVD mortality … There was a 23% reduction in the combination of MI, stroke, or CVD death…Among those with prior CVD, the active vitamin E group experienced fewer major CVD events …” [-11%] "A marginally significant reduction in the primary outcome with active vitamin E was observed among the prespecified subgroup of women with prior cardiovascular disease (RR, 0.89; 95% CI, 0.79 - 1.00 [P = .04]; P value for interaction = .07). There were no significant interactions between agents for the primary end point, but those randomized to both active vitamins C and E experienced fewer strokes (P value for interaction = .03)." Why did the researchers gloss over these admitted benefits (that those assigned to take vitamin E who actually did take it had "significant" benefitsand those with prior CVD who took the relatively low levels of C plus E experience fewer strokes)? This was wholly ignored in the study's conclusion, as well as the subsequent press release and extensive news coverage. I have found and published (2) criticisms of this particular failing (reaching improper conclusions not truly supported by the data) before: (3-10) REFERENCES: 1. Cook N, et al. A Randomized Factorial Trial of Vitamins C and E and Beta Carotene in the Secondary Prevention of Cardiovascular Events in Women. ARCH INTERN MED. VOL 167 (NO. 15), AUG 13/27, 2007 2. 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 3. Edgar R. Miller, III, MD, PhD; et al. High-dose vitamin E supplementation may increase all-cause mortality, a dose response meta-analysis of randomized trials. Annals of Internal Medicine: Online: Nov. 10, 2004: Print: 4 January 2005 | Volume 142 Issue 1 4. A study conducted by USA Today found that more than half of the experts hired to advise the government on the safety and effectiveness of medicine had a direct financial interest in the drug or topic they were asked to evaluate. An analysis of financial conflicts of interest at 159 FDA advisory committee meetings from January 1, 1998, through June 30, 2000, found that at 92% of the meetings, at least one member had a financial conflict of interest, while at 55% of meetings, half or more of the FDA advisers had conflicts of interest. These conflicts included helping a pharmaceutical company develop a medicine, then serving on an FDA advisory committee that judges the drug. 5. Lonn E, et al. Effects of long-term vitamin E supplementation on cardiovascular events and cancer: a randomized controlled trial. JAMA. 2005 Mar 16;293(11):1338–47. PMID: 15769967 6. Blumenthal M, Farnsworth NR. Echinacea angustifolia rhinovirus infections [letter]. N Engl J Med. Nov.3, 2005;353(18):1971–1972. 7. 21 C.F.R. Pt. 119, Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (Published February 11, 2004) (Effective April 12, 2004) available at http://www.fda.gov/ohrms/dockets/98fr/1995n-0304-nfr0001.pdf 8. Taylor JA, Weber W, Standish L, Quinn H, Goesling J, McGann M, Calabrese C. Efficacy and safety of Echinacea in treating upper respiratory tract infections in children: A randomized controlled trial. J Amer Med Assn Dec 3, 2003;290(21):2824–30. 9. Fugh-Berman A, Myers A. Citrus aurantium, an ingredient of dietary supplements marketed for weight loss: current status of clinical and basic research. Exp Biol Med (Maywood). 2004 Sep;229(8):698–704. Review. PMID: 15337824 10. Effects of Long-term Vitamin E Supplementation on Cardiovascular Events and Cancer. JAMA. Vol. 293 No. 11, Vol. 293 No. 11, March 16, 2005

Neil to be on radio, listen to current or past shows

Neil is regularly a guest on the Tampa Bay radio program Let's Talk Nutrition with Dr. Michael Garko. Click on the link to listen to programs, a schedule is listed there with program links or Listen Live. 2-3 pm on weekdays, I'm on 1-2 times a month.

Neil to be on radio Monday 7/23

Neil will be interviewed about omega-3 oils on Healthy Talk Radio with Deborah Ray. http://www.healthytalkradio.com/

Selenium and Antioxidant Safety

My letter criticizing their editorial in Annals of Internal Medicine was accepted and published online by that journal: http://www.annals.org/cgi/eletters/0000605-200708210-00177v1#21702 It is unfortunate that synergistic nutrients are tested individually, like drugs. This is a pharmaceutical practice, not human nutrition, and shouldn’t imply that comprehensive mixtures of nutrients (like a multivitamin) would have the same effects. I dispute that “randomized, controlled clinical trials have shown that ß-carotene and vitamin E supplements, which were widely believed to be safe, increase mortality and morbidity”. The choices, increasing variables, and manipulation by statistical models in meta-analyses are often questionable. In this report, prediabetic symptoms were not even considered as a variable. Buijsse noted that high carotenoid intake, confirmed by measures of blood levels, was associated with lower mortality rates among the elderly over a ten-year period, countering the claim that ß-carotene dangers are proven. The Miller meta-analysis, cited as proof of vitamin E’s dangers, was heavily criticized in published responses, and its conclusions were NOT replicated when the same data was re-analyzed (Hathcock). It should therefore not be cited as proof of the vitamin’s danger. Another meta-analysis cited (Bjelakovic) reported that antioxidant vitamins may increase death rates. But the authors did not determine a dose-dependent or cause-and-effect relationship between antioxidants and deaths (from all causes) of study participants. The researchers pooled 68 published trials, excluding 405 published studies with no deaths reported. Too wide a range of potencies (Vitamin A 1333 IU - 200,000 IU, vitamin E 10 IU to 1000 IU), and durations (28 days to 12 years) were lumped together. The statement, “No dietary supplement, including selenium, has proven useful so far for the prevention of cardiovascular disease or cancer in the general U.S. population,” is questionable. The Alpha-Tocopherol, Beta- Carotene Cancer Prevention (ATBC) Study published by the National Cancer Institute demonstrated a 32% reduction in prostate cancer incidence in response to daily alpha-tocopherol supplementation. The Women’s Health Study (JAMA) reported a significant 24% reduction in cardiovascular death with supplemental vitamin E. The NIH reports, “Taking a daily supplement containing 200 μg of selenium … significantly reduced the occurrence and death from total cancers. The incidence of prostate cancer, colorectal cancer, and lung cancer was notably lower in the group given selenium supplements.” Yet you suggest lowering consumption below the Daily Value (70 μg) used in multivitamins and far below the current upper limit. On the contrary, the Lewin Group reports that the use of antioxidants could save the vision and independence of many senior citizens, saving billions of dollars in healthcare costs. REFERENCES: Bjelakovic G, et.al. Mortality in Randomized Trials of Antioxidant Supplements for Primary and Secondary Prevention: Systematic Review and Meta-analysis. JAMA 2007. 297(8):842-857 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;82:879–886. DaVanzo JE, et al. An Evidence-Based Study of the Role of Dietary Supplements in Helping Seniors Maintain their Independence. The Lewin Group Inc. January 20, 2006 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 Weinstein SJ, et al. Serum α -Tocopherol and γ-Tocopherol in Relation to Prostate Cancer Risk in a Prospective Study. J. Natl. Cancer Inst. 2005 97: 396-399; doi:10.1093/jnci/dji045

Neil rebuts article on GMO (Biotech) safety

My response to the AMERICAN COUNCIL ON SCIENCE AND HEALTH's Health FactsAndFears article titled, "Studies Indicate GM Crops Are Safer and Healthier" is posted on their website below the original article: http://www.acsh.org/factsfears/newsID.962/news_detail.asp

The China Syndrome: Where do your vitamins come from?

The China Syndrome: Where do your vitamins come from? By Neil E. Levin, CCN, DANLA A large number of people have been recently asking whether dietary supplement ingredients come from China, with the implication that everything from China is dangerous and adulterated. Some have been misinformed, being told that most supplements originate in China and that there may be some reason to worry about them. These people are scared and some even promise to stop buying any product made in China. How valid is this fear? While it is true that much of the domestic vitamin C supply comes from China, that is not true for most ingredients in American dietary supplements. And, believe me, American vitamin manufacturers have long been wary about buying cheap, generic ingredients from China. It has taken a lot of time and successful testing of materials for Chinese ingredients such as vitamin C to eventually penetrate the American market. Some Chinese suppliers have demonstrated a dedication and history of quality manufacturing, which in turn has established a measure of confidence in their American and European customers. These are not a few “bad apples” that are trying to sell substandard ingredients to us. These are the tried and true good guys that have a devotion to quality. Why punish them for the mistakes and misdeeds of Chinese pet food manufacturers? Guilt by association has never been my favorite prejudice. In fact, the Natural Products Association (NPA) has inaugurated a new Chinese affiliate organization, with the express purpose of establishing pre-testing and certification of select Chinese dietary supplement ingredients before they are shipped to the US. This is yet another measure intended to protect the American public by testing and screening raw materials intended for the US market. Joint ventures with European and Japanese manufacturers has recently placed brand new, state-of-the-art pharmaceutical-grade production facilities in China that meet the same exacting standards as US, European or Japanese plants that have long been associated with the highest quality ingredients. These new plants are registered with the FDA and meet current good manufacturing practices for pharmaceuticals (cGMP), with some facilities also registered as ISO compliant and kosher certified. These are not shady operations, and in some cases exceed the quality standards of older Western facilities. You could walk through them and feel like you were in a top pharmaceutical plant in Switzerland. The best US manufacturers, those who have earned the coveted GMP certification for good manufacturing practices, have quality control programs in place to evaluate both suppliers and ingredients. Testing provides a means to ensure that both vendors and ingredients are identified and approved before use. In the case of vitamin C, testing to assure that the material meets strict US standards of quality and identity for pure L-ascorbic acid is a key control point, with the material typically meeting pharmaceutical monographs for purity standards. Microbiological screening is another quality measure employed by some US manufacturers to assure safety in plant and animal derived ingredients. And some manufacturers actually help to advance the science of quality by publishing validated test methods in peer-reviewed scientific journals. These new methods include recent publications for advancing the testing of unadulterated glucosamine and chondroitin. I have a fear that the enemies of dietary supplement use and American health freedom have irresponsibly cooked up this campaign of fear to swamp US supplement companies with requests for country-of-origin information for every ingredient and to waste both their and their customers’ time chasing a red herring. As we have seen no indication of any specific problem with dietary supplements (other than television pundits apparently trying to morph legitimate pet food fears into unfounded fears of possibly tainted supplements), someone is obviously riling up American consumers in an effort to create doubts about the safe use of vitamins. Who stands to gain from this fear-mongering? The news media obviously thrives on sensational reports that make us question everyday conveniences. The medical/pharmaceutical complex is another obvious beneficiary of people being afraid to use vitamins. Self-appointed consumer advocates think that they can reduce risks by getting people to avoid “unproven” and “unregulated” natural products and therapies, hoping to get them to use “safe” medical therapies instead. These folks have failed to read the annual reports of the American Associations of Poison Control Centers, which prove that even lip balms and household cleaners are more deadly than vitamins. Don’t be fooled by reports of vague dangers from Chinese ingredients used in American dietary supplements sold by large, reputable US manufacturers. Until there is some basis in fact, I regard this as strictly a cynical attack by enemies of natural products, intended to erode our resolve to making better health choices, including the use of dietary supplements. If we fear to take our supplements, we will abandon them and be left with drugs as our only means to correct health problems amplified by nutritional deficiencies, often caused or aggravated by by our poor diets. And since over 90% of Americans fail to eat even the minimal RDA levels of nutrients, that means you!

Beta-carotene (β-carotene ) forms and safety

Beta-carotene (β-carotene ) forms and safety By Neil E. Levin, CCN, DANLA Amid the hype about “food grown” vitamins in general, and beta-carotene specifically, here is some science that may shed light on the issues. “Synthetic” beta-carotene comes in a form called “all-trans-beta-carotene”. However, since this form is found in nature, it is not really a “synthetic form” at all. In fact, about 50% of the carotenoids in algae sources of beta-carotene exist as the all-trans form, while beta-carotene from carrots has less than 14% cis-isomers and is about 86% trans-beta-carotene. Moreover, the all-trans form is much more efficient at raising body levels of vitamin A than the cis forms. This, plus its lower cost, smaller volume and better stability, make all-trans-beta-carotene the preferred form in many multiple vitamins. Here is a report stating that both cis and trans forms are found in a natural algae source: In the current study, we used a natural 9-cis retinoic acid precursor, 9-cis β-carotene, which is found in fruits and vegetables and in the highest levels in the alga Dunaliella bardawil. The alga accumulates high concentrations of β-carotene when grown under appropriate conditions. The β-carotene in the alga is composed of approximately 50% all-trans β-carotene and 50% 9-cis β-carotene isomers [11]. The 9-cis β-carotene isomer has been shown to be a precursor of 9-cis retinoic acid both in vitro in human intestinal mucosa [12] and in vivo in a ferret perfused with 9-cis β-carotene [13]. Hence, 9-cis β-carotene administration has the potential to improve fibrate action via its conversion to 9-cis retinoic acid. Shaish A, et al. 9-cis β-carotene-rich powder of the alga Dunaliella bardawil increases plasma HDL-cholesterol in fibrate-treated patients. Atherosclerosis. Volume 189, Issue 1, November 2006, Pages 215-221 Both forms are used by plants: Electroabsorption spectra of all-trans, 13-cis and 15-cis isomers of carotenoids violaxanthin and b-carotene frozen in organic solvents were analysed in terms of changes in permanent dipole moment, Dl, and in the linear polarizability, Da, on electronic excitation...For instance, the isomeric 15-cis form is usually present in the reaction centers as optimized for quenching of chlorophyll triplet states [1,2], while differently perturbed all-trans forms are optimized for non-radiative energy transfer in antenna systems [3]. Krawczyk S, et al. Electroabsorption spectra of carotenoid isomers: Conformational modulation of polarizability vs. induced dipole moments. Chemical Physics 326 (2006) 465–470 trans-beta-carotene is the best form to provide vitamin A activity: Among the more than 600 carotenoids identified so far, only some 50 act as precursors of vitamin A, the presence of at least one unsubstituted b-ionone ring being the prerequisite for this important biological property. Because all-trans-b-carotene possesses two b-rings and may be cleaved into two molecules of retinal in the intestine by the enzyme b-carotene-15,150-dioxygenase, it has the highest provitamin A capacity. In contrast, considerably lower relative provitamin A activities of 53 and 38% are observed for 13-cis-b-carotene and 9-cis-b-carotene, respectively. Minguez-Mosquera,M. I., Hornero-Mendez, D., & Perez-Galvez, A. (2002). Carotenoids and provitamin A in functional foods. In W. J. Hurst (Ed.), Methods of analysis for functional foods and nutraceuticals (pp. 101–157). Boca Raton, London, New York, Washington, DC: CRC Press. Algal sources have different profiles of trans and cis carotenoids than other common sources, such as carrots: ..extracts of Dunaliella salina, which are known to contain relatively large amounts of b-carotene cis-isomers (Orset, Leach, Morais, & Young, 1999), are often used as a source of carotenes in supplements (Aman et al., 2004). In contrast, synthetic b-carotene is mainly applied in functional foods such as ATBC drinks, which contain provitamin A, vitamin C, and vitamin E as quality determining agents (Carle, 1999; Marx et al., 2000; Schieber et al., 2002). ATBC…drinks exclusively containing synthetic b-carotene were characterized by high relative amounts of cis-isomers (up to 44.5%), whereas those beverages containing carrot juice as a natural source of provitamin A showed significantly lower isomerization rates of up to 13.6% (Marx et al., 2000). These pronounced differences in the extent of isomerization have been explained by hot dissolution of synthetic microcrystalline all-trans-b-carotene and subsequent high-pressure homogenization, which are indispensable steps during manufacture of ATBC drinks (Carle, 1999). In continuation of these studies on carotenes in functional foods, commercial dietary supplements (soft gelatin capsule formulations, dragees, and effervescent tablets) have recently been investigated for their carotenoid stereoisomer profile. While both 9-cis- and 13-cis-b-carotene were detected in all samples assessed, no evidence for trans–cis-isomerization of lutein and zeaxanthin could be obtained (Aman et al., 2004). A. Schieber, R. Carle. Occurrence of carotenoid cis-isomers in food: Technological, analytical, and nutritional implications. Trends in Food Science & Technology 16 (2005) 416–422 The all-trans form is the most abundant in nature (which is the form found in many dietary supplements): Most naturally occurring carotenoids are in the all-trans-configuration; but under conditions of heating, for example, cis-isomers such as 13-cis-β-carotene (Figure 8-1) are formed. Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids (2000)Institute of Medicine (IOM) Of the many carotenoids in nature, several have provitamin A nutritional activity, but food composition data are available for only three (α-carotene, β-carotene, and β-cryptoxanthin) (Figure 4-1). The all-trans isomer is the most common and stable form of each carotenoid; however, many cis isomers also exist. http://books.nap.edu/openbook.php?record_id=10026&page=83 Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc (2000) Food and Nutrition Board (FNB) Institute of Medicine (IOM) beta-carotene supplements are more efficient at making vitamin A than food sources: Until recently it was thought that 3 μg of dietary β-carotene was equivalent to 1 μg of purified β-carotene in oil (NRC, 1989) due to a relative absorption efficiency of about 33 percent of β-carotene from food sources. Only one study has compared the relative absorption of β-carotene in oil versus its absorption in a principally mixed vegetable diet in healthy and nutritionally adequate individuals (Van het Hof et al., 1999). This study concluded that the relative absorption of β-carotene from the mixed vegetable diet compared to β-carotene in oil is only 14 percent, as assessed by the increase in plasma β-carotene concentration after dietary intervention. Based on this finding, approximately 7 μg of dietary β-carotene is equivalent to 1 μg of β-carotene in oil. This absorption efficiency value of 14 percent is supported by the relative ranges in β-carotene absorption reported by others using similar methods for mixed green leafy vegetables (4 percent) (de Pee et al., 1995), carrots (18 to 26 percent) (Micozzi et al., 1992; Torronen et al., 1996), broccoli (11 to 12 percent) (Micozzi et al., 1992), and spinach (5 percent) (Castenmiller et al., 1999) (Table 4-2). The matrix of foods affects the ability of carotenoids to be released from food and therefore affects intestinal absorption. The rise in serum β-carotene concentration was significantly less when individuals consumed β-carotene from carrots than when they received a similar amount of β-carotene supplement (Micozzi et al., 1992; Tang et al., 2000; Torronen et al., 1996). This observation was similar for broccoli (Micozzi et al., 1992) and mixed green leafy vegetables (de Pee et al., 1995; Tang et al., 2000) as compared with a β-carotene supplement. The food matrix effect on β-carotene bioavailability has been reviewed (Boileau et al., 1999). The extent of conversion of a highly bioavailable source of dietary β-carotene to vitamin A in humans has been shown to be between 60 and 75 percent, with an additional 15 percent of the β-carotene absorbed intact (Goodman et al., 1966). However, absorption of most carotenoids from foods is considerably lower and can be as low as 2 percent (Rodriguez and Irwin, 1972). Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids (2000). Institute of Medicine. Vitamin A production is the primary function of carotenoids in humans. “…the only known function of carotenoids in humans is to act as a source of vitamin A in the diet… Lycopene, lutein, and zeaxanthin have no vitamin A activity and are thus referred to as nonprovitamin A carotenoids.” Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids (2000) Institute of Medicine (IOM) The following table shows that dietary beta-carotene is about 1/6 as efficient at making vitamin A versus the form found in dietary supplements: Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc (2000) Food and Nutrition Board (FNB) Institute of Medicine (IOM) beta-carotene safety: Regarding beta-carotene safety, little has been resolved and the negative studies have been vigorously disputed. It has become apparent that blood levels of beta-carotene are not predictors of risk, but low levels of total antioxidants are. In fact, the dietary level of antioxidants is 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.” Brighenti F. The total antioxidant capacity of the diet is an independent predictor of plasma beta-carotene. European Journal of Clinical Nutrition (2007) 61, 69–76. doi:10.1038/sj.ejcn.1602485; published online 12 July 2006. 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. The National Institute of Medicine (NIH) has this to say about the safety of beta-carotene: What are the health risks of too many carotenoids? Provitamin A carotenoids such as beta-carotene are generally considered safe because they are not associated with specific adverse health effects. Their conversion to vitamin A decreases when body stores are full. A high intake of provitamin A carotenoids can turn the skin yellow, but this is not considered dangerous to health.Clinical trials that associated beta-carotene supplements with a greater incidence of lung cancer and death in current smokers raise concerns about the effects of beta-carotene supplements on long-term health; however, conflicting studies make it difficult to interpret the health risk. For example, the Physicians Health Study compared the effects of taking 50 mg beta-carotene every other day to a placebo in over 22,000 male physicians and found no adverse health effects [54]. Also, a trial that tested the ability of four different nutrient combinations to help prevent the development of esophageal and gastric cancers in 30,000 men and women in China suggested that after five years those participants who took a combination of beta-carotene, selenium, and vitamin E had a 13% reduction in cancer deaths [55]. In one lung cancer trial, men who consumed more than 11 grams/day of alcohol (approximately one drink per day) were more likely to show an adverse response to beta-carotene supplements [1], which may suggest a potential relationship between alcohol and beta-carotene.The IOM did not set ULs for carotene or other carotenoids. Instead, it concluded that beta-carotene supplements are not advisable for the general population. As stated earlier, however, they may be appropriate as a provitamin A source for the prevention of vitamin A deficiency in specific populations [1]. 1. Institute of Medicine. Food and Nutrition Board. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. National Academy Press, Washington, DC, 2001. Here is my report on beta-carotene safety, as published in the peer-reviewed Journal of Applied Nutrition (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) as recently updated with a newer study: Beta-carotene: Myth and Fact (Updated) The Myth: Beta-carotene causes cancer The Fact: Total antioxidants reduce cancer Some years ago an antioxidant study in Finland was halted early because of a widely reported increase in cancer rates among male smokers taking beta-carotene. 1 Headlines associated this supplement with cancer risk. Despite objections that the study was flawed, beta-carotene use dropped. A later analysis published in July 2004 took another look at that same Finnish smokers' study data, but now taking into account total antioxidant intake, which clears away the scientific controversy. The smokers’ risk of getting lung cancer was inversely associated with total antioxidants in the diet, with more total antioxidants meaning fewer cancers. 2 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: the combination of antioxidants lowered lung cancer risk in male smokers. Another large study has noted that high carotenoid intake, confirmed by measures of blood levels, was associated with lower mortality rates among the elderly over a ten year period. 3 The dietary level of antioxidants is an independent predictor of plasma beta-carotene, especially in moderate alcohol drinkers. A more 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.” 4 Still, news reports continue to refer to beta-carotene as harmful, largely because of the original study reports. The “media myth” continues long after the science has moved on. REFERENCES: 1. The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med. 1994 Apr 14;330(15):1029-35. http://content.nejm.org/cgi/content/full/330/15/1029?ijkey=bd47b716724d0dad4cad0fb19337308753658337 2. Wright ME, et al. Development of a Comprehensive Dietary Antioxidant Index and Application to Lung Cancer Risk in a Cohort of Male Smokers. July 2004 American Journal of Epidemiology http://aje.oupjournals.org/cgi/content/abstract/160/1/68?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=1&andorexacttitle=and&andorexacttitleabs=and&fulltext=beta+carotene&andorexactfulltext=and&searchid=1100534768534_1530&stored_search=&FIRSTINDEX=0&sortspec=relevance&fdate=7/1/2004&tdate=7/31/2004&journalcode=amjepid 3. 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;82:879–886. 4. Brighenti F. The total antioxidant capacity of the diet is an independent predictor of plasma beta-carotene. European Journal of Clinical Nutrition (2007) 61, 69–76. doi:10.1038/sj.ejcn.1602485; published online 12 July 2006. 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.

My interview by NBC-5 TV News

This was broadcast on 6/20/07 on the topic on Men's Health. Text summary: http://www.nbc5.com/health/13537462/detail.html Video (about 3 minutes, plus a short ad at the beginning) http://video.nbc5.com/player/?id=121856

converting grams to milligrams and micrograms

These are ounces of weight, not volume (Ounces, especially, are confusing and whether they refer to weight or volume depends entirely on context)

• 1 gram = 1,000,000 micrograms (mcg) = 1.ooo milligrams (mg)
• 1,000 micrograms = one milligram = 0.001 gram
• 1,000 grams = one kilogram (one kilo, kg) = 2.2 pounds (LB, #)
• one pound = 454 grams (g)
• one ounce = 28.35 grams
• 16 ounces = one pound (LB, #)

Measures of volume:

• 3 teaspoons = 1 tablespoon
• 2 tablespoons = 1 ounce = 1/8 cup
• 8 ounces = 16 tablespoons = 1 cup
• 1/2 teaspoon = 2.5 mL (milliliters)
• 1 cup = 240 mL

My review of studies supporting the use of aromatherapy to reduce symptoms of aging

http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD003150/frame.html Aroma therapy is the use of pure essential oils from fragrant plants (such as Peppermint, Sweet Marjoram, and Rose) to help relieve health problems and improve the quality of life in general. The healing properties of aroma therapy are claimed to include promotion of relaxation and sleep, relief of pain, and reduction of depressive symptoms. Hence, aroma therapy has been used to reduce disturbed behaviour, to promote sleep and to stimulate motivational behaviour of people with dementia. Of the three randomized controlled trials found only one had useable data. The analysis of this one trial showed a significant effect in favour of aroma therapy on measures of agitation and neuropsychiatric symptoms. More large-scale randomized controlled trials are needed before firm conclusions can be reached about the effectiveness of aroma therapy. Aroma therapy for dementia. Cochrane Database Syst Rev. 2003;(3):CD003150. Review. PMID: 12917949 http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=9672344&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus RESULTS: Eight randomized, controlled trials were located. Collectively they indicate that peppermint oil could be efficacious for symptom relief in IBS. A metaanalysis of five placebo-controlled, double blind trials seems to support this notion. In view of the methodological flaws associated with most studies, no definitive judgment about efficacy can be given. Peppermint oil for irritable bowel syndrome: a critical review and metaanalysis. Am J Gastroenterol. 1998 Jul;93(7):1131-5. PMID: 9672344 In aromatherapy, grapefruit is used to treat depression and induce euphoria, whereas lavender is beneficial in reducing stress and relaxing the mind. This raises the possibility that stimulation with grapefruit or lavender may influence the activity of sympathetic nerves. Mechanism of changes induced in plasma glycerol by scent stimulation with grapefruit and lavender essential oils. Neuroscience Letters, Volume 416, Issue 3, 18 April 2007, Pages 241-246 The antimicrobial and antioxidant properties of essential oils have been known for a long time, and a number of investigations have been conducted into their antimicrobial activities using various bacteria, viruses and fungi. A common feature of plant volatiles is their hydrophobic nature, and studies addressing the mode of antimicrobial action of such compounds generally point to the cell membrane as primary target (Stammati et al., 1999). Recent studies have shown that essential oils of oregano, thyme, clove and cinnamon are among the most active in this respect. Chemical analysis of these oils has shown the constituents to be principally carvacrol, thymol and eugenol and their precursors...Essential oils—their antimicrobial activity against Escherichia coli and effect on intestinal cell viability. Toxicology in Vitro, Volume 20, Issue 8, December 2006, Pages 1435-1445 Symptoms of tiredness, lack of muscle co-ordination and dysarthria, and difficulty in maintaining attention in elderly people may be wrongly labelled as part of the ageing process and so ignored. If adequate sleep can reduce these symptoms and restore therapeutic activity, it is of enormous value to elderly people in retaining their independence and quality of life. Safe promotion of sleep without daytime lethargy is needed. In order to test the hypotheses that Essential Oil of Lavender has a sedative effect, and that the resultant sleep promotes therapeutic activity, a pilot study was arranged with acutely ill elderly people. This was followed by a more detailed trial with long-term patients. The results show a positive trend towards improvement with lavender. The value of lavender for rest and activity in the elderly patient. Complementary Therapies in Medicine. Volume 4, Issue 1, January 1996, Pages 52-57 These findings clarify that lavender and rosemary enhance FRSA [free radical scavenging activity] and decrease the stress hormone, cortisol, which protects the body from oxidative stress. Smelling lavender and rosemary increases free radical scavenging activity and decreases cortisol level in saliva. Psychiatry Research Volume 150, Issue 1, 28 February 2007, Pages 89-96 A general feature of these various antioxidant parameters measured was that their activities remained higher in rats whose diets were supplemented with thyme oil, suggesting that they retained a more favourable antioxidant capacity during their life span. Dietary supplementation of thyme (Thymus vulgaris L.) essential oil during the lifetime of the rat: its effects on the antioxidant status in liver, kidney and heart tissues. Mechanisms of Ageing and Development. Volume 109, Issue 3, 8 September 1999, Pages 163-175 Symptoms of tiredness, lack of muscle co-ordination and dysarthria, and difficulty in maintaining attention in elderly people may be wrongly labelled as part of the ageing process and so ignored. If adequate sleep can reduce these symptoms and restore therapeutic activity, it is of enormous value to elderly people in retaining their independence and quality of life. Safe promotion of sleep without daytime lethargy is needed. In order to test the hypotheses that Essential Oil of Lavender has a sedative effect, and that the resultant sleep promotes therapeutic activity, a pilot study was arranged with acutely ill elderly people. This was followed by a more detailed trial with long-term patients. The results show a positive trend towards improvement with lavender. The value of lavender for rest and activity in the elderly patient. Complementary Therapies in Medicine. Volume 4, Issue 1, January 1996, Pages 52-57 Aromatherapy can be a useful addition to self-care especially in managing stress and minor self-limiting conditions. Caring for the wounded healer—nurturing the self. Journal of Bodywork and Movement Therapies. Volume 10, Issue 4, October 2006, Pages 251-260 The goal of this study was to investigate the impact of the essential oils of orange and lavender on anxiety, mood, alertness and calmness in dental patients. Two hundred patients between the ages of 18 and 77 years (half women, half men) were assigned to one of four independent groups. While waiting for dental procedures patients were either stimulated with ambient odor of orange or ambient odor of lavender. These conditions were compared to a music condition and a control condition (no odor, no music). Anxiety, mood, alertness and calmness were assessed while patients waited for dental treatment. Statistical analyses revealed that compared to control condition both ambient odors of orange and lavender reduced anxiety and improved mood in patients waiting for dental treatment. These findings support the previous opinion that odors are capable of altering emotional states and may indicate that the use of odors is helpful in reducing anxiety in dental patients. Ambient odors of orange and lavender reduce anxiety and improve mood in a dental office. Physiology & Behavior. Volume 86, Issues 1-2, 15 September 2005, Pages 92-95 In this review we detail the current state of knowledge about the effect of lavender oils on psychological and physiological parameters and its use as an antimicrobial agent. Although the data are still inconclusive and often controversial, there does seem to be both scientific and clinical data that support the traditional uses of lavender. Biological activities of lavender essential oil. Phytother Res. 2002 Jun;16(4):301-8. Review. PMID: 12112282

Am I biased?

A reader of my nutrition blog wondered if I may be biased. That's a fair question. Actually, I believe that everyone has to deal with the issue of bias, and the Scientific Method is supposed to help us all overcome these biases by focusing on valid, reproduceable data. Unfortunately, some of us seem to be trying harder than others to fairly represent unbiased data. For one example, my letter published by the cancer journal CA, the Journal of the American Cancer Society http://caonline.amcancersoc.org/cgi/eletters/55/5/319#176 rebutted an article positing that antioxidants should be avoided during cancer therapies. However, none of the references provided in that article showed any evidence of risk! In my rebuttal, I catalogued a number of studies that used nutrients with drugs or radiation therapies, which showed no harmful effects and in some cases even enhanced anticancer effects. I also pointed out the 40% of cancer patients who die of malnutrition while under their doctors' care, much of which may be preventable if physicians actually follow evidence-based medicine instead of clinging to conventional therapies and theories. Click on the title of this article to see the original report and my response. I think that you'll find that I presented relevant published scientific reports to counter a biased opinion that was not even supported by the author's references. How did that crappy opinion even get published in a peer-reviewed journal in the first place?

The FDA has a legal framework for authority over dietary supplement safety and accurate/proper labeling

Senate Bill 1082, passed 93-1 on 5/9/07 SEC. 605. ADULTERATED FOOD REGISTRY. (a) Findings- Congress makes the following findings: (1) In 1994, Congress passed the Dietary Supplement Health and Education Act (P.L. 103-417) to provide the Food and Drug Administration with the legal framework to ensure that dietary supplements are safe and properly labeled foods. (2) In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (P.L. 109-462) to establish a mandatory reporting system of serious adverse events for non-prescription drugs and dietary supplements sold and consumed in the United States. (3) The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act will serve as the early warning system for any potential public health issues associated with the use of these food products.