Tuesday, August 08, 2017
Wednesday, November 03, 2010
The Truth About Fructose Dangers
Pure crystalline fructose is an alternative natural sweetener that has long been used in the natural products industry as a common sugar substitute. Its major claim to fame is that in the short term fructose raises blood sugar far less than sucrose, the primary sugar found in white sugar that is made from sugar cane or sugar beets. Crystalline fructose should not be confused with the synthesized liquid sweetener called high fructose corn syrup (HFCS), which is made by a different process and is a mixture of roughly half fructose and half glucose (dextrose) that is widely used in the beverage and processed food industries. Unlike HFCS, fructose is a naturally occurring sugar made by plant photosynthesis that is a primary sugar in many healthy fruits. Being about 50% sweeter than sucrose, fructose can also be used more sparingly in recipes to cut their caloric intake by about 1/3.
Because of the unique challenges of formulating natural products without the use of artificial sweeteners or flavorings, sometimes a small amount of fructose is the best match for the flavorings in a product. For example, liquid vitamin B-12 has a distinct flavor profile and other sweeteners do not mask it quite as well as fructose can. Often a mixture of sweeteners may be used to create a “mouth feel” that is acceptable to consumers, who often use white sugar as their sensory standard for sweeteners. While some people may intellectually prefer other sweeteners or even white sugar, in sensory tests the fructose mixture often gets higher marks from consumers, and this leads to high compliance with recommended label uses.
I appreciate the concerns over the use of fructose. It has certainly been abused in the Western diet, especially in the form of HFCS. Americans' fructose consumption on average has tripled over the past century. But increased consumption of fruit juice and sucrose itself also are implicated in our national health decline; certainly not fructose alone, nor fructose in low doses.
According to Dr. Lustig*, an authority on fructose metabolism, human studies have not consistently shown the effect of fructose to induce insulin resistance; a negative effect reported in some animal and preliminary human studies related to altered liver metabolism. Dr. Lustig also admits that not all human studies show a negative effect of fructose on liver health or metabolic syndrome. There appear to be certain individual factors involved that make such effects somewhat idiosyncratic. Many of the studies cited are cell studies, animal studies giving high doses of fructose to mutant mice, or human studies where consumption of a lot of soft drinks were involved that provided a large number of calories comprising an unhealthy proportion (25% or more) of total daily caloric intake (about 500 calories as fructose every day). Contrast this with a healthy nutritional product that provides only a few calories, a very low percent versus those unhealthy diets!
Dr. Lustig notes that "In the hypocaloric (eg, starvation) state, fructose is as beneficial as glucose"; while also noting it has ill effects in the "hypercaloric state". He also discusses how a small amount of ethanol, a substance with similar liver effects to high fructose diets, is actually health-promoting while large amounts have the opposite effect. This reinforces that the ability of substances to elicit ill effects on the liver are typically dose dependent and require larger-than-normal amounts. In effect, 'the dose makes the poison;' as has been noted for many substances throughout history.
Dr. Lustig specifically cites three what he calls "antidotes" to the negative hepatic (liver) effects of fructose:
1. reduce the amount consumed
2. exercise
3. increase fiber intake.
So, upon reviewing these facts, the consumption of a small amount of fructose is unlikely to be harmful to the general public. Additionally, consumption of reasonable amounts may also be quite harmless if the person gets enough fiber and/or exercise. And the accepted fact that fructose does not directly raise blood glucose still gives it some short term advantages over certain other sweeteners for many people, if consumed at appropriate levels. Faster acting sugars that are higher on the Glycemic Index like glucose (which represents close to half of the sugar content of HFCS) would more immediately impact one's blood sugar, with chronic overuse eventually leading to insufficient/reduced insulin sensitivity (increased insulin resistance) that is associated with a loss of blood sugar control. Higher Glycemic sugars would affect this blood glucose control system much faster than an equivalent amount of pure fructose. And a lack of insulin sensitivity also indicates a problem in properly absorbing and recycling vitamin C in many of our body's cells; especially immune, muscle, and bone cells.
There are a variety of natural sweeteners to fit into most individuals' personalized dietary regime; but I do not promote the indiscriminate use of any sweetener, especially refined or synthetic ones. People like to have choices and will select sweeteners according to their own taste and health issues. For example, some avoid barley malt because of gluten sensitivity or certain other sweeteners because of corn allergies. People on limited diets need to scrutinize the available sweeteners and select what seems right for their own situation. But it's clear that a small amount of almost any natural sweetener, say to sweeten a cup of tea, does not seem to have any demonstrable health risk. For overly large amounts, the potential risks do increase. But a demonstrated risk level typically represents consumption of several hundred calories a day of refined sugars, including fructose, and it obviously is unwise to take in most of our daily carbohydrates in the form of refined sugars of any kind.
Consumption of small amounts of pure crystalline fructose simply doesn’t have a measureable effect on health and doesn’t need to be avoided. It’s the fructose consumed in large quantities in processed foods and beverages, where it comprises perhaps the major source of carbohydrates in the modern diet, that is the real health concern.
* Lustig RH. Fructose: metabolic, hedonic, and societal parallels with ethanol. J Am Diet Assoc. 2010 Sep;110(9):1307-21. PubMed PMID: 20800122.
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Labels: blood sugar, calories, danger, fructose, HFCS, high fructose corn syrup, insulin resistance, liver, metabolic syndrome, sweeteners
Thursday, April 24, 2008
Myths about stearate "risks"
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.
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Labels: danger, Dietary Supplements, food, food safety, immune, magnesium stearate, stearate, stearates, stearic acid, T cells, toxic, vitamins
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
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Tuesday, July 03, 2007
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!
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