Myths about stearate "risks"

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What is pharmaceutical grade (USP)?

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

Should cancer patients take vitamins?

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

Response to inquiries about my credentials and independence

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

Unbalanced Fox news report misleads about vitamin-mineral safety

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

More about steroids and DSHEA

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