Thursday, December 26, 2013

The Top Ten Vitamin Myths of 2013

The Top Ten Vitamin Myths of 2013
  1. All multivitamins are exactly the same, so a study on any one product is applicable to all other multis (ignoring variations of number of nutrients, the dose and form of each one, any supporting substances, the delivery form and excipients is good science)
  2. People take multivitamins primarily to prevent/treat cancer and heart disease (therefore any lack of definitive proof of efficacy against these diseases means that people should immediately stop taking vitamins, and all research on multivitamins is futile and should be halted even though they still are proven to prevent deficiency diseases and supply nutrients needed to preserve joint health, eyesight, healthy cholesterol and blood lipids, reduce cardiovascular risk factors, prevent birth defects, etc.)
  3. Our food supply is perfect and unchanging, as are our eating habits, making multivitamins unnecessary (Although USDA food tables were drafted around 1940, it’s okay to ignore changes in soil, seed, agriculture, food processing, how much processed and fast food we consume, the detoxification burden of environmental contaminants, and our lifestyles when telling Americans that they don’t need to supplement their diets to ensure adequate basic nutrition)
  4. Definitive answers of nutrient safety/efficacy can be found by “data mining” older studies (the practice of another team applying a “secondary data analysis” to certain fields within previously published studies in which nutrient values were reported but were not the intended research subject (“lacking depth”), and therefore all relevant variables for the nutrient(s) were probably not identified nor properly controlled as they should be in primary research)
  5. Perfect classic control groups can exist in nutrient research (obviously, this would require subjects who don’t ingest any vitamins or minerals from food  or supplements (or sunlight for vitamin D), had their serum levels at the beginning of the study measured and equalized, and had identified/controlled all co-factors that influence those nutrient levels in the body)
  6. Editorials in medical journals accurately and impartially reflect the true state of science regarding nutrient research (by honestly addressing shortcomings and limitations of the reports instead of adding their spin to well-publicized controversial articles appearing in their journal)
  7. Media coverage of vitamin controversies is always  balanced and put into proper perspective (utilizing reporters and editors who know the topic, really research stories, and present comprehensive reports)
  8. Researchers who make political statements in their reports should still be regarded as unbiased experts in nutrient study design and execution (for example, when they inaccurately state that dietary supplements are “unregulated” simply because they are not regulated as drugs it raises questions of impartiality, as well as exposing basic ignorance of the topic they claim to be experts on)
  9. A single study, especially if blending data from several other studies, can be regarded as Definitive (especially data-mining secondary data analyses that look for possible associations but lack the depth of original design to control all variables)
  10. A single study can reasonably claim to contradict decades of rigorous research (especially when it is a preliminary study not designed to screen all relevant factors that would allow it to demonstrate cause-and-effect and dose-dependent relationships)
None of these statements are true, in my opinion, but in my experience still appear to be typical operating procedures in the brave new world of research and reporting that we live in today. Questionable studies may have been designed based on questionable models, often due to ignorance or unconscious bias - even if well-intentioned

Peer reviewers for medical journals may have their own biases, ignorance, or motives for allowing statistically significant reports based on fundamentally flawed designs to be published, or for not questioning some studies' conclusions for poorly matching the reported data. 

For example, I have actually seen supplement studies reporting a conclusion that the supplements weren't effective even when the subgroup that actually followed protocol and took the supplements had success. If the overall failure of the supplements in the study were actually attributable to non-compliance subjects, that shouldn't be interpreted as the supplements being ineffective, failing the test. 

Some controversial studies are heavily marketed, even enlisting reporters to write stories based partially on sound bites and press releases in advance of embargoed reports' publication dates. Authors of controversial studies may become celebrity "experts" in the field, with their famous work widely cited by succeeding authors and being sought for media interviews during future controversies. Often, expert criticism of their work - and even failure to replicate the results in subsequent reports, a hallmark of the Scientific Method self-correcting the scientific record - typically is ignored; perhaps in light of their celebrity status.   

©2013 by Neil E. Levin, CCN, DANLA; may be cited with full attribution

Wednesday, November 06, 2013

How Important is it to have "Human Strain" Probiotics?

“Human Strain” Probiotics

The origin of a strain simply specifies from what source that particular strain - often part of a blend - was first isolated. Its origin is related to establishing intellectual property and a chain of custody, but not to any possible health benefits. There are all kinds of organisms, both desirable and undesirable, in our guts, but microbiologists do not consider the first identified/isolated source to be predictive of the health benefits that any particular strain (substrain) will provide to people.

So touting a “human source” or “soil organism” is actually a marketing game, not a valid scientific argument, and in fact is an anti-scientific message. Just because an organism was obtained from human feces (or rarely, saliva), perhaps because the person actually obtained it by eating fermented foods or even from contact with soil, doesn’t mean that it has probiotic properties…or even different properties than eating it in that yogurt or directly consuming those soil organisms. We all probably have some small quantity of E coli and Salmonella in our bowels; should they therefore be promoted as “human strain” probiotic bacteria? Obviously not…

In the scientific literature the benefits of a probiotic strain (or blend) depends solely on its technical qualities: proper identification of the specific strain (substrain), its stability in a consumer product, its bile and acid resistance, its ability to colonize and persist in the human GI tract, and any specific health effects it provides as measured in both test tube and human clinical trials when given to a human being. None of these qualities depend on its original sourcing. Specific label claims relating to substrains of probiotics depend totally on the body of clinical evidence of how that substrain provides benefits to people.

Look for the addition of a third name to the Latin binomial (2-word Latin name) of a strain to indicate a specific substrain, as in “Lactobacillus acidophilus La-14” or “Bifidobacterium lactis BL-04”.

If a company is touting the origin of their strain(s) rather than their proven clinical health benefits, then they may have no clinically validated strains and are just trying to promote theoretical rather than demonstrated benefits. Why would they promote strains based on irrelevant historical factors related to the strain's discovery rather than providing evidence of their product's demonstrated health benefits if they do have clinically relevant strains?

Smart consumers will look for evidence-based label claims, such as clinical trials utilizing their particular strain to assure that a probiotic product will have some credible evidence of being health promoting.

Tuesday, August 06, 2013

Supplements vs. Food to Obtain Key Nutrients

Supplements vs Food

Supplements vs Food [Infographic] by the team at Supplement Centre

Monday, July 15, 2013

The Facts About Omega-3 Fatty Acids and Increased Prostate Cancer Risk

A study released this week, “Plasma Phospholipid Fatty Acids and Prostate Cancer Risk in the SELECT Trial,” published in the Journal of the National Cancer Institute (JNCI)) suggests that the omega-3 essential fatty acids EPA, DPA, and DHA - but not the omega-3 fatty acid ALA, found in flax, chia, hemp seeds, and nuts that have repeatedly been shown to lower prostate cancer rates - are somehow associated with increased risks of high-grade prostate cancer. At the same time, higher amounts of normally harmful trans fats in these subjects were associated with lower rates of advanced prostate cancer. [1] Because of the known limitations of this particular kind of study, all of these reported results were completely unproven, highly questionable, and highly unlikely to be true.

What kind of study was this? It is data mining of a previously published population study in which important variables and endpoints for fish oil's relationship to prostate cancer were not controlled, nor any cause and effect demonstrated. Because it is a secondary analysis of a largely epidemiological (population) study, it represents the lowest level of evidence in human studies because most relevant variables, confounding factors, and clinical endpoints are not systematically collected for proper analysis as they would be in an actual controlled clinical trial. Instead, the limited goal was to look for possible associations that were admittedly not rigorous enough to be considered as actual evidence of a causal relationship. As a preliminary study, it was consciously designed only to raise questions, rather than to provide answers, and it did accomplish that goal but also created a messy splash of misleading and over-emphatic headlines inaccurately suggesting that this one study somehow trumps many more robust clinical trials. So much for the media knowing of and respecting the Scientific Method. [2]

Dr Marilyn Glenville PhD, the UK’s leading nutritionist specializing in women’s health and former President of the Food and Health Forum at the Royal Society of Medicine, has noted some deficiencies in the current JNCI report; some examples: [3]
  • “This is not a randomised controlled trial but a trial comparing Omega 3 levels in men with prostate cancer with healthy men. The men with prostate cancer had higher levels of Omega 3. But you cannot extrapolate cause and effect from this finding. It is like saying that if the majority of men with prostate cancer played tennis compared to healthy controls then tennis could trigger prostate cancer.”
  • In 2009 the Harvard School of Public Health reported that “Omega 3 deficient diets cause up to 96,000 preventable deaths a year in the US. The researchers estimated the number of deaths resulting from 12 preventable causes and Omega 3 deficiency ranked as the sixth highest killer of Americans. A deficiency in these fats was classed as a bigger killer than high intake of trans fats.” [4]
  • “…there are many cultures such as the Japanese who eat high amounts of oily fish containing Omega 3 fatty acids and yet have one of the lowest prostate cancer death rates in the world.”
Duffy MacKay, N.D., vice president, scientific and regulatory affairs of the Council for Responsible Nutrition, also noted some concerns with the report: [5]
  • “Hundreds of studies over the past two decades have shown omega-3 fatty acids to have positive effects associated with cardiovascular health, perinatal health, inflammation, cognitive function, or cancer. Collectively, this body of research serves as the basis for numerous recommendations from respected organizations, scientific boards and healthcare practitioners that Americans get omega-3 fatty acids in their diets.”
  • “While we encourage researchers to continue to study omega-3 fatty acids with an open mind, it is counterproductive when studying nutrition for researchers to promote their study as if it were the only piece of research that counts. In this case in particular, it is especially disingenuous for the researchers to make the kinds of assertions we've seen in the press, given their results are in stark contrast to previous epidemiologic studies that not only demonstrate no correlation between omega-3 consumption through fish and/or supplementation and the risk of prostate cancer, but in many cases also showed a protective effect against prostate cancer.”
  • “One should also consider whether this study could have simply been measuring a biomarker reflecting recent intake of fish or fish oil supplements in a group of high risk cancer patients that had been told to increase their EPA and DHA levels, as compared to a group of non-cancer patients that had not been told to consume more EPA and DHA. Plasma levels of EPA and DHA reflect very recent intake and are considered a poor biomarker of long term omega-3 intake especially when compared to red blood cell levels, which reflect medium term intake. A single fish oil dose (or hearty serving of fish at lunch) results in >100 percent increase in plasma omega-3 levels. So looking at plasma levels in healthy and sick people may only provide insight into the recent habits of these individuals.”
  • “The American Heart Association, the World Health Organization (WHO), the U.S. Institute of Medicine’s Food Nutrition Board (IOM FNB) and the 2010 Dietary Guidelines all have current policies advising Americans to eat more fatty fish to get the benefits of omega-3 fish oils. It is highly unlikely this one study will change that advice. Omega-3s can also be obtained by taking one of the many supplement products on the market. For those consumers who have concerns about prostate cancer or other questions about omega-3 fatty acids, we recommend speaking with your doctor or other healthcare practitioner.”
If you are a man and believe this report, then you’ll probably want to eat partially hydrogenated artificial trans fats instead of omega-3 fats for prostate health; though that change would greatly increase your risk of suffering far deadlier cardiovascular diseases, based on evidence from many clinical trials. But that would be ridiculous. In fact, many cultures around the world consume far more fish oil than Americans without having increased risks of aggressive prostate cancer; these include the Inuit people ("Eskimos"), Scandinavians, Southeast Asians, Pacific Islanders, Japanese, Filipinos, and others. 

In any case, in the absence of proper controls or any evidence of causation, we actually can’t know what these study results really mean. For example:
  • Were DHA levels related to diet, supplementation, or both?
  • Were fish and/or fish oils perhaps consumed as a deliberate health choice because of prior knowledge of prostate issues, rather than actually causing or aggravating those issues? In other words, could the consumption represent an attempt to improve a pre-existing condition by improving one’s nutritional status and be unrelated to the disease itself? Perhaps even suggested by medical teams as potentially helpful for patients' diet?
  • If they had been collected, what would key inflammatory and oxidative markers, that are much likelier to be related to prostate health problems than long-chain omega-3 fatty acids such as DHA, have told us about these men’s state of health and disease?
  • Where is the biochemical evidence that DHA itself may negatively contribute to prostate concerns? None is presented, even theoretically.
The Global Organization for EPA and DHA Omega-3s (GOED) also criticized these and numerous other some aspects of the JNCI report, among them these important points: [6]
  • “The difference in mean blood plasma phospholipid fatty acids blood level for omega-3s was 4.66% in the combined cancer group versus 4.48% in the control. They are basing their results on just ca. 0.2% difference in omega-3 levels.”
  • “Plasma phospholipid fatty acids as measured in this study are not a good index of long term intake and are influenced dramatically by a single meal, or even timing of a fish oil dose. A single fish oil dose massively increases LC omega 3 (typically increasing levels by 100% or more) in about 4-12 hours and then washes out around 48 hours.”
  • “The study was not designed to look at omega-3 and confounded with selenium and Vitamin E used in the treatment arms.”
  • “The test cohort included sick and healthy people. It is possible that sick people were taking fish oil supplements at a higher rate than the healthy individuals.”
  • “A recent meta-analysis of fish consumption and prostate cancer by Szymanski et al. (2010) reported a large reduction in late stage or fatal prostate cancer among cohort studies." [7]
  • "Several population based studies have shown a benefit of increased omega-3 fatty acid intakes to reducing prostate cancer risk.” [8], [9]
As I said earlier, this type of study raises questions about possible associations; but due to its built-in limitations, and results conflicting with most other related studies, provides no real answers.  Unfortunately, its counter-intuitive results generate sensational press coverage rarely accompanied by any true perspective on what this new study really means (not much).

In real life, most Americans and others in Western societies no longer consume the ideal amount or ratio of omega-3 fatty acids in their diet as our ancestors did a century or two ago. This reduction reportedly contributes to the large increase in chronic health problems that plague these societies. It is a public disservice to inappropriately scare people away from healthy foods and supplements, which help balance the diet in these many cases where the lack of essential nutrients is actually causing harm, based solely on such flimsy “evidence”. 

After reviewing this study I, a vegetarian, will continue to take my vegan DHA supplement twice a day with absolutely no concerns that it will negatively affect my own prostate health. Why am I not at all concerned? Because there is still no hard evidence explaining how long-chain omega-3 fatty acids like EPA and DHA may promote prostate cancer. There is still no demonstrated mode of action for this concern, and there are still no plausible explanations of any biological mechanisms that could justify the theory that long-chain omega-3 fatty acids may promote prostate cancer. My lack of concern is evidence based, after carefully reviewing the studies in question. Contrast this with the fear-mongering about fish, fish oil, and omega-3 fatty acids in foods and supplements that is overwhelmingly based on speculation, flimsy data, ignorance (on several levels), and maybe even some bias.

By Neil E. Levin, CCN, DANLA


[4] The Preventable Causes of Death in the United States: Comparative Risk Assessment of Dietary, Lifestyle, and Metabolic Risk Factors" study, April 2009, PLoS Medicine
[7] Szymanski KM, Wheeler DC, Mucci LA. Fish consumption and prostate cancer risk: a review and meta-analysis. Am J Clin Nutr. 2010;92(5):1223–1233
[8] Terry P, Lichtenstein P, Feychting M, et al. Fatty fish consumption and risk or prostate cancer. Lancet, 2001,357:1764-6.
[9] Lietzman MF, Stampfer MJ, Michaud DS, et al. Dietary intake of n-3 and n-6 fatty acids and the risk of prostate cancer. Am J Clin Nutr 2004;80:204-216.

Tuesday, May 28, 2013

Is Canola Oil Better than Olive Oil for Cardiovascular Health?

Canola oil has less oleic (omega-9) and more ALA (omega-3) than olive oil and been shown to:

• improve lipid measurements greater than olive oil in human subjects in a randomized, double-blinded trial:

• improve cardiovascular health more than olive oil in a rat model:

Tuesday, May 07, 2013

Does Fish Oil Dissolve Styrofoam - and Does That Prove It's Bad?

Recent attention given to the effects of various fish oils on polystyrene (Styrofoam®) cups has led to some misunderstanding of how these products work in terms of nutrition and safety. It is unfortunate that the use of these stunts imply may confuse or even scare people away from taking this natural product which provides constituents that are essential to human health. Don’t be fooled by this trick! If someone tries to use it as a means to push one product over another, challenge them to explain exactly what the test is supposed to mean. Here’s what you need to know about the test, how it works, and what it means:
Styrofoam® (polystyrene) cups can be dissolved by pure fish oils. All fish oils will have this same effect on polystyrene, but some will take much longer than others. Various healthy natural substances, like fresh lemon oil, will also dissolve polystyrene. In the Styrofoam® cup test, the esterified ethyl ester form of fish oil works to dissolve Styrofoam® much faster than the triglyceride form simply because the number of chemical bonds in the two forms of oil are different; with ethyl ester fish oil having its number of bonds closer to that of Styrofoam®. This similar chemical polarity is the same reason why pure lemon oil also works quickly to dissolve Styrofoam®. No solvents are used to produce the fish oils, so none are present in the finished products. This magic trick does not translate into any legitimate safety concerns, despite its obvious visual impact. Fortunately, the human body is not composed of polystyrene and is not negatively affected by fish oils in its commonly available forms.

Fish oil naturally comes in a volatile triglyceride (triacylglycerol) form and can be esterified for additional benefits. As soon as a fish is caught the oils begin to degrade and can easily go rancid. Esterification is a process that stabilizes and maintains the freshness of fish oil to prevent rancidity and allows higher concentrations of the essential omega-3 EPA and DHA fatty acids to be available. During this esterification process, the triglycerides are removed, changing the number of molecular bonds in the fish oil. Both the purified ethyl ester form and the triglyceride form must be digested to a simpler fraction, the free fatty acid, to allow bioavailability from the human gut. Ethyl ester and triglyceride forms are equally well digested by lipase and available for absorption as free fatty acids, and the ethyl ester form is at least as bioavailable as the triglyceride form. (1)

There is some evidence that the ethyl ester form will sustain circulating levels of the omega-3 fatty acids EPA and DHA better than the triglyceride form. The ethyl ester form of EPA and DHA is the form that is used in most successful clinical studies evaluating the potential health benefits of supplemental Omega-3 fats. In fact, clinical trials on the ethyl ester form more consistently generate positive results than those done with the triglyceride form. Also EPA and DHA as ethyl esters inhibit platelet aggregability and control serum triglycerides while leaving other serum lipids essentially unaltered. (2) The ethyl ester forms build up body stores, allowing conversion to free fatty acids more consistently than the triglyceride form. (3) Because of their proven benefits and safety, it would be unfortunate if a misunderstood “test” causes some people to reject the use of solvent-free ethyl ester fish oils as part of their diet.

Expert opinion:

Technical explanation:

Chemical Polarity plays a role in how compounds react with one another. Polarity refers to the electro-magnetic charges of a molecule, or the attraction between the positively and negatively charged parts of a molecule. Compounds are considered polar due to the unequal sharing or electrons. For example, water is a polar compound. A compound is non-polar when the electric charge is balanced. Edible oils are typically non-polar.

In Chemistry there is a rule to describe how polar and non-polar solvents react with similar solutes: “like dissolves like”. We all know that oil and water do not mix. The reason why is that water, which is polar, will not react (mix) with oil, which is non-polar. “Like dissolves like.”

Two common compounds, sugar and salt, are both polar and in nature they readily mix with water, another polar compound.

With polarity, compounds of differing polarity do not react/mix, while those with like polarity do mix. So a chemical reaction occurs when a non-polar compound comes into contact with another non-polar compound, and more readily when the number of chemical bonds in one substance more closely matches the other.

Polystyrene, a moisture-resistant foam commonly known as Styrofoam®, is formed from a long chain of polymers. This plastic is used in the manufacture of coffee cups and plates as an insulator and as packaging material, and is non-polar. What makes Styrofoam® ideal for keeping most hot beverages hot and cold beverages cold is that as a non-polar compound it will not react with the polar water used to make coffee, tea, and other beverages. This same material will react with any form of edible oil; this can be olive oil, lemon oil, fish oil, etc. This reaction is naturally occurring and its intensity is based solely upon the chemical properties of both compounds and the polarity of each.

All edible oils, which like Styrofoam® are non-polar, are made up of fatty acids; and these fatty acids are made up of a long chain of hydrocarbon molecules. With Fish Oils, some contain triglycerides and some contain ethyl esters. Both the triglyceride form and the ethyl ester form first need to be digested and broken down to a free fatty acid for absorption from the GI tract. After uptake, the free fatty acid is then converted to a triglyceride form in the liver by the addition of already available triglycerides obtained from circulating lipids (fats).

In the example of fish oils, ALL will react with Styrofoam over time; the length of time is determined by the number of chemical bonds in each type of fish oil relevant to the number of chemical bonds in Styrofoam®. Triglycerides will take longer to react with the cup, while oils bonded to ethyl esters, which have more chemical bonds, will naturally penetrate the cup wall faster.

  1. Krokan HE, Bjerve KS, Mørk E. The enteral bioavailability of eicosapentaenoic acid and docosahexaenoic acid is as good from ethyl esters as from glyceryl esters in spite of lower hydrolytic rates by pancreatic lipase in vitro. Biochim Biophys Acta. 1993 May 20;1168(1):59-67. PMID: 8504143
  2. von Schacky C. A review of omega-3 ethyl esters for cardiovascular prevention and treatment of increased blood triglyceride levels. Vasc Health Risk Manag. 2006;2(3):251-62. Review. PMID: 17326331
  3. Rupp H, et al. Risk stratification by the "EPA+DHA level" and the "EPA/AA ratio" focus on anti-inflammatory and antiarrhythmogenic effects of long-chain omega-3 fatty acids. Herz. 2004 Nov;29(7):673-85. Review. Erratum in: Herz. 2004 Dec;29(8):805. PMID: 15580322

Monday, March 25, 2013

Canola Oil was developed without GMO biotechnology

The rape plant (Brassica napus) is related to mustard, turnip, cabbage, radish, and horseradish plants. Its oil has been used for centuries as a cooking oil in Europe and Asia (India and the Far East).

Both rapeseed oil and mustard seed oil contain relatively high levels of a fatty acid called erucic acid. As with some other oils, when heated to high temperatures unrefined rapeseed oil can release fumes which have been theorized to be associated with an increased lung cancer risk. These fumes have been blamed on its high erucic acid content; perhaps undeservedly since refined rapeseed oil did not seem to share this characteristic and since mustard seed oil is still a staple cooking oil in South and East Asia.

In any case, rapeseed oil was not sold as a food in the United States for many years, and this is why a low-erucic acid version was developed by traditional cross-breeding of varieties that had lower than usual levels. Originally developed in Canada in 1974, it was dubbed “Canola” oil to distinguish it from traditional rapeseed oil; the name implies its Canadian origin. This oil is often sold in Europe under its more commonly known “rapeseed” rather than the “Canola” name, even if the low erucic acid type is used.

Canola (low erucic acid rapeseed) oil received GRAS status in 1985, allowing it to be sold as a food or food additive in the United States.

These dates are long before the first commercial GMO crops were approved by the U.S. government in the mid-1990s. Since Canola’s breeding history actually goes back decades before that, it clearly was originally developed without the use of genetic engineering (GE, or biotechnology). Today, most of the canola grown in North America is GMO (from GE seeds); though there are still some Identity Preserved (IP) canola crops, from which is produced non-GMO canola oil.

The history of the use of rapeseed oil in food in the US is well summarized in the preamble of the final rule which affirmed the GRAS status of low erucic acid rapeseed (LEAR) oil (Federal Register, 1985: 21 CFR 184.1555 (c)(4)).


Thursday, February 21, 2013

Vitamin D Testing & 3rd Party Certification

A letter in a recent medical journal stated that in a recent study the only vitamin D supplement to pass the authors’ potency testing was a USP-verified product.  The authors explicitly endorsed the USP certification program and the brands that utilize this standard. [1] News reports are duly reporting that consumers should only purchase USP-verified Vitamin D. (12) But the data in the study did not justify that conclusion, so those news reports were based on inaccurate information and are therefore wrong.  

The  authors claimed that “the Food and Drug Administration [FDA] does not regulate vitamin D supplements.”  1  This is simply not true.  [2]  The FDA does indeed regulate all dietary supplements, including Vitamin D. 2  A summary of dietary supplement regulation is posted on that agency’s website. [3], 9   There are also various third-party summaries of current dietary supplement regulation available. [4], [5], [6], [7], [8], 10 

The USP-verified OTC standards require a potency of 90% - 110% of the active label claim, as the authors point out.  But this allows levels which are below the minimum required by the Dietary Supplement Health and Education Act of 1994 and the resulting FDA current Good Manufacturing Practices (cGMPs) that regulate supplement manufacturing and labels.  The federal cGMPs require greater or equal to 100% potency; the capsules must at least match the label claims.  This means that a product tested at 99% potency would be acceptable by the USP standards, but would not meet the FDA cGMP standards set in the regulations governing dietary supplements.  This also means that a USP-Verified product could actually be deemed “misbranded” under these regulatory standards, and therefore illegal. So you can quickly see that the USP’s OTC (over the counter) drug standard is not applicable to dietary supplements. 10  

In the letter published in that medical journal the authors reported that four of the 12 brands tested had samples that met the authors’ standards as being within their stated acceptable range of variance from label claim, yet only one of these was from a USP-verified company. Why was that brand singled out as superior when at least 3 other brands were within those same chosen (and as we discussed already, unacceptable) limits? And why did the authors specifically endorse that brand‘s certification program when admittedly one of the two USP-verified brand’s products tested actually failed this testing? 1  That’s a 50% failure rate, and the one USP-verified product that didn’t fail that standard still did not reliably meet the cGMP legal standard.  To me, an experienced science writer, these inconsistencies of logic suggest a bias against the non-USP-verified brands and an unjustified conclusion that conveniently met the authors’ preconceived notions of dietary supplements being ‘unregulated’.  

In this study, only 5 brands are USP-verified (Berkley & Jensen, Kirkland, Nature Made, Sunmark, TruNature).  All are sold in mass market (Albertsons, BJ’s Wholesale Club, Costco, CVS, Eckerd, Giant, Health Mart, Hy-Vee, K-Mart, Kroger, Long’s, Osco Drug, Ralph’s, Rite-Aid, Safeway, Sam’s Club, Stater Bros, Super Valu, Target, Valu-Rite, Walgreen’s), not health food stores. [9] Brands sold in the natural products channel (health food stores) typically don’t verify their products to the non-compliant USP standards. Most good natural products brands are certified by different 3rd party organizations that certify their compliance to the FDA’s cGMP standards, which are the law of this land.  [10], [11] We don’t know if any of the brands tested were third-party certified by these other organizations because the authors did not disclose those brands or discuss any other claims of third-party certification. 1  

Why do people buy vitamins at health food stores instead of drug stores in the first place?  Many people reject some of the pharmaceutical ingredients that are commonly used in products sold in that channel but which are not used in vitamin products sold in the natural channel.  These questionable ingredients include petroleum and coal tar derivatives, talc, hydrogenated oil, artificial colors/flavors/sweeteners, crospovidone, butylated hydroxytoluene, and hypromellose.

The moral of this story is “don’t accept everything you read,” even if published by well-credentialed scientists in a “prestigious” scientific journal and dutifully reported by well-meaning news organizations.  Under U.S. law, USP-Verified is not an acceptable standard for dietary supplements because its standard fails to meet the legal requirements for dietary supplements.  Instead, look for dietary supplements that are third-party GMP-certified in order to assure that your vitamins are manufactured under proper conditions to assure safety and efficacy, and are properly tested to meet 100% of label potency as required by law.  

Monday, February 18, 2013

How Dietary Supplements are Regulated

How Dietary Supplements are Regulated

A Timeline of Dietary Supplement Regulation since 1994

1994 The Dietary Supplement Health and Education Act (DSHEA)
  • Continues to define dietary supplements as a special Food category; not as food additives 
  • Sets new safety standards and FDA authorization to prevent imminent hazards
  • Requires manufacturers to follow Good Manufacturing Practices (GMP) set by the FDA
    • GMPs were fully implemented between June 2008 and June 2010
  • Regulates labels
    • All claims must be truthful and not misleading; documentation must be maintained
    • All ingredients must be declared on product labels
  • Approves pre-existing dietary ingredients already on the market as of October 15, 1994
    • Common vitamins, minerals, herbs
    • “Grandfathering” was twice applied to pharmaceuticals already on the market:
      • The 1938 Food, Drug and Cosmetic Act
      • The 1962 Kefauver-Harris Amendment
    • This is analogous to pharmaceuticals where all drugs entering the market after 1938 and then after October 10, 1962 require an FDA submission/approval process
  • Requires pre-market submission to FDA of all New Dietary Ingredients (NDIs), not products
    • The agency questions or rejects the majority of submissions
 1997 The Food and Drug Administration Modernization Act (FDAMA)
  •  Provides for health and nutrient content claims based on an authoritative statement by a scientific body of the U.S. government (i.e. NIH) or the National Academy of Sciences
    • Such claims may be used only after review of a health claim notification by FDA
2002 The Public Health Security and Bioterrorism Preparedness and Response Act
  • All food manufacturers, including dietary supplement manufacturers, are required to be registered with the government and give advance notification of raw materials imports
 2003 The FDA Consumer Health Information for Better Nutrition Initiative
  • Provides for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation
2004 The Anabolic Steroid Control Act amendment
  • Bans steroid precursors sold as dietary supplements
  • The FDA and DEA have authority to take action against adulterated products
2004 The Food Allergen Labeling and Consumer Protection Act
  • Requires label disclosure of the 8 major allergens that cause 90% of all food allergies
 2006 The Dietary Supplement and Nonprescription Drug Consumer Protection Act
  •  Requires record-keeping of all adverse events (AERs) and reporting of all serious AERs to FDA; for both dietary supplements and OTC drugs
 2007 Food and Drug Administration Amendments Act
  • Prohibits interstate commerce of any food, including dietary supplements, containing drugs or medical biologic products approved by FDA as such or clinically investigated as drugs/biologics
2010 The annual report of the American Association of Poison Control Centers
  •  Published in the journal Clinical Toxicology
  • Reports zero reports of accidental deaths from dietary supplements
2010 Full implementation of mandatory federal cGMPs was completed in June
  • All manufacturers & suppliers are now bound by FDA standards of safety and documentation
2010 The FDA Food Safety Modernization Act
  • Includes enhanced mandatory recall authority for most foods, including dietary supplements
  • Expanded facility registration and HACCP (safety handling) rules
  • Requires FDA to issue guidance on New Dietary Ingredients (NDIs), per DSHEA
2011 The FDA released a new Guidance on its enforcement of NDI regulations
  • Requires approval of NDIs by the FDA, not just pre-market notification to the agency
  • Redefines NDIs as all products containing an NDI ingredient, not just the ingredient itself
  • Expands the definition of NDI to include new ingredient processing techniques
  • Would encompass tens of thousands of products versus dozens of ingredients earlier projected (1997)
2012 Due to objections from Senate leaders who had co-sponsored DSHEA, FDA notifies Senators Hatch and Harkin that its NDI guidance will be revised & reissued


Tuesday, January 08, 2013

Flu Shot Realities

Nutrition and Seasonal Flu

Antibiotics fight bacteria but won’t help against viral infections, and there are limited medical options. Flu drugs must be taken within 48 hours of the first symptoms of influenza and only claim to reduce symptoms by about 1.5 days. [1], [2]

Flu shots are only effective against 1-3 strains of influenza; depending on how lucky the researchers’ guess was several months earlier. But exposure to one or more flu strains, such as by getting a flu shot, actually make us more susceptible to infection from other virus strains by reducing our immune response.  Researchers know that, theoretically, when people are exposed to bacteria or a virus, it can stimulate the immune system to create antibodies that facilitate the entry of another strain of the virus or disease. For example, Canadian researchers in four separate studies found that people who had received the seasonal flu vaccine in the past were more likely to get sick with the H1N1 virus. [3]

There is evidence that the nutrient status of the host even affects the genetic expression of viruses. An unsuitable environment like a well-nourished body inhibits the ability of a virus to freely replicate and thrive. This not only makes viruses more virulent, but also more prone to mutate inside us to become more immune- and drug-resistant strains if we are nutrient deficient! [4], [5], [6], [7]

Research going back over a century has proven that nutrient deficiencies, for example of vitamins A or D, can lead to increased susceptibility to infectious diseases. A well-known and decades-old example is the strong association of vitamin A deficiency with the development of more severe measles infections, leading to a much higher rate of mortality. 5

Although the immune response has been demonstrated to be impaired in nutritionally deficient hosts, the actions and vigor of the virus itself may also be affected by the nutritional deficiency. Viruses have been shown to develop increased virulence due to changes in their genomes when replicating in a nutritionally deficient host. The exact mechanism for viral genetic changes is not well documented but seems related to increased oxidative stress in the host. For example, selenium-deficient mice were more susceptible to viral infections, and developed severe forms of illnesses even when infected with mild viral strains. Both the immune system and the viral systems were affected by the nutrient deficiency in ways that strengthened the virus and weakened the host. 5

Volunteers inoculated with live attenuated influenza virus are more likely to develop fever and evidence of an immune response in the winter when vitamin D levels are naturally low.  And an interventional study showed that vitamin D reduced the incidence of respiratory infections in children. [8]

Compelling epidemiological evidence indicates that vitamin D deficiency is a stimulus causing seasonal flu rates to be much higher in the winter months than the summer months. Evidence now confirms that lower respiratory tract infections are more frequent, sometimes dramatically so, in those with low serum vitamin D levels. In an intervention study, 800 IU of vitamin D daily reduced seasonal flu levels in winter months to the low levels commonly reported in summer months...virtually eliminating seasonal flu in that population. [9]

We can see that vaccines and flu drugs convey only limited protection and treatment against viral infections, and that the wisest course is to fortify our immunity with adequate nutrient intake.

[3] CBC News 9/23/09; Dr. Michael Gardam, director of infectious diseases prevention and control at the Ontario Agency for Health Protection and Promotion
[4] Cunningham-Rundles S, McNeeley DF, Moon A.  Mechanisms of nutrient modulation of the immune response.  J Allergy Clin Immunol. 2005 Jun;115(6):1119-28; quiz 1129. Review.
[5] Zaslaver M, Offer S, Kerem Z, Stark AH, Weller JI, Eliraz A, Madar Z. Natural compounds derived from foods modulate nitric oxide production and oxidative status in epithelial lung cells.  J Agric Food Chem. 2005 Dec 28;53(26):9934-9.
[6] Calder PC, Kew S.  The immune system: a target for functional foods? Br J Nutr. 2002 Nov;88 Suppl 2:S165-77.
Janeway, Charles A.; Travers, Paul; Walport, Mark; Shlomchik, Mark (2001) Immunobiology, 5th Ed., Garland Publishing, New York and London.
[7] Beck MA, Handy J, Levander OA. Host nutritional status: the neglected virulence factor. Trends Microbiol. 2004 Sep;12(9):417-23. Review. PMID: 15337163
[8] Cannell JJ, Vieth R, Umhau JC, Holick MF, Grant WB, Madronich S, Garland CF, Giovannucci E. Epidemic influenza and vitamin D. Epidemiol Infect. 2006 Dec;134(6):1129-40. Epub 2006 Sep 7. Review. PMID: 16959053
[9] Cannell JJ, Zasloff M, Garland CF, Scragg R, Giovannucci E. On the epidemiology of influenza. Virol J. 2008 Feb 25;5:29. Review. PMID: 18298852