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 3^rd 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.  

REFERENCES (links accessed Feb. 18, 2013)

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[1] http://archinte.jamanetwork.com/article.aspx?articleid=1570096

[2] http://www.fda.gov/Food/DietarySupplements/default.htm

[3] http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm071547.htm

[4] http://honestnutrition.blogspot.com/2013/02/how-dietary-supplements-are-regulated.html

[5] http://www.npainfo.org/NPA/Communications/SeparatingSupplementFactsfromFiction.aspx

[6] http://www.crnusa.org/leg_DSHEApub.html

[7] http://www.crnusa.org/leg_glance.html

[8] http://americannutritionassociation.org/newsletter/assessing-claims-functional-foods-nutritional-supplements

[9] http://www.usp.org/usp-verification-services/usp-verified-dietary-supplements/verified-supplements

[10] http://www.npainfo.org/NPA/EducationandCertification/GMPCertification/NPA/EducationCertification/NPAGMPCertificationProgram.aspx?hkey=d37fc8c5-7b43-4a6d-bcf4-af67d5814bfe

[11] http://www.npainfo.org/NPA/EducationCertification/GMPCertifiedCompanies.aspx

12 http://www.koinlocal6.com/news/local/story/Taking-Vitamin-D-Dont-trust-that-bottle/94U3oiVyCU2bv85MQxYDtw.cspx

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Mercola, Weston Price wrong on Soy "dangers"

I regularly see research on soy and the vast majority of research papers prove the health benefits of soy. Based on the body of science and the errors evident in his "Facts", what Dr. Mercola has stated is undocumented, unreferenced bull recycled from Weston Price.

All legumes contain significant levels of phytoestrogens; why is soy singled out for this abuse using cherry-picked out-of-context "facts" that aren't really backed them up when the research is reviewed. Do you ever hear such slanders against the #2 source of phytoestrogens (pinto beans)?

In fact, many of the negative studies cited come from the animal feed industry and refer to raw defatted soy meal, the pulp left over after extracting soybean oil. This is not what humans eat! We aren't fed raw defatted soy meal as the major protein source in our diet, and many of the negative issues with raw dried soybeans disappear with proper food preparation (i.e., cooking). They also don't apply to edamame (raw soybean pods with the beans inside), since some of these "anti-nutrient" factors form during drying and are removed during cooking (except for genetically engineered soy that contains exceptionally heat-resistant anti-nutrient compounds).

Here are some actual facts about soy (in contrast to the Mercola/Weston Price data dump of uncritically collected studies); and I have the studies to back this up:

 

• Phytates are common in grains, less in legumes; the supplement IP-6 is this exact compound, useful to stimulate NK cells and immunity
• Trypsin inhibitors are only a problem in raw soy flour and GMO soy products, not the typical uses of non-GMO soy
• Phytoestrogens such as isoflavones are not endocrine disruptors, this is nonsense; have you ever heard of these problems with pinto beans, the #2 most abundant food source and a major component of the Mexican diet? Of course not.
• Soy, like cruciferous vegetablles, only affects thyroid function if one is iodine deficient and the addition of iodine to the diet corrects this symptom. The real problem is a nutrient deficiency.
• Most plant foods are known to be poor sources of bioavailable B-12, not just soy, and this is common knowledge so why single soy out? Bias?
• D-2 is a natural compound found in the food supply and is neither toxic nor a synthetic form; all vitamin D is produced by chemical synthesis, whether in the body or in a lab, but the forms of D-2 and D-3 utilized in supplements and food fortification are both nature-identical natural forms synthesized in labs.
• Most soy protein isolate is not denatured; by the way, another term for denaturing is "digestion" and this is good unless you need intact proteins from food (as in whey protein isolate's valuable immunoglobulins).
• All proteins when digested produce free glutamates; this is natural. Only susceptible people who have had severe chemical exposure or are low in protective nutrients like antioxidants and magnesium suffer from this. I have spoken with and attended lectures by Russ Blaylock for about 20 years and am well versed in this mechanism and its causes and solutions.
• Soy proteins do not test high in heavy metals; rice protein is actually far higher in actual tests at parts-per-billion detection levels.
• Asians consume far more soy products than is claimed by your sources; the typical isolflavone content of the diet there is established to be about 50 mg daily, the amount found in a couple ounces of soy protein at 90% strength, which represents several ounces of unconcentrated soy at about 30% protein.
• Soy is not carcinogenic; review studies confirm that soy protein isolate, not fermented soy, has been proven to reduce cancer rates from breast, prostate, and colorectal cancers by about 30%.
• Soy upregulates Phase 2 liver detoxification, much like cruciferous vegetables, and is actually a detox aid rather than a source of toxins.
• Long term studies of infants fed soy formula find no differences in age of puberty, sexual maturity, or other hormonal measures; soy is 'implicated" only by those unwilling to openmindedly review the research to confirm or prove false their wild theories.
• PS, I was in China recently and they eat plenty of tofu and edamame, both unfermented soy foods, in greater quantities than fermented soy.

Some of Weston A. Price Foundation's citations listed as "evidence" of soy's "toxicity" include these titles that obviously don't fit the negative label; that's why I characterize their list as a "data dump":

 

• "Salt poisoning due to ingestion of soy sauce." (How does this prove that non-fermented soy is toxic?)
• "Hypothesized health benefits of soybean isoflavones." (A study that is positive of soy's health benefits)
• "Rhinitis and dermatitis caused by exotic woods." (This is a non-soy herb: Pterocarpus soyauxii)
• "A nutritional comparison of rapeseed oil and soybean oil."
• "[Concerning the absence of goitrogenic factors in soybean oil for cooking.]" (Exonerates soybean oil from thyroid issues)
• "Eastern black nightshade: An increasing concern for soybean and forage producers." (A farming issue, not a nutritional one)
• "Medicinal Plants of lndia and Pakistan." (Actually refers to a non-soy plant: Indian red wood tree, Soymida febrifuga Adr. Juss.)

My report on regulation of health claims

On April 24, 2010, I was asked as a representative of the American Nutrition Association to participate in a panel discussion at the annual conference in Chicago called Health Journalism 2010, held by the Association of Health Care Journalists. The panelists presented short statements and slides, then answered audience questions. This is a link to my report and slides from that event:

http://americannutritionassociation.org/newsletter/assessing-claims-functional-foods-nutritional-supplements

Second Opinion on Herbs

Second Opinion on Herbs In a recent opinion, physician Henry I. Miller advocates a new way to regulate dietary supplements (DS), arguing that they are currently unregulated. Although a onetime FDA official and longtime industry critic, Dr. Miller seems out of touch with the current state of DS regulation, including recent major advances in quality assurance by manufacturers. His bias against natural products is made evident by his use of the slur “snake-oil” to dismiss herbal products as simultaneously ineffective and “dangerous”. Many observers, including FDA commissioners during congressional testimony, have testified that the agency has all of the authority it needs to regulate DS. Recent advances include the FDA’s current imposition of mandatory Good Manufacturing Practices (GMP), which was authorized by a 1994 law (DSHEA) that Dr. Miller inexplicitly claims exempted DS from government oversight. That same law stipulates that supplements must not be mislabeled or adulterated and the FDA has repeatedly taken action against such products, again proving Dr. Miller wrong. Manufacturers are now required to have procedures in place to assure product identity, potency and safety, as authorized by a law that Dr. Miller misrepresents. DS manufacturers supported a serious adverse event reporting (AER) law to track patterns of serious side effects. In the first year, the number of DS reports was significantly less than the FDA had predicted. An AER is casually linked to, but not proven to be caused by, a product. Dr. Miller’s assertion that foods and DS like herbs interfere with drugs (Miller’s ‘“real” medicines’) is telling. Is it professional bias to claim that foods, herbs and vitamins are unnecessary nuisances that are interfering with all-important medical treatment? In fact, these legendary interactions appear to be a minor issue. When the Mayo Clinic did a large patient survey to scientifically assess the risk, it reported that there were few such interactions, none serious, limited to only a handful of drug types and a few supplements such as garlic. Dr. Miller’s proposal for a new voluntary oversight entity for herbal products to correct a supposed lack of regulation is illogical; such entities already exist, and how could a voluntary program replace adequate regulation? His seeming ignorance of the current regulatory status of herbs is troubling, undercutting his rationale for such tinkering. Statistically, dietary supplements are safer than drugs and even safer than eating a meal, as recent AER reports prove. DS labeling and manufacturing are currently well-regulated. I suggest that studying drug-nutrient-herb interactions and addressing these on drug labels – where they belong - is a far wiser strategy than creating a “voluntary oversight” entity for dietary supplements, especially as there are already voluntarily GMP-certified brands available.

Neil wins prestigious national award!

On July 17, 2008, the Natural Products Association awarded Neil the prestigious Industry Champion Award. This award is given to people who have made notable individual contributions to industry above and beyond what is expected to achieve commercial success.

Neil is a Truth Advocate recognized by the industry. He responds to negative stories - both in the media and in scientific/medical journals - that are biased or flawed.

NPA President Debra Short presented the award at the association's annual business meeting. Neil's brief off-the-cuff comments from the podium at the national meeting are on the accompanying video.

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?

My second letter to Reader's Digest about vitamins

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

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

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

Am I biased?

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

LAND OF CONFUSION: How Poor Science and Misleading Media Coverage Create Public Confusion About How Dietary Supplements Affect Health

Click on title above to read full article