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The Latest in the Effort to Bash Supplements

FOR IMMEDIATE RELEASE
Orthomolecular Medicine News Service, October 30, 2015

Big Names; Big Mistakes
Consumers Misled by Supplement Bashing

by Gert Schuitemaker, PhD (1) and Bo Jonsson, MD, PhD (2)

(OMNS, Oct 30, 2015) Big names: the New England Journal of Medicine (NEJM), arguably the most prestigious medical journal in the world. Plus, the New York Times. On October 14th, the latter mentioned: “Dietary Supplements Lead to 20,000 E.R. Visits Yearly, Study Finds.” It was a report of a study published in the NEJM with the headline: “Emergency Department Visits for Adverse Events Related to Dietary Supplements.”

Whoa! What is that again? Is there really something new and terrible about vitamin C or magnesium?

Naturally, it was time to investigate. First, a look at the original paper from NEJM, and a direct examination as to how the study was designed. [ http://www.nejm.org/doi/full/10.1056/NEJMsa1504267 ] This was a revelation in itself, which can best be explained as follows:

Let’s say someone is exercising Sunday morning and suddenly gets palpitations. Oh, he thinks, what’s going on here? A little bit frightened, and just to be sure, he decides to go to the E.R. He says: “Doctor, something is going wrong. I have palpitations.” The doctor examines him and asked about the circumstances. Then he learned that the visitor had used that morning a dietary supplement. Aha! That’s it! Dietary supplements! Suspicious!

There was not even one death caused by any dietary supplement in 2013, according to the most recent information collected by the U.S. National Poison Data System. [Reference at http://orthomolecular.org/resources/omns/v11n02.shtml ]

This observational report is done by just the one doctor serving at that time. The data collection in this investigation can be considered as poor as well as subjective. It falls scientifically short. Moreover, as we already know, too many physicians 1) have little affinity for dietary supplements and 2) are virtually untrained as to nutrition and supplements.

But wait: there’s more

We continued by looking over the results section. We had already noticed that the researchers drew the conclusion that problems with dietary supplements were underestimated. Duffy Mackay, a spokesman for the Council for Responsible Nutrition, a supplement industry trade group, argued that the results showed that only 0.01% of all Americans demonstrated an adverse effect from dietary supplements. So he came to an opposite conclusion: the study highlighted how relatively safe supplements are given how many people took them. [Scroll down at http://well.blogs.nytimes.com/2015/10/14/dietary-supplements-lead-to-20000-e-r-visits-yearly-study-finds/ ]

In the study, it was striking that the biggest segment of that 0.01% was 20 to 34 year olds who took energy products and weight loss products. They showed symptoms like chest pain, heart palpitations and irregular heart rhythms. What kind of supplements could these be? We are not aware that vitamin C, vitamin B3 or any of the essential nutrients show these types of adverse effects.

The most misleading part of the NY Times article’s headline is “leads.” It is important to distinguish causation from correlation, and guilt from association. – W. Todd Penberthy, PhD

Where, then, is the problem? Mainly so-called “supplements” containing alkaloid substances. In most cases caffeine, but also ephedra, already banned in 2004 by the FDA as a supplement, but still offered for sale via the internet. Therefore, a comparison with “energy drinks” is more apt than to label these products as dietary supplements. However, caffeine-laden drinks were for some reason not included in the study. Aside from both being available as tablets and capsules, caffeine and nutrients have very little in common. Caffeine is a (medicinal) stimulant; nutrients are part of the human metabolism which are necessary for maintaining proper health.

It is significant that neither the New York Times nor the original NEJM paper mentioned caffeine or coffee-extract. The researchers only mentioned ‘energy products’ and ‘weight loss products,’ not specifying the substances involved. In order to find out that the study mainly concerned caffeine, we had to get into a separate annex which was somewhat difficult to for the public to find, and only available via the website of the NEJM.

And what is in the future for unsuspecting consumers? The headline, “Dietary Supplements Finally Banned.”

It could happen. You can be sure the media will let you know when it does.

1. Gert E. Schuitemaker, PhD
Ortho Institute
Gendringen, The Netherlands

2. Bo H Jonsson, MD, PhD
Department of Clinical Neuroscience
Karolinska Institutet
Stockholm, Sweden

Nutritional Medicine is Orthomolecular Medicine

Orthomolecular medicine uses safe, effective nutritional therapy to fight illness. For more information: http://www.orthomolecular.org

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Editorial Review Board:

Ian Brighthope, M.D. (Australia)
Ralph K. Campbell, M.D. (USA)
Carolyn Dean, M.D., N.D. (USA)
Damien Downing, M.D. (United Kingdom)
Michael Ellis, M.D. (Australia)
Martin P. Gallagher, M.D., D.C. (USA)
Michael Gonzalez, D.Sc., Ph.D. (Puerto Rico)
William B. Grant, Ph.D. (USA)
Michael Janson, M.D. (USA)
Robert E. Jenkins, D.C. (USA)
Bo H. Jonsson, M.D., Ph.D. (Sweden)
Peter H. Lauda, M.D. (Austria)
Thomas Levy, M.D., J.D. (USA)
Stuart Lindsey, Pharm.D. (USA)
Jorge R. Miranda-Massari, Pharm.D. (Puerto Rico)
Karin Munsterhjelm-Ahumada, M.D. (Finland)
Erik Paterson, M.D. (Canada)
W. Todd Penberthy, Ph.D. (USA)
Gert E. Schuitemaker, Ph.D. (Netherlands)
Robert G. Smith, Ph.D. (USA)
Jagan Nathan Vamanan, M.D. (India)
Atsuo Yanagisawa, M.D., Ph.D. (Japan)

Andrew W. Saul, Ph.D. (USA), Editor and contact person. Email: drsaul@doctoryourself.com This is a comments-only address; OMNS is unable to respond to individual reader emails. However, readers are encouraged to write in with their viewpoints. Reader comments become the property of OMNS and may or may not be used for publication.

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OMNS archive link http://orthomolecular.org/resources/omns/index.shtml

 

Who’s Afraid of Supplements? “Do You Believe in Paul Offit?”

by Alison Rose Levy

The Medical Establishment’s “Favorite” Doctor and His Crusade Against Supplements and Alternative Medicine

Paul Offit’s new book and media blitz pretend to be objective, but really offer one-sided bashing of natural healthcare.

Dr. Paul Offit, chief of the Division of Infectious Diseases at? Children’s Hospital of Philadelphia? has authored a new book, Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine (Harper, 2013 ). Now on the stump, he encourages thinking more critically about healthcare treatments. Too bad his is a one-sided view. And that his intended audience is unlikely to be convinced because health information has been increasingly available over the last 25 years. Nor do many physicians and prominent medical organizations subscribe to his views (although a few legislators do).

“People are systematically choosing to manage their own health in a way that is unprecedented,” points out James S. Turner, chairman of Citizens for Health, a health advocacy group with over 100,000 members. “The conventional treatments that Offit champions are often very helpful. The problem is that the industry has oversold them, and more and more people see that now.”

If Offit’s book had aimed to explore all health options even-handedly for their upsides and their downsides, it might have truly advanced the conversation about how to better health and lower healthcare costs. (And ranking below 16 developed nations across the lifespan and for all income levels, while stuck in the midst of a polarized debate over costs and coverage, the U.S. sorely needs that conversation.) But instead, in his book and media tour, Dr. Offit plays the predictable role of debunker, single-mindedly championing his own medical brand. Unfurling an arch skepticism about the use of herbs and other nutritional supplements, for example, Offit presents himself as the stalwart for science. But it’s instructive to see what happens when he encounters someone conversant with the health literature.

Chicago Conference Covers Latest Research on Natural Products for Women’s Health

By James J. Gormley

On October 20th, 2012, the Natural Health Research Institute (NHRI) held its 8th Annual NHRI Scientific Symposium, entitled, “The Effectiveness of Natural Products for Women’s Health.”

Presented by the University of Illinois (UIC) College of Pharmacy and the American Nutrition Association (ANA), the UIC College of Pharmacy auditorium was attended by a students and practicing pharmacists, nurses, chiropractors and Certified Nutrition Specialists.

The event featured a stellar line-up of world-class experts in natural products and women’s health. The speakers were:

Tori Hudson, N.D., Clinical Professor at the National College of Naturopathic Medicine and Medical Director of A Woman’s Time.

Richard B. van Breemen, Ph.D., Professor of Medicinal Chemistry & Pharmacognosy and Director of the UIC/NIH Center for Botanical Dietary Supplements Research.

Harry G. Preuss, M.D., CNS, Professor of Biochemistry, Medicine and Pathology at Georgetown University Medical Center.

Dennis B. Lubahn, Ph.D., Professor of Biochemistry & Child Health and Director of the NIH Botanical Center, University of Missouri-Columbia.

William Helferich, Ph.D., Professor of Nutrition, Diet, Women’s Health & Aging, University of Illinois at Urbana-Champaign.

Liz Lipski, Ph.D., CCN, Director of Doctoral Studies & Educational Director, Hawthorn University.

Dr. Hudson’s presentation, entitled “Evidence-based Natural Solutions to Symptoms of Perimenopause and Menopause” busted some media-fed myths regarding black cohosh, in which she detailed its strong safety record and efficacy for peri-menopause and menopause symptoms.

She also outlined the benefits of ginseng, hops, kava, kudzu, maca, red clover, Pycnogenol, Sibiric rhubarb, St. John’s wort, valerian, omega-3 fats, multi-ingredient combinations and specific treatment protocols she uses for specific symptoms.

Dr. van Breemen’s talk was entitled: “Safety and Efficacy of Botanical Dietary Supplements As Alternatives to Hormone Replacement Therapy.” His presentation detailed research into botanical alternatives to HRT, including promising studies on hops, red clover and black cohosh.

Dr. Preuss’ presentation, entititled “Managing Obesity With Natural Dietary Supplements: Lessons Learned From Clinical Research Studies,” emphasized the importance of reduced body fat, not just overall weight, in improving body composition, and looked at research into chromium, carb blockers, green tea extract, and conjugated linoleic acid.

Dr. Lubahn’s talk was entitled “Using Botanicals, Hedgehogs, and Estrogens in the Prevention of Human Disease,” in which he outlined studies showing experimental benefits against prostate cancer  with high concentrations of genistein from soy, EGCG from green tea, curcumin and resveratrol, and low concentrations with the new botanicals under study, like sutherlandia (Lessertia frutescens), and how these plant compounds are able to hold back unwanted signaling in mouse and human prostate cancer cell lines, which researchers link to estrogen and which may point to benefits for cancers in women.

Dr. Helferich’s presentation, entitled Isoflavones and Breast Cancer Growth and Progression: Insights From Pre-Clinical Models,” pointed to a potentially better safety profile for soy genistein-containing diets (for example, from fermented foods) than from isolated extracts of genistein.

Dr. Lipski’s entertaining talk was entitled “Women and Digestive Issues: Focus on IBS, Constipation and Leaky Gut.” She gave a detailed discussion of the intestine’s impact on virtually every single health area, and covered such as topics as small intestinal bacterial overgrowth (SIBO), dysbiosis and depression, psychiatric symptoms and irritable bowel syndrome (IBS), fibromyalgia, leaky gut and associated conditions, the benefits of bone broths and gut-healing foods, and supplements and dietary approaches to all of these conditions.

With the event having been organized by the NHRI and the American Nutrition Association, and hosted by the University of Illinois at Chicago College of Pharmacy, support for the conference was provided by the NOW® Health Group and Kabco Pharmaceuticals. The conference proceedings are available here.

About the NHRI

The NHRI is an independent, non-profit organization that supports science-based research on natural health and wellness.  It is committed to informing consumers, scientists, the media, policymakers and legislators about scientific evidence on the usefulness and cost-effectiveness of diet, supplements and a healthy lifestyle to improve health and wellness, and reduce disease around the world.

“Health at Gunpoint: The FDA’s Silent War Against Health Freedom”

What forces and interests direct the Food and Drug Administration (FDA) and why is this out-of-control law enforcement agency working so hard to take dietary supplements out of our hands?

These are the central questions explored by Citizens for Health’s very own VP and Senior Policy Advisor, James Gormley, in Health at Gunpoint: The FDA’s Silent War Against Health Freedom, what we at CFH hope you will consider to be a groundbreaking book that brings into clear focus the silent war now being waged by the FDA against all of us:  American consumers.

Please view this new video about the book:

The FDA was established in 1906 to protect the U.S. public from misbranded and adulterated foods, drinks and drugs. While the original intent may have been honorable, over the years the execution of this mission has become tainted by lobbyists and money.

In Health at Gunpoint, James Gormley presents a history of both the natural foods movement and of this over-reaching Federal agency and examines how the agency has changed over the years. He then looks at the FDA’s most controversial decisions and the troubling reasons behind them.

Why did the FDA try to shut down the supplements industry by getting most supplements classified as drugs? Why did the FDA drag its feet on folic acid fortification while thousands of babies were born with devastating birth defects? Why did the FDA try to get life stages (such as pregancy and aging) and normal discomforts (such as headaches) classified as diseases? Why are irradiated and genetically-altered foods not labeled as such? Why does the FDA favor synthetic additives and dangerous drugs over natural ingredients and dietary supplements? Why did the FDA propose a guidance that would cripple the health food industry as we know it today?

Today, as in the past, the FDA is poised to make decisions that would have a major impact on the health of all Americans. Health at Gunpoint not only sheds light on what is happening, but also explains what you can do about it.

In many European countries, nutritional supplements are now available by prescription only. If you don’t think harmonization-friendly, anti-consumer, restrictions can be put in place here, you may be in for a rude awakening.

Health at Gunpoint will help prepare you for the coming fight!

Hostile Bedfellows Assail Vitamins

Part 2 of “Media May Kill Vitamins”  – Submitted as a guest editorial by Suzanne Jenkins, November 29, 2011

Over-the-counter dietary supplements are endangered as evidenced by ongoing attacks reported in the media. Currently Senator Dick Durbin and Congressman Henry Waxman are trying a new tactic to discredit dietary supplements after previous legislative failures by asking the Government Accountability Office (GAO) to review adverse event report data for dietary supplements only, excluding the far more dangerous and numerous adverse event reports for drugs and vaccines. Since the media shapes public opinion, individuals and special interest groups that are hostile to dietary supplements will continue to use the media to discredit them and ultimately make them ineffective or unavailable to the public in the over-the-counter manner we enjoy now.

Two thirds of Americans take dietary supplements every day. A significant number of physicians take supplements and recommend at least a multi-  vitamin/mineral combination to their patients. Most supplement takers are well educated and have studied how to use good nutrition and dietary supplements to stay well or improve their health. The skilled choose a healthy lifestyle including a good diet, exercise, stress-reduction and targeted dietary supplements as their first line of defense to maintain and regain health, looking to drugs and the rest of the conventional medical model only when necessary.

Many retiring baby boomers are especially interested in longevity medicine — living healthier and longer by nourishing their brains and bodies in well thought out plans using foods and supplements to prevent or postpone dementia, osteoporosis, heart disease, cancer, diabetes, etc. It is the do-it-yourselfers that bypass conventional medicine’s “standard of care” as much as possible that are a threat to drug companies and government control.

The not-so-well-informed are easily frightened by the attacks on supplements. Many people are unaware of the behind-the-scene shenanigans by politicians and their alphabet agencies such as the FDA — entities that are supposed to protect the public. Adding to the confusion is media failure to provide the public with balanced information. What we have is mainstream corporate journalism devoted to official positions that encourage public fear and corporate greed to dominate the health care landscape.

When one sees an assault on dietary supplements it comes from the conventional arm of medicine – the arm that has established itself as the “standard of care” and the only care that is reimbursed by insurance. Of course, education and discretion in the arena of dietary supplements is necessary. One wouldn’t go into a pharmacy and start taking every drug in sight. The same applies to dietary supplements.  A good multi-vitamin/mineral preparation without iron (look for the GMP seal or its equivalent) is a good place to start while one is learning about the benefits and risks of more sophisticated applications.

When it comes to dietary supplements, a quick way for the public to determine which conflicting medical faction is vying for their allegiance is to look at the rhetoric and source of information. This is important because the media takes all of the health-related information it reports to the public from conventional sources, sources which officially promote that Americans get all of the nutrients they need from a good diet.

The ongoing attack on supplements boils down to money and control issues involving a multifaceted mix of players. In the U.S., the powerful pharmaceutical industry uses its money to influence policy. Politicians need money to fund campaigns for public office. News media, both printed and electronic, accepts advertising dollars from pharmaceutical interests, which makes it easier for media to look the other way instead of reporting on the influence of pharmaceutical dollars as a major source of problems in U.S. health care.

The scenario looks like this:

  • Over-the-counter dietary supplements are the primary source of competition for the pharmaceutical industry.
  • Americans spend $27 billion on dietary supplements; pharmaceutical interests want to re-route the money to their bottom line.
  • In order for the federal government and the medical industry to control health care completely, over-the-counter supplements must be banned or reduced to an ineffective dosage.
  • With Medicare spending projected to increase to $900 billion by 2018, the Feds are looking for ways to trim cost and dietary supplements are on the Feds’ radar screen as a cost-cutting measure, thus providing more incentive for pharmaceutical interests to gain control of supplements.
  • DSHEA (Dietary Supplement Health and Education Act of 1994) presents a problem for conventional medicine. DSHEA gives Americans the right to purchase safe, over-the-counter supplements in useful dosages.
  • The FDA is currently attempting to undermine and re-write DSHEA by re-defining the terms regulating dietary supplements in its new Draft Guidance.  NDI (new dietary ingredients) is a side door which provides an indirect way to decimate the dietary supplement industry by increasing the cost to manufacturers in the name of providing a higher degree of “safety” for products appearing on the market after 1994, resulting in increased seizure of products and driving smaller companies out of business.  The newer products which could disappear include supplements such as the Ubiquinol form of CoQ10, Resveratrol, Grape Seed Extract, Pycnogenol,  Alpha Lipoic Acid, N-Acetyl-Cysteine, Green Tea Extract, etc. Details may be found in the FDA’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredients: Notifications and Related Issues.”
  • On the international front, the U.S. signed the World Health Organization’s trade agreement, Codex Alimentarius, which may supersede the laws of the countries signing it. Countries not in compliance are considered holdouts and may not be allowed to trade. Codex has the potential to override our DSHEA if the FDA doesn’t undercut it first.
  • When pharmaceutical interests control the supplement industry, conventional medicine will control health care options.

A take-over of dietary supplements by conventional medicine will destroy the self-care/wellness care industry, reduce the quality of life for many, and result in premature death for people who depend on supplements to survive. This is especially true  where conventional treatments have failed but individuals have found a restorative combination of options beyond standard of care.

In the U.S., conventional medicine’s “standard of care” for health care is based on detecting disease, NOT on preventing it. Conventional doctors are trained to focus on symptoms, identifying and naming the disease, trying to match the drug to the name, and if drugs alone fail, then combinations of surgery, radiation, and drugs may be employed.

In conventional medicine, if there is no insurance code for a health issue, insurance will not pay. Insurance covers very little, other than prescription drugs, surgery and/or radiation, for a recognized health problem. Conventional medicine is a closed system wherein billions of pharmaceutical dollars influence doctors, osteopaths, pharmacists, hospitals, nurses, dietitians, nursing home facilities, insurance companies, research institutions, med school curriculum,  physicians continuing education, Medicare, government regulatory agencies such as the FDA, professional associations such as the AMA, National Cancer Institute, American Heart Association, etc., and politicians who set up the system and allow it to operate in the current manner.

Dietitians also want part of the action. In the state of Texas, registered dietitians (RD’s) petitioned the courts to recognize RD’s as the only legal source for dispensing nutritional information. So far, RD’s have lost their bid for exclusivity but the turf war is also flourishing in the field of nutrition. Fortunately, dietitians are beginning to question the influence of junk food purveyors and the results of overuse and abuse of pharmaceuticals experienced by their clients. You will know dietitians are making progress when foods in hospitals, nursing homes, and public schools are nutritious, delicious, and build health rather than destroy it. Up until recently, dietitians told the public there is no such thing as a bad food, only bad diets.

Quackwatch, an American non-profit organization, has the stated aim of combating health-related frauds, myths, fads, fallacies, and misconduct, according to Wikipedia. Most alternative treatments, including commonly used dietary supplements, are considered quackery on this site. Google “CanLyme, Quackwatch Founder Loses Major Defamation Trial in Hometown” and “Quackwatch Review” by Dr. Ray Sahelian, M.D.

An entrenched medical model built around disease is more profitable for those in control of the system, but it only represents half the deck. Limiting options places a strangle-hold on treatment plans available to the patient, especially in a hospital setting where malnutrition and acquisition of hard-to-treat super bugs like MRSA and C-Diff are common.

Conventional medicine is at its best in acute illness or trauma but doesn’t work well in treating complex, chronic disease because its primary focus is not on understanding the drivers causing the disease and working with reframing how the biology works, using raw materials that build health and removing impediments to good health. However, there are doctors who are becoming more open to modalities outside conventional medicine’s “standard of care” but it may take many years for a discovery to be accepted into clinical practice. People who are seriously ill do not have many years to wait for their physician’s enlightenment or for the system to reinvent itself.

The best health care option is called functional medicine, a patient-centered, science-based health care approach that integrates the best of both traditional Western and alternative or integrative medical practices. Functional and conventional medicine use the same concept of science but the difference is in the details and the application. Functional medicine involves understanding the origins, prevention, and treatment of complex, chronic disease using the continuum concept. There is a continuum from optimal health to hidden imbalance to serious dysfunction to disease. Intervention and reversal of the process can occur anywhere along that continuum, but the sooner it is addressed, the better.

Functional medicine creates a focus on prevention through nutrition, diet, and exercise; use of the latest laboratory testing and other diagnostic techniques; and prescribed combinations of drugs and/or botanical medicines, supplements, therapeutic diets, detoxification programs, or stress-management techniques. In the case of inflammation, conventional medicine would suppress it and functional medicine would focus on finding out why inflammation is happening in the first place and change the trigger causing the problem. For example, if an individual has a problem with gluten, a gluten-free diet would be used.

Practitioners of functional medicine look “upstream” to consider the complex web of interactions in the patient’s history, physiology, and lifestyle that can lead to illness. The unique genetic makeup of each patient is considered, along with both internal and external factors.

Functional medicine is a whole-system medicine; a GPS system that connects the the patient to the whole story of medical science by looking for and addressing upstream causes of downstream disease processes before they become debilitating or life threatening. Combining everything that works increases the likelihood of optimal patient outcomes at a lower cost to the system and the individual.

No American wants to be without conventional medicine’s crisis intervention in acute, life threatening situations but it shouldn’t be the only choice for chronic health problems that are managed best by an integrative approach.

The media needs to question conventional medicine’s obsession with the risk of taking supplements rather than with the value supplements provide to the knowledgeable consumer. Today, 50,000 Americans have no insurance to pay for U.S. health care, which is the most expensive and fragmented health care in the world. People need access to diverse, not restricted, health care options.

High tech medicine is only about 100 years old. Compare that to other cultures which have thousands of years of historical controls involving the use of diet, plants, and herbs to ameliorate health problems. Conventional U.S. “standard of care” health care is not the repository of all wisdom. For the media to allow itself to be used in the scheme to eventually deny the public access to safe and affordable supplements is a blow to wellness care and freedom of choice.

You Did It!!!!!

Citizens for Health supporters made grassroots history last week by joining forces to amass over 12,000 “Withdraw the NDI Petition” signatures in 10 days! Here is a Thank You video tweaked by Australian truth rapper-activist, Jody Lloyd (aka “Trillion”):

Since over 12,000 of you made a commitment to health freedom and Citizens for Health (CFH) by signing your name to this critical petition to stop this FDA over-reach (!!!), we at CFH (Jim Turner and James Gormley) honored that commitment this past Friday by meeting with top aides from 11 key U.S. House of Representatives and U.S. Senate offices, where we dropped off the petition along with the 12,686 signatures from all of you!

While we received the warmest reception at the offices of Congressman Darrell Issa (CA) and Congressman Ron Paul MD (TX) — thank you Congressmen and your aides! — we look forward to working with a number of Congressional movers-and-shakers to push for a withdrawal of this misguided Guidance.

We at CFH have been calling for the withdrawal of this Guidance since September 13th, and we are pleased that the health-food industry associations are now calling for the Guidance withdrawal as well.

With signatures now approaching 15,000 even though the official comment period is over, we are going to continue to collect petition signatures and pass them along (in batches) to Congress and the FDA.

In the days ahead, we will be following up with the 11 legislators whose offices we visited in order to ask for their support in calling on the FDA to withdraw the Guidance and to hold a public hearing if it is not immediately withdrawn.

You can rest assured that your having made history with this petition will not be forgotten, and we use the power of your signatures, and your commitment, to achieve continued consumer health-freedom victories!

10,000 Americans Tell FDA: Withdraw the “NDI Draft Guidance”!!

By James J. Gormley

WE DID IT!

WASHINGTON, DC – On December 2nd, representatives from Citizens for Health (a non-profit health advocacy group with over 100,000 supporters) will deliver a petition to The United States House of Representatives, The United States Senate, the U.S. Food and Drug Administration (FDA) and President Barack Obama signed by 10,320 Americans, calling for the FDA’s outrageously anti-supplement and anti-consumer NDI Draft Guidance to be summarily withdrawn.

This history-making petition drive, one which generated well over 10,000 signatures in under 10 days, received support and inspiration from many sources, including New Zealand truth rapper and activist Jody Lloyd, aka “Trillion,” whose re-mastering of CFH’s “10,000 Signatures” video for YouTube helped inspire and activate thousands of health-freedom-conscious Americans to “Sign the Petition” (watch the video here: http://youtu.be/3knIwX09d9Y).

In July the FDA issued its “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” (what is called the “NDI Draft Guidance”). The agency issued the guidance purportedly to clarify requirements for filing new dietary ingredient (NDI) submissions.

However, the FDA is going way beyond simply clarifying existing requirements. It is attempting to drastically change existing law by saying that finished product manufacturers must make a submission for every product that contains an NDI or whenever a formula is changed, if an NDI is present. If this guidance is not withdrawn and its misinterpretation of law is backed by the FDA’s own policy, review and enforcement powers, it would cause major disruption in the dietary supplement market; force a significant number of products off the shelves; and, say estimates from Emory University, result in revenue losses of over a billion dollars and the unemployment of over 100,000 Americans.

Neither American consumers nor the dietary supplement industry will stand for this unconscionable attempt by the FDA to, via various NDI-related side doors, effectively re-write DSHEA, maim the health-food industry and drastically reduce consumer choice.

That is why Citizens for Health supporters are calling on Congress and the President to demand that the FDA summarily withdraws the NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in its Guidance document but, instead, will honor the law that the American people gave to the FDA (via Congress) to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.

Citizens for Health and its army of supporters were aided by, and would like to thank, many liberty-loving people and organizations, including (but not limited to): Suzanne Somers (Actress); Michael Schoor and William Schoor (Essential Formulas); Bob Barrows, Jr. (Bluebonnet Nutrition); Charles Brown (Consumers for Dental Choice); Dr. Betty Martini (Mission Possible World Health International); Alliance for Natural Health; Living Naturally; Gary Null; “The Power Hour With Joyce Riley”; “Tunies Friday Health Line Show”; Michael Ostrolenk (The Liberty Coalition and Campaign for Liberty); Bill Sardi; Martie Whittekin (Healthy By Nature radio show); Wayne Gorsek; and Mary F. Christopher.

 To read the petition go to: http://tinyurl.com/ndi-petition.

END – ###

About Citizens for Health: Citizens for Health, one of the nation’s oldest and most respected consumer action groups. Citizens for Health is a non-profit organization that provides over 100,000 supporters with consumer news, action alerts, and ways to demand access to healthy food, non-toxic products, and truthful, non-misleading health information.  More information is available at www.citizens.org.

Media May Kill Vitamins

Submitted as a guest editorial by Suzanne Jenkins, November 20, 2011

What happened to the media that investigates and reports both sides of the story? The practice of denigrating dietary supplements and raising public concern over “safety” has been elevated to an art form by the media. Sound bites and articles with such titles as, “Vitamins May Kill Elderly Americans,” ignore the number of documented deaths caused by prescription drugs. Without both sides of the story, media is playing with half a deck – when this happens in oppressed countries, we call it propaganda.

The current rant over the safety of dietary supplements is really not about safety. Lack of “safety” is being touted as the main reason supplements are under siege. However, ignored by the media is the Adverse Events Reporting System (AERS) of the Food and Drug Administration (FDA), which contains over 4 million adverse events reported from 1969 to the present for FDA approved drugs. From 2000 to 2009, the FDA AERS received 370,056 reports of deaths and 2,345,066 reports of serious patient outcomes from FDA approved drugs, NOT from dietary supplements. Eleven years ago on July 26, 2000, the Journal of the American Medical Association (JAMA) reported that behind heart disease and cancer, ­­­­American medicine was the 3rd leading cause of death.

The study inspiring the media to create confusion, “Dietary Supplements and Mortality Rate in Older Women: The Iowa Women’s Health Study,” was observational and not the double-blind placebo gold standard with controls on every test component. Doctors and scientists know that an observational study based on a self-reporting questionnaire does not prove cause and effect – but the reader wouldn’t know that from a flamboyant title that indicates sensationalism is more important than substance. Studies like these look for clues that should then lead to further research. They are not designed to be used to guide clinical medicine or public health recommendations.

The value of using dietary supplements to improve the health of the elderly, as well as the health of other sectors of the population, has been confirmed in published studies. The Lewin Group is a health care consulting firm that does policy research and data analysis on Medicare, etc. In their study, “A Study of the Cost Effects of Daily Multivitamins on Older Adults,” the Lewin Group summarized that “given the available evidence, we conclude that daily multivitamins can be beneficial for older adults. Because suboptimal nutrient intake has been linked to chronic disease, the risk from not taking a multivitamin outweighs the minimal risks of taking one.”

Various think tanks have determined that a significant number of older Americans are deficient in vitamins and trace elements and could benefit from taking a multivitamin. A study entitled, “Effect of Selected Dietary Supplements on Health Care Reduction,” commissioned by the Dietary Supplement Education Alliance and updated in 2007, found that taking four specific supplements could reduce health care cost by over $24 billion.

Reviews supporting the use of nutritional supplements have appeared in both JAMA and The New England Journal of Medicine. Some people, due to age, genetic predisposition, environmental insult, lifestyle choices, disability, or disease, have a heightened requirement for dietary supplements.

Media cannot fulfill its obligation to the public when the only source of information considered originates from government, corporations that represent conventional medicine, or sectors that serve both. Media shapes public opinion about dietary supplements with information coming from entities representing only the conventional standard of care model. The Feds, pharmaceutical industry, and media make interesting bedfellows. What we have is mainstream corporate journalism devoted to official positions.

The purpose of thorough and unbiased investigational reporting is to empower the public to deal intelligently with information.  Besides knowing where and when a medical study took place, reporters need to ask critical questions and provide the people they serve with answers to the following:

  • Who funded the study?
  • What was the original purpose of the study?
  • What substances were tested (types and dosages)?
  • Did the research involve combinations of nutrients?
  • Was the research on isolated components only?
  • In the case of hormones, were they synthetic or compounded bio-identical hormones?
  • What type of study was it (observational or double-blind placebo)?
  • What was the outcome of the study?
  • Whose health stands to benefit from the outcome?
  • Who stands to profit monetarily from the outcome?
  • Were physician/researchers from ACAM (American College for   Advancement in Medicine) or other scientists without financial ties asked to comment on the study?

To connect the dots, the media has to recognize itself as a significant part of the health care problem in the U.S. Since the media shapes public opinion, special interest groups will continue to use the media to discredit dietary supplements and ultimately make them ineffective or unavailable to the public in the over-the-counter manner we enjoy now. Does the media want conventional medicine, with its heavy reliance on expensive physician-dispensed prescription drugs, to be the only game in town? Media must not offer a Trojan horse to a public that relies on it to be impartial and knowledgeable enough to report both sides of the story.

10,000 Signatures in 10 Days; We Can Do It!

By James J. Gormley

With Citizens for Health supporters already having generated over 11,000 letters to Congress demanding that the FDA’s NDI (New Dietary Ingredient) Draft Guidance be withdrawn, the organization is now on a mission to collect 10,000 petition signatures in 10 days calling for Congress to withhold FDA appropriations until this unaccountable agency is held to account: by adjuring the FDA to withdraw the supplement-killing NDI Guidance and to cease and desist from reviewing and enforcing against dietary supplements and nutritional ingredients according to its willfully adversarial re-interpretation of the laws governing dietary supplements.

To help us in this effort, Australian truth rapper and activist Jody Lloyd, aka Trillion, has re-mastered CFH’s “10,000 Signatures” video to make our call-to-arms that much more impactful!

Please sign the petition today and send out the link (and video!) to all of your contacts, friends and family, work colleagues, in short, everyone in your personal universe who cares about their rights to high-quality, innovative dietary supplements!

CFH Submits Its NDI Comments to the FDA

Click here to submit yours now!

October 6, 2011

Division of Dockets Management
(HFA-305)
U.S. Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852

Re: Docket No. FDA-2011-D-0376, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”

Dear Commissioner Hamburg:

Citizens for Health (CFH) is hereby submitting its organizational comments on the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”

CFH and its over 100,000 supporters call on your Agency to summarily withdraw this Draft Guidance and go on the record stating that the FDA will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in this document but, instead, will honor the law that the American people gave to your Agency to uphold via regulation according to both the spirit and letter of DSHEA.

BACKGROUND

According to a July 7, 2011 report from your Agency, Pathway to Global Product Safety and Quality, government spending on healthcare has been on the rise since at least 1990 in the world’s leading economies.

U.S. Medicare spending is projected to reach $900 billion by 2018, partly a factor of the fact that the Medicare population has been, and is expected to continue, growing at four times the rate of the “employed” population between 2000 and 2025. Public hospital expenditures alone are predicted to reach over $1 trillion by 2015.

With this as a backdrop, we are certain that your Agency is aware of the study entitled, “Effect of Selected Dietary Supplements on Health Care Reduction” that was commissioned by the Dietary Supplement Education Alliance (DSEA) and updated in 2007, which found that only four specific supplements, alone – calcium with vitamin D (bone health); folic acid (neural tube defects); omega-3 fats (heart health); and lutein with zeaxanthin (eye health) – could reduce healthcare costs by over $24 billion.

These are only direct cost savings, and savings directly related to them, however. If we were able to add all indirect costs and downstream cost-of-care burden projections to these data, and if we were able to assess savings from other critical dietary supplements such as CoQ10, multivitamins, brain health ingredients (such as Huperzine A), liver health nutrients (such as milk thistle and Picrorhiza kurroa), joint health nutrients (such as biologically active silicon), and so on – it is likely that the ultimate healthcare savings to Americans and to society would be … staggering.

THIS GUIDANCE DOCUMENT

Therefore, it is mystifying to us, and to many others, why your Agency would endeavor, 17 years after the passage of DSHEA, to re-interpret the laws governing dietary supplements as evident in this Draft Guidance.

It is likewise baffling as to why your Agency would, as evident in the regulatory and policy viewpoints underpinning this guidance, seek to use wholly new interpretations of “what is a dietary supplement ingredient,” “what is a dietary supplement,” and “what is a new dietary ingredient,” for example, as bases for what is obvious is your new and intended supplement and ingredient review and enforcement position.

Your Agency is attempting to drastically change the law by saying that finished product manufacturers must submit an NDI for every product that contains an NDI or whenever a formula is changed, if an NDI is present.

Your Agency is in disregard of the law, Section 413 [21 USC §350b] of DSHEA, which says an NDI submission is not required if “there is a history of use or other evidence of safety” supporting its inclusion, use and marketing prior to 1994. Instead, your Agency is proposing that NDI submissions be product-specific rather than ingredient-specific, which contravenes the spirit and the letter of the law.

For your Agency to assert that newer technologies and improved processing and extraction methods would render ingredients as NDIs since these methods were not known prior to 1994 is akin to saying that meat-packing plants should observe the filthy and unhygienic practices that led to today’s modern food-safety system because these antiquated methods were approved then and these new processes are different.

Review and enforcement based on the re-interpretation of DSHEA expressed in the guidance would be expected to cause major disruption in the dietary supplement market, forcing a significant number of products off the market, resulting, according to estimates by a leading economist cited by another commenter, in revenue losses of over $1 billion dollars and causing the unemployment of over 100,000 Americans.

In the area of innovation, the direct result of policies behind this guidance would come from “dumbed down” formulations that exclude innovative natural ingredients that will have received objection notices from your Agency.

The American people would be harmed by the market and access implications within this document.

The harm would come from whole swaths of products and categories (such as probiotics) being eliminated by responsible supplement companies that cannot afford the hundreds of thousands, or even millions, of dollars that would be required in order to perform toxicology tests and to develop safety dossiers on ingredients that are already known to be safe. The harm would come from companies reverting their supplement formulations to antiquated processing and ingredient compositions that were in place prior to 1994. The harm would come from reduced consumer health in America as innovative, high-quality dietary supplements are removed from shelves or never see the light of day.

Your Agency’s attempt to create new regulatory requirements using a guidance document is in violation of the Administrative Procedure Act (APA), and therefore the agency is in violation of the law on the basis of this alone.

CONCLUSION

Neither American consumers nor the dietary supplement industry are going to stand for this unconscionable attempt by your Agency to, via various NDI-related side doors, effectively re-write DSHEA, maim the health-food industry and drastically reduce consumer choice.

We call on your Agency to summarily withdraw this Draft Guidance and go on the record stating that the FDA will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in this document but, instead, will honor the law that the American people gave to your Agency to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.

Sincerely,

James S. Turner, Esq.
Chair
Citizens for Health
jim@swankin-turner.com

James J. Gormley
Vice President and Sr. Policy Advisor
Citizens for Health
jamesgormley01@gmail.com