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Live Feed of Health Coach Conference

Sample a ClassCitizens for Health has partnered with the Institute for Integrative Nutrition because we have seen the impact of their Health Coach curriculum and how it can empower you to transform your health and happiness and launch a fulfilling new career. Click on the banner to the left to learn more.

Get an exclusive look at the The Institute for Integrative Nutrition® annual conference!

On March 5th and 6th, you’ll have the opportunity to learn from the world’s most influential experts in health and wellness during IIN’s annual conference. They’re opening up exclusive access to their live stream to give you a sneak peek into this incredible weekend. Register now to gain access and witness the transformation made possible through their Health Coach program. It is absolutely free, and it is the only way you can eavesdrop on this powerful event.

The Details:

  • What: Access to an exclusive LIVE STREAM of the annual conference!
  • When: Saturday, March 5th and Sunday, March 6th from 10am – 12pm ET.
  • Where: Anywhere! Use your computer or mobile device – All you need is internet access!
  • Who should attend: Everyone who wants to experience the amazing energy of an Integrative Nutrition live event and sneak a peek at student life! It is specifically recommended for anyone considering becoming a Health Coach. IIN has created a special page and video for CFH supporters – just click on the banner to the left.
  • Note: There will not be a replay. So be sure to register now and mark your calendar!

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.

Dieticians and Efforts to Monopolize Nutrition

By James J. Gormley

There are many healthcare professionals who provide dietary advice.  One subset is “Registered Dietitians” or RDs, a private credential offered by the private trade association, the Academy of Nutrition and Dietetics (AND), formerly known as the American Dietetic Association, or ADA.

RDs typically provide government-sanctioned dietary advice, such as the USDA dietary guidelines.  There is a large other set of professionals – fully 2/3 of the nutrition community!– more commonly referred to as “nutritionists” who typically take a very different approach to dietary advice (not constrained by government-imposed guidelines), and there are many other professionals who use nutrition as part of their practice.

Despite an urgent need for more nutrition therapy and advice (not less), nutritionists claim that the dietician lobby has engaged in a campaign to monopolize nutrition advice through regulatory capture, specifically state nutrition licensing laws and federal regulations.

Regulatory capture of health professions is nothing new.  But this attempt is said by nutritionists to be particularly egregious, because the ‘scope’ of the so-called ‘dietetics and nutrition’ profession is not a set of competencies unique to a particular health care provider (like an MD or a nurse).

It does not involve substances that the law otherwise forbids the public to use (such as a medical license permitting the prescription of pharmaceuticals).  This is the purveying of advice with regard to a substance freely available to all and consumed every day: food.

The dietician lobby seeks to not just prevent laypeople from providing dietary advice, but non-RD health professionals as well!  The crux of the problem is this:

Unlike many health professions, “nutrition advice” is not a single profession, but is a tool-set legitimately used by many professionals (and the public).  Those professionals include dietitians, nutritionists, medical doctors, chiropractors, naturopaths, acupuncturists, health coaches, and many more.  Thus, it is much more difficult to reduce nutrition to a uniform regulatory scheme than it is for a discrete profession, such as nursing, for instance.  It is like trying to license “exercise advice” – which is a tool used by many professions, not the domain of a single profession.

The dietician licensing bills make it a crime for those who give nutrition advice without a license. These laws prevent the vast majority of non-RDs from providing nutrition advice and artificially constrain the number of nutrition advisers and practitioners.  In over half of states in the U.S. these one-sided licensure laws have passed, and entire segments of nutrition practitioners – such as naturopaths, nutritionists, herbalists and many others – are often barred from providing advice.

The sole beneficiaries of the dieticians’ drive for monopoly are its Registered Dietitians.  And they are by no means the most highly qualified. The RD credential requires a bachelor’s degree, while several other nutrition credentials require a Masters or Doctoral level.  What the dietician lobby does have is far greater financial resources.

According to the American Nutrition Association (ANA), the dietician lobby is acting as legislator, executive, judge, and jury:

1. It has attempted to insinuate itself into federal regulations, so that only members of its professional trade group are permitted to be reimbursed for nutrition counseling.

2. It has been fairly successful at getting state laws passed, substantially similar to North Carolina’s, that criminalize the provision of nutrition advice.  This at a time when their own data show a shortage of nutrition professionals relative to the demand

3. Those dietician-friendly state laws enshrine Registered Dietitians as the dominant force on each of these state licensing boards.

4. The state licensing boards play a large role in determining who can and cannot obtain a license, first by drafting ‘rules’ that spell out the details of licensure requirements (which mimic the dietician group’s requirements), and second by being the gatekeeper for applicants for licensure.

5. The association then encourages its members to file complaints with the state licensing boards

Then the Registered Dietitians in the state, encouraged explicitly by the dietician lobby to police the field, report unlicensed practitioners to the state’s licensing board, which are referred for prosecution.

6. Hearings and settlements during the course of such prosecutions are conducted by or in close contact with the particular licensing board.

Progress in Illinois

While Current Illinois law has been a near-monopoly for dietitians, we’re pleased to announce that the American Nutrition Association’s bill to open up access to nutrition practitioners is up for a vote, likely by tomorrow morning, November 29th. If you are in Illinois or have a family member, friend or colleague in the state, we urge you to pass along the this link asap!

The ANA has approval of the bill sponsor, Sen. Iris Martinez, many other legislators, and the Illinois Department of Professional Regulation, on an amended bill that would:

–Change current law from an RD-only law, to one that permits a wider variety of nutrition education and allows other nutrition exams and credentials (the CNS, CCN, and DACBN).

–Strengthen exemptions protecting acupuncturists, health food stores and other businesses and employees who respond to consumer questions regarding nutrition and dietary supplement information.

According to the ANA, “This bill doesn’t correct every provision of current law we sought to change. However, the significance of rolling back a monopolistic RD practice law to one which includes other nutritionists and exemptions, is immense.”

Ending a dietetics monopoly and ensuring protection for a diverse range of nutrition care providers for Americans is underway. This is a huge step in the process, and we at Citizens for Health look forward to working with all of you to roll back these nutrition monopolies in other states.

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!

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!

NHRI Chicago Symposium Heralds A New Era for Dietary Supplements

By James J. Gormley

The ballroom was packed at the Natural Health  Research Institute (NHRI) 6th Annual Scientific Symposium in Schaumburg, Illinois on October 28th, as well it should have been not only considering the event title, which was “Cutting Healthcare Costs Through Prevention: Measuring the Efficacy, Safety, and Cost Savings of Dietary Supplements,” but also given the stellar lineup of world-class experts.

The speakers were:
Meg Jordan, PhD, RN, Department Chair and Professor of Integrative Health Studies at the California Institute of Integral Studies, and Director of Integrative Practice at the Health Medicine Institute;
Mark Blumenthal, Founder and Executive Director of the American Botanical Council (ABC) and Founding Member of the American Herbal Products Association (AHPA)
Allen Dobson, PhD, Health Economist and President of Dobson DaVanzo and Associates;
Artemis Simopoulos, MD, Founder and President of the Center for Genetics, Nutrition and Health; and
Russell Jaffe, MD, PhD, Fellow of the Health Studies Collegium and Founder of PERQUE.

Dr. Jordan, whose presentation was entitled “Let Sanity Reign: The Undeniable Health-Wealth Connection for a Happier, Healthier Society,” electrified the audience with what could have been an indictment of how unhealthy the U.S. is but, instead, pointed the ways we can build a well-being society that takes into account: spirituality, nutrition-food, physical health, social belonging, intimacy and love, financial well-being and occupation-livelihood.

Mark Blumenthal’s talk was entitled: “Review of Safety and Benefits of Numerous Herns and Phytomedicinal Dietary Supplements as Demonstrated by Systematic Reviews and Meta-Analyses of Controlled Clinical Trials.” Mr. Blumenthal stunned many attendees with the statement that over a 3-year period, the annual number of herbal medicine papers rose from 739 in 1977 to 6,364 in 2007, most of which were scientific reviews and randomized controlled trials. He compared thenumber of studies with the imbalanced, typicaly negative coverage of herbal studies by the mainstream press, especially noticeable in journals that have the highest ratio of pharmaceutical ads, and reviewed the worldwide research on a wide range of medicinal plants.

Dr. Dobson’s presentation, “Discussion of Methods Used to Study the Reduction in Health Care Cost Through Dietary Supplements,” reviewed the billions of dollars in healthcare savings that could be achieved by widespread public-health promotion of a number of nutrients (including: calcium with vitamin D; folic acid; omega-3 fats; and lutein with zeaxanthin). Of great interest to many in attendance, he punched a number of holes in the recent multivitamin and vitamin E studies that have achieved such infamy.

Dr. Simopoulos’ talk was entitled: “Economic and Health Implications of Changing America’s Oil: The Omega-3 Opportunity.” She outlines the many downsides of the dramatic decrease in omega-3 fat consumption over the past 150 years due to agribusiness and food processing and the reasons why it is utterly imperative that we, as a society, significantly increase our consumption of omega-3 fats and decrease our intake of omega-6 fats.

Dr. Jaffe closed out the presentations with a talk entitled, “Evidence of Savings Through Application of Supplements to Treat Dietary Deficiencies.” He explained how by our correcting essential nutrient deficits relating to diabetes alone could save $135 billion each year, and that supplements for other health areas can save America an additional $50-100 billion annually, all while improving quality of life.

With the event having been organized by the NHRI and the American Nutrition Association, 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 efficacy and cost-effectiveness of diet, supplements and a healthy lifestyle in order to improve health and wellness, and reduce disease, around the world.”

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

FDA Must Withdraw NDI Guidance or Extend Comment Period to July 2012

By James J. Gormley

In our August 23rd post, we alerted you to a U.S. Food and Drug Administration (FDA) draft guidance on “new” dietary ingredients. We recommended that our 100,000+ members ask the FDA to withdraw the guidance and to not adopt the policies underpinning the interpretation behind this “guidance” in its review and enforcement activities.

In the meantime, Attorney P. Scott Polisky and Susan Brienza — on behalf of Jarrow Formulas, many members of the natural products industry and consumers who value innovation in their dietary supplements — are asking the FDA to at least extend the comment period for this guidance until July 5th, 2012.

Short of an immediate withdrawal of the guidance, Citizens for Health agrees with Attorney P. Scott Polisky and also with Hyman, Phelps and McNamara, which, in its July 26, 2011 request letter, said that “a one-year comment period is further justified given that there is no apparent and certainly no urgent public health need for a shorter period.”

Indeed, the draft guidance itself ignores the stellar record of supplement safety (vis-à-vis drugs and other FDA-regulated products).

As shown in FDA’s response to a 2006 Freedom of Information Act Request (FOIA) by JFI, in stark contrast to the more than 400,000 annual Adverse Event Reports (AERs) for drugs, there were only 129 non-Ephedra serious AERs for supplements in over 12 years — and six deaths that the FDA, in its 2006 response, found to be “biologically plausible” but not caused by the supplements.

Clearly, as many have noted, dietary supplements are safer than tap water, table salt, aspirin and even food, and it is unlikely that the newly proposed guidelines will make them any safer. Finally, when needed, the FDA has numerous regulatory and enforcement mechanisms (supplement GMPs, import alerts, Physicians Advisories, inspections, mandatory MedWatch reports for serious AERs, etc.) with which to monitor and ensure supplement safety.

Let’s ask the FDA to withdraw the guidance and to assure American consumers that it will not be heading down the road of trying to re-classify hundreds, if not thousands, of safe, historically used ingredients as “new dietary ingredients,” as this could serve as a fatal blow to the dietary supplement industry, especially those companies which feature innovative processes and formulations!

In the meantime, we can buy time by asking them to extend the comment period to July 2012.

Preventing The Swine Flu: A Comprehensive Approach

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Sneezing, coughing, fever, aches and pains…

Worried about flu symptoms like these? As winter approaches, most of us are.

But this year, the flu seems even more alarming, thanks to increased health concerns about the H1N1 influenza strain, also known as the swine flu. Even though this strain doesn’t appear to be particularly threatening, it has the potential to mutate into a more dangerous form.

The main question my patients have been asking is whether they should get vaccinated against H1N1 or against the regular flu.

This is not a simple yes or no answer. The guiding principle of functional medicine is personalized care, not the one-size-fits-all belief that everyone should have the same treatment. This applies equally to vaccines. There is risk and benefit to every medical treatment or procedure.

That is why in today’s blog I want to review what you need to consider if you are thinking about vaccination, discuss some of the risks involved, and provide you with a comprehensive 7-step plan for preventing swine flu and staying healthy all winter long.

Should You Get Vaccinated?

The choice to get vaccinated is an individual one. Selective vaccination may be helpful for some groups of people–but not everyone. Here are the facts as I see them:

The current strain of H1N1 is a generally mild strain of the flu. It sounds scarier, but, so far, fewer people have actually died from it than from the traditional flu. It may mutate but it hasn’t yet. Pushing widespread vaccination on low-risk populations exposes them to unnecessary risks.

If the H1N1 mutates, the current vaccine may not be effective against it.

The studies on the H1N1 vaccine have been limited in the rush to market.

The 1976 swine flu vaccine was linked to a serious neurological disease called Guillain-Barré syndrome, which causes severe (but usually temporary) paralysis.

The government has agreed to protect vaccine manufacturers from any lawsuits due to side effects of the vaccine, otherwise pharmaceutical companies would not make it.