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You Did It Again! Dump the FDA’s NDI Draft Guidance

By James J. Gormley

You made it clear that 10,000 petition signatures in 10 days was only the beginning salvo in American consumers’ call for Congress to demand that the FDA withdraw the misbegotten, supplement-industry- and innovation-killing NDI Draft Guidance. Partly thanks to a stirring video re-mastered by Australian truth rapper Jody Lloyd, aka Trillion, over 12,000 of you signed the petition that we delivered to Congress, the White House and the FDA.

Our next goal was 25,000 signatures by February 25th, and for this truth rapper Trillion came to our aid once again. Thanks to all of you, we met this goal as well.

But, we’re not just setting goals and trying to reach them as some exercise in advocacy; we hand-delivered the first 12,686 signatures to 11 key legislators on Capitol Hill. As a direct result of those meetings we had in Washington on December 2, 2011, Congressman Ron Paul (R-Texas) sent out a letter to his entire Congressional District outlining the dangers of the NDI Draft Guidance and how this outrageous document represents the very worst of Big Government, over-regulation and of an agency run amuck.

We are going to deliver the next batch of 12,000+ signatures soon, and you know that it is getting serious attention in Washington DC. And the more the petition grows in signatures, the stronger will be the mandate from the American people that this NDI Draft Guidance must not stand!

If you have not already signed it, please do so now and pass along to everyone you know…..your e-mail contacts, your Facebook friends, your Google+ circles, your Twitter followers, your church, temple or synagogue congregation, your town or city council—you name it!

NDI Groundhog Day: Let’s Start a New Day!

By James J. Gormley

25 by 25: 25,000 Signatures by February 25!!

Do you feel like we are all living in some sort of reality that keeps repeating a day until we get it right, as Bill Murray’s character, Phil, learned in the 1993 movie, Groundhog Day?

Well, in this case the FDA is Phil and it needs to learn a lesson here. Please sign the petition!

Talking about lessons, in November, Citizens for Health (CFH) supporters made grassroots history by joining forces to amass over 12,000 “Withdraw the NDI Petition” signatures in 10 days!

Representatives from CFH (Jim Turner and James Gormley) honored that commitment on December 2nd 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 many 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. [You can sign the petition here]

In fact, two of the three original authors of the law that protects our supplement rights, Senator Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) met with the U.S. Food and Drug Administration (FDA) a few weeks ago, but  their request that the Guidance be withdrawn was denied.

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 CFH’s petition campaign signatures now approaching  19,000 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. You can sign the petition here to help us reach 25 by 25!

In the weeks ahead, we will be following up again with the 11 legislators whose offices we visited in order to ask for their support in calling on the FDA to summarily 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!

Our new goal is 25 by 25, or 25,000 signatures by February 25, and with your help we can reach it! Sign it today to make history … again!

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Sign the Petition Supporting a Healthier Workplace!

Dear Citizen for Health,

As the Consumer Voice of the Natural Health Community we are committed to preserving and expanding your health freedoms and ensuring that you have access to the resources you need to make informed decisions about maintaining your health and wellness.

It is from that perspective that we bring to your attention this article: The Case for a Four-Day Work Week, by respected technology entrepreneur, Jay Love, based on his personal experience with his company. Hardly a new idea, the “work four 10-hour days with Friday off” model has been implemented in a variety of workplace environments with overwhelmingly positive results.

Workplace stress and dissatisfaction drops while productivity soars; employees have the opportunity each week to deal with domestic responsibilities that couldn’t be addressed during a non-business day; one day less to commute means money and energy saved; and people have three days to spend in the company of family, making it easier to schedule meaningful activities as a group.

Naturally, all these benefits contribute to a happier, more balanced lifestyle and greater overall health.

We at CFH put on our thinking caps and Senior Policy Advisor James Gormley took the idea one step further: “But getting home after dinner and as the children are being put to bed on four days does not compensate for one free day…It should be a 32-hour work-week…It’s all about being rested, having time for family, feeling appreciated, and achieving better work-life balance. A four-day 9-5 (or 10-6) schedule with Friday off would revolutionize the American workplace.”

Indeed it would! That’s why we created a petition to both Congressional Committees on Health Labor and Pensions suggesting a feasibility study by the U.S. Governmental Accountability Office (GAO). We’re urging that the GAO, in consultation with the U.S. Department of Labor, work to ascertain the  benefits to American workers that would result from officially creating an alternative definition of the U.S. work week based on four  days and 32 hours – 8 hours a day with time for lunch – in addition to the  current 40-hour, five-day definition.

If you agree with the available data and believe that everyone would benefit from more time with family, more time to tackle personal responsibilities, and more time to rest and rejuvenate for the week ahead, sign our petition now! 

Sincerely,

Frank Herd, Program Coordinator, CFH

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.

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.

Sign the Petition! Time to Knock It Out of the Park!

By James J. Gormley

After a brief technical snafu, our PETITION is once again operational…….our apologies to all who tried to add their name but could not since midnight. But it is working again, so please try again to sign if you tried last night!!

CLICK HERE to add your name to the petition!

WE NOW BROKE 9,OOOPETITION SIGNATURES!!!  We’re now at 9,808 signatures!!

A few days ago it seemed like a far-fetched, impossible goal: 10,000 petition signatures in 10 days! What organization could possibly do that!? Well, Citizens for Health supporters are on the road to doing JUST that!

For those who have asked, here is additional information as to WHY this New Dietary Ingredients (NDI) Draft Guidance is so bad.

As of this writing, 1:51 PM EST on November 30th we have 9,808 signatures and counting!! Thank you to all who signed the petition!!!

That being said, we’re at 98% of our goal and we have  ONE AND ONE-HALF DAYS LEFT to make history.

Click here to add your name!

We need to take it to the streets. To our e-mail address books. To our Facebook friends. To our LinkedIn connections. To our Twitter followers as well!

So…………to make that even easier, here is the link to “SIGN THE PETITION.”

…and here is the link to the video.

Now is the time for righteous indignation, so let’s express that indignation by sending in a massive boatload of petition signatures this week!

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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!

Petition Demanding that the FDA Withdraws the NDI Draft Guidance!!

We call on Congress 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.

That’s why we created a petition to The United States House of Representatives, The United States Senate and President Barack Obama, which says:

“I hereby join with Citizens for Health (CFH) and its over 100,000 citizen supporters in calling on Congress to withhold funding appropriations for the FDA until the agency summarily withdraws its 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 the NDI Draft Guidance, but, instead, will honor the law that the American people gave to that agency to uphold via regulation according to both the spirit and letter of DSHEA.”

Will you sign this petition? Click below:

Sign the petition now!

Thanks!

A Defining Moment for the Dietary Supplement Industry

By James J. Gormley

The Federal Register states that the New Dietary Ingredient (NDI) Draft Guidance, “when finalized, will represent  the Agency’s current thinking on NDIs and dietary supplements that contain NDIs.”

Although this same notice observes that the Guidance is not binding, the U.S. Food and Drug Administration’s (FDA) new dietary supplements’ director and erstwhile industry representative, Daniel Fabricant, PhD, made it clear that the FDA believes that the guidance contains “no surprises” (It, in fact, contains many) and merely provides “clarity” (Yes and no: it makes it clear that the FDA is willfully re-interpreting DSHEA is several key areas but is fuzzy on specifics).

And while Dr. Fabricant and his new employer may persist in believing that the Guidance contains no rabbits pulled out of a proverbial hat, a chief architect and co-author of DSHEA, Sen. Orrin Hatch (R-Utah) is alarmed by the Guidance.

Recently, at least one industry opinion leader has suggested that playing nice with the FDA on the Guidance would be the way out of the NDI quagmire since the FDA supposedly has such a stellar track record of working collaboratively with industry.

Nothing could be further from the truth. Every major victory won by the natural products industry has been always bloody, sometimes ugly and never cordial.

War seldom is.

In 1966, the FDA announced plans that it was going to ban nutrient potencis over the RDAs by reclassifying them as drugs, along with labeling restrictions that would have forbidden the inclusion of any useful information about supplements.

When this, the health-food industry’s, first defining conflict was waged in the late 1960s and 1970s, the battle cry that the great, and recently departed, Max Huberman rallied the industry and consumers around was, “No surrender!  No retreat!”

The battle cry was not “Let’s play nice,” of that I can assure you.

In the early 1990s, when the industry and consumers were fed up with FDA raids on health-food stores and efforts by the agency to use food additive provisions of existing law to go after supplements and companies for which the agency bore a deep-seated animus, a dramatic response was needed, an aggressive, coordinated grassroots action was with what consumers and the industry fought back: black, funereal fabric was used to cover dietary supplements in health food stores, a major public service announcement was aired and millions of Americans demanded the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

And we won.

Offering  an olive branch to the FDA at the time would have led to the destruction or gutting of the dietary supplements industry before many of us were even a part of it.

So for our industry to offer concessions on the Guidance while the battle has just begun is diametrically opposed to what the greatest debaters have known since the time of Cicero: being unattached to the outcome. Master negotiator Herb Cohen said this often: “I care, I really do … but not that much.”

Modern-day Cicero, Jeff Schneider explains this to mean that whichever party has the greater need to get the deal done is the party that is at a competitive disadvantage. He says that the moment we start making concessions prematurely is the moment we lose our leverage.

“It is unwise to assume that the person [or Agency] you are negotiating with maintains the same commitment to Win-Win outcomes that you have,” writes Schneider. He advises negotiators to “establish your line in the sand. […] You must vow not to cross the established line in the sand for any reason.”

Do those industry experts and pundits applauding accomodationist approaches to the NDI Draft Guidance know that the FDA is not our industry’s friend, and that the agency bears an institutional resentment (some might say hatred) against our marketplace and its products and has shown this since the 1960s with raids, illegal wiretaps, improper seizures and a boatload of adversarial rulings and decisions?

Do those self-appointed savants know that the legal duty of any agency is to solely regulate and enforce according to the law given to it by the American people through Congress, and agencies do not have the power to devise policy and are not allowed to issue regulations or enforce one millimeter outside of the express letter of the law?

They should.

When any agency, in this case the FDA, violates the law by re-interpreting the plain and intended letter and meaning of it, in this case DSHEA, it must be called on it.

We must not stand for side-door efforts to cripple or maim our industry, and we have no obligation to give one inch on this, especially when dealing with an out-of-control agency that is, through stated intent, itself violating the law with which it was entrusted by the American people to uphold.

For those who have not yet taken action on the issue, there are only about 20 days left to so, given the current deadline of December 2nd. Please write to Congress here (http://salsa.democracyinaction.org/o/750/p/dia/action/public/?action_KEY=8252) and to FDA Dockets here (https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=833),
and circulate these links via all of your consumer, customer and retailer lists.

Let no one in our industry fall victim to the romance of “having a seat at the table” as a representative of the regulated industry.

Because that plate in front of them might well be empty.

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