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“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!

The FDA Goes Back To The Drawing Board On NDI Draft Guidance!

Over 30,000 of you – Citizen for Health supporters, all – responded to the call to urge the FDA to revise or scrap the supplement-killing New Dietary Ingredient (NDI) Draft Guidance after we launched our multi-pronged campaign in September 2011.

Together with the outreach efforts of fellow health-freedom groups and the natural products industry, we were able to force the FDA to go back to the drawing board on the NDI Draft Guidance!

According to Natural Products INSIDER, “After close to a year of industry outcry, FDA apparently will issue a revised draft guidance on the topic of new dietary ingredients (NDIs).”

According to news reports, FDA’s Commissioner Margaret Hamburg, Deputy Commissioner Mike Taylor, and Assistant Commissioner Jeanne Ireland met with Sens. Orrin Hatch [R-UT] and Tom Harkin [D-IL] on June 19.

Word on the street is that, as a result of that meeting and the overwhelming outcry from the natural health and wellness community, the FDA will be releasing a revised draft guidance that the agency hopes will provide greater clarity and address concerns that the document is not in line with the intent of the original statute. However, industry observers do not expect a revised draft guidance will be released until after the election.

As mentioned, we began our campaign in September 2011, and shortly thereafter, on October 6th, Citizens for Health submitted its own organizational comments to the FDA in opposition to the NDI Draft Guidance.

In November, we launched a viral petition campaign accompanied by a video re-mastered by Australian truth rapper Jody Lloyd a.k.a. Trillion, electrifying American consumers and setting a new benchmark in grassroots advocacy: 10,000 petition signatures in 10 days!

In fact, over 12,000 of you initially made a commitment to health freedom and Citizens for Health (CFH) by signing your name to that critical petition to stop what would have been a dangerous extension of the FDA’s reach!!! We at CFH (Jim Turner and James Gormley) honored that commitment by meeting with top aides from 11 key U.S. House of Representatives and U.S. Senate offices, providing copies of the petition strengthned by 12,686 citizen activist signatures!

Here is a Thank You video tweaked by Trillion:

And we didn’t stop there.

Not only did you help us reach past our original goal and amass 25,000 signatures by February 25th – today we have 30,215 petition signatures calling on the FDA to do what is right.

While the FDA has to be watched very carefully as this process unfolds, it is certain that consumers successfully sent the agency a clear, irrefutable message. To borrow some jargon from the world of boxing, we made them “retreat to a neutral corner” for the time being.

While we still maintain the position that a complete withdrawal of the petition is what is needed, mothballing it and massively overhauling may hold some promise.

But only time will tell. In the meantime, you can (very briefly) sit on your high horse AND rest on your laurels! How many people get to do that?!

Stay tuned for updates as we move forward with this historic effort.

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!

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.

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!

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