CFH Submits Its NDI Comments to the FDA

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October 6, 2011

Division of Dockets Management
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Re: Docket No. FDA-2011-D-0376, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”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Citizens for Health (CFH) is hereby submitting its organizational comments on the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”

CFH and its over 100,000 supporters call on your Agency to summarily withdraw this Draft Guidance and go on the record stating that the FDA will not, now or ever, review, consider, surveil or engage in enforcement activities according to the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.


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.


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.


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.


James S. Turner, Esq.
Citizens for Health

James J. Gormley
Vice President and Sr. Policy Advisor
Citizens for Health

Comments (35)

I am a 75 year old senior citizen, living in a retirement community. I have been taking supplements prescribed by a certified nutritionist for the last 25 years, and feel infinitely better than I ever did the first 50 years of my life. I work around young people at a local college and am exposed to all kinds of “stuff” floating around, yet I am the only one in my area who is never sick. I never get “what is going around,” do not even get colds. Nor do I get flu shots, take absolutely no prescription drugs, and in a recent physical, amazed the doctor at how healthy I was without taking any prescribed medications at all. I live in a retirement community, and am the only one I know of who is not constantly beseiged with one medical problem/emergency after another, requiring more and more medications, yet never getting any better. I truly resent the intrusion you seek to make in my life in a lifestyle that is healthy and well. How dare you try to force “your” version of “healthy living” on me. I tried the medical profession’s way for the first 50 years of my life, and it did not work. Now that for the past 25 years I have found what “does” work, you have the right to take that away from me? I don’t know what gives you that right. You should be ashamed of yourselves. How many people die of prescription drug mis-use every day? How many people die of supplement overdose in a similar situation. At least make an educated, comprehensive, fair study of what you portend to “do for us.” We are more intelligent than you give us credit for. Some of us are not ignorant and/or uneducated, and know how to seek professional help that is right for us. We are Americans, last time I checked, and have the right to take care of ourselves as we deem best – not organizations that have an agenda over our lives that is questionable.

I withdraw my consent to the Gov. or any agency their of to control my choice in food, supplements, herbs & minerals etc. As I am a free soveigen human being…

I am a person who cannot take traditional ‘drugs’ for the most part. I get serious side effects from some and most drugs that are prescribed by my alleopathic doctors. For example, for most antibiotics, I get serious UTI’s. I have one kidney and, the danger for me, is high for a kidney infection. With one kidney, a kidney infection can be more serious for me than for people with two kidneys, although no one wants to get a kidney infection.

I use probiotics and other supplements to treat infections that antibiotics treat. I do this with guidance from a health care provider who is an MD, but who believes in non-drug treatment when possible.

IF probiotics and other supplements were not available OR where available through DRUG COMPANIES, then I can see either my health in great jeopardy or the products I rely on to create a healthy body being ALTERED and MODIFIED so much so that I will be HARMED greatly by the chemicalization of these natural products.

Where is a person like me supposed to go for health treatment. There NEEDS TO AND OUGHT TO BE an area of health care NOT CONTROLLED BY THE DRUG COMPANIES.

therefore, I state that leave these effective natural products UNADULTERATED and LEFT ALONE. I need these products to remain in the hands of companies who have no outside agenda other than providing a viable alternative to what the DRUG companies offer. It is IMPERATIVE for my health.


I’ve been saying that government agencies originally set up to protect the public have been corrupted, and now protect the large pharmaceutical corporations and chemical corporations that they, the agencies, are supposed to be regulating. Instead, these agencies are attempting to regulate the consumer’s right to choose out of existence, or to be strangulated by the FDA or the medical establishment… and which is both a travesty and an outrage. Someone had it right when he stated that these agencies were NEVER set up to protect the public, but were set up to regulate evil.

My son Willy Darman and I came up with a comprehensive nutritional supplement regime in 2004 that has a profound affect on depressive, ADHD, bipolar, and schizophrenic symptoms. This has resulted in my being monitored, hacked, and/or disrupted on any computer that I use for any length of time since June 2006. It has also resulted in multiple attempts on my life in the past 21 months. (See my blog on titled “The FDA Will Mandate That Mental Illness Can Not Be Cured” for more details in this regard.) Big Pharma HAS to use the FDA to take critical nutritional supplement access away from the American public… for if they do not, this industry of lies is doomed.

i’ve tried to post my comment on the site for the last 30 minutes and it keeps saying that the form is incomplete–and I promise you it is not. They just don’t want the comments.

Please post the email address for a person I can send my comments to!

Greetings, and thank you for taking the time to contact us.
I was away on vacation and just submitted my comments with no problem or delay. I got this message:
“Success! Your Comment Has Been Submitted
Comment Tracking Number: 80f51244
Thank you for submitting a comment on the following Other
Document ID: FDA-2011-D-0376-0002: Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”

We haven’t received any other messages sharing your problem.
It is with complete respect for your internet savvy and assertion nothing was incomplete that I still suggest you may have missed something.
You are, I’m sure, correct in believing they don’t want our comments – so much would be easier for the FDA if they could just ignore them! So, it is no surprise that the comments submission page is less-than-simple.
What I’ve noticed in the past is that when someone encounters an issue, it is due either to going over the limit on characters in the comments field, or to missing one of the required fields, especially since one or two of the fields don’t seem to apply to individual consumers.
Those fields are: “Category” and “Organization Name”.
Please give it another shot, and keep characters in your comments to less than 2000. Then be sure to fill out both fields listed above. You can simply type “None” in the “Organization” Field, and use the drop-down menu for “Category” to select “Individual Consumer”.
I believe this will address your problem. If not, there may be something else the system isn’t recognizing, or it may be due to high volume on the system. (It is difficult to offer any other suggestions since I cannot see what you do). But I do encourage you to try my suggestions first.
If you still have no luck, I’d be happy to submit your comments for you. Just let me know if you’d like me to do so.

By the way Susan:
I re-emphasize giving the comments submission form another shot, since it is where the FDA will turn to gauge public opinion.
However, if you wish to try sending an email, you can try: for Commissioner Margaret Hamburg. However, I would guess they have something set up in case she starts receiving a flood of email. Entities that use webforms for submitting comments tend to do so as a way of blunting email campaign efforts.

Twenty years ago I had double by-pass surgery. I have kept my cholesterol under control and my arteries clear through the use of nutritional supplements. The status of my arteties has been verified by a nuclear stress test. Taking supplements as recomended does not have any side effects. Every drug or vitamin a drug company makes has side effects. The proper use of supplements provides one with good health and lowers the cost of health care.

I know that you too have relatives who take and may have benefited from supplements. Vitamin K given to most infants, or protein and CoQ10 to prevent muscle wasting, or calcium and Vitamin D for bones, or vision formulas. Where are the safety concerns you are using to justify these NDI’s Guidance?

While health and safety issues are being used for their justification, the all to obvious ramifications will be to limit nutrient variety and dosage choices for the consuming public. Codex’s limiting regulations have been shown to be weak in Scientific support, but were pushed through anyway. Please put PUBLIC Health and choice as the priority deciding FACTORS and not special interests.

I have greatly benefited from supplements and lifestyle choices. Without them, I would have been on many drugs (prostate, hypertension) that have limited positive time effects, numerous adverse side effects, and my health today would be in jeopardy.

Konrad Anderson

Thank God for a group like Citizens for Health. We have to take control of our own health and nutrition and keep bureaucrats out of it. FDA is in collusion with big pharma to steal natural products, modify them, and patent them. Thereby severely increasing the price to the consumer and increasing the danger because of the side effects of modified natural products or artificially produced ones. The NDI is an onerous regulation that almost no natural product can meet.

This is just another law, that is good for no one, but instead hurts everyone – the supplement companies that now have to lose thousands complying, and many will go out of business, and of course the consumers, who now will lose their health, and lives.

Supplement users are watching and we will not stand for youR continued attack in dietary supplement (which are found in our food). All this to support the horrible drug industry.


I am 61 now and feeling pretty good. I take my vitamins everyday. Please don’t take what makes me feel so good away.

I am old enough to retire and I still work part time. I don’t take any medications and rely completely on natural supplements and vitamins. Please don’t manipulate my rights or take them away.

Isn’t it time we petition Congress to start an investigation of collusion between Big Pharma and FDA, and payoffs by Big Pharma to FDA officials, and FDA officials who get big jobs with Big Pharma after they put the shaft to the American people in favor of Big Pharma. My guess is there is lots of collusion, payoffs and just plain too much coziness between FDA and Big Pharma. This NDI regulation proves it.

“Life, liberty, and the pursuit of happiness” Without our health there will be NONE!

Supplements are one of the last defenses we have against the terrible treatment of our beautiful blue jewel, mother earth. The government has failed to protect us from industries that pollute every single inch of our home. The FDA allows toxic chemicals to be sold to us as “medicine” and allows toxic chemical additives in our “food”. All to keep people in a sick care system for GREED. The “revolving door” of people that run the FDA then return to Big Pharma for their lavish lifestyles all deserve to be in prison.

Do not touch our supplements! We the People have the right to the pursuit of happiness. That means I have the right (AND OBLIGATION) to keep my family healthy!!

After going through Cancer I feel empowered knowing that I am in control of what I put into my body. I choose to put hormone free, chemical free, pesticide free, organic (whole food) supplements that I know benefit my health. The people of the United States of America should have the right to know what is in our food. It should be labeled and transparent. I’m tired of the government trying to take control of everything. They should be sticking to the constitution and working with the people of this country. I feel they are the enemy.

After signing the petition to Sen Chuck Schumer I received a reply that he was in favor. I drafted one back on why he shouldn’t be and couldn’t get it through because his box was filled. We need to get the message across to him.


The DSHEA law was passed unaminously in 1994 so that we the people could have our safe and non-toxic supplements and have the science of these products made available. It is cheaper than Big Pharma and safer but we continue to have to fight for our rights to choose our own health care. Big Pharma continues to pressure the FDA to control nutritional supplements. They are threaten by there safety and effectiveness. The the FDA needs to stop this and support the DSHEA act as it was passed.

Just a thought….

The earth cannot sustain the amount of human beings that are living on it. We have caused so much destruction, and have polluted and contaminated most of our natural resources.

A small percentage of the human population is aware of this, and care about it. (eg. People who read Citizens for Health, and subscribe to other newsletters, and websites, that give us the “real” news.)

Then, there is an even smaller percentage of the human population, who benefit from the degregation, and destruction, of the huddled masses.

If our environment is toxic, our food supply is contaminated, and genetically altered, our water is polluted, and there is a hole in the sky, then where do the sensative souls go for refuge?

We can fliter our water, filter our (indoor) air, eat organic (until the crops have been cross-contaminated by all the GMO farming that is happening right next to our beautiful real food), and supplement with the minerals, enzymes, vitamins, probiotics, herbs, and other nutrients we require according to our individual lifesyle, food consumption, and biochemistry.

If the government can take away our right to keep ourselves healthy, in the way we see fit, this would certainly hurt the individuals fitness of a healthy mind, body and soul. However, this stands to accommodate the small percentage of human beings that are thriving due to ” The Masses” demise.

By tightening control of supplements, “The Elite” can accomplish more monetary gains. By subjecting supplements to regulations, eg. increased fees, and decreased supplies, another big business is booming. Much like the pharmaceutical companies are currently exploiting us, as well as the healthcare insurance companies, the FDA, our congress, and our government in general.

The population needs to be on the decline, and it is currently on the incline, as people are living longer in these times. Perhaps, by removing our access to the resources we are so knowledgable of, the trend of the population can go on the decline.

It certainly seems like the government wants us dead, and at a very expensive price.

I have heard repeatedly that most MD’s are not properly trained in nutrition and the use of supplements. So why on earth would we want them to prescribe and dispense these items which they know very little about.?

The American Public is not stupid. We are well aware that YOU in BIG Pharma, Wallstreet, Big Corp, the USDA and FDA, and Monsanto Cargill are keeping us sick for greed. Our economy could be built on letting the US demand drive pure, organic, sustainable, healthy nutritional supplement supply. We are on to you. And your campaigns to misinform and fail to inform the public shows how corrupt the USA is. Get your hands off of the Presidents of our proud country and support that which creates health in our people, our earth and hence guess what, our economy.
I almost died in 05. By the time I was almost died I thought I was nuts that it felt like the MDs were trying to kill me. Turns out MDs, Pharmaceuticals, and the “food” and Seed industries are all making us sick. Well I didn’t die. I got smart. I dont trust the government nor big business anymore. Keep your hands off the nutritional supplements that saved my life, and still do.

Your agency, the FDA, has done enough damage to the health of Americans in that it favors the Big Pharmaceutical companies over the US citizen. This is very obvious when it comes to prevention remedies of health that are in direct contradiction to Big Pharma’s synthetic drugs. Supplements work well and save the tax payers tons of money in terms of a great reduction in extra Medicare and medicaid expenses. Now you want to introduce draconian laws via Docket No. FDA-2011-D-0376, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” It is not wanted by we Americans nor by the supplement Industry which is saving our health and tax payers dollars.

In 1994 the DSHEA law was passed in Congress.has stood us well in good times and in bad. Now is no time to change that law because it would be illegal, in my opinion, since it has been passed, and in use for many years. The FDA attempt is a thin disguise to deny Americans the right to supplements. Americans live by them and need them and no change to that law should be admitted.
I am sending this to my three Congressional people and also to all my friends and relatives. We will be watching their voting and your actions. Do the right thing and cease and desist from trying to get this nefarious law passed…Withdraw your infamous attempt to unseat the Dietary Supplement Health and Education Act of 1994 (DSHEA). It is and should remain the law on Dietary Supplements,

Noah and Natasha Brenner

Control the FDA before you interfere with our supplements. There is more there to investigate and regulate than supplements. One of us will be 90 in December and takes no pills, but lots of vitamins and supplements. Hands off!

I am 62 years old and am not taking any medications. I use vitamins and suppliments. I work in a job where I need to have a lot of energy and do a lot of lifting. I’m doing just fine and would appreciate being able to continue getting my vitamins and suppliments without interferance from the government.

I am a senior who believes vehemently in preventative health care. It is imperative that in a country like the United States, which prides itself on personal freedoms,that it is a travesty to deny us our rights in taking charge for ourselves in choices of health care that we individually believe is in our own best interest. Please do not allow the pharmaceutical industry to dictate to the public, FDA, Congress and deny us our rights to decide what natural supplements we can purchase and what amounts we will be limited to. When something works as well for years that has been tried and true “the proof is in the pudding” and “if it ain’t broke, don’t fix it” DO NOT TAMPER WITH MY PRODUCTS AND ACCESS TO MY NUTRITIONAL SUPPLEMENTS. THEY ARE SAFER THAN MANY PRESCRIPTION MEDICATIONS ALREADY APPROVED BY THE FDA!

Many of my family and friends have proven this to be true also from young children and adults in their nineties!

I am politically active and will be contacting all my United States and Massachusetts representation on my strong beliefs to put a stop to this action on revising Dietary Supplements and giving complete control and profits over to the pharmaceutical industry.

That we are disputing an issue like this demonstrates clearly the eroding of and loss of our freedoms,our right to choose, and the unwanted intrusion of government, corporations,big Pharm, insurance companies, and beaucracy in our lives. I’ve been feeling an oppression that I have never felt before. Our American way of life is changing fast. I fear we are moving in the direction of fascism and total control by a network of very connected, powerful, uber- wealthy, evil,corrupt, and self-serving unethical, immoral,souless people. For all the good it will do, I too will be contacting my legislators telling them to OPPOSE this. NOW,GET THE HELL OUT OF OUR LIVES AND BUSINESS AND LEAVE SUPPLEMENTS ALONE!

I am a healthy, older adult who does not take any prescribed medications.I practice a good diet, exercise and take dietary supplements which enhance my heath and well-being. It is my constitutional right to choose to care for myself in a way that works for me. The government was set up to support “the welfare of the people,by the people and for the people” .Please honor this agreement and do not take this right away from me and other Americans .It is unconstitutional.It is criminal and unjust.

How dare Senator Dick Durbin, Congressman Henry Waxman and the FDA try to sneak another law to ban natural supplements again. There are over 85% of people whom depend on them to stay healthy and prevent disease and costly hospital and ER visits. Many
are without any health insurance and survive on these natural supplements. If this bill passes, all of the stores shelves of supplements will disappear and the people that depend on them will get sick and die. We as Americans have the right to health freedom and many have faught and died for that freedom. Simple shills of the pharmaceutical companies in Congress shouldnt have the audacity to take away the lives of billions of people. What is fair about this? Nothing, just another attempt to ban supplements so the people that desperately need them won’t have access and will be forced to go to the hospital to get prescriptions for something natural. Surely these two cretins in Congress know that Americans can’t afford to do that and it is a lose-lose situation for both parties. This is such a disgrace. Congress is supposed to be of, by, and for the people, not against them. Withdraw the NDI guideline/No access to natural supplements bill. Thanks.

I was raised in a household where my father was a pharmacist and mother worked for doctors. I had all the advantages that drugs could offer whenever I became sick. It took me many years to recouperate from the damage those drugs did to my body. I studied nutrition and natural supplements intensly for 10 years and now am able to heal my body with non-toxic herbs and vitamin supplements. I eat organic food and support alternative medicine for nearly every ailment there is. In truth, I don’t want my supplements to be as “safe” as modern drugs, which do more harm than good as doctors advise their patients to use medicine the patient knows nothing about. My way of taking care of my body requires study and responsibility rather than blind trust in an establishment that can’t possibly know enough to heal all the people who come to them for answers they don’t really have.
Really, let us use our supplements as we have come to know how to use them and stop trying to convince us that they are more dangerous than the medications in the pharmaceutical market today. I am 64 years old and am healthier than most people I know…younger or older than me. I believe I am doing the right thing and challenge you to try it yourself before trying to remove the rights of my conciencious community.

I agree with Judy Miller and others who object to this blatant disregard for our freedoms and personal well being. The DSHEA law was passed unaminously in 1994 so that we the people could have our safe and non-toxic supplements and have the science of these products made available. It is cheaper than Big Pharma and safer but we continue to have to fight for our rights to choose our own health care. Big Pharma continues to pressure the FDA to control nutritional supplements. They are threaten by there safety and effectiveness. The the FDA needs to stop this and support the DSHEA act as it was passed.

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

Dear Commissioner Hamburg:

I would like to submit my personal comments on the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”

I am a consumer who benefits greatly from:

the pain relief I experience from using Glucosamine Chondroitin for my arthritis.
My cholesterol is down by 30% due to use of OTC cholesterol-reducing natural supplements.
My heart, which is genetically predisposed to heart disease, is NOT diseased, thanks to the multiple supplements I take to aid my body in protecting my heart, diet and exercise. Please know that my parents did not take these supplements, and they both had heart disease–and I, who have the genetics of both parents but can have these supplements–do NOT have heart disease.
I have rosacea but I have a beautiful complexion 365 days a year thanks to a supplement I take that helps maintain a proper nutritional balance in my body that I could not get from the “chemistry sets” our M.D.’s wanted me to use.
I take a memory aid supplement, and it is helping. I care for two adult disabled children, and the stress from that alone can cause memory lapses–which I no longer experience, thanks to that supplement.
I take anti-oxidants which are known to be helpful for many body functions and body parts, and while I am 62, people nearly fall over when I tell them my age. They think I must be 50, perhaps. Maybe. These anti-oxidants are very helpful for this general health benefit.
I have GERD and take a proton pump inhibitor which eats away at the calcium in my bones. If I don’t take the proton pump inhibitor for 2 days, I can’t swallow due to the severely painful cramping of my esophagus–but if I can’t take the calcium with vitamin D to replace what the proton pump inhibitor leaches away, I will wind up in a wheelchair and probably long-term care at some point.

If your Agency “re-interprets” the language of DSHEA to use wholly new interpretations of “what is a dietary supplement ingredient,” “what is a dietary supplement,” and “what is a new dietary ingredient,” here is what will happen to people like me. Multiply this by millions and ask yourself if you can sleep at night after participating in this carnage:

you will drive people like me to reduced quality of life
you will force people like me to buy lesser-quality products from outside the US
you will force people like me to spend more money on less effective remedies for pain and suffering — if those who are on fixed income can spend more for that
you will notice that all around you people like me are becoming less healthy and/or sicker
you will notice YOU can’t get these supplements when you need them, and trust me, if you’re reading up on health, you should know you need them.
you will be considered by people like me to be among our most hated domestic terrorists because you drive our lives with fear for our health and our future (please don’t think I’m unique in this opinion)

When an agency seeks to reinterpret an existing law, it risks overstepping its boundaries by doing the job of another agency without the authority required to institute such interpretations. In this case, I believe your Agency is in direct violation of the very law it seeks to “interpret.” That’s one point.

When the FDA seeks to reinterpret the quality of my life by using spurious methods to impose unnecessary delays and interruption of market supply, FDA executives do not appear to have the ethical or technical expertise needed to help the agency maintain its position along the “supply line.” That’s the other point.

I can’t figure what is so “sexy” about putting FDAs agenda as a priority over all others, including your nation–and there cannot be an Agency agenda that supersedes the importance of everyone’s health. Just know that I am aware that an agency may be appearing to take action, but I am also aware that no agency acts without the input of the humans who drive that action. This action appears to me to be no less than a poorly-disguised money-grab from a nation of people who are already overwhelmed and stressed by a poor economy. Maybe you want to be seen as the person who fixed things so your Agency brings in the big bucks. But you and your cohorts, if you act in ways that harm your fellow citizens, cannot be considered much better than the terrorists who seek to make us live in fear of fast destruction from their bombs–you are only different from them in the speed of the destruction you mete out.

“Dietary supplement ingredient,” “dietary supplement,” and “new dietary ingredient,”–no matter how you interpret it–that was known to be safe and effective since 1994 is still safe and effective. “Spin” isn’t going to change it. It’s like the witches dancing around the cauldron–what you say about the brew doesn’t change what’s in it. The same is true of newly-developed supplements. If they work, they work, and putting obstacles to reaching the marketplace won’t change that fact. Money-grubbing won’t endear you to us. We see right through you.

Unless and until the U.S.F.D.A., the agency charged with protecting the American public from dangerous products, is not also involved with endangering our health with its spurious pre-market obstacle course and systemic derailment of products currently on the market, I cannot feel my tax dollars are well spent in paying for your Agency’s services.

I am requesting that your Agency abandon its attempt to harm our national health and withdraw this Draft Guidance. I am also requesting a further statement of a hands-off position on the interpretation of Dietary Supplement Health and Education Act of 1994 –that your agency will never attempt in any way to do anything that does not honor the spirit, letter, and intention of the law your Agency is charged to enforce.

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


Michele Williams

I have taken herbal supplements since the late 60s, (while always keeping up with research updates from natural health journals and publications). I believe in
the effectiveness of the regiment of ‘nature-sourced’ health enhancing properties of green supplements from all over the world. (as opposed to the big pharma philosophy of test Rx drug on human
‘Guinea pig’ … wait for human to get sick … THEN try to ‘cure’ affliction with drug for maximum profit). Not to mention risk of
addiction/side-effects, whereas natural supplementation, has extremely low,(most often, NO risk of ‘side-effects’) … unless, while in combination, with taking a prescription drug!
It makes so much more sense to take something to stay healthy, than to introduce a potentially toxic drug to one’s system, after succumbing to an illness that well MAY have been prevented!
There seems to be an under lyingGreed factor here. I wish that there were more of a TRUE concern for The Children, or, are they just future ‘consumers’, with their lives hanging literally, in the balance of unwise decisions to be?

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