Are the NDI guidelines the ultimate FDA tool to freeze dietary supplement innovation? A special report by Robert Verkerk, PhD, ANH-USA Scientific Director and ANH-Europe Executive and Scientific Director.
(Note: Once again, please do not forget our two related Action Alerts—one on the FDA’s new NDI guidance, the other on the Durbin bill—in the last paragraph of this article. We are emphasizing these Action Alerts so strongly because the guidance and the bill could have a devastating effect on your natural health freedoms.)
If the US natural products industry values its ability to keep a diverse range of products available for the benefit of the American public, and believes in not exposing the public to unnecessary costs, we strongly suggest that it look very closely at the latest guidelines from the FDA—with eyes wide open. We refer to the FDA guidelines on so-called “new dietary ingredients” (NDIs) that we’ve been telling you about over the past several weeks. These guidelines preempt a crackdown on ingredients used in natural products, one that appears to be coordinated closely with a similar clampdown happening currently in Europe. The guidelines bear an uncanny likeness to the European Union’s Novel Food Regulation.
The justification given for the new guidelines is—as is always the case when facing a tighter regulatory noose around dietary supplements—consumer safety. This of course brings about a predictable response from the natural health sector: “But where are the dead bodies?” It’s actually quite a pertinent question, and one that is rarely taken seriously by the FDA or other regulators.
A careful examination of the most recent two years of US National Poison Data System (NPDS) figures reveals that, of all products to which we are exposed that might cause harm, pharmaceutical drugs caused 80% and 81% of fatalities, respectively. The majority of these were from unintentional poisoning. Are you surprised? It makes it even more of a wonder that regulators continue to try to convince the public that pharmaceutical-like regulation will be the best way of guaranteeing their safety!
The NPDS data, combined with other data from the Centers for Disease Control and Prevention (CDC), shows emphatically that botanicals and dietary supplements are the safest products that we put in our mouths. This is especially the case given that they are almost never associated with nasty pathogenic bacteria in food, which cause millions of Americans to be hospitalized and thousands to die each year.
Actually, deaths associated with dietary supplements are extremely rare. For example, in the most recent 2009 NPDS dataset, there is only one death reported. As we noted last week, it was concurrent with an “unknown dietary supplement or homeopathic agent.” So there was an alleged supplement or homeopathic agent, but they don’t know what it was! There was another death attributed to ephedrine, but the report indicates that this was in the “Miscellaneous Stimulants and Street Drugs” category—not a dietary supplement. Not a single death by vitamins or any other category of nutritional supplements. What’s especially revealing is that ingredients which might be classified as NDIs don’t enter the picture.
Like all guidelines, the devil is in the details. The Dietary Supplement Health & Education Act of 1994 (DSHEA) fully envisaged pre-market notification (though not approval) of NDIs, that is, dietary ingredients not marketed prior to October 15, 1994. But it didn’t set any hard-and-fast rules over what was required to show their safety. And now, seventeen years on, we see where the FDA is taking this. And what we see is an unashamed attempt to blueprint one of the most lethal weapons presently being used in Europe to decimate its natural products industry.
What the NDI guidelines force companies to do, once an ingredient is deemed to fit the NDI classification, is prove its safety before it can be sold. This notion is fundamental, because it moves us away from the long-cherished notion of presumption of safety for natural dietary ingredients, and places the burden of proof on the manufacturer. It actually may sound quite reasonable to some, but the reality is that proving safety is a very complex process—and one that is simply out of reach of most of the smaller companies that have been at the forefront of pioneering the natural health foods revolution since the 1960s.
This article serves as a distress call to practitioners and citizens who rely on diverse natural ingredients for healthcare. In Europe, there are two main ways that regulators are forcing products off the market. Either they get declared unlicensed drugs, or they get classified as unauthorized “novel foods.” In our experience of these problems in the EU, the novel food bans are proving at least as important a tool for the regulators as unlicensed drug classifications. Well, now it’s the FDA’s turn to use this same weapon on its people!
The FDA reckons there are around 55,600 dietary supplements on the US market, and the Institute of Medicine estimates that around 1,000 new products are brought to market each year. The FDA says that over the last sixteen years or so, it has processed around 700 NDIs. With these guidelines, expect to see many more being forced through this tortuous route. Ingredients that can’t jump the new hurdle will simply fall by the wayside—and cost is going to be one of the biggest barriers.
An obvious challenge is the effect of the guidelines on new products. They might be botanicals for which evidence of bulk use pre-1994 is hard to demonstrate (many have discarded their sales records), or nutrients that are delivered in a different molecular form (even if it’s one that is more natural). But an even bigger challenge—and this is central to the issues we now face in the EU—is retrospective effect of the guidelines. There may be very large number of products on the market that are structurally and chemically different to those that were on the market pre-1994, the era before the massive expansion of the US natural products industry.
In short, we see the NDI guidelines, modeled on the EU’s Novel Food Regulation, as being nothing less than a mechanism to freeze-frame the US natural products industry, and haul it back to its pre-1994, pre-revolutionary state.
Technically, there are a huge number of issues with it, the most fundamental of which is how to classify a particular nutrient, and especially its chemical structure, as an NDI. This includes a manufacturer’s need to demonstrate how much of it was used, since the FDA says that the ingredient must have been used “in bulk” in dietary supplements to not fall afoul of the NDI classification. Secondly, how one is to go about demonstrating safety of an NDI needs radical review. We think the requirements should be graded according to the nature of the substance in question.
We urge the US industry to immediately consult with European supplement manufacturers who have had experience with the Novel Food Regulation, because accepting these guidelines blindly will, in our opinion, sound the death knell for the vibrant and innovative natural products sector that has done so much in the last seventeen years to help people to manage their health naturally.
If you have not done so already, please send your message to Congress through our Action Alert on the FDA’s NDI guidance and our Action Alert on the Durbin bill. Both these issues are monumentally important if you want to maintain your access to natural supplements.
61 comments
Comments are closed.
I’ve been following the CODEX issue for more than a decade. We expected this but when I was trying to warn folks no one was paying attention. “Now, here we are.”
Thanks to all the communists in govt. now. They want us to be like them. Unhealthy and angry.
You seem to be confusing communism with fascism, as intended by the Cold Warriors. Our “true” freedom would reduce profits of the corporate capitalists (fascists). The most communist element in America I see is the military industrial complex, which we pay for, under a false premise of it benefiting us. Semantic witchcraft has us all divided, now they can conquer.
Doc, I’ve been warning people for nearly 20 years about the Federal Reserve, the Globalist movement, false-flag events to justify locking down on our rights, etc., and no, people don’t want to hear it, or know. They’ll know, when it’s in their face, and too late. I guess. Ignorance, truly must be bliss. Those who don’t know history, are doomed to repeat it. Today’s generation is ignorant about Nazi Germany, or the years leading into Hitler’s rise to power. They don’t care about World History. Without it, they can’t see what is coming. I gave up trying, all I did was frustrate myself. They know they will never get the guns and ammo from the People. The government is fully aware of what will happen, should they ever try it. Hunger. There, is a weapon. If they control the food, and all means of production, then you’ll eat at their whim. Want food? Swear loyalty to the New Order. You get the idea. I’d think the average American would too…….yeah, right.
Too much government control!!!!!!!!!!!!!
only really dangerous chemical such as mercury….etc should be eliminated.
thanks for keeping myself and others informed about how this slimeball progressive/communist democrat party is constantly trying to screw small businesses and the people over when will it end?? 2012 i hope.
The government, both Democrats and Republicans, is controlled by the corporate capitalists, not the communists or socialists. All capitalism cares about is business, money, and profits. People and communities mean nothing. There’s not a dime’s worth of difference between the 2 major parties, both serve the wealthy and corporations. The pharmaceutical corporations are among the most powerful, if not the most powerful.
Elections have consequences.
Well then…I guess people will have to start selling vitamin/dietary supplements as bath salts and incense…
A thinly veiled attempt by pharmaceutical companies to mantain their hold of synthetic and poisonous drugs and the billion dollar income it provides, no matter how many people are killed.
As has been shown for years, the FDA is a compliant arm of the pharmaceutical industry which subsidizes the FDA with money to approve its own testing procedures and to cast doubt on the natural food and vitamin industry. There is collusion to keep the populace un-healthy so the drug industry can make obscene profits, thereby funneling more money to our congressmen via the strong lobbying forces.
Your assessment is tragically correct. But we can become more specific. Pharma is one phase of financial attack on the public. All phases are united in membership organizations by means of which financial attacks are coordinated, leading society towards neo-feudalism. The organizations are set up as “rings within rings,” with the topmost organization being the controlling group. Mafia, Cosa Nostra, Triad et al are muted cyphers. The most visible of the actually important organizations is the Council on Foreign Relations, with many Pharma execs and directors as members. This is controlled from above and back of an enormous wall of silence and secrecy by The Pilgrims Society, the “World Money Power,” which amazingly turns out to be a creation of the British Crown and its worldwide financiers. Yes, Pharma is part of Royalty’s plan for international control and it deeply involves huge population reduction. The Review of Reviews, New York, May 1902, pages 557-559 speaks of “a secret society gradually absorbing the wealth of the world” and “the seizure of the wealth necessary” and a 200 year plan for global revival of the British Empire (by means of the United Nations).
vote out the republicans. they are destroying America to help the evil wealthy people steal ALL the money.
Don’t mean to be rude, but Dick Durbin is a Democrat. The current administration is Democrat. Not too sure why you are whining about the Republicans. The issue here isn’t a partisan issue at all; It’s a “…too much government” issue. Failing to see this – not just you, but most – has led to a bunch of non-elected bureaucrats deciding what is fit for our consumption. How far does it have to go before we “get it”???
Corporations run our Govt. regardless of who is in the white house or the majority in Congress.
Since the FDA wants to regulate everything, why don’t they regulate the very pollen in the air we inhale? Where are the lawyers counter-suing these proposed policies? Where are the lawyers protecting natural rights????????????
Unfortunately, ginaann, our system doesn’t work that way. We elect Representatives and Senators to Congress. Congress proposes new laws. The President (also elected by us) signs the proposals he likes into law. These new laws can be “tested” for constitutionality through the Judiciary. This is what happens when someone files suit. They are “complaining” that a new law violates the Constitution of the United States and challenges that law in the court system. Most laws remain in effect forever… even if unconstitutional… because no-one ever challenges them through the legal system. ANH & others take the approach that it is easier to prevent bad proposed laws from taking effect than it is to repeal them through the court system. Better still…? Inform yourself and only vote for congressmen who take their oath seriously. Every public servant swears an oath to defend and uphold the Constitution of the United States. The sad fact is that few congressmen have ever read the Constitution, let alone defended or upheld it in any substantive way. The real solution: Don’t vote representatives and senators into office who show no evidence of taking their solemn oath seriously. Only vote for those who will protect your rights and freedoms. If they fail, vote them out immediately and try again. Every Vote Makes A Difference. Believe it.
I can only take natural supplements. Too many bad reactions to drugs because that is exactly what the FDA makes… Where did my FREEDOM go????????? I am 67 and very healthy because I don’t take garbage drugs. Thank you very much!
Keep the FDA the hell out of my kitchen!!! It’s governments job to serve and respond the the will of the public and protect the rights of the public not to violate and dictate over the public. Who the hell do they think they are.
We want all natural supplements.
Not a single death by vitamins or any other category of nutritional supplements.
Sounds safe to me.
This is just as described in your article. It is undisguised regulations to ruin the supplement industry. I object to this as a business owner but mostly as an individual who uses supplements heavily to maintain health, fitness and slow aging. Fundamentally it is my right to choose what I put into my body!! There are more than adequate controls in place. The FDS should just apply those and do it properly instead of with an eye to publicity and personal ego pandering of poor insecure little hitlers who have no idea what the voters who pay their salaries need or want. The US is rapidly becoming a place where fundamental freedoms are being destroyed by a government that is way too big, out of control and running us into the poor house. Everyone needs to get into gear like we did in the early 90s and stop this crap. Stop taking our freedoms for granted. This government is rotten, infected with a self serving agenda and no expertise or foresight. We all know who this benefits financially and the Rx drug industry doesn’t want you to be well. Our sickness and disease is fundamental to their obscene profits and future. Get with it now and voice your opinions. We have the power now. Let’s exercise it and let them know that this is one industry that won’t get bullied!
It seems very hypocritical for the FDA to accept GMO foods without testing or any kind of proof that they are safe and then trying to restrict natural substances.
People Spread the word , it”s related to codex alimentarius in europe where they’ve Outlawed Vitamins,Herbs,Supplements. Also has to do with the Food Safety Modernization Act recently passed inUS which has made it Illegal to Grow,Share,Give Away,or Sell Produce from your backyard and also will Drive Small Farmers,Ranchers and Organic Producers Out of Business under a Ton of Paperwork. Spread The Word Fast as the Scum are Working Faster. Revolt,Rebel,Resist,Defy! Peace to You All
I am opposed to theFDA’s NDI guidance and the Durbin bill.
Putting harsh restraints on all vitamins and minerals has been the agenda of big Pharma since the beginning of big Pharma, how can they keep us sick and buying their pills, unless they have total control of our wellness . That’s why vitamins and minerals are in the way and the FDA is just the means to the end. We have obviously been duped by a agency that was supposed to be looking out for the welfare of the average US citizen, but now recognizes big Pharma as clients! My question is when is the average person going to wake up and start taking responsibility for letting some of these rogue agencies get out of control. The lobbyists for big Pharma, exert way too much power on our Congress. Until we the people push Congress to be responsible to the American people, this unhealthy relationship will continue. I suggest that you take action anyway you can with any group that is willing to stand up to the FDA. I support a petition at change.org, and I wish you would to.http://www.change.org/petitions/fda-vs-the-people-of-united-states-of-america
Please safeguard the world’s freedom, beginning with the United States, to use herbs and supplements in complete freedom as well as protecting each individuals rights to practice Health Freedom.
Unfortunately we most likely are dealing with more than the big pharmaceutical industry’s greed here. To really get a good look at the bigger picture, google Codex Alimentarius. A good way to do this is to go to YouTube.com/videos and type Codex Alimentarius into their search window for some good videos on what Codex Alimentarius actually is intended to do. After you thoroughly understand its intent, somewhere in your search you are likely to glean the information that S.510 which initiated this bill you are talking about, is intended to bring us into harmony with the Codex Alimentarius of Europe. This harmony will make it impossible to obtain any of our vitamins, minerals, herbals and supplements stronger than 1/100th of the amount that will make a detectable difference in our bodies.
When you really realize the intent behind this heinous plot, one has to ask who the plotters are and what is their intent. The only explanation that I have come up with is that the plotters must
be those who are pushing for the one world global government, aka the new world order and its
ultimate goal is 85 to 95% reduction of the worldwide poplulation……and they must not like the
natural substances we are and have been using to keep them from succeeding more rapidly….
there is the reason why they are making access to anything successful in maintaining your health unavailable.
Observation of the fact that after many attempts to get the FDA to remove monosodium glutamate
(MSG) from baby formula and foods secondary to its causing mental retardation and failing,
a group of doctors went before Congress and got them to pass a bill to outlaw putting MSG in
baby foods and formulas. Somewhere along the line, they also passed a law that when MSG
is in a food it must be listed in the ingredients so that those who were allergic would be warned
to not eat or drink anything containing MSG. (Read “Excitotoxins: The Taste That Kills” by Russell Blaylock) The FDA has to know of this law, so now we must ask why has the FDA turned a blind eye and a deaf ear to anyone trying to get them to stop giving their GRAS rating to both MSG and
aspartame, both well known excitotoxins. Obviously the FDA knows that they have been slipping
MSG back into baby foods/ formulas under bogus names and must know all the names they are hiding it under. Today there is more evidence than the mental retardation caused by both aspartame and MSG – death of neurons or the nerve cells of the brain and central nervous system, damage to the retinas of the eyes, also that they cause our pancreas glands to kick out excess insulin which is the first stage of Metabolic Syndrome X otherwise know as Insulin Resistance, which ends up with diabetes mellitus, type 2 or what used to be called adult onset DM. This onslaught has been going on since back in the 40’s with the MSG – do any of you remember when they added the aspartame. Interesting fact is that both of these amino acids cause obesity even though one is sold as a healthier substitute for sugar. Interestingly enough
2 of the names they hide MSG under is “natural flavors” or “natural flavoring”. There is a smidgen
of truth in their saying MSG and aspartame are natural substances found in plants, but the truth they left out is that they are not naturally found in the concentrations they put into our foods. You can find all the other bogus names by typing “names monosodium glutamate is hidden under” into your search window. Once you realize that the flooding all our processed foods with MSG and aspartame is the major cause of the so called “epidemic of obesity”, you most likely will wonder
why all the smoke rings to blame the obesity on things other than the MSG and aspartame. That is obviously trying to keep us from seeing the obvious. I haven’t heard of any epidemic obesity in the Amish people, have you? The Amish grow most of the foods they eat, avoiding most processed junk foods laden with the excitotoxins.
While we are on the subject of the Amish, another questions arises. When the so-called health
experts tell us that there is no evidence connecting vaccines and autism, it doesn’t carry much
weight or truth for me when it is said that the Amish don’t vaccinate and they have no autistic
children. Considering all the excitotoxins in our food chain compared to that in the Amish home grown and home cooked foods, I wonder if they have any Alzheimer’s disease, Parkinson’s
disease, ALS or Lou Gehrig’s disease, epilepsy and other things which are rapidly escalating
in our processed food group, diabetes mellitus, types 1 & type 2 or many of the other diseases connected to the ingestion of MSG and aspartame.
The line about vitamin D in excess of 4000 IU struck home. My wife is a cancer survivor and must take 10,000 IU daily; she also does not take pills well. One at 5000 IU morning and night is much easier to choke down than two and three in addition to other things required. Considering the number of deaths annually caused by FDA approved pharmaceuticals compared to nil by more natural supplements, I would prefer the FDA focus on improving the former and leaving alone what is already working well. As my Scot grandfather, an engineer, told me, “If it ain’t broke, don’t fix it.”
Yup… but I would check D3 levels regularly. The “health care networks” are removing folks who refuse their chemicals from the “survivor” lists. (this is actually a felony since it is “altering medical records”) but no agency will pursue it.
It’s sounds too me it’s all about the money not controlling safe effective supplements these big men paying the FDA and governments greedy people nit fooling anyone when did governments ever really care about people’s health approving genetically modified crops where there is no long term studies to prove there safety
It seems that the record should be the proof. People don’t die or get sick from supplements. Drugs and drug reactions are the number one killer of people. They aren’t proven safe before releasing them onto the public as evidenced by the recalls after many deaths.
This is so wrong. Synthetic Rx’s are OK with the FDA but this is not. WHY?
I never thought I would live to see this type of B.S. With vitamin and mineral supplements, I have saved Medicare a lot of money…less visits to the doctor for minor ailments that can be corrected in my very own home; plus, maintain my health in order not to be subjected to various illnesses.
As far as I’m concerned, FDA’s NDI guidance and Durbin can stick their ignorant ideas. If they don’t have anything better to do than go after health supplements, they need to be removed from payroll.
I just learned that FDA is not reading actual Food labels. Blueberries are high in V-C and some companies are touting that they have blueberries in their products. When, in fact, blueberries are not found on label ingredients. But, sugar bound with food dye of red and blue and some other agent make their products appear to have blueberries added. Blueberries are not mentioned. Blueberry Chips are NOT blueberries but colored sugar. So, where is FDA on this issue? I can tell you where. They are too busy trying to appease big pharma by going after health supplements. How dumb is this? I thought FDA was supposed to help protect public health? They are not doing such a hot job from what I’ve been reading.
FDA gives the green light to various chemotherapy agents that actually harm patients instead of helping them. Just recently, Avastin was pulled from the market because, guess what, Avastin did not help cancer patients. How many cancer patients have taken Avastin and died? If you read the side effects, it is no wonder. Avastin is like giving lye or Decon to rats and watching them internally bleed to death! Holes in the stomach. nose bleeds, blood coming from the ears…and FDA approved of Avastin for cancer patients!!!
The more I learn about FDA and Big Pharma, I want to regurgitate!
Drugs hurt many people. the drug companies don’t seem to care how there products hurt so many innocent people. why are they worried about regulating supplements? supplements have helped so many people when the doctors and drugs have not. help protect our rights to still take care of ourselves and not the government!
Please inform Senator Durbin that the supplement industry needs protection from Big Pharma, not destructive legislation like that of Europe. At 91 years of age I have relied on high quality supplements, to the near exclusion of patent medicines from Big Pharma, for two decades, at least. The comparative mortality statistics back me up.
To Whom It May Concern,
I use natural products, for my health and well being, and have most of my life.
The push to destroy these small industries is a testament to the core problems found in the political and financial systems that have so badly failed the worlds’ population to-date.
Be assured when the inevitable redress is required, we won’t forget.
Common sense, common decency and common moral rights cry out for justice.
This is no longer about casting votes. You must live with the choices you make, including those that kill us by insuring we have a lack of healthy choices.
It raises the question – should we try to adjust ridiculous laws or simply abandon the governments that write them.
Derrek Haynes
Canada
I cannot believe that this is taking place. It is unfathomable. Please, for those of us who have had miracles, literally, miracles take place in our lives by substituting personal care management for the poisons that were being prescribed by drug pushers, I beg you, respectfully; please come back to good sense. Taking rights and choices away are just wrong.
Seems, some think the population is too healthy. An easy way to cull the lot might be to limit nutrition, especially after the Fukushima effect. .
Codex
http://youtu.be/SliRq4jQ2eE
Global Warming and you.
http://youtu.be/F3WXcRfsrTQ
I sure hope that all of the readers of this article will contact their respective representatives and express their displeasure at the above mentioned regulatory changes being implemented.
This is serious. If the government succeeds in outlawing all living, non toxic foods, we will be left only with processed, dead, toxic foods. It’s all about power, and profit. Maintaining the stranglehold the big pharmaceuticals have over us all. This will actually enlarge their power greatly. We all have to try to do something about it.
So many of us “have” contacted our respective representatives and expressed our displeasure at the above mentioned regulatory changes being implemented and have gotten nowhere. My reps just sent me these canned responses (probably put out by their staff and the rep never even saw my letter, email, or fax) about how Durbin’s bill will save us from adulterated bad supplements yada yada yada, and we need protection yada yada yada. Their campaigns were all funded in part by huge financial contributions from big Pharma. Money talks and no one bites the hands that feed. We have done it all, and the FDA just thumps its nose at us while congress sits by and reassures us that this is all done for our own good and protection when it fact it is all done to line political pockets. It is time for the supplement industry to take the FDA to court for abuse of power.
Now that the FDA has turned from a regulatory agency to protect consumers into a regulatory agency to protect large drug firms from competition, it should be abolished. If any product really needs to be banned and/or recalled, the CDC can do what needs to be done. It would be better if even the CDC were permitted to act only after at least two deaths clearly from the product or enough deaths from a larger sample to provide a 95% confidence level that the product is to blame for the deaths. Even here, it is important to distinguish between a bad batch and a totally bad product.
Do not interfere with my access to natural foods and the supplements of my choice
I worked in Rochecter, Minn. and knew older employees who took many drugs. I finally figured out they were getting older faster,slower and costly. I decide to go natural and am enjoying being retired over 25 years. I went to many funerals of my age area because these people told me I only take snake oil. and they know better. I REALLY BELIEVE THAT THESE DEAD PEOPLE DID IT WRONG IN MOST CASES.
We are the rigth to keep our freedom for our health..Respect it!!
If the government were really worried about our health, they’d have made it mandatory to fully test the effects of Genetically Modified crops on animals (including humans). Since they have NOT done this and they actually fight legislation to do this, the whole dietary supplement war is absolutely transparent. ALL they want is MONEY from GMO foods and MONEY from the pharmaceuticals industry.
The FDA is just another Socialist shadow government of which we have no controls. The FDA has sold us out all for the Profits of the Pharmaceuticals and Food Processors. Here is a Quote from Herbert Ley, M.D., Former FDA Commissioner. Quote”THE THING THAT BUGS ME IS THAT PEOPLE THINK THE FDA IS PROTECTING THEM. IT ISN’T. THE FDA IS PROTECTING THE PROFITS OF THE CORPORATIONS THAT PAY US AND THE POLITICIANS!”. There is the proof of the pudding for a old saying. This why they want to destroy the health giving Vitamins which cannot be patient there not the profits of poison prescription drugs. Look at just a few, Celebrex profit % is 21,712%, Clartin 30,306% and the list goes on and on. Food toxins allowed look at just one in breads, AZODICARBONAMIDE. Azodicarbonmide primary use is production of foamed plastics. Outlawed in almost all countries on earth, yet this chemical is additive is allowed by the FDA for your daily bread. There is much, much more but that is up to you. So Citizens enjoy your plastic bread. Please Note just who receives the 30 pieces of blood stained silver, POLITICIAN.
Gov. needs to support the people instead of corporations who only want money.
Thank you for your newsletter – it helps me understand the technical and political workings of the issues. The FDA has allowed the pharmaceutical companies to conduct their own clinical trials on drugs and products up for approval. My suggestion is to have the natural supplement/food industry conduct trials with VOLUNTEERS. I don’t think one person who wants to protect their health freedom would not participate for free.
I order supplements from Vitacost and they keep email list information as well as physical addresses. Vitacost is a distributor but the companies that sell through them could recruit volunteers via email, which is fast and pretty much free. Release and medical questionaire forms could also be done online and the products shipped to the participants. Hopefully, this would keep the costs down. Through your newsletter a poll could be taken to see how many people would volunteer. Plaquenil gave me retina damage and I had no choice but to take Krill Oil for my rheumatoid arthritis.
Sincerely,
Ladye Hahn
There are certainly enough regulations in existance to provide the consumer safety desired and required.
The imposition of the requirements outlined would be devastating to the natural supplement market and I am sure would cause a universal rebellion of the consumers in the United States.
If the US natural products industry values its ability to keep a diverse range of products available for the benefit of the American public, and believes in not exposing the public to unnecessary costs, we strongly suggest that it look very closely at the latest guidelines from the FDA—with eyes wide open. We refer to the FDA guidelines on so-called “new dietary ingredients” (NDIs). These guidelines preempt a crackdown on ingredients used in natural products, one that appears to be coordinated closely with a similar clampdown happening currently in Europe. The guidelines bear an uncanny likeness to the European Union’s Novel Food Regulation.
We urge the US industry to immediately consult with European supplement manufacturers who have had experience with the Novel Food Regulation, because accepting these guidelines blindly will, in our opinion, sound the death knell for the vibrant and innovative natural products sector that has done so much in the last seventeen years to help people to manage their health naturally. In short, we see the NDI guidelines, modeled on the EU’s Novel Food Regulation, as being nothing less than a mechanism to freeze-frame the US natural products industry, and haul it back to its pre-1994, pre-revolutionary state.
Deaths associated with dietary supplements are extremely rare. Can that be said for the drug industry?
If this “novel food designation” is applied to natural supplements why wouldn’t a genetically engineered food get this designation? It is certainly a novel food and not the natural food of the earth. To designate a natural supplement a novel food and a genetically engineered food not a novel food is to turn everything upside down and backwards.
The FDA and pharmaceutical companies apparently hate healthy people.
Of course they do. Our poor health is in their best interest.
Our President is asking for help from us to give advice now to solve the debt issue. Ok, I’ll give it. Let the government dissolve and you all can pack your bags and go home. FDA, USDA, CDC, IRS, DEA, TSA, BLM, FBI, CIA, DE, FR, FTC, and all the rest on the list. GO HOME and LEAVE US ALONE.
I promise, you’ll feel much, much better. You’ll be able to make all your own decisions and you’ll feel free. Now there’s Novel Food for Thought.
How horrible that would be for this country! As far as vaccines are concerned, they are NOT harming adults or children. That is a lie, probably perpetrated by right-wingers who want to return our civilization to the 1700s.
I find it of supreme interest when one pieces together various laws written and passed during the last several years, a clear and well defined future of what’s being planned without our consent to hold all of us captive with respect to food, begins to emerge from the NWO murk.
For the sake of time (mine) I’ll just name a few off the top of my head.
The following laws are….
1. No labeling of food items as to the use of GMO crops used
2. New Eminent Domain laws so Corporations can be given land without the owners consent.
3. Codex alimentius and the outlawing of herbal and vitamin supplements
4. Relief of the FDA for overseeing food safety.
5. Fed’s new water ownership laws, where they own all water rights including private wells.
6. Outlawing growing, selling, giving away or distribution of food grown in gardens or farms.
7. The ability of Monsanto to sue farmers because their GMO uses wind to cross pollinate the farmers natural crops. (Patent infringement)
8. Hidden laws exempting pharmaceutical companies from law suits for the production of drugs that are added to processed foods, vaccines and doctor prescribed medicines, that do harm.
The above laws and many others have been passed quietly over the years without mention by the mainstay media or consent by the citizens who will labor under them.
The bottom line here is to gain total control of all food you can buy and eat. That further more once that’s a done deal. Your wide open to being quietly poisoned and eliminated for maybe Agenda 21? I’m guessing here, but having seen the behavior of the elite in the past…..
So what if they try to regulate? We will just start a black market and create more crime because of it. Better idea. US gov get out of my life and stop trying to micro manage all of our exsistance. We don’t need your kind of leadership. you can’t even balace your check book, and yet you think we actually care about your intrusive laws? get over yourselves.
You are exactly right. The core of secret societies already exists in the networks of people who are into natural healing and are knowledgeable. Up till now most will share, but that will end when they try to enforce this BS.
Why doesn’t the FDA spend its time worrying about the poisonous vaccines that are pumped into America’s babies and children. We need LESS vaccines….not LESS supplements and vitamins!! FDA….just LEAVE ME ALONE!
Sic Semper Tyrannous, Pretty much says it all
We must End the Tyranny before it ends us…..
better if its in Love and light healing those sic people