The FDA could be preparing to unleash an anti-supplement policy as early as next year that could eliminate tens of thousands of products from the market—in the middle of a pandemic.
Recently, the FDA announced that, by the end of June 2022, it plans to release drafts or final versions of a number of policies, and among them is the “new dietary ingredient” (NDI) guidance (“new supplement” guidance, in plain English). It is no exaggeration to say that this is the most dangerous threat to supplements we’ve seen in decades. We must continue to vehemently oppose the guidance as currently written and demand that substantial changes are made before the final version is released. It is especially dangerous given that we are in a pandemic situation that is constantly evolving, with scientists warning of viral variants that evade vaccine-induced immunity.
Here is some brief background. Under the Dietary Health and Supplement Education Act (DSHEA), any dietary supplement introduced to the market in the US after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of marketing the product. In implementing this policy, however, the FDA has turned a simple notification procedure into a de facto pre-approval process akin to that which is required of pharmaceutical drugs.
The FDA’s policy is nothing less than a massive broadside aimed at crippling the supplement industry. How do we know this? An economic analysis estimated that the guidance would result in:
- tens of thousands of products disappearing from store shelves;
- an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA’s NDI notification protocols; and
- the loss of between 55,270 and 104,475 jobs in the supplement industry.
How does the FDA’s guidance do this? First, the guidance imposes safety requirements on new supplements that are not even expected of drugs! The FDA’s guidance describes how to determine what kind of safety studies to submit with an NDI notification. The agency states that additional safety studies may be needed if the target population of supplements changes. For example, if a history of safe use has been established with adults, but a substance will be used in a dietary supplement marketed for young children, the FDA would require another NDI notification. Not even drugs are held to this standard: the FDA states that “most drugs prescribed for children have not been tested in children.”
Safety studies for supplements may sound reasonable, but just remember: requiring these studies is part of the FDA approval process for drugs. Drugs can afford them because they are patentable. Supplements are natural and are not strongly patentable, so if they are also required to conduct pre-market studies, they don’t have the same ability to recoup those costs. This will either force companies to go out of business or it will make supplements so expensive that they are priced out of the market. Supplements also have a consistently sterling record of safety.
The FDA is also broadening the group of substances that must submit new supplement notifications by adopting a loose definition of what it means for a supplement to be “chemically altered.” If a post-DSHEA ingredient has been present in the food supply and has not been chemically altered, it is exempted from submitting an NDI notification. The problem is that the FDA’s definition of “chemically altered” is so broad that only the most basic manufacturing methods would not “chemically alter” an ingredient. This language will stifle innovations in manufacturing and ignores the fact that new and more effective ways of producing supplements have arisen in the last twenty-two years since DSHEA passed.
There are even more problems with the guidance that interested readers can reference in our previous coverage of this topic.
If the FDA sticks to its timeline of June 2022, the release of the final guidance could seriously hinder our ability to stay healthy, naturally, during this pandemic. And using supplements to shore up our immune system against COVID is even more important as scientists learn more about the ability of multiple COVID variants to adapt and “escape” the immunity conferred by current vaccines and even natural infection. As noted in Science, “Such ‘immune escapes’ could mean more people who have had COVID-19 remain susceptible to reinfection, and that proven vaccines may, at some point, need an update.”
In light of these concerns, our friends at ANH International have wisely advised that we don’t rely exclusively on vaccines; we need a diverse array of tools to protect ourselves, including access to quality supplements. We can’t use these strategies if the FDA makes sure they’re out of reach. We must push back against this bureaucratic indifference to our health and well-being.
Action Alert! Write to Congress and the FDA to urge drastic changes to the NDI guidance to protect supplement access. Please send your message immediately.
This is totally ridiculous and must be stopped.
The FDA is out of control
Protect Supplement Access: I and my brilliant physiologist, PA-C, Pharmacist husband (who is dying of Lyme disease complications) RELY on products such as curcumin, melatonin, L-tryptophan, N-acetalcysteine (NAC), and more to deal with all of the devastating problems encountered with Lyme (Borrelia), Babesia, Bartonella. The US government funded experiments on ticks as part of their biological weapons program to see how many organisms could be inserted into them, then launched them on its own citizens. Willy Burgdorfer, his “Swiss Agent” (see the book: Bitten by Chris Newby) and the labs at Rocky Mountain Labs in Hamilton, Montana, Ft. Dettrick with the US Army Chemical Corps back in the 1950s knew what they were doing & knew the organisms would suppress the human immune system. So the US government makes people sick from the consequences of their actions, then the CDC minimizes the devastation it leashes out with no real studies to help with stopping the spread of Lyme disease or treatment (or acknowledgement – that would require accountability); lives RUINED!!!! forever. Now lawmakers want us to not even try to feel better by eliminating what little we have left to treat ourselves. Scumbag lawmakers who do not have a clue about human suffering need a lesson in humanity. Lawmakers who entertain withholding help from its citizens and an agenda to do so, are really psychopaths with no real human connections except for the facade they maintain for the convenience of vampire sorts but instead of blood (the ticks do the sucking – pun) they feed on the hopes & dreams of destroyed lives roping people into physical suffering, monetary debt and eventual death. We won’t shut up and go quietly so you can carry on your sickening means to our sickening end. NO. We will annoy you over and over and it is hoped that someday karma will meet with you and you will finally see the light of humanitarianism. Protect Supplement Access.
Patricia, please contact Dr. Steven Phillips. He also nearly died from Lyme disease. Here’s a link to his book, “Chronic” https://stevenphillipsmd.com/the-book/
I pray you find answers for your husband.
please protect supplements.
Protect our rights to supplements.
We cannot let this happen. Our health and wellness is at risk!
Science and common sense should reign, not corporate profit and greed. Safety as usual. However, let’s actually look at pharmaceutic safety/risk to have same standards. I have worked in the medical field since 1974 with RN, MSN degree. Both have a place in health. Please don’t take my freedom away, especially when risk is minor. Tylenol,aspirin, and most OTC have significant risks if not used properly. And, yes, I have seen deaths as a direct result of drugs.
Once again there is a threat to undermine our personal freedoms and especially our ability to use natural products to heal us and help us. What has happened to American freedom?
Please do not make unfair rules for supplements. People who believe in big pharma can go to big pharma. Let those
of us who believe in natural cures have our supplements. It is only fair.
My wife & I rely on supplements to keep us going. Deficiencies of some vitamins, minerals and other necessities are vital to optimal cellular function. Doctor prescribed blood tests are monitored and measured clinically to monitor our deficiencies. My wife has had severe adverse reactions from pharmaceuticals and their included fillers. We need and require alternatives!
We believe in spending a little more money on nutritional food and some additional supplements to stay healthy, rather than to get sick and spend it on doctor visits. Our health care system is already strained enough.
Please keep our supplements available and the industry viable for our economy. Resist special interest and political pressure to merely line pockets, put people out of work, and deprive those who rely on supplements for optimal health.
That’s the problem. The FDA only cares about those who pay them, which are those in the pharmaceutical industry. Even most doctors won’t discuss treatments with vitamins. “Big Pharma” wants to rule all. Don’t even tell them that Vitamin D3 is what kept me from getting Covid when I spent many weeks nursing my husband through his terrible case.
Spend our tax dollars for the people, not to placate drug companies and those who would benefit monetarily from denying affordable supplements to those who need them.
Your desire to remove life affirming supplements that come from the Earth in which we were made is akin to prehistoric thinking, but much worse . . it’s akin to harming the health of millions and forcing them into the pharmaceutical pipeline which has cured nothing, but only leads people to a sickness management program with the pay off to the pharmaceutical lobby, who is obviously giving Congress and anyone else then can bribe, billions of dollars to take away the right of a free person to get Vitamins and health supplements. Stop this madness. It is your family that will also suffer. Why are you taking marching orders from the UN, the WHO and Big Pharma. Have you forgotten who you work for? Or have you been paid your money like a Judas Iscariot? Whom do you serve?
Thank you ANH for the alert contained in your article about what the FDA may do to remove supplements from our shelves. I strongly believe in them because the food that is grown today is produced on soil that is exhausted, lacks structure, and is laden with chemicals instead of being alive with organisms that promote its health and ours. Let us stop any changes to the DHEA and other legislation that is designed to protect the availability and efficacy of food supplements as they are now known.
FDA is nothing but an organized crime institution. Criminals yet to be tried and convicted. I’m looking forward to their perp walks! We’ll all be dancing in the streets!
Do not restrict our ability to supplement with vitamins that we are unable to consumers on a daily basis. This would negatively affect the health of millions of people
I depend on supplements to help augment my medical treatments and lessen side effects of drugs I take. Supplements have an excellent safety record, and legislation further restricting supplements is unnecessary and would be harmful, particularly now during the pandemic. I did get vaccinated, but still take vitamin D and other things to help my immunity. I’m 65, and need all the help I can give myself!
This will be the last straw with the FDA for me. I just had a very serious reaction to to the drug Amylopidine,prescribed to me by my primary health doctor! It took me a month to get the drug out of my system and still having residual swelling in my legs and ankles….I’m ninety-one years old and credit supplement for my longivity…I have never had any of the problems with supplements that I have had with reactions to drug companies products. I will be up in arms at their greed and stupidity! And so will a lot of other folks!!
The FDA is supposed to protect us, not supposed to take away our health-promoting supplements!
Do not allow the FDA to stop natural supplements. Natural supplements are needed to have a good immune system.
FDA’s policy is nothing less than a massive broadside aimed at crippling the supplement industry.
Tens of thousands of products would disappear from store shelves;
It would mean an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA’s NDI notification protocols.
It would cause the loss of between 55,270 and 104,475 jobs in the supplement industry.
“Safety studies for supplements may sound reasonable, but just remember: requiring these studies is part of the FDA approval process for drugs. Drugs can afford them because they are patentable. Supplements are natural and are not strongly patentable, so if they are also required to conduct pre-market studies, they don’t have the same ability to recoup those costs. This will either force companies to go out of business or it will make supplements so expensive that they are priced out of the market. Supplements also have a consistently sterling record of safety.”
I am urging drastic changes to the NDI guidance to protect supplement access.
NAC destrys graphene oxide, which is the killer in all vaccines.
At 90YO, I depend on a spectrum of supplements, many prescribed by my health care professionals, and on fruits and vegetables, to maintain my health and vitality. Many affordable vegetables and fruits are often sprayed with toxic chemicals that undermine my bodily functions at the cellular and tissue levels. Cells, tissue, organs need the various vitamins, minerals, trace minerals, amino acids to function, as proved by many studies.
To Congress and the FDA: I urge drastic changes to the NDI guidance to protect supplement access.
I and many others are willing to fight and die if necessary to preserve and even expand our freedoms that the globalists are trying to destroy. We need to stop this….now!
could a terrible medical system get even worse?
Please dont take away our options!
I take supplements because I do not eat right. I eat one meal a day. I feel the supplements help me.
I’m 74 years old, and have been relying on natural supplements to keep me healthy for over 40 years. I haven’t had a cold (which I used to get yearly) or the flu or any other illness ever since. Except that about age 60 a bone scan revealed the most advanced stage of osteoporosis, so doctors insisted that I take the drug used for that. I chose not to but worked with an alternative medicine practitioner instead. About 7 years later out of curiosity I requested a bone scan, and my bones were extremely healthy. Big Pharma is highly invested in ensuring as many people buy their drugs as they can. That’s understandable, given that profit is their bottomline. But please don’t give them more power to take away our choice to use supplements/natural products, which are not only inexpensive and highly effective, but actually healthy!!!
supplements are important to health and people should decide whether or not to take them for themselves
I use supplements all the time for better health. Many of our foods are depleted of nutrition any more-particularly minerals. The dangers are in pharmaceuticals, not natural supplements-independent studies corroborate this fact!
Thank you for all you do for fighting this challenging situation we are all facing to stay healthy!
My thoughts are not too vague for words, but words are too vague for my thoughts.
This blows circuits out in my mind to even try to discuss!
It is very very important for people to get their necessary supplements-especially seniors! Supplements help to keep people healthy, avoid surgeries and stay productive. Anything and everything that can be done to keep our supplements available is the right way to proceed. Letting the FDA have control is a restrictive nightmare that would create more ill health in the US and set the Us up for even worse pain and suffering in the future.
I smell a rat from the FDA.
Are they going to try to eliminate DSHEA for supplements or weaken it even more so they can stop almost every nutrient we can now access?
FDA approved drugs are the 4th leading cause of death in the US.
Please protect access to supplements that are used by many .
Supplements should be available to citizens without government interference. Please continue to protect supplement access. The FDA is not qualified to assess supplements. More people are injured by prescribed medications and it is a major issue when people are hospitalized. Allow people to choose how they want to treat health issues with supplements which do not pose a serious health risk like drugs.
NAC breaks down graphene oxide which the vaccines contain by increasing glutathion: https://www.orwell.city/
That is why they want it off the market.
Ken, I have been researching NAC. So many companies make it and I end up not buying because I don’t know who to trust. I am 78 and get so weary trying to decide who I can trust. Thank you for your comment.
To FDA ~ I don’t understand why you continuously want to take away our access to nutritional supplements. There is no question as to their safety and they can help us keep our bodies healthy and balanced so we can go to work and be productive members of society. Most likely it is a push from the pharma industry who wants no competition and wants to reap all the profits. Don’t you think they make enough money? The more they push against us the more suspect I become of them, and lose faith and trust in their system. Please leave supplements alone for the average person to choose as they see fit. Thank you for doing the right thing.
Leave supplements as they are a let Americans make their own decisions.
We know that supplements add quality and health to our lives. It seems plausible that the FDA disregards our wishes and it may even be you would purposely have it that way. We want the right to choose our own supplementation without your interference and dictation . We are bright enough to choose for ourselves. Remove yourself from any further adverse rulings of supplements and let us, the public, decide what is best for us.
are we not entited to our rights
This cannot stand!
They want you sick and dependent on your doctor and outrageously overpriced pharmaceutical drugs. They want to remove all control you have over your own health. They want to remove the ability to get or keep yourself healthy through supplements. Sadly this is the truth. Psychopaths are running the show now, in case you haven’t figured that out by now.
Leave our supplements alone. They are safe & affordable. Big pharma is already making billions on legitimate prescriptions.
Enough is enough let Americans have their supplements. Who are you to take away peoples supplements? And why?
I take supplements because of my Chronic Fatigue Syndrome and my Fibromyalgia. Before going to the integrative medicine doctor, I went to my family doctor. I found out that I am alergic to all conventional medicine, because I had to go to hospital with a severe allergy that made me so swallen. The hospital doctors had difficulty to get me normal again. The told me to never go to the hospital, they would kill me. So, I found an another doctor that helped me with supplements, 35 pills in the morning and 14 in the afternoon, and this regimen for the last 30 years, that gave me my life back. I can have a normal life like everybody else, and if one day I don’t take my supplements I am sick, so tired I cannot walk and take care of myself, I am bed ridden. So if greed is at play here,the FDA will have our death on their mind. We can see now with the covid jab how they care. Millions will die and for what Money and control. Don’t touch our life and well being.
I have had autoimmune issues on and off my entire life. Back in the 80s as a teenager I started seeing what Natural supplement stores had to offer. One comment one day by two working in the store changed how I felt about the government and my health care forever. It was a natural cheap herb, I don’t even know its name but it was the go to for women going through menopause and needing hormone replacement therapy. I was informed the FDA just banned the supplements because there was no money to be made and It worked better than their synthetic hormone replacement therapy. They told me to stock up now before it was gone. New at this and not needing hormone replacement therapy at the time I did not take their advice. Over the years I have watched countless women get breast cancer from the FDA approved hormone replacement therapy including my mother-in-law who I loved dearly.
To the FDA KEEP YOUR DIRTY HANDS OFF OUR SUPPLEMENTS
Government/Big Pharma/Bill Gates/Anthony Fauci, and every other power hungry, evil possessed demon, will not rest till they have destroyed our lives by any means they can perpetrate on us. The whole Covid ‘plandemic’ and now the lethal injections weren’t enough? Now they want to take away our only safe means of protection…nutritional supplements. They will stop at nothing. THEY NEED TO BE STOPPED!!
The FDA’s revolving doors are being used to legalize corrupt and unsafe practices by big pharma. If the USA adopted safe oral vaccines instead of bypassing the immune system unnaturally with injections and if the USA banned Genetic engineered food and chemical or seed-based pesticides, I believe the 1 in 2 persons with chronic disease in the USA would rapidly decrease. The FDA does not protect us from big pharma or from big ag or from big chemical–all of which have interlocking directorships on their boards.
My husband and I are seniors on a fixed income . Dietary supplements help us greatly with our health issues. Please keep them available and affordable for the public now and for the future generations.
They have been planning this for a long time. They do not care what we want. They want us sick, so we can be sucked dry of any funds you have, no matter how small. Read the Georgia Guidestones and see what they want. Claus Schwabb: you will own nothing and be happy. These are the type of people who want full control of every single thing on earth.
Until people understand that the “governments” of this world are currently waging war on humanity, none of these “outrageous” proposals make sense. They are not “outrageous” proposals, but rather calculated attacks on that which allows humanity to live their lives as they wish. They are driven solely by evil intentions.
Impose a de facto ban on life saving supplements for “safety,” while rabidly pushing the Liquid Idol, with its self-evident and very real dangers of illness and death.
The government has too much say in my life. Socialism
I have freedoms they are quickly taking away. Protect my right to make my choices of what I put into my body that makes me healthy. They fear a healthy, happy country. God help us ALL.
If they do keep, they will be so outrageous only ahem,,,,,they will afford.
This does not surprise me. If they get paid off they will do anything. Our government is so corrupt that just thinking about how bad they are makes me need to take supplements to stay sane.. Maybe when we are completely socialism they will give all these supplements to everyone for free until they run out of our money, Trump would not have done this.
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