FDA Threatens to Ban Critical Toxin Protection Supplement

May 20, 2021
Category: Uncategorized

On shaky legal grounds, the FDA has targeted N-acetylcysteine (NAC), an important antioxidant supplement. Action Alert!

The FDA has declared that NAC, a vital antioxidant with a number of important health benefits, is not a legal dietary supplement. This is a direct threat to a supplement that many integrative doctors and patients rely on to address a variety of health conditions. We must ensure the FDA doesn’t remove these supplements from the market.

In a slew of warning letters sent last year, the FDA targeted a number of supplement companies marketing “unapproved” cures for hangovers—which the agency absurdly considers to be a “disease.” Some of these products contain NAC. In the letters to those companies, the FDA states that NAC does not meet the legal definition of a supplement because it was approved as a drug in 1963; according to federal law, any substance approved as a drug before it was sold as a supplement cannot be sold as a supplement. All of this means that the status of NAC as a supplement is currently in dispute.

There are a number of problems with the FDA’s position. For one, the agency considered many health claims (both structure/function claims and qualified health claims) in relation to NAC supplements, and did not raise these objections about the legality of NAC supplements then. For years, the FDA treated NAC like a supplement, and companies invested considerable resources in developing NAC products and submitting health claims to the FDA. Doctors and patients have also come to rely on these products. In legal terms, this is referred to as “serious reliance interests”: the supplement industry took certain steps in reliance on the FDA’s decades-long treatment of NAC, and then the agency does a complete about-face without explaining why. Courts have found that when agency policies involve “serious reliance interests,” it is arbitrary and capricious for those interests to be disregarded without adequate explanation.

Additionally, there are serious questions that must be answered about the FDA’s assertion that NAC was approved as a drug in 1963. As stakeholders have pointed out, the available documentation, obtained through Freedom of Information Act requests, allegedly proving that NAC was approved as a drug in 1963 is a handwritten note. The fact that the date is handwritten throws doubt on the reliability of the FDA’s assertions. Are consumers really to be denied access to such a beneficial product on the authority of a handwritten note (allegedly) from 1963?

Further, the alleged 1963 approval, and subsequent NAC drug approvals, were for inhaled drugs. For the FDA’s logic to apply here, the supplement would have to be the same “article” as the approved drug. Because NAC supplements are taken orally, at different dosages, there are significant differences between NAC drugs and NAC supplements. These important differences should be enough to keep NAC supplements on the market.

Threatening to ban NAC supplements negatively affects the health of many patients and would remove an important tool from the arsenals of integrative doctors. NAC protects the body from toxins, is a selective immune system enhancer, and helps remove free radicals, which contribute to neurogenerative diseases and aging. In Europe, NAC is a prescription medicine used to reduce congestion.

NAC is also a precursor to glutathione, one of the body’s most important antioxidants. Glutathione plays crucial roles in nutrient metabolism and the regulation of many cellular events (such as gene expression, protein synthesis, cell proliferation, and more); glutathione deficiency contributes to oxidative stress, which is implicated in the development of many diseases: Alzheimer’s, Parkinson’s, liver disease, HIV, heart attack, cancer, stroke, and diabetes. Note that acetaminophen depletes glutathione, so those who regularly take it should consider, in consultation with an integrative doctor, supplementing with NAC to replenish glutathione levels. In fact, NAC is routinely used in hospitals to counteract acetaminophen toxicity.

There are already repercussions: Amazon has announced plans to remove NAC supplements from its site. NAC is far too important to be threatened by the FDA under any circumstances, much less on the authority of a handwritten note they think might be from 1963.

Action Alert! Write to the FDA and tell them not to threaten NAC supplements. Please send your message immediately. 

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73 responses to “FDA Threatens to Ban Critical Toxin Protection Supplement”

  1. Debra K Hoots says:

    stop the FDA from banning NAC

  2. Chuck says:

    Do not ban NAC supplements.

  3. Nikki says:

    I used N-A-C as part of a protocol 6+ years ago to holistically treat any aftermath of ovarian cancer, which I was diagnosed with after surgery for a huge tumor. I have used this supplement ever since and feel that it has been helping me maintain continued good health. I feel that the government is overreaching in this matter and has no legal foothold.

  4. Frank Wiewel says:

    FDA is out of control.

    NAC is not a drug.

    Stop the madness.

  5. Tracie Monson says:

    Like many I have come to rely on NAC as an adjunctive treatment that enhances the effectiveness of medical treatment I receive. Please to not remove this important supplement.

  6. Dusty Young says:

    WHO PULLS YOUR CHAIN? THIS IS AN EVIL DECISION. N.A.C. IS GOOD FOR ME AND OTHERS!

  7. Vicki Clark says:

    The FDA should not ban NAC supplements! I do not believe the FDA should listen to here- say! There are so many natural supplements that I take to stay healthy. I do not take NAC Without, the doctors would have me on so many meds. I have severe nightshade and dairy allergies. Alliance for Natural Health, thank you for being here for us. I will not be getting the Covid vaccine, are YOU?

  8. Bari conover says:

    Please do not ban NAC supplements – they help me a lot.

  9. al shayne says:

    another shameless attempt to perpetuate the pharmaceutical industry’s monopoly…

  10. Lyn says:

    FDA and government always want to rid anything that’s good for us

  11. Barb E says:

    I read your article about this last week and the run is already underway. We always bought NOW NAC on Vitacost along with our other supplements, but there are slim pickings left of any NAC. The only one available was the Vitacost brand so we bought 5 bottles. I’m sure after that is gone we won’t be able to find anymore anywhere. I never buy anything from Amazon they are such a crooked company. The FDA is going more insane than usual, along with Bill Gates they are purposefully taking away any supplement that truly helps people stay well. They want all of us sick and dependent on their murderous drugs. No thank you. We are 68 & 78 and don’t take any pharma drugs.

  12. Elaine says:

    We need a FOIA on what ones and how many drugs have been approved by the FDA via a handwritten note. My guess would be ZERO! It was never declared a drug. They are doing this because NAC is good to fight Covid.

  13. Will says:

    Note that N-acetylcysteine iis widely used (conventionally) as the specific antidote for acetaminophen overdose.

    Pharma favorite Acetaminophen, in overdose, destroys the liver before the victim realizes it, leading to a painful death or a liver transplant (if ‘lucky’).
    It causes many deaths every year (adding to the iatrogenic total that makes Pharma, even ‘correctly’ used, the third leading cause of death in the developed world – “death by medicine”, Starfield report.)

    Even when given in ‘normal’ doses, when given repeatedly , it raises the chances of hepatic failure.

    It is commonly used to reduce a patient’s temperature, rather than allowing a low fever to bring about cure.

    If you are lucky, sometimes an ER doc will check the victim’s hepatic status. and list of allergies.

    But maybe that is why FDA think it’s a drug, after all they never ant to admit that a food supplement is useful. Thin end of the wedge, they think. Especially if it can’t be patented or stolen.

    Their usual trick is to claim there’s no proper ‘evidence’ [by not looking in the right place], then to offer a monopoly to some chosen preferred pharma company to conduct pointless trials.
    Brown envelope job.

    Strangely enough they did that with intravenous vitamin C, just before the Covid thing hit. Couldn’t find any evidence it was useful (really!), so banned its use. Handed a monopoly out, if memory serves.
    Bunch of crooks.

  14. Will says:

    Note that N-acetylcysteine is widely used (conventionally) as the specific antidote for acetaminophen overdose.

    [edits:]

    Pharma favorite Acetaminophen, in overdose, destroys the liver before the victim realizes it, leading to a painful death or a liver transplant (if ‘lucky’).

    It causes many deaths every year (adding to the iatrogenic total that makes Pharma, even ‘correctly’ used, the third leading cause of death in the developed world – “death by medicine”, Starfield report.)

    Even when given in ‘normal’ doses, when given repeatedly , it raises the chances of hepatic failure.

    It is commonly used to reduce a patient’s temperature, rather than allowing a low fever to bring about cure.

    If you are lucky, sometimes an ER doc will check the victim’s hepatic status, and list of allergies.

    But maybe that is why FDA think it’s a drug, after all they never want to admit that a food supplement is useful. Thin end of the wedge, they think. Especially if it can’t be patented or stolen.

    Their usual trick is to claim there’s no proper ‘evidence’ [by not looking in the right place], then to offer a monopoly to some chosen preferred pharma company to conduct pointless trials.

    Brown envelope job.

    Strangely enough they did that with intravenous vitamin C, just before the Covid thing hit.

    Couldn’t find any evidence it was useful (really!), so banned its use. Handed a monopoly out, if memory serves.

    Bunch of crooks.

  15. Carissa smith says:

    Please don’t ban NAC. This would be a communistic action!!! How are you going to make regular hard drugs legal and ban an amino acid? It is a supplement that allows me to function and without it, I have severe chronic asthma and it helps prevent asthma attacks and pneumonia for me personally. I survived Covid just fine because of it.

  16. Lonnie Brown says:

    I’ve counted a minimum of 33 FDA approved drug advertisements . (I can send you the list) Almost all, state publicly, that their FDA “approved” drugs can maim and even “result in death to the user”. They even proudly claim that , deaths have already occurred. Followed by the audacity to ban or remove safe and effective supplements. Are we just supposed to take their drugs and wait n see if we develop symptoms or drop dead?
    Apparently, this is a discussion no one seems to want to have.

  17. Holli Adams says:

    NAC is a regular part of my supplementation for years. I have an issue with oxidative stress and I would be devastated to not have NAC as a part of my health regimen. Glutathione is key to neuro health and I have to be careful to support my brain as I have former family members that had Alzheimer’s. Please don’t reduce our ability to be healthy. Thank you.

  18. Tom Hall says:

    I want N-AcetylCistene to continue as a supplement

  19. Karl says:

    Don’t ban antioxidants!]

  20. Patricia Ochsner says:

    LEAVE NAC ALONE !! I AND MY HUSBAND HAVE USED THIS GREAT ANTIOXIDANT FOR MANY YEARS. IT IS NOT HARMFUL IN ANY WAY AND IT IS USED LEGALLY IN OTHER COUNTRIES. WE ARE IN OUR SIXTIES AND VERY HEALTHY BECAUSE OF THE SUPPLEMENTS WE USE INCLUDING NAC AND HAVE NO NEED FOR PRESCRIPTION DRUGS, MANY OF WHICH YOU WELL KNOW CAUSE A GREAT DEAL OF HARM TO THOSE WHO USE THEM!!
    WHY DON’T YOU GO AFTER BIG PHARMA FOR POISONING PEOPLE WITH THEIR SIDE EFFECT LADEN DRUGS JUST TO HAVE MORE PROFIT. SHAME ON YOU! WE ARE TAXPAYERS AMD YOU WORK FOR US! LEAVE NAC AND OTHER SUPPLEMENTS ALONE!!

  21. Thomas Berton says:

    How can they be doing this when it is clear that it also has become an important weapon against “Long Covid” and other inflammatory conditions?

  22. Michael L Kelley says:

    NAC should not be messed with as it is not inhaled. Trying to hurt prescribers only hurts those that depend on the product.

  23. Joseph Puglia says:

    A delusional brain one day says to itself, N-Acetyl-L- Cysteine is a drug.
    How did that thought process begin ? Was it a little birdie whispering into the ear of this neuron deficient government official chirping , “NAC is a drug” over and over again until this schill, stands up and declares, “it is not a supplement but a drug”! Why was this so-and-so looking for dirt on NAC?
    It all goes back to that little birdie, AKA big pharma, there is money to be made here. Screw the little guy they won’t even know what happened. It’s time to revamp the FDA, clean house and start over.

  24. Fred DeLuca says:

    In regard to the FDA trying to band N-Acetylcysteine (NAC), I have used this supplement for the past 8 years or more with out negative side effects. I take at least 2 capsles per day (2X 500 mg ). It has many health benefits, and is a big factor in helping to get toxins out of my system and keep me relatively healthy. I depend on a lot of supplements to keep me alive and well.

    I do not appreciate that FDA has been waging a constant battle, supported by big pharma, to gain control of supplements, all under the pretense that they are protecting the public when the real reason is big pharma wants more money. FDA approved drugs are killing more than 400,000 people per year. Two drugs, within 5 years, one damaged my liver, the other set me back 18 months. Whistle blowers have talked about the dishonesty inside the FDA. They lied about my grandson’s autism. I do not trust them. Please don’t sell your vote to big pharma and the FDA.
    Vote for the health of children, mothers, fathers, the elderly and all the people depending on your vote. I am 89 years old and have been living drug free. I need access to my supplements. Thank you for your support.

  25. based on a hand written note with the date wrote on it ,does not really back up the claim it was used for a drug ,I strongly advise this be put back on the market as a vit,and quit messing with it ,the people are tired of this,

  26. Rebecca Gorlin says:

    Amazon has already removed NAC, and supplements containing it, from its shelves. And I bet the reason they did the about-face, with its particular timing, is that it’s also a COVID-19 remedy.

  27. Bradley Rule says:

    The FDA yet again will take from the consumer the power to make decisions about their own health if it bans NAC. Such an act is cruel and capricious, and forces the consumer to depend on the monopolistic and corrupt drug cartels for expensive, patented medications. I no longer have any faith that the FDA acts in the interests of “protecting” the consumer: more often than not, there is ample evidence that your agency works to advance and protect the interests of the drug manufacturers. NAC has been a useful supplement for me to treat a health condition that traditional allopathic medicine has offered little hope for. Can you please tell me what I am to do if I can no longer obtain it? Go on the government dole and become a dependent rather than a contributor?

  28. Lacey Morton says:

    Dear FDA,
    I’m a citizen of the US and I’ve used N-ACETYL-CYSTEINE for maybe 30 yrs w/o any complications. As a user of integrative medicine, I’m active in promoting my own health ad much as possible. NAC is one of the good guys. If you want to ban OTC supplements, I suggest you start with Tylenol and Acetaminophen and Aspirin. I’ve recently found myself in the situation of having to stock up on NAC out of fear, yes fear, of the FDA banning an extremely valuable supplement. I’m a poor American, so it irks me that I have to do this. Please leave NAC alone. You may not use but others do and do so safely.
    Sincerely,
    LPM

  29. John Mihopulos says:

    Maybe it is time the FDA is banned !
    They are allowing experimental mRNA gene therapy shots to continue after they have killed 4,000 people (per VAERS which has shown to capture approx. 1% of adverse events), but yet they go after a supplement that is helpful and causes not damage. Does that SCREAM conflict of interest??

  30. John Betlach says:

    I have personal heath issues , as a medical Practioner had my teachers recommend this for me , I consider this a need and a right do not ban this or I will be left no choice but to file in court to protect the interests of the people

  31. Lorraine Po says:

    Please do not threaten NAC supplements. Because NAC supplements are taken orally, at different dosages, there are significant differences between NAC drugs and NAC supplements. These important differences should be enough to keep NAC supplements on the market. They are an important supplement which effectively help to remove harmful toxins and free radicals!

  32. Stan Idel says:

    Do not threaten NAC supplements. Many of us find this much more beneficial than prescriptions!

  33. Do not threaten NAC supplements. NAC protects the body from toxins, is a selective immune system enhancer, and helps remove free radicals, which contribute to neurogenerative diseases and aging. In Europe, NAC is a prescription medicine used to reduce congestion.

  34. Ellen Hoffman says:

    I take NAC on a daily basis — sometimes 2x per day. Do not ban this product from the market — to do so infringes on the freedom of all Americans to choose what they Will and WON’t take into their body. It is not toxic, and if the FDA is protecting Americans from toxic products, please target actual Toxic products, not something that is nothing but helpful to our health.

  35. jim schnelle says:

    The fda is way out of line on this once again BIG PHARMA is in there pockets Makes no sense whats so ever !!!!!

  36. Grant Ritter says:

    I dislike saying this; but, this is government overreach.
    Enough is enough already

  37. Lynn True says:

    We the People expect you to do complete due diligence and follow all due process BEFORE making any decisions regarding N-acetylcysteine (NAC), which has safely benefited people for many years.

  38. Big Pharma hard at work….

  39. Laura says:

    It is HORRENDOUS and HOGWASH that a very important nutraceutical that helps the human body in so many ways to restore natural immunity is being attacked by the FDA and being banned.

    WAKE UP people, your hearts are in the wrong place. please check with the many integrative care providers!

  40. James Roach MD says:

    NAC is a supplement that plays an important role in support of cancer, in support of brain health and as the most important nutrient the body can use in synthesizing the key nutrient detoxifier glutathione, a cornerstone and maintaining optimal health. I take it daily and it is a common supplement I recommend in many scenarios including support in eliminating contrast after CT scans and other contrast imaging studies. There is a LARGE body of research demonstrating its supportive role in a wide body of important health conditions. It is incomprehensible that the FDA would consider removing such a widely used vital nutrient resulting in substantial harm to the public. If you have a life review in association with a near-death experience, as many of my patients have had, it will be a searing emotional experience for you to explain to God how you could have created such harm.

  41. Yvonne says:

    Do not band!!!

  42. donna casciola says:

    NAC IS A POWERFUL SUPPLEMENT FIR MY IMMUNE SYSTEM. I HAVE HAD CANCER AND NEED TO SUPPORT MY IMMUNE SYSTEM. I WOULD HOPE THAT THE FDA PAY AS MUCH ATTENTION TO HORRIBLE SIDE.EFFECTS OF PRESCRILTION DRUGS AS THEY DO WITH NATURAL SUPPLEMENTS. GET YOUR FACTS STRAIGHT BEFORE LOOKING RIDICULOUS

  43. donna casciola says:

    NAC IS A POWERFUL SUPPLEMENT FOR MY IMMUNE SYSTEM. I HAVE HAD CANCER AND NEED TO SUPPORT MY IMMUNE SYSTEM. I WOULD HOPE THAT THE FDA PAY AS MUCH ATTENTION TO HORRIBLE SIDE.EFFECTS OF PRESCRIptION DRUGS AS THEY DO WITH NATURAL SUPPLEMENTS. GET YOUR FACTS STRAIGHT BEFORE LOOKING RIDICULOUS

  44. Mary Brandon says:

    NAC has been designated a supplement for a long time. Unless you can find dangerous results from using NAC, you have no grounds for changing the designation. It is a natural nutrient used by the body and there can be deficiencies in it like there can be of any other nutrient. Leave it alone.

  45. Bruce says:

    Follow the money. Someone stands to gain from this. Has anyone ever been harmed by a NAC supplement? I doubt it.
    I will be checking my stock and ordering a large supply soon.

  46. Sher J. Bash says:

    YOU HAVE NO RIGHT OR AUTHORITY TO STEAL NAC FOR BIG PHARMA PROFITS. THIS BELONGS TO THE PEOPLE. THIS IS AN ORCHESTRATED REMOVAL OF OUR HEALING SUPPLEMENT, NOT UNDER YOUR JURISDICTION!

  47. Janet Geren says:

    Please do not take NAC supplements off the market. I have an autoimmune disease and they have been helping me for vern15 years. Stop messing with our supplements. Drugs are much worse, I promise.

  48. Peter Booth Lee says:

    NAC is Non-Harmful, and it Works.

  49. Sheila de Koekkoek says:

    Stop the control of NAC this is a help line for people with over abundance of mucos. With the recovery of Covid is this a help line for many.

  50. Rho says:

    Supplements should not be targeted unless there are specific issues with a company and the way they process them. This is about money and greed.

  51. Paula Morgan says:

    Big Pharma is the source for the medication which, supposedly, will help you get better when sick. In America the base says one is sick and we can heal you. Instead I feel we need to concentrate on staying we’ll thus not needing pills from Big Pharma in order to get better. Antioxidants are available and are used by many to maintain health. I strongly believe this is an avenue for choice as to what we take to maintain our standard of health. Staying well in these times is important. We need to use what ever we deem best in order to do just that. Taking away our choices is against the essence of the American government.

  52. jan says:

    this supplement is amazing and i have already written to the FDA and my local state senator and Gov DeSantis about this. everyone please email directly your local representatives on this! thanks

  53. Jeffrey Bell says:

    I appreciate what you are trying to do. I appreciate that you are bringing to our attention the FDA’s efforts to prevent access to yet another safe and effective remedy that has helped so many, hurt none, and that could continue to help many, many people. There really is no scientific or medical excuse to even restrict to otherwise lower the level of access to NAC.

    The FDA is a “captive agency” – it no longer works to protect the public health. That is NOT its present agenda, assuming it ever was. The FDA’s current priority is to protect the obscenely large profits of Big Pharma and the “Medical Industrial Complex.”

    The FDA is out of control, and has been for decades, at the very least.

    It is pointless to try and get Congress to act on a single issue like this. They will not because they are addicted to the vast flow of wealth from Big Pharma. Collectively, they also do not have the moral fiber to do the right thing.

    In my humble opinion, this campaign is a waste of time.

    Instead, we need to acknowledge that the FDA is corrupt beyond any hope of redemption or restoration. Our agenda, that is if we really care about protecting health freedom and honoring the principle of Informed Consent, to completely abolish the FDA and create a new agency to take its place. This project needs to be transparent, insulated from Big Pharma, and informed by all that has gone wrong since the founding of the FDA.

  54. Amy Ollice says:

    This is an important supplement for the health of many – something that has been SAFELY used for decades. People deserve to have a choice and the banning of a completley safe supplement is really not what the FDA needs to be focusing on – why not go after the chemical food companies that are causing obesity, ADD and cancer?

  55. GARY KRASNER says:

    Cysteine CURED my plantar faciitis in 90 days. it’s a nutrient, not a drug.

  56. Linda says:

    My husband has been taking NAC for more than 10 years and his asthma is so much improved that he doesn’t need medications. We would be lost without NAC. Please do not ban it. Thank you

  57. Julie Hemmings says:

    There is no ethical or medical reason to target NAC as a supplement. The timing of this threat shows malice in an attempt to stop a supplement useful in regards to COVID19. The optics show the FDA as a biased, captured agency only interested in promoting patentable, money making drugs and vaccines and intent on destroying their competition. Is is not in the interest of health and safety. It is time for the FDA to start representing the people and not the corporations.

  58. David Fink says:

    Do not ban NAC. It has helped so many people for years and has hurt no one. DO NOT BAN NAC or we will get you thrown out of office!

  59. Bharat Adarkar says:

    Do not threaten NAC supplements.

  60. I am a Nutritional Biochemist, licensed to practice Medical Nutrition Therapy in Maryland and Virginia. I have 30 years experience. NAC is an essential component of Glutathione, the rate limiting component. Glutathione does not absorb properly, only 1.5%, and must be taken with other components to be effective for detoxification. It is NOT a drug. It is a natural supplement, essential in bodily biochemical pathways, not a patented drug. Your actions could cause bodily harm to thousands of patients, and result in law suits.

  61. Brian Cunningham says:

    I take NAC regularly to help with congestion related to allergies. Before I started taking it I would suffer sinus infections each year. These were painful and required a treatment with antibiotics. Since I started taking the NAC I have been free from these infections.
    Please don’t force me back to this needless suffering.

  62. Billii Roberti says:

    Allow people to choose to take supplements!

  63. WILLIAM ORR says:

    Where are the FDA required large scale studies and scientific laboratory research costing hundreds and hundreds and hundreds of millions of dollars, taking many, many years and producing huge volumes of research data that the FDA would have to review and approve with formal documentation published by the FDA before this preexisting, natural amino acid can legally be accepted as a “drug”, again taking even more years? So, what are we looking at here, time-wise? Probably, 20 to 30 years of recorded research. And where is the IMPOSSIBLE (preexisting, natural amino acid) patent on this NAC “drug”? All real drugs have libraries full of research documentation costing hundreds and hundreds of millions of dollars and patents. In other words there are forest sized paper trails for every approved drug! And all the FDA has deigned to do to the American people, in its overbearing, exaggerated, imperiousness, is to flip at our feet a hand scrawled note “approving” NAC to be a drug? Obviously this can only be done as the imperious edict of a megalomaniac.

    This is such blatant, duplicitous, fraudulent treachery that it could only be perpetrated by an arrogantly autocratic entity that perceives itself to be above the law of this democratic nation. The FDA is rapaciously frivolous to disregard its own lawful requirements!

    “POWER CORRUPTS AND ABSOLUTE POWER CORRUPTS, ABSOLUTELY.”

    By the way, I’m curious… was this hand written note, by any chance, scrawled on the back of a piece of used toilet paper, with a crayon?

  64. Steve Reineke says:

    FDA please stay in your lane. You do an excellent job at reviewing and approving prescription drugs that have both great healing powers for a specific problems, but also may have great negative side affects. Please concentrate on those drugs.

    This is a minor supplement. It may help some and not others. As long as it doesn’t have significant side affects, please leave it to us to decide if it works…it it works we will continue to buy it, it it does not work, we won’t buy it any more. Please don’t take away a supplement that has helped many. I just ask WHY would you do that?

    Thanks for listening

  65. Brian Crouse says:

    N-acetyl cysteine is a naturally occurring amino acid and should not be considered a drug but a supplement and should be allowed.

  66. Diana Johnson says:

    Please do not make NAC supplements unavailable to those of us who rely on it for our health.

  67. Pip says:

    I use NAC daily since I do have a lot of congestion and it helps aid in other supplemental healing. I take it right before I go to bed. No one has been harmed by this. The FDA might want to start looking into all the drugs that actually harm us and have harmed me. Please stop being in the pockets of big pharma. This one sided alliance with big pharma will destroy our country, our government and freedoms. The people of America want this invasion of our rights to stop. Why is it that vaccines are harming and killing children but when one person dies, from what is “alleged” to be a natural supplement, then the whole industry has to be burned to the ground? I no longer feel confident in the FDA’s part in keeping us safe from big pharms so why would I feel the FDA is keeping us safe from NAC or whatever other natural supplements they deem unworthy? Please stop this attack on perfectly safe supplements. American’s are sick and also sick and tired of side effects from synthetic drugs. Let us have our natural healing and become whole and healthy. We should get to decide what we want to take to help us or not. Thank you.

  68. John Burket says:

    NAC just happens to be the remedy of choice to combat AIDS / HIV. HIV is said to be one of the constituents of one or more of the new DNA-modifying inoculations. “We don’t want you to talk, we want you to die, Mr. Bond!”
    .

  69. Susan Newman says:

    I was about to sign the letter to the FDA about the threat to NAC, but I was not able to find any incidence on the FDA website of NAC being declared “not a supplement,” nor of a threat to NAC’s sale as a supplement. The only relevant information I found was a letter to John Gray’s Mars Venus LLC warning against making direct health claims for a variety of supplements, including NAC. According to the FDA, representing supplements to the public in this way establishes “that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease”. A lot of violations then result from the company failing to meet rules about the marketing, sale, and distribution of both new and established drugs, whether OTC or prescription. In short, what I see is the FDA reining in supplement companies’ claims about the use of various supplements in the treatment of specific diseases.

    I’m wondering what, if anything, I have missed in my brief research. I am very concerned about the disappearance of supplements from the marketplace and will act to oppose that happening. At the same time, I think we should all be worried about the proliferation on the internet of broad claims about supplements in the cure, mitigation, treatment or prevention of diseases, claims being made to anonymous patients with serious conditions who have not been seen by a qualified practitioner. I do (strongly) support the licensing and reimbursement of functional medicine practitioners like naturopaths, but I feel that the unfettered marketing practices one sees on the internet are a threat to the entire natural health industry.

    Please direct me to anything that you think would help clarify the situation. Thank you very much.

  70. Dianna Vagianos Armentrout says:

    Do not ban NAC, as my licensed doctor recommends it for immune boost during flu season. Let Americans have their freedom to have the supplements that they need to be healthy.

  71. Lori E says:

    You prove your corruption as an agency when you suddenly decide to cherry pick supplements from a vast range of products you refuse to regulate in the first place. Looking forward to you explaining it to a judge.

  72. Janine Holland says:

    I’m 62yo and work full time shift work.I love and support my 82 yo Mother, my children, grandchildren and foster grandchildren and foster great grandchildren. I take NO pharmaceutical drugs, I don’t smoke drink or take recreational drugs. I rarely take paracetamol or Aspirin as pain and fever are part of recognising and recovering from illness. I researched N-Acetylene myself and then consulted with my Naturopath at a Health Food Store. I joined face book groups to chat with others using NAC and other supplements. NAC are essential amino acids and antioxidants. Give them back, we are adults here, who are informed and live in a democracy

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