Why the FDA is Attacking NAC Supplements

July 15, 2021

N-acetyl-L-cysteine (NAC) has been on the market as a supplement for decades—why is the FDA attacking it now? Action Alert!

A few weeks ago, we told you about the FDA’s recent actions threatening NAC supplements—products which the FDA has allowed on the market for decades. The question is, why now, after all these years, is the FDA doing this? Digging a bit deeper, it seems obvious that the FDA is clearing the market of affordable NAC supplements in an effort to eliminate competition for NAC drugs that could be coming to market in the next few years. If our suspicions are correct, this would be another outrageous example of the FDA doing Big Pharma’s dirty work. We cannot let it happen.

To briefly recap how we got here: 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.

So, why is the FDA threatening NAC now, during a pandemic when a new FDA commissioner hasn’t even been appointed? For starters, a drug company is investigating NAC as a treatment for a rare genetic disorder that damages the myelin sheath, which insulates nerve cells in the brain. The Phase 1 trial was completed in March 2020.

But that’s just the beginning. A search through the government’s clinical trials database shows considerable interest from the pharmaceutical industry in NAC. There are 17 trials looking at NAC, in both drug and supplement form, in the treatment of COVID. Additionally, there are over 50 trials looking at NAC for a variety of other conditions, including: autism spectrum disorder, obsessive compulsive disorder, alcohol abuse disorder, rhinosinusitis, bronchiolitis, cardiac arrhythmia, and more.

Note that NAC drugs are currently available in generic form since it is off-patent, but a company could bring a new branded NAC drug to market if it was proven effective for an additional indication.

Given these facts, it seems reasonable to assume that the FDA is setting the stage for a new NAC drug to come to market by removing the competition from much cheaper NAC supplements. We called it when the FDA pulled a similar move a few years back when they went after brain health supplements, trying to clear the market for a new Alzheimer’s drug—culminating in the recent approval of an Alzheimer’s treatment that many experts think is not effective. CBD supplements may face a similar fate if Congress does not force the FDA’s hand by legalizing CBD in dietary supplements.

It is critically important to maintain access to affordable NAC supplements. In a recent interview with the Life Extension Foundation, Dr. Daniel Amen noted that NAC “has shown promising results in people with bipolar disorder, schizophrenia, OCD, and addictions. It can also decrease inflammation and may help delay brain atrophy in Alzheimer’s disease.” 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.

NAC is far too important to be threatened by the FDA, especially under such dubious circumstances.

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

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61 responses to “Why the FDA is Attacking NAC Supplements”

  1. Walter Kryshak says:

    So, why is the FDA threatening NAC now, during a pandemic when a new FDA commissioner hasn’t even been appointed?

    It is critically important to maintain access to affordable NAC supplements. In a recent interview with the Life Extension Foundation, Dr. Daniel Amen noted that NAC “has shown promising results in people with bipolar disorder, schizophrenia, OCD, and addictions. It can also decrease inflammation and may help delay brain atrophy in Alzheimer’s disease.” NAC protects the body from toxins, is a selective immune system enhancer, and helps remove free radicals, which contribute to neurogenerative diseases and aging.

  2. Anndrey Lather says:

    Please stop the assault on our supplements. Stay out of our health!

    • Mary J Nelson says:

      I did not realize what a health powerhouse NAC was until I got the notice Amazon would not be carrying it.
      SwansonVitamins.com still shows they still have it as of July 24, 2021.

      The FDA is probably going to be working on a DRUG $$$$$ to replace NAC and do not want competition from cheap generic NAC.
      My suggestion is if you use and like NAC, order enough to last for a while until this shakes out.

      When I looked at several sites, I am amazed it was ever sold so freely.

  3. Judith Wester says:

    Please reconsider keeping NAC supplements off the market. Nac is essential for my husband’s allergies and keeps him from having allergy attacks. I just don’t understand why this supplement should be kept off the market when all of us can share it and everyone can appreciate its healing properties.

  4. A Friend says:

    The reason is that they found out its effective against covid. 4X reduction in deaths. https://pubmed.ncbi.nlm.nih.gov/33177829/

  5. James Cayon says:

    …..BECAUSE as noted by Quinta Columna – a group of Spanish scientists and healthcare experts who analyzed samples of at least both Pfizer’s & Astra-Zeneca’s COVID-19 experimental injections these past several weeks, it’s one of the ONLY substances that ELIMINATES the GRAPHENE OXIDE, nearly 100% of it, found within them…..QUESTION then, is this just their PATHOLOGICAL need to avoid ‘contaminating’ such unprecedentedly-MASSIVE trial studies – or, EVIDENCE of cold-blooded SOCIOPATHY, premeditated MURDER? Additional suggestion OF as much, may be seen in an astronomically-UNLIKELY coincidence that mRNA spike glycoproteins-120 & GO display VERY similar rates of light absorption: 260-270 nanometers…..

  6. LAWRENCE Cormier M.D. says:

    Thousands of patients being treated by medical doctors and other non-MD/DO health care practitioners will be HARMED by the banning of nutraceutical supplement NAC.

  7. Larry Ryan says:

    My wife and I use NAC as a supplement for many maladies described on numerous publications. It is no more a drug than water is.

  8. Michael G says:

    Leave NAC Be!!
    It is too important for too many things to restrict it to just a small footprint of big pharma uses!!

  9. The FDA is only concerned with the Almighty Dollar, not people’s health !! They leave drugs on the market that kill people !! I have suffered due to taking FDA approved drugs !!! The side effect of one of them was DUCTAL ADENOMAS in mice !!! I ended up with pancreatitis due to this drug PROTONIX !!!!! I would feel much safer taking natural supplements !! Look at the Johnson and Johnson sun screen , able to hide under the Nutragena name !! They contain carcinogens !!! Look into these things FDA !!!!

  10. Joan says:

    Sirs, It has become apparently obvious of the Pharmaceutical industry to monopolize the supplement industry by calling natural supplements medicine. Aspirin was once a natural analgesic and because of the pharmaceuticals manipulation of chemical structures, it is now a synthetic of the natural element. There is no comparison. Leave natural products to those who want them. Making a synthetic version of this, available by prescription, will not hurt anyone’s business. Those who want doctored, and prescriptions, are welcome to them. Those who chose an alternative path should have the freedom to go their own path.

  11. Kaye Hayes Antis says:

    stop threatening NAC

  12. Shivani Arjuna says:

    The move coincided with the discovery that NAC is extremely beneficial to CV-19 patients. If you want the populace to depend on vaccines, you remove the competition.

    • Rich says:

      You hit the nail on the head, and we all need to wake up to the true intent of FDA and other “regulatory” (corporate protection) agencies that have become wholly owned subsidiaries of the very corporations they are charged to regulate. These sociopaths will not respond favorably to any comments submitted by petitions that they won’t even acknowledge, much less read or consider thoughtfully. It’s going to take something much stronger and more effective than that, as we’ve been working for decades trying to get these agencies to just do the mission they are responsible for, but they’ve only become more corrupt and captured by the corporatocracy.

    • Mary J Nelson says:

      Beneficial for CV plus LOTS of others. I am surprised it has been on the market for so many years and not pulled off.

  13. Barbara Buck says:

    This supplement has been around for years. It is mind-boggling to see the FDA now threatening its availability. How much are you getting paid to go after this and on behalf of what manufacturer working with NAC?

    • Mary J Nelson says:

      NAC is available as a generic. I know that today, July 24, 2021, Swanson Vitamins still lists it.

      Place a large order now so you have it for a while.

  14. Travis Bachert says:

    Removing safe and effective NAC from health food stores and the like is an evil act against Americans. Stop this criminal act now.

  15. Thank you for all your great work! My email is [email protected], my website is https://flowmanagement.net

  16. Barb Tervo says:

    Please don’t take away access to NAC supplements. They are common good for common people, used safely and successfully for a long time now. Please support the Good for the many, not riches for a few.
    Thank you,
    Barb

  17. Mark Sutton, DC says:

    Please do not just be an arm of the pharmaceutical industry! NAC has been a harmless but very useful supplement for decades. It is outrageous you would even consider taking this important supplement away from non physician health care practitioners. Where are you seeing harm for us to continue recommending this to our patients?

  18. Michael Friedmann says:

    Please don’t experiment on Animals.

  19. Greg Timpany says:

    NAC is a vital nutrient that has numerous beneficial uses. The American public should have access to this nutrient, free and clear of government prohibitions.

    Thank you in advance.

  20. Pamela Sachs says:

    Taking away access to supplements that have proven effective for many people to pave the way for big pharma to roll out some expensive new medicine is totally beyond belief. As a natural holistic person who believes in the value of so many of these supplements personally this appalls me.

  21. My product was taken off of Amazon because it has 2% NAC, but wasn’t promoted inappropriately.

    This has wrecked my business for no reason other than corruption 🙁

  22. I use NAC on a regular basis along with gluthatione. My liver enzymes were elevated for a period of time but doctors couldn’t find anything wrong. Since taking these natural products, my enzymes are now normal and none of my doctors object to taking my own action to help myself. I do suffer from rare autoimmune immune diseases and use natural supplements, which have kept me alive. Thank god for homeopathics and other natural treatments or I would be dead. My I use NAC on a regular basis along with gluthatione. My liver enzymes were elevated for a period of time but doctors couldn’t find anything wrong. Since taking these natural products, my enzymes are now normal and none of my doctors object to taking my own action to help myself. I do suffer from rare autoimmune immune diseases and use natural supplements, which have kept me alive. Thank god for homeopathics and other natural treatments or I would be dead. My allopathic doctors had no way to help me. No doctor or drug company has a monopoly on treating complicated diseases. If the FDA and the Congress cared about the health of people, they would have integrative practitioners working alongside of allopathic doctors. The curriculum in the medical schools needs to change, it won’t because Big Pharma controls them to the detriment of our people. Health care costs would become lower and people would be healthier if this were the case. Instead, medicine, and in particular cancer is big I use NAC on a regular basis along with gluthatione. My liver enzymes were elevated for a period of time but doctors couldn’t find anything wrong. Since taking these natural products, my enzymes are now normal and none of my doctors object to taking my own action to help myself. I do suffer from rare autoimmune immune diseases and use natural supplements, which have kept me alive. Thank god for homeopathics and other natural treatments or I would be dead. My allopathic doctors had no way to help me. No doctor or drug company has a monopoly on treating complicated diseases. If the FDA and the Congress cared about the health of people, they would have integrative practitioners working alongside of allopathic doctors. The curriculum in the medical schools needs to change, it won’t because Big Pharma controls them to the detriment of our people. Health care costs would become lower and people would be healthier if this were the case. Instead, medicine, and in particular cancer is big business and there is no incentive to look for prevention and cures for diseases, which is rampant in the US. and there is no incentive to look for prevention and cures for diseases, which is rampant in the US. doctors had no way to help me. No doctor or drug company has a monopoly on treating complicated diseases. If the FDA and the Congress cared about the health of people, they would have integrative practitioners working alongside of allopathic doctors. The curriculum in the medical schools needs to change, it won’t because Big Pharma controls them to the detriment of our people. Health care costs would become lower and people would be healthier if this were the case. Instead, medicine, and in particular cancer is big business and there is no incentive to look for prevention and cures for diseases, which is rampant in the US.

  23. Rita Kelly says:

    Please don’t threaten NAC supplements. This s something that we should be able to buy and use for our benefit.

  24. Mark Waters says:

    Do not erode your credibility even more. Leave the existing supplements alone.

  25. Lisa Jo Finstrom says:

    I am a licensed nutritionist in the state of Maryland and am outraged that the FDA is thinking of taking NAC out of the supplement market. It’s a simple protein peptide for Christ’s sake! Let people have access to this safe supplement as they have for decades. DO NOT DO THE BIDDING OF BIG PHARMA!!!!!!! This is an egregious example of overreach by the government.

  26. Carol Saur MD says:

    How can NAC be considered a drug when it is a part of normal metabolism and an important part of the molecule glutathione?
    I have used NAC for years with no ill effects. Along with a good, organic and grass-fed diet, optimized Vitamin D and curcumin, at the age of 74 I am almost completely pain free and have very minimal arthritis. NAC is an important part of my daily anti inflammatory lifestyle. I have used it to help keep myself well during the COVID pandemic, in spite of continuing to work full-time and not isolating myself from people.

  27. Francesca Anne Rago says:

    Please continue to allow NAC to be sold as a supplement.

  28. TIM MEIER says:

    This Must be stopped! Facebook will not let you suggest a supplement to help with PAWS. the are in bed with Big Pharma too.

  29. Jim Merritt says:

    The ND/MD who saved my life in 2010 with his understanding of electroSMOG (wifi, cell phones, & now 5G/”small cell” towers, etc.) told me that NAC would help stop the inflammation caused by electroSMOG & NAC has! So, shame on you FDA LIARS, frauds, & deceivers. You don’t care about keeping cheap (compared to a drug NAC) NAC as a supplement to help those suffering like me. I have ABSOLUTE contempt for the FDA, like you do NOTHING about aspartame aka NutraSweet which harms people, even killing some, meaning I VOMIT on you MONSTERS of evil who actually HELP the AMA/BIgPharma “Nazis” to MURDER people with drugs, etc., meaning you DESTROY those who help those like me so that you allow the AMA/BigPharma to extract the MAXIMUM money from us will the AMA “Nazi” doctors LITERALLY murder us with their vile, evil drugs that have LITERALLY nearly killed me & my AMA “Nazi” doctor will sometimes get ANGRY at me for REFUSING to be murdered by his/her evil drugs!!! I base this on spending over 35,000 hours listening to over 1500 people & to sum up what they’ve told me: “Jim, you have helped me MORE than my AMA doctor who actually HARMS ME.” One even said: “Jim, here’s $100.00. I ought to give you $900.00 since that’s what I paid AMA doctor IDIOTS $900.00 for advice that HARMED me. I then decided to follow YOUR suggestions & got better, so please take this $100.00

  30. Rex Kittle says:

    It’s not the FDA that wants to take it off the shelves, it’s the drug corp’s. Kill the drug corp’s laws and then you have something and also KILL THE FDA !!!!!!!!!!!!!!!!!!!!!! Change the laws so the FDA will no longer get money from the drug, food and medical device corp’s and companies. Other wise kill the Democratic Party.

  31. Barry C says:

    It’s a simple fact that the FDA is in bed with Big Pharma! They want to stop natural nutraceutical products that work so they can push out and make money from hard-core drugs that will kill you!

  32. Annette Farrell says:

    Please do not remove NAC from publicly available OTC supplements to give it to pharmaceutical companies to synthesize this important anti-oxidant that is NATURAL to human biology and turn it into a drug. I need NAC for nerve sheath issues and do not want a synthesized version.

    I have a master’s degree in Health Ethics and find this action considered by the FDA to be unethical, so that pharmaceutical companies can make MORE PROFIT.

  33. Peter Booth Lee says:

    It is critically important to maintain access to affordable NAC supplements. In a recent interview with the Life Extension Foundation, Dr. Daniel Amen noted that NAC “has shown promising results in people with bipolar disorder, schizophrenia, OCD, and addictions. It can also decrease inflammation and may help delay brain atrophy in Alzheimer’s disease.” 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. George Baschiera says:

    I am appalled that the FDA focuses 100% of its efforts on cheap, effective natural methods and health givers and health stores, and not focus on EUA’s, and pharmaceuticals. that are often over prescribed and abused.

  35. Verna Rodgers says:

    Please leave NAC supplements available over the counter for customers since they provide many benefits at a low cost.

  36. Hanne Koplev says:

    The body needs Cysteine to create Glutathione to defend the body from infections in the lungs.
    https://pubmed.ncbi.nlm.nih.gov/11028671/
    Oxidative stress and regulation of glutathione in lung inflammation

  37. Please do not inhibit my ability to buy the supplement NAC as it has helped my family and patients for years

  38. Tony P says:

    this is ridiculous.

  39. Jeff Reese says:

    Strongly object to the FDA’s proposed action in pulling NAC supplements from the market. NAC has been safely used by consumers for decades, with no adverse effects. I use it myself to good effect. The idea that the FDA is simply trying to protect pharmaceutical industry profit-minded drug development rather than public access to affordable, safe, and useful supplements does not sit well.

  40. DON’T TRUST THE FDA AS FAR AS I COULD THROW THEM!!! BUNCH OF POLITICAL HACKS THAT DON’T HAVE THE PUBLIC’S BEST INTEREST IN MIND……ONLY $$$$$$$

  41. Krofter says:

    “NAC is also a precursor to glutathione…” In a nutshell, that is the real reason why they want to ban it as a supplement. Why? Because glutathione is the primary defense we have against the graphene oixde (GO) used in the jabs, the pcr test swabs and the masks. For more on GO go here –
    https://secularheretic.substack.com/p/graphine-oxide-epidemic

    • Marie says:

      Glutatione will not mitigate the damage made by the jab. Unless the jab is saline the effects are not reversible, of course. Graphene is a nano programmable metal and the program when turned on knows no bounds. Keep searching. And resist.

  42. peteywinnieluketuffy says:

    Medcram Coronavirus Pandemic Update 69: “NAC” Supplementation and COVID-19 (N-Acetylcysteine) https://www.youtube.com/watch?v=Dr_6w-WPr0w
    Medcram Coronavirus Pandemic Update 70: Glutathione Deficiency, Oxidative Stress, and COVID 19 https://www.youtube.com/watch?v=OtL0B1bqXak

    Dr. Roger Seheult has several videos on Medcram.

    It would seem there could be a co-relation between the regulation of NAC and Covid 19.

    Thank you for your good works. Have a good weekend. 😻

  43. Bharat Adarkar says:

    To the FDA: Do not threaten NAC supplements.

  44. John Keldon says:

    The last thing we need is lab drugs that come with lots of side effects. The drugs companies are trying to take away our rights to nature’s medicines and have us relying on their lab drugs which when taken causes another problem within the body thus adding more chemical drugs to treat the new condition.
    They want to keep and control our lives like a revolving door. I will never use their filthy drugs. For those who are not in the know, I feel sorry for them as they are drawn into such dogmatic practice. I would say I’m in better health than 99.9 percent of the world’s population. I will always rely on my natural herbs. I’ve never had the flu or ever been sick for over 45 years. I will continue to do so. Thanks to ANH-USA who is trying to protect our rights to live free as we can as we choose what we want for our health.

  45. Mark M. Dolezal says:

    NAC has been used for affectively for years including in hospitals, its current supplement status keeps it affordable. It seems some companies are looking at it as a drug which makes it appear you are paving the way to let them declare it as one and then charge more (probably much more) which would be unethical at the least. People already face too high a price for help with their health. I urge you to leave its status as a supplement for the good good of the people.

  46. Susan Schmitz-Penfield says:

    NAC is a friendly supplement that PTOTECTS the body in many ways and is a precursor to glutathione. It has proven that it is safe and effective. It has a good track record. Individuals who need it can afford it. Big phorma should let it alone and so should the FDA.

  47. Avis Dillon says:

    Stop doing the dirty work for Big Pharm. You already gave them permission to prescribe more blood pressure drugs by changing the NORMAL reading (which has been 140/80 for decades) and lowering it so more people will be prescribed the high blood pressure drugs and increase Big Pharma’s bottom profit line. Leave NAC alone. If as a supplement for those who appreciate natural treatments without horrible side effects, which every drug on the market has, this is our right to choose,

  48. Debra DiMarco says:

    I would like to sign the petition, but you are asking too much personal info like street address, phone number, etc.

  49. annie prochera says:

    they banned it because glutathione destroys graphene oxide. they put it in all the vaccines.

  50. Nancy Sumner says:

    Please do not threaten NAC supplements – they are too important! It is crucial to maintain access to affordable NAC supplements. According to the Alliance for Natural Health, there are 17 trials looking at NAC, in both drug and supplement form, in the treatment of COVID. Additionally, there are over 50 trials looking at NAC for a slew of other conditions, including: autism spectrum disorder, obsessive compulsive disorder, alcohol abuse disorder, rhinosinusitis, bronchiolitis, cardiac arrhythmia, protecting the body from toxins, as a selective immune system enhancer, and removal of free radicals, which contribute to neurogenerative diseases and aging. In Europe, NAC is a prescription medicine used to reduce congestion.

  51. I use N-Acetyl Cysteine because I was offered no medication or therapy by Stanford Neuromuscular Clinic for Sensory Motor Demyelinating Polyneuropathy, cerebellar atrophy, gate ataxia and Multiple Foci of T-2 Enhancement in both cerebral hemispheres. Big Pharma’s NAC pharmaceuticals does no neurology patient any good if NAC prescription medications are not on your drug plan’s formulary!

  52. Rich says:

    If the FDA’s past and recent behavior on such actions is any indication of motive and intent, it would seem a useless waste of time to submit any comment to them suggesting that they actually consider protecting the health of the American public as a priority over protecting the wealth and power of the corporate medical industrial complex that they actually serve. They all rotate back and forth through the revolving door between “regulatory” (corporate protection) agencies such as the FDA and their mother ship corporate boards, being subsidized by you and me, the American taxpayer as they rape and plunder the public health and welfare. These are the marks of true sociopaths and psychopaths, and they are incapable of empathy or acting in the best interest of someone other than their own.

  53. Rich says:

    My comment submitted to the FDA: “As a veteran medic who served in the US Army Special Forces and Rangers, and later as a Registered Nurse, I see absolutely zero benefit to the public health by taking away affordable and unfettered access to NAC, which has such a stunning record of safety and efficacy across a broad range of uses. If the FDA takes away the current easy access to NAC it will be a blatant, ugly and traitorous action with only one purpose: the protection of the wealth and power of the corporate pharmaceutical industry. As such, FDA will have served official notice to the American public that there is no longer the shadow of a doubt as to who it is FDA actually serves the interests of, and we the people will decide to no longer allow FDA to pillage our public health and welfare for profit. I served under the motto “De Oppresso Liber” or Freedom from Oppression; is there anything more oppressive than any agency of our “representative” government acting to enrich the corporations they are supposed to regulate at the detriment to health and wellness of the public they are supposed to serve?”

  54. Marie says:

    You can make NAC. Soak garlic in white vinegar for 6 months. Yields an awesome amount of sulphur which is NAC. There are probably recipes all over the interwebs. If you can make it in your kitchen with food it’s not a drug unless you are forbidden to combine foods such as, for example, apples and oranges, which is a metaphor (or something like that) for some kind of logical fallacy but there’s got to be a better metaphor for that because if you add oranges to a Waldorf salad you may be in violation of the recipe but I’ll bet it would improve the salad. Especially if you get rid of the walnuts. I might try that. Pregnant women sometimes DEMAND pickles and ice cream (or other unconventional combinations) which can get their husbands arrested if the FDA says so, except for the husband of the pregnant woman who heads the FDA, of course. Say goodnight, Gracie!

  55. Maya says:

    CEO’s of pHARMaceutical companies ARE on the Board of our FDA.
    Therefore we MUST take down big pHARMa and rebuild our system!!!

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