Will Congress Halt FDA’s NAC Attack?

August 5, 2021

The FDA’s recent actions against a critical supplement have spurred some in Congress to action. We must build more support on Capitol Hill to protect access. Action Alert!

Over the last few months, we’ve been telling you about the FDA’s attack against N-acetylcysteine (NAC), an important antioxidant supplement. We believe 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. Now, Congress is stepping in. Senator Mike Lee (R-UT) has submitted a letter to the FDA asking serious questions about their conduct towards NAC. He also released a video discussing this issue. We need to help Sen. Lee build momentum behind this important work to hold the FDA’s feet to the fire.

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, allegedly and rather suspiciously, to a hand-written note at the time). 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.

We’ve also related how there are various NAC drugs in development for COVID-19 and other purposes. Importantly, 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. We believe this is the real reason why the FDA is attacking it now, given that the agency has not acted against NAC for decades, and has even considered health claims for NAC supplements.

Among other things, Sen. Lee’s letter asks the FDA to clarify why it has changed its longstanding policy towards NAC, to clarify possibly inaccurate information as to when NAC was approved as a drug, and to clarify whether the FDA intends to remove more than 1,170 NAC products from the market. Major online retailers like Amazon have already removed NAC products from their website.

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 is implicated in many serious, chronic diseases.

NAC is far too important to be threatened by the FDA. Our advocacy has brought much-needed attention to this issue; we must support Sen. Lee’s work to keep up the pressure.

Action Alert! Write to Congress and tell them to protect access to NAC supplements and support Sen. Lee’s work to hold the FDA accountable for its attack on NAC. Please send your message immediately.

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60 responses to “Will Congress Halt FDA’s NAC Attack?”

  1. Hunter Hornby says:

    Please protect access to NAC supplements and support Sen. Lee’s work to hold the FDA accountable for its attack on NAC

  2. Merna Kochel says:

    PLEASE protect our need for NAC supplements. Doctors know what we need.

  3. Susan Guinn says:

    I had surgery which has caused me to deal with horrific daily headaches. My headache meds contain acetaminophen which is toxic to my liver. NAC is used in England to help remove those toxins. Please do not remove this from the market it has many other health benefits we rely on, and it is imperative, I use it for my current health situation.

    I thank you for your time in this matter.

  4. Marianne Waugh says:

    Please protect the rights of all citizens to take the supplements they choose by keeping them available and on the market. Freedom of choices that effect our health, including access to NAC is essential to everyone’s health and well being. Thank you!

  5. Kris Knoll says:

    I have a right to make my own choice about how I treat my body. Choosing natural ingredients/vitamins/supplements is key to keeping me healthy. At 74 in the day of COVID, I rely on them to maintain my immune system and keep me OUT of the hospital. Pharmaceutical companies make plenty of money with drugs for people who truly need them and that’s how it should be. But they don’t have a right to regulate how I maintain my health.

  6. Mary Gorski says:

    Protect the citizens right to purchase NAC supplements. Our family has been using NAC for years safely and with great success. Leave what is safe and works alone.

  7. Rudy r Engle says:

    NAC needs to be protected against big Pharma Back off supplements THANK YOU!

  8. Nancy burger says:

    Leave natural medicine alone!!!

  9. Paula Benner says:

    Please protect access to NAC supplements and support Sen. Lee’s work to hold the FDA accountable for its attack on NAC.

  10. Leslie Klotthor says:

    Unfortunately it appears monetary gain is the only motive to attack the ability to obtain NAC with it’s benefits. Please stand in the way of this absurd gesture that desires to take away our freedom of choice in regard to which options we may choose from.

    Thank you, Senator Lee for caring enough and taking action.

  11. Jeanne Mullen says:

    Please leave NAC alone.

  12. Robert Lukey says:

    Please stop the FDA from this type of action. I do not belive this was the intentions when the FDA was started and it should be prevented from doing this type of action.

  13. Krofter says:

    The real reason why they’re going after NAC is because it’s an effective treatment for the havoc the graphene oxide (GO) in the jabs wrecks in those who get them. Think of GO as a knot of razor blades that rips apart mitochondria. The vaxx makers have created a massive customer base for decades to come with the jabs and they’re maneuvering to take full advantage of the millions who are now permanently damaged by the jabs and will need treatment for the rest of their life. Yes, it is the biggest scam ever.
    https://secularheretic.substack.com/p/graphene-oxide-epidemic-2-the-transhumanist

  14. NAC is a necessary supplement to those who, like myself need liver detoxification due to injured or over taxed liver. Now it is available as I need it, allowing me to continue to enjoy what time I have left. Please do not classify as a drug as I have been able to mitigate and control my chemical allergies without paying prescription drug price for it.

  15. Lisa Grimes says:

    Most diets, whether economically rich or poor, do not have all of the vitamins and minerals that are needed for good health. Therefore, supplements can help to provide the nutrients that a person’s diet may not be providing, due to seasonal production, or what vitamins and minerals that are provided may be in a form that an individual person may otherwise not be able to absorb. Each individual and the various ages, often do not fit the “average”. Supplements help to balance this.

  16. Carolyn Andrews says:

    If you make NAC unavailable over the counter and at low cost then you are preventing those who need it from getting it. How does that make sense. You will be responsible for people not staying healthy! What right do you have to do that? Pharmaceutical companies make enough money. You dont need to be party to their influences.

  17. Zoya Ambasi says:

    Please protect access to NAC supplements and support Sen. Lee’s work to hold the FDA accountable for its attack on NAC. NAC is N-acetylcysteine. NAC protects the body from toxins, is a selective immune system enhancer, and helps remove free radicals, which contribute to neurogenerative diseases and aging. 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 is implicated in many serious, chronic diseases.
    Please protect our access to NAC from the dirty special-interest monstrous hands of the FDA. They work for big pHARMa and do NOT care of the health of the American People, who you represent. Thank you.

  18. Peter H. Proctor, MD, PhD says:

    I’m an MD, PhD medical toxicologist. Acetylcysteine has long been used to treat acetaminophen poisoning. This reminded me of something– when I first got into toxicology in the early 1980’s, you had to call the Rocky mountain poison center to use acetylcysteine because such use was “experimental”. So I checked in my library.

    Sure enough, the “Bible” of drug therapy, Goodman and Gillman’s Pharmacological Basis of Therapeutics, sixth Edition, (1980) p704. states “The use of N-acetylcysteine is considered experimental in the United States”. Followed by instructions on how to call the Rocky Mountain Poison center. That is, it did not have regulatory approval in 1980. The same chapter lists acetyl cysteine along with a number of other dietary items sometimes useful in the treatment of acetaminophen poisoning.

  19. sandra s wolf says:

    please protect nac

  20. Carol R Treacy says:

    Please protect access to NAC supplements and support Sen. Lee’s work to hold the FDA accountable for its attack on NAC. This is unacceptable behavior from the FDA

  21. P Messier says:

    We from Canada would like to help, like we were able to do a few years ago, but now your letter sending system is reserved to the US citizens only; it excludes anybody who does not have a Zip code. We don’t.

  22. Claudia says:

    Stop the removal of safe and effective supplements.

  23. Walter Kryshak says:

    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 is implicated in many serious, chronic diseases.

    NAC is far too important to be threatened by the FDA. Our advocacy has brought much-needed attention to this issue; we must support Sen. Lee’s work to keep up the pressure.

  24. Terry Hodges says:

    Stop the war on NAC. It has been around a long time and is perfectly safe. I have been taking it for decades, and I totally reject the FDA’s contempt for all of us, and demand that the FDA drop this protection racket for Big Pharma.

  25. RANDOLPH SKORA says:

    NATURAL REMEDIES HAVE BEEN AROUND FOR THOUSANDS OF YEARS. ONLY DRUG COMPANY GREED IS TRYING TO ELIMINATE THESE NATURAL COMPOUNDS, SOME OF WHICH THEY WILL NEVER BE ABLE TO EQUAL IN EFFICACY.. THEY ARE FIGHTING “Mother Nature” AT WHAT THE EARTH CAN DO BETTER.

  26. James C. Moseley says:

    PROTECT ACCESS TO NAC SUPPLEMENTS!! I have taken NAC products for several years and have found them to be safe, health-improving, and inexpensive. Please do all you can to keep these over-the-counter supplements on the market. Thanking you for your support! James Moseley

  27. Melissa Volz says:

    Do unto your brothers as you wish done unto you. One day your family member may need NAC or something of the like.

    Wake up. May wisdom guide you.

  28. Ann-Marie Bagley says:

    Please protect access to NAC supplements.

  29. David Nolet says:

    Please help keep our access to NAC supplements available. Thank you!

  30. Daniel Safron says:

    It’s so unfortunate and unfair how the FDA seems to be in cahoots with, or at least highly influenced by, the Pharmaceutical Industry. I heard that Amazon has already stopped selling NAC products. There’s no reason for this valuable and safe nutritional supplement to be sold solely as a prescription drug.

  31. Erin says:

    NACs help keep our family healthy while traditional medicine and doctors offer little results. In a world of big pharma, we should still be allowed to use natural remedies that have worked for centuries!

  32. Jana Shiloh says:

    Please protect us from the FrankenFDA They are not protecting us from bad drugs – many of which are killing people. They are trying to force all natural supplements known to protect people from illness, and homeopathy to be shut down. NAC is one, all of homeopathy is another. Natural substances arae going to be required to do “research” the way each drug is, and we know that their studies are beyond questionable for THEIR DRUGS!!!
    PLease stop their attacks. PROTECT OUR ACCESS PLEASE!!! Senator Lee is trying in spite of the bribery/lobbying of Big Pharma. Please do the RIGHT thing!!!

  33. Ann Ritter says:

    I am asking that you allow NAC to continue to be available over the counter to health-conscious consumers. I am 78 years old and in great health. I have used it for many years to keep me that way. Please don’t put profit over the rights of your fellow citizens. We know what works for us.

  34. Maleta Mahalic says:

    NAC is critical to our health. And we (ALL) know FDA is in “BIG PHARMA’S” pocket!!! So they will do anything to get our critical or very beneficial supplements off the market in order to give (BIG PHARMA) the power to control that area. I dont know what I’d do without it because of having “SEVERE” sinus, allergies and asthma. It’s one of my major supplements to allow me to be able to function!!!!

  35. tarbella says:

    Greed is the predominate source of many things and especially in the field of chemicals [ medicine ]. This is not to say there are no good medicines, there are, but there are also many good supplements and herbs for mankind’s health…
    Those that love money so much and care nothing about others are putting themselves in one horrible situation with God, rather they want to believe it or not. He has allowed these people to gain their money and their vanity in hopes they would change…has given them all the time in the world. The time is coming now, when mankind is going to have to make a decision, to go the right way or the wrong way in helping their fellowman. And that includes man’s health…after all, God told us herbs were good for healing and health…look it up, its there in the Bible.

  36. Deana L MacKelvie says:

    NAC supplement has helped me tremendously because I had Lyme disease and suffered for years. Please, please, please do whatever is in your power to allow us access to NAC. Not having NAC would be horrible!

  37. Jeffrey Bell says:

    How do we get a coy of Senator Mike Lee’s letter to the FDA? I think having that available to the public would help us to stop the FDA’s very reckless and evil action in this case.

    BTW, many of those of us on the front line through this pandemic know all too well how helpful NAC can be in combatting covid-19.

    I hate to be so cynical, but is it possible that the usefulness of NAC in helping people suffering from covid-19 is what led the FDA to try to make it inaccessible? Does the pharmaceutical industry view NAC as competing with their very expensive drugs, such as Remdesivir, which, BTW is quite toxic and not very effective?

  38. a concerned American says:

    An attack on human health and access to supplements supporting it, is an act of medical violence. And to extend even further, on the CA Bar’s website, it is written that to hasten death (wherever this actually applies) is legally, murder.

  39. Bharat Adarkar says:

    Support Sen. Lee’s work to hold the FDA accountable for its attack on NAC.

  40. Dr. Jan Corbett says:

    Maintain FDA independence and integrity. Stop bowing to agenda of Pharma’s business plan. Leave NAC alone! Permit the OTC sale of products as they have been sold safely for DECADES! There is no concern for safety here. Merely concern for cornering the market!!

  41. kathleen peterson says:

    Americans want freedom of choice. Being able to use natural supplements is vital. Everyone’s bodies respond differently
    to healing methods. Big pharma should not have control over our health choices. Its all about them making money at our expense hitting our pocketbooks and in many cases keeping Americans unhealthy. I urge our congress to protect our access to NAC supplements and support Senator Lees work to hold the FDA accountable for it’s attack on NAC.

  42. Karen Ahrenholtz says:

    Congress,
    Please please protect access to NAC supplements and support Sen Lee’s work to hold the FDA accountable for its attacks on NAC.
    Thank you!!!

  43. Kaylene Vargo says:

    Protect access to NAC supplements and support Sen. Lee’s work to hold the FDA accountable for its attack on NAC.

  44. Mary Midtbo says:

    Please protect access to NAC supplements and support Senator Lee’s work to hold the FDA accountable for its attack on NAC. NAC is an important antioxidant and precursor to glutathione which plays crucial roles in nutrient metabolism and many cellular events. NAC is important to many patients and has been used safely for decades, which raises the question of why the FDA is seeking to ban it now.

  45. Allen says:

    Sorry, but I am now suspicious of ANYTHING that Republicans support. And that includes you!

  46. Molly A Jakeman says:

    Leave NAC alone, I take it and it has helped so much, why get rid of something that works, oh maybe that is the whole reason, shame on you..

  47. Lorna Fischer says:

    It is the desire of every person who values their personal freedom to make choices for themselves and their families….Thank you for honoring humanity by supporting alternative health options. Thank you for keeping the life force of diversity and personal use of intelligence the power that creates life and at all cost never cowering to force….

  48. Donald Robert Jezwinski says:

    We the people love the ability to choose..

  49. Evie Gaul says:

    We need to keep our Natural healing herbs away from government takeover and the pharma industry!

  50. eileen juric says:

    Thank you for putting your attention to this important issue.

  51. Please do not take away our rights to natural medicine.

  52. Nina Luban says:

    I am copying the letter Senater Blumenthal from Connecticut sent me in response to the “Action Alert” letter I sent from your website.. I’m not sure that I support this much FDA involvement or oversite. I”m not sure that the AFNH approves of that much oversite either. Would appreciate your opinion Here is his letter to me:

    Dear Miss ________,

    Thank you for your message regarding dietary supplements. I appreciate hearing from you.

    As you may know, dietary supplements are not subject to premarket review by the Food and Drug Administration (FDA), or to the rigorous manufacturing practices required of prescription drugs. I support efforts to increase the FDA’s oversight of dietary supplements, and I have urged the FDA and Federal Trade Commission (FTC) to use their full authority to take action against misbranded, adulterated, or deceptive dietary supplements.

    In the 113th Congress, I introduced the Dietary Supplement Labeling Act, which would require dietary supplement manufacturers to register products with the FDA and disclose known risks posed by ingredients on products labels. This bill would curb the practice of manufacturers marketing drinks and foods as dietary supplements to avoid FDA regulation.

    As I continue to work on measures to protect consumers from potential dangers associated with the use of products that have not received FDA approval, I will be sure to keep your thoughts in mind.

    Thank you again for your message. Please do not hesitate to contact me if you have any future questions or concerns.

    Sincerely,

    Richard Blumenthal
    United States Senate

  53. t.antonacci says:

    we need alternate medical treatments.even homeopathic!

  54. Kathy Dabanian says:

    NAC is a life saver for many people! After decades of selling it un regulated should be the reason to keep it that way! It has saved many lives and improved their health. Regulating it now so one company can profit is a crime! For someone with chronic pain that takes pain meds it has helped offset the long term affects of acetaminophen which they put in everything. So my vote is no the FDA has no right to do this for the sake of one or a few companies. I personally would not function without this and SamE. I have had on going issues from Lyme disease and chronic back pain from car accidents and just went thru the worst pain from a compression fracture in my middle back this past April. So my pain meds were upped to help me just to live. NAC allows that without leaving any damage to my liver so I at 63 years old can continue to work cleaning houses. So my point in telling you all this is how important it is to keep this supplement available to all and affordable. Thank you!

  55. Kathy says:

    NAC is a life saver for many people! After decades of selling it un regulated should be the reason to keep it that way! It has saved many lives and improved their health. Regulating it now so one company can profit is a crime! For someone with chronic pain that takes pain meds it has helped offset the long term affects of acetaminophen which they put in everything. So my vote is no the FDA has no right to do this for the sake of one or a few companies. I personally would not function without this and SamE. I have had on going issues from Lyme disease and chronic back pain from car accidents and just went thru the worst pain from a compression fracture in my middle back this past April. So my pain meds were upped to help me just to live. NAC allows that without leaving any damage to my liver so I at 63 years old can continue to work cleaning houses. So my point in telling you all this is how important it is to keep this supplement available to all and affordable. Thank you!

  56. Kathy Pearson says:

    NAC has been helping me with asthma and COPD for quite some time. Removing my ability to easily purchase it would be detrimental to my health and quality of life.

  57. errol phillips says:

    This is more of the Fascism we see in our government. The FDA has become the pitbull for Big Pharma, an industry riddled with crooks of every stripe. Big Pharma was responsible for over a half-million American deaths from Covid-19 because they wouldn’t support things like hydroxychloroquine, Ivermectin, and colloidal silver — all proven remedies that are not only extremely effective but proven to be very safe. It was all about money and power, not saving American lives.

    Fauci has gotten by with serial lying and the FDA has gotten by with serial and blatant corruption. Now they think they own medicine in America. They can go to hell, and no doubt will.

  58. Keith Crudgington says:

    LEAVE MY SUPPLEMENTS ALONE

  59. Anton McInerney says:

    Violation of free choice of treatment!

  60. Blair says:

    This has improved my quality of life so much!!

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