FDA Moves Toward Monopoly Medicine

July 1, 2021

A regulation that threatens supplement access is gaining traction. Action Alert!

A well-organized, coordinated campaign from the FDA and Big Pharma is threatening access to the supplements you depend on. Using the false premise that supplements are unsafe, the FDA is working to gain more power over the regulation of supplements in order to further solidify Big Pharma’s monopoly over medicine. These efforts must be opposed.

The House Appropriations Committee report for the FDA’s 2022 funding contains concerning language regarding the development of “mandatory product listing and registration” for dietary supplements. The Committee report states that members are concerned with the “lack of robust regulation of dietary supplements, some of which cause an estimated 23,000 emergency room visits per year.” The Committee encourages the FDA to “issue regulations requiring mandatory product listing and registration to create transparency in the supply chain.”

This language isn’t enough to give the FDA the power to create a mandatory list; Congress would need to pass legislation giving the FDA this power. What is concerning, though, is that this issue is on Congress’s radar, so we may see such proposals in the not-too-distant future. We also know that the authority to create a mandatory list of supplements is something that the FDA has asked for a number of times.

Simultaneously, news articles appeared this week describing how some bad actors in the industry use illegal ingredients in predominantly weight loss, sexual enhancement, and body building supplements, seeking to justify a push for more regulation. This can’t be a coincidence.

The stated purpose for mandatory listing is to improve the FDA’s ability to root out these kinds of bad actors who sell dangerous products, since the agency claims it has little information about the thousands of products on the market. It is a laudable goal, but the FDA already has the authority to go after companies that break the law and use illegal ingredients, including those referenced in the news articles this week. The agency can, and has, enforced this law, as it should.

Using safety as a justification to give the FDA more power over supplements is a smokescreen because we know that supplements are overwhelmingly safe. The report language refers to 23,000 hospitalizations from supplements. To put this in perspective, acetaminophen alone causes 50,000 emergency room visits and 25,000 hospitalizations every year. So, even if we accept the government’s figure, all dietary supplements cause as many hospitalizations as a single drug. Properly prescribed drugs are estimated to cause 1.9 million hospitalizations a year.

Do supplements really cause 23,000 hospitalizations per year? This number comes from a 2015 Department of Health and Human Services-funded study, and we issued a critique when it was released. More details are provided in that coverage, but we’ll briefly note here that over 20% of the cases analyzed were the result of unsupervised children swallowing pills and 40% of cases among those 65 and older were caused by choking.

The idea that supplements are unsafe and more regulation is needed doesn’t pass the laugh test. So why would the FDA want more power to go after supplements which are overwhelmingly safe, during a pandemic in which the evidence shows supplements can help support health?

We believe this is about extending Big Pharma’s monopoly power over medicine. A mandatory list could be used by the FDA to target and eliminate supplements that have not yet complied with the agency’s over-reaching “new supplement” policy. Recall that the FDA’s “new supplement” guidance seeks to impose drug-like pre-approval requirements on all “new supplements” that came to the market after 1994. The “new supplement” policy has not been completed yet, having languished in draft form since 2011. But the FDA just indicated that its goal is to complete this policy by the end of June 2022.

A mandatory list of all supplements and a completed “new supplement guidance” would be potent tools for the FDA to efficiently remove thousands of supplements from the market. With a comprehensive list of products, the agency could very easily create a supplement “hit list” and remove supplements that it believes have not complied with the guidance, which is already expected to eliminate as many as 41,700 products from the market. A mandatory list makes the FDA’s job that much easier.

A mandatory list is also a concern because of its likely use to create a list of supplements, potentially including high-dose supplements, that might lead to “adverse events,” similar to a legislative effort by Sen. Dick Durbin (D-IL) we defeated a number of years ago. A mandatory list could be used to target supplements and to remove “dangerous” high-dose supplements that don’t gel with the government’s pitifully low recommended dosages.

We must oppose these efforts. The FDA, in conjunction with Big Pharma, is working methodically to eliminate all healthcare options outside of drugs. We see similar dynamics playing out with NAC. NAC is a critical supplement that has been available for decades, but all the sudden the FDA has issued warning letters stating it isn’t a legal supplement, saving this essential compound for the drug industry. We must fight for our right to choose the healthcare options that best fit our needs.

Action Alert! Write to Congress and tell them to oppose any effort to establish a mandatory list for supplements. Please send your message immediately.

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49 responses to “FDA Moves Toward Monopoly Medicine”

  1. Lynda Grandinetti says:

    HELP!! I’m 72 yrs old and I LOVE my vitamins and supplements. I despise meds from Big Pharma – remember – sooo many overdoses!! I am 1000% certain that the ONLY reason I didn’t get Covid is because I take lots of Vitamin C and other necessary vitamins.

    The FDA is CORRUPT and they MUST BE STOPPED. Big Pharma is CORRPUT and MUST BE STOPPLED.

    I’m sorry that I only have a very small income. Getting old means getting POOR. I have ZERO money to give – but I will be sending POSITIVE energy into the Universe to STOP THIS. STOP BIG PHARMA. STOP THE FDA.

  2. Norman Cavior, Ph.D. says:

    I have been using supplements for more than 30 years, since I was diagnosed with Type II diabetes more than 30 years ago. I was also told, many years ago that I would develop prostate cancer within a years. I started using supplements to deal with these 2 issues. I am currently 86 years old. Supplements have likely helped me to avoid more serious ailments and to maintain my current state of good health. Pleasxe do not shut down the supplement industry.

  3. Bernadette Belcastro says:

    Using safety as a justification to give the FDA more power over supplements is a smokescreen because we know that supplements are overwhelmingly safe. The report language refers to 23,000 hospitalizations from supplements. To put this in perspective, acetaminophen alone causes 50,000 emergency room visits and 25,000 hospitalizations every year. So, even if we accept the government’s figure, all dietary supplements cause as many hospitalizations as a single drug. Properly prescribed drugs are estimated to cause 1.9 million hospitalizations a year.

    This is just another case of big Pharm wanting more money from people who can ill afford it. It is shameful how little our government considers the welfare of the people.

  4. Linda Shea says:

    I take a variety of supplements every day and I am in excellent health because of my supplements. My physician is fully aware of what I take and supports me in this endeavor. It would be a big mistake to remove these life supporting aids from the public’s ability to take responsibility for their health.

    Please oppose any effort to establish a mandatory list for supplements.

    Thank you,

    Linda Shea

  5. Marvin L. Zinn says:

    Well of course! Federal government gets more money for Pharmacies returned with tax. This is comparable with COVID-19 made about 4 years ago by doctor Rashid Buttar in charge. It was made for science experiments never intended to be released. He reported after this project was completed, it was sold or stolen for pharmaceutical profits.
    Drug stores sell a lot of junk food with the most dangerous addictive drug in the world – SUGAR! That gives them more profits from drugs the doctor prescribes.
    My most quoted Bible verse is 1 Timothy 6:10 “Love of money is the root of all evil!”

  6. Francene Shed says:

    How many years has BigPharma denied the efficacy of supplements? Quite a few as I recall. But now they see a way to make more money! Hello! Back off BigPharma!!!

  7. Merna Kochel says:

    Having a life-time of autoimmune disorders I could not live without the natural and well-documented ones I take from my physician. Please do NOT take this life-line away from people like myself.

  8. MaryAnn Siniscalchi says:

    Unfortunately in NC, Senator Burr has been absent for the last five years after announcing his intention to retire in 2022 shortly after being reelected in 2016 and Senator Tillis is bought and paid for by Big Pharma. Senator Tillis’ office staff spews Big Pharma’s lies on any topic related to compounded drugs and supplements. No interest is doing what is best for the citizens for NC but only interested in accumulating wealth supplied by Big Pharma. No point in signing anything as I don’t need another blah-blah-blah response extolling the wonders of Big Pharma and Big Brother FDA needing to control and supress all aspects of healthcare that doesn’t line Big Pharma’s pockets. Also the implied insulting language that my health care provider and I are too stupid to know what is medically best for me and what has worked for the last 11 years.

  9. Judith Lavezzi says:

    I take supplements and I take FDA approved medicine both. I try to take a reasonable approach to the medicines and the supplements I do take. It is my impression that you work for pharmaceutical companies more easily than you do natural health products. I ask you to consider getting off the neck of the vitamin and supplement industry and let people, with informed decisions and research- readily available, I might add – purchase what they will. You are charged with the care of people’s unknown drugs- and you have a grave responsibility to do that. Please do that well. and please let go of the natural health field.
    sincerely,
    Judith Lavezzi

  10. Sy;via Schultz says:

    Thank you for notifying me about this.They should keep their hands off our supplements.

  11. Scott Jon says:

    The only thing which needs to be done with supplements is to reign in false claims. However, ALL non-toxic materials should be accessible to the public, period. Let the marketplace determine what works and what does not. Stop meddling in things you have no right to entangle.

  12. Sharon Powell says:

    Please oppose any effort to establish a mandatory list for supplements!

  13. alexei says:

    You have pressured me to write to my Representatives so many times on this issue that they have stopped even acknowledging my emails, let alone explain their own position on the subject.

    I have also come to the conclusion that there actually needs to be SOME regulation on supplements since as things stand, the customer has no proof any products on the market actually contain the ingredients listed.

    • Beverly says:

      Your post immediately gave me a gut punch. Are you sure your Congress critters are no longer replying to you or do you think maybe the email sensorchimp might be keeping them from arriving @ their destination? It had never crossed my mind before which makes it more likely this might be the case – because I know the way my intuition works and a gut punch gets my attention!

      I can say with certainty that I have not received 4 emails which were sent to me and 3 which I sent but did not reach their destination. I know this chimp is real.

      I would not put it past both sides to control the narrative. One asks the other to keep so many comments from reaching those critters who could do something – and bingo it’s cut in half or more!

  14. Steven Andrychowski says:

    People have a right to choose.

  15. Nancy Howard says:

    I am still alive almost 8 years after doctors assured me I would live no longer than 2-3 weeks following open heart surgery. And the reason I truly believe this is so is due to natural supplements. I put together a regimen that complements my prescribed medications and what do you know. Still here.

    If the FDA or any other entity takes away my right to natural supplementation, that would be a travesty on the highest level. This is absolutely a life and death issue. Please do not allow any changes in our rights and keep our supplements legal and easy to procure.

  16. Thomas Esposito says:

    Leave over-the-counter supplements alone.

  17. Peter Booth Lee says:

    Monopoly is BAD for Our Health!

  18. CAROL Harry says:

    Please do not allow the FDA to establish a mandatory list for supplements. They already have enough power to remove harmful products. We should have freedom to choose the products best for our health needs.

  19. jim schnelle says:

    this is not needed leave supplements alone

  20. Laura says:

    More people die from medications given by doctors every year than people ever have died from supplements. I have easily gone to 20 to 30 doctors trying to fix my condition and they kept telling me there was nothing wrong with me. Going to an alternative doctor, and supplements has helped me where the regular doctor just gave up on me. I speak to many people during the year who have similar issues and they also pursue alternative treatments because doctors do nothing for them. Please do not let this happen. The FDA has the authority to take supplements off the market that are detrimental to ones health. They do not need to give supplements to doctors or pharmaceutical companies. It is Unnecessary!

  21. Ronald Elmore says:

    A tiny few supplements have caused humans problems, however the elephant in the room-pharmaceuticals have created innumerable illnesses to people. Get your priorities straight!

  22. Joe Myers says:

    No AGENCY or CIVIL SERVANT has the Constitutional authority to force or manipulate anyone to use any so called medicine the crony FDA promoted because the FDA is bought and paid for by Big Pharmacy!!!

    No AGENCY or CIVIL SERVANT can deny anyone the use of any natural remedy solution they choosers use for their health!!!

  23. Linda says:

    Stop big pharma from infringing on our rights to use alternative healing supplements and practices. It took too many years for the U.S. to allow acupuncture to be legal, now it is time to admit all alternative healthcare options outside of drugs. Break up (too big to fail) big pharma before it destroys us with their greed to prevent our rights to choose the healthcare options that best fit our needs where they don’t make a profit.

  24. David clinton says:

    I believe that all supplements should VOLUNTARILY list all ingredients. Were the supplement industry totally transparent they could keep government out of the regulatory p pop rices.

  25. Karl Hamann says:

    Keep supplements safe and legal. No monopoly medicine!

  26. Jennifer Lauer says:

    How about we make a list of all of the FDA approved pharmaceuticals that kill hundreds of thousands of Americans every year? Statins, sleeping pills, opiates, just to name a few! I’ve never heard of anyone dying from a supplement!

  27. Yvonne P. White says:

    I (an ordinary citizen), am writing to you to ask you to oppose any effort ( including by the FDA and Big Pharma) to establish a mandatory list for supplements.

    Thank you for your consideration concerning this very important matter.

  28. Lundi says:

    Congress, please oppose any effort to establish a mandatory list for supplements. I have been doing business from an established company that sells these supplements for years. I have never had any reaction or problem with them at all, quite to the contrary — they work! I had bone on bone knees to the point I could not walk. When I seen an arthritis specialist he wanted to give me some kind of shots to my knees but I told him I had to think about it. When I told my friend about it her husband had overheard us talking and told me not to take the shots because they hurt worse than his knee pain. I took his advice and did not get the shots. I started to research methods to get rid of the knee pain and found this company that sold a triple joint soother consisting consisting of glucosamine, chondroitin and MSM. I tried it for a few weeks taking it as directed. After a couple of weeks I still was having the knee pain and decided to take It one more more week. That week it must have kicked it cause to this day I no longer have any pain in my knees This was In was in 2002. One time I had run out of it and thinking I was now fine I didn’t pre-order it. After not taking it for a couple of weeks the pain came back full force. Since that day in 2002 I have never let myself run out of it again.
    I have purchased other products from this company. I have ridded myself of a kidney infection by myself by taking green tea capsules and Cranberry gel caps. I’ve purchased colloidal silver from this same company as it was touted as a “natural antibiotic”. I tried using it for my children’s ear infections and it cleared them up in no time without having to go see a doctor saving me both time and money. Please do not take these products off the market.

  29. Lynette Daudt LAc says:

    Can you pull together the numbers of iatrogenesis annually or hospital mistakes? 23,000 seems so small. Especially if 60% of that 23,000 is child and elderly error — not the supplement itself causing harm. This could be helpful for resisting the push for regulation.

  30. francesca testa says:

    The FDA, in conjunction with Big Pharma, is working methodically to eliminate all preventative healthcare options outside of drugs.

    Please oppose any effort to establish a mandatory list for supplements!

    Thank you.

  31. Bharat Adarkar says:

    Please oppose any effort to establish a mandatory list for supplements.

  32. lorraine foster says:

    Find something important to the nation to worry over!!

  33. Betty Morton-Perich says:

    Please keep the government from taking away our rights to have our supplements!

  34. Erin Bailey says:

    Please stop the overreach of big Pharma in limiting the public’s free access to supplements.

  35. Margaret Wisler says:

    Please don’t let this happen!

  36. Deborah Richards says:

    Supplements are safe and beneficial that must be available to all!

  37. Gayle Longhurst Longhurst says:

    This has to stop. Allow natural health to always be here, not an industry that only makes money when you’re sick

  38. Sinikka Pember-Coulter says:

    It is insane that the FSA and drug companies want to regulate and control natural supplements due to safety concerns! I am 63 years old. Take no medications and use about 9-13 different supplements a day. I am in excellent health, and credit the supplements with saving me, my husband who is a liver transplant recipient, and my 91 year-old mother in law with a history of strokes, from suffering greatly with Covid. She got Covid a few days after taking the flu shot, and then passed it to me and my husband! I take no vaccines as they make me sick, but believe in vitamins D and C, and zinc, as well as oil of oregano. These have no side effects at all, and protect the immune system in remarkable ways. We need to protect our rights as citizens to make our own choices concerning health care. Drugs are not the answer. They do not cure but rather cover up symptoms. Vitamins and nutritional products in general enhance health and prevent disease from starting. Plus they are inexpensive to produce in most cases. They make so much more sense than drugs for our national health care!

  39. Virginia Creitz says:

    I do believe that some supplements have ingredients that could be harmful so emphasis should be on having guidelines to be sure they are safe not reducing sale but concern for product. For me l would not trust it if made in China!

  40. Rose Walker says:

    Stop the monopoly!

  41. Penny Johansson says:

    Only I should be the one who determines what goes in to my body and what doesn’t. I’m an educated person doing my own research on health, illness origins and supplements, and I have lived through decades of multiple painful conditions no doctor could figure out no matter how many tests they did. And they had absolutely no answers to give either, not even suggestions. Now, thanks to further education and enlightenment on my own, I am managing my personal health and freeing myself up from a life time of woes and sick time away from a productive life, thanks to diet and supplementation that is just right for my constitution and genetic makeup. Don’t you dare remove supplements that are life saving to people like myself! That is arrogance beyond belief, and all to give a few folks even more dollars in their fat pharmaceutical (non-helpful pills) pockets. It is appalling – and extremely unethical to say the least! We have rights, you know.

  42. Kris Knoll says:

    If America is “land of the free” … why are so many restrictions being attempted on our right to determine what we put in our bodies? My good health depends on supplements; the current value of food has diminished so badly as the land has lost nutrients. Supplements are crucial to many people and any attempts to prohibit access are simply a way that big pharma can make more money. Stop selling us out! This is supposed to be government of the people, not of the corporations.

  43. Margaret Batty says:

    Please oppose all effort to establish a mandatory list for supplements.
    Thank You,
    Margaret Batty

  44. MELINDA HEBERT says:

    THIS JUST GOES TO SHOW YOU THAT BIG PHARMA HAS CONGRESS UNDER ITS CONTROL! POLITICIANS SHOULD BE ASHAMED OF THEMSELVES! WHY DON’T YOU DO YOUR JOB AND PROTECT US FROM BIG PHARMA AND BIG AG!

  45. HANDS OFF OUR NATURAL FOODS SUPPLEMENTS!!!

  46. eerolex.com says:

    superb content, i like it

  47. Emily says:

    Stop trying to mandate Nature. God gave it to us for a reason. Oh wait you don’t believe there is something far greater than you.

  48. John says:

    Food supplements are key to health as our food producers are for making money, not our health and the food they produce are missing what our body needs for good health. This is why we need ALL the supplements to help our body! Now we ALL don’t take ALL the supplements available as each one of us are different as we eat different “foods” and our body’s have different supplement needs.

    I would be dead if I hadn’t found the supplements to help reverse my health issues!!!

    Drugs COVER UP health issues, they don’t solve them!

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