Your Supplements on FDA’s Hit List

A new regulation for supplements threatens access. Action Alert!

The FDA is on the record supporting mandatory product listing for dietary supplements—that is, requiring each supplement manufacturer to register all the products it makes, including all the ingredients of those products, with the FDA. It’s a strong possibility that with a Democratic appointee—which could be anti-supplement crusader Dr. David Kessler—as FDA commissioner or Secretary of Health and Human Services (HHS), this dangerous regulation will be aggressively pursued. Make no mistake: this innocuous-sounding proposal could spell big trouble for supplement access. We must proactively oppose it.

The stated purpose for mandatory listing is to improve the FDA’s ability to root out bad actors who sell dangerous products. It is a laudable goal, but the FDA already has the authority to go after companies that break the law and use illegal ingredients. The agency can, and has, enforced this law, as it should.

The mandatory list is a concern given the current state of the FDA’s “new supplement” guidance. This guidance, seeks to impose drug-like pre-approval requirements on all “new supplements” that came to the market after 1994. The FDA’s proposed definition of a “new supplement” is extremely broad, and the agency’s guidance is estimated to eliminate as many as 41,700 products from the market. A mandatory list could then be used to target and eliminate supplements that have not yet complied with the FDA’s over-reaching policy.

A mandatory list is also a concern because of its likely use to create a list of 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. In that case, the list would be created by the FDA and the National Academies of Science, Engineering, and Medicine (NASEM)—the same body that once said people up to the age of 70 don’t need more than 600 IU of vitamin D per day, and above 4000 IU may be dangerous. Keep in mind that researchers are recommending 4,000 IU of vitamin D a day to help reduce the severity of COVID-19. Some people may need four to five times that amount to achieve optimal blood levels of 60 ng/ml.

The point is this: 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. It doesn’t matter who is in office, this is a threat: Dr. Scott Gottlieb, former FDA commissioner under Trump, voiced support for the idea.

The main issue, though, is the FDA’s still-incomplete “new supplement” guidance that threatens thousands of supplements on the market, which, under a Democratic administration, is in danger of moving forward. We have to push back.

Action Alert! Write to Congress and tell them to oppose the “new supplement” guidance being completed as is. Please send your message immediately. By sending this message, you will also be supporting our petition to ungag doctors so that they can share with patients the benefits of supplements and natural treatments for COVID.

70 comments

  1. I’d like to do this but I don’t want to perpetuate the idea that Biden has a right to assemble a team while the election is being legally contested. Can you create a petition that fights this situation without this angle?

    1. So you want to use the legal system to prevent overreach about your supplements, by supporting the abuse of the legal system and legitimizing Trump’s overreach on an election he lost?

  2. I would gladly sign your Action Alert except that I will NEVER give my phone number. If you want me to ever sign anything, please remove that requirement.
    Thank.

  3. Do not take my supplements away. They have helped keep me healthy as I age (82) and in better condition should I ever need surgery according to my health providers.

  4. I do not agree with you. I want to know exactly what is in every thing I put in my mouth. I have been in stores selling all kinds of so called heathly herbs. My husband was a natural products chemist and knew how risky it could be to trust the claims made on the bottle. I want more regulation of these drugs, not less. Treatments with Natural Productst need more research and testing to find the benefits and risks.

  5. Iam totally against taking a vaccine that is so new and who knows what weird side affects we will all have . This needs mere study more testing . I don’t like it one bit!

  6. People need to be informed about supplements, not shut off from them as if we were kindergarteners.
    Many are extremely helpful and make notable differences in well-being. We do not need interference and misguided attempts at eradication. Why not promote education instead of suppression?
    Thank you.

  7. Big Pharma is worse then the Drug Cartel and Doctors are glorified drug pushers!
    The American public should have the option of choosing to treat themselves with vitamins, natural supplements and homeopathy! I don’t take any prescription medication at all, it’s becomes an endless cycle of one band aid after another, with side effects that are off the charts. Stop the damn money grab!!!!!

  8. MONEY ALWASY SEEMS TO BE THE MAIN TALKER.
    WE HAVE BEEN ON NATURAL SUPPLEMENTS FOR YEARS. They have kept us healthy through thick and thin. My husband is 84 and takes nothing but one prostate medication occasionally. I am 78 and take different supplements but no drugs. We never seem to get sick.
    I think that it is time doctors have the right to use natural supplements to heal. But of course, money always talks.
    At least give each individual the right to decide what they would prefer and not force drugs on all of us that study and practice alternative medicine and have used it successfully for many years.

  9. The FDA should only just randomly check that various supplements consist of all the ingredients and milligrams/micrograms listed on that supplement’s labeling! If the FDA starts to require what they do for Big Pharma’s medication drugs then supplements will just end up becoming super expensive and unaffordable for most people to purchase,just like so many of Big Pharma’s Medication drugs have become so overpriced!

  10. Please do not nominate Dr. David Kessler to head the FDA or HHS. He has an axe to grind, and we do not need any more of that.

  11. Supplements are very important to the health of a great many people. The supplements prescribed by my naturopathic doctor saved my life. Please make sure consumers have access to these safe and effective health aids.

  12. Please support our petition to ungag doctors so that they can share with patients the benefits of supplements and natural treatments for COVID – oppose the nomination of Dr. Kessler to head the FDA or HHS!

  13. Please oppose the nomination of Dr. David Kessler to head the FDA. Please allow doctors to use the best methods possible, which include supplements, to help with treatment/prevention of COVID.

  14. I take a vitamin for my vision (AMD). It has helped so much hold the AMD at bay. Please don’t do anything to interrupt the

  15. Banning supplements would be a disaster for the public health of the American people. DON’T DO IT!

  16. There is a such thing as the wrong person. Dr Kessler is the wrong person. Do not hurt the last lifeline folks have if they can not afford health care or pharma prescriptions. Let it remain a choice.

  17. I strongly oppose the nomination of Dr. David Kessler to head the FDA. Because of governmental mismanagement, the nutritional desity and quality of American foods have suffered. We need the freedom of wide choices in our supplements. Dr. Kessler has a history of opposing those necessary freedoms for our choices in supplements.

  18. I, and my family,take a number of qualified suppliments, and, have had very good health support from taking them. I think you know, or can determine, which ones are suspicious, without causing such an upheavel with the reliable companies.

  19. Leave my supplements alone. I have the ability to critically think for myself and research products. I do not need nor want government infringement on my right of free choice!

  20. I adamantly support supplements and natural treatments. They have kept me in excellent health for over 75 years! Please don’t make any changes to regulatations!

  21. I oppose the nomination o Dr. Kessler to be head of the Food and Drug Administration . I stay healthy and am never sick due to my ability to purchase high dode vitamin D3 ,other supplements like Vitamin C, Zinc, B complexs, and different hebal extracts or compaounds that have been very effective as afr as my health status and very small history of having to seek treatment from the medical health care system. nominating him during a pandemic would only cause difficulties with people being able to maintain a vibrant and always well health statu.s

  22. This is just another way to control our heath and lives, and rip us off via big pharma as well!

  23. Especially at a time during the greatest pandemic of the century, this is not the time to deny people supplements they may be taking to boost immunity and help defend themselves from catching Covid-19!!

  24. The Who population needs to stand up to the FDA.. and then put them out of business. They are no longer doing what there job is.. they are totally out of control..

  25. Please leave our supplements alone. They are already cleaner than most of the food we eat.

  26. Oppose the nomination of Dr David Kessler to head the FDA or HHS. We need to buy supplements without their interference. If we want to “overdose” on supplements then we should be able to. God gave us a brain to use.

  27. There is no reason to regulate these supplements. People should be in charge of their own health.

  28. I’ve been using supplements for 20 years and it sure beats some drugs from Big Pharma. One must be careful and buy only quality products but that is the buyers choice and his or her choice. I am capable of checking all supplements that I buy and will continue to do so.

  29. These possible actions take away my freedom to choose and decide what is best for me. Worse, these possible actions could limit specialists’ advice for what is best for me. Our government has no right to be my brain.

  30. The only regulation that needs to occur for supplements is that of accurate content in the supplement. It is important that supplements contain what they say they contain. Let the consumer decide what works best for them with regard to supplements.

  31. Please stop the addition of Dr. Kessler to the Biden team as he is anti-supplements. Please choose anyone else.

  32. As someone who has benefited greatly from a serious chronic health condition by using targeted nutrient supplementation and who now works as a clinical nutritionist who helps others with chronic health issues with diet and targeted supplementation, I urge Congress to oppose the nomination of Dr. Kessler to head the FDA or HHS. Many health conditions can not be resolved by medication alone. Most physicians are not trained in nutrition, diets and natural support for these conditions. Thus, many are not served by medicine alone.
    Linda Clark, MA, CNC

  33. These are absolutely unwarranted limitations on vitamins that are 100% safe for us Americans to take at our own discretion!! The FDA must not be allowed to impose these ridiculous and unscientific restrictions!! Vitamin/mineral supplements are not and cannot be under the FDA’s jurisdiction/scrutiny!!!

  34. Supplements are like medication – we actually have different responses to them. Why it’s up to us to make those decisions — NOT the FDA!

  35. Please do not take about our right to alternative healthcare measures. Supplements have saved my life – no exaggeration. Pharmaceuticals nearly killed me. The FDA should not be using their agency as a bully pulpit.

  36. Please oppose Dr.Kessler for the nomination to head the FDA or HHS. It’s time for people to care more for others other than themselves. Some people have got to quit putting a chock hold on those that seriously [ good doctors ] could and want to help others. I will say this…God is truly watching that free will people have. Do good unto others…that’s called love.

  37. The day Dr. Scott Gottlieb held a meeting in D.C. w/people who came from all states and opposed to vaccines, the Trump Administration asked for Gottlieb’s resignation and before the meeting expired, news hit the airways that he resigned. He was a swamp creature and was asked to leave. I’m not sure the reputation of the current FDA Commissioner but hopefully he isn’t another Gottlieb.

  38. Health freedom!
    For doctors and patients!
    Alternatives and Big Pharma can co-exist!
    Stop the Monopoly!

  39. Ungag doctors so that they can share with patients the benefits of supplements and natural treatments for COVID.

  40. Please oppose the “new supplement” guidance! As one with a Traumatic Brain Injury and epilepsy, pharmaceuticals are in most cases too dangerous for me, and natural options are essential for me.

  41. We need the freedom to CHOOSE, not this draconian type of measure against free will given to us by God.

  42. At this time, with COVID 19 at such high rates, research has shown Vitamin D, high potency Vitamin C and Zinc are essential to ward off disease. Those with low D levels were very likely to contract and die. This is no time to take good supplements off the market.

  43. Most people have a Vitamin D3 deficiency and taking this Vitamin D3 reduces the result of contracting the Covid 19 virus. This is absolutely outrageous.

  44. This is a great idea. I hope FDA is successful, now that Orrin Hatch isn’t around to stop regulation of an industry that could harm millions.

  45. I can’t believe this guy is still around..As a health food retailer in the 80’s and 90’s
    we fought our asses off against this guy to save our supplements….what a drag..
    We won then we will do it again…What a terrible decision Dr. Fauci

  46. I AM APPALLED THAT SOMEONE COULD BE SO EXTRAORDINARILY IGNORANT REGARDING THE IMPORTANCE OF NUTRITIONAL SUPPLEMENTS TO PEOPLES OVERALL HEALTH!!! WHILE RX DRUGS ARE KILLING THOUSANDS OF AMERICANS A YEAR, NUTRITIONAL SUPPLEMENTS ARE ACTUALLY SAVING LIVES. THERE IS MASSIVE RESEARCH PROVING THIS. FURTHER, I AM ONE OF THE AMERICANS WHOSE LIFE HAS LITERALLY BEEN SAVED BY THESE SUPPLEMENTS. WE HAVE A DIVINE RIGHT TO CHOICE. MY CHOICE LIKE MANY OTHER AMERICANS IS TO TAKE NUTRITIONAL SUPPLEMENTS. BY THE WAY, I AM 76 YEARS OLD AND IN FAR BETTER HEALTH THAN MOST PEOPLE 1/3 MY AGE., THANK YOU YANENA

  47. There are a lot of snake oil salesmen out there. Example- St Johns Wart. 6 different brands were tested. 2 had what they claimed. The others had some or none of the product and one was moldy. Another is CBD. Unless they have been tested by an independent lab you can find most anything in any amount and even if it is CBD, there is a lot of different substances that are all labeled full spectrum. There are a lot of unscrupulous people out there

  48. It is not only vitamins/minerals. They seek to regulate the very foods and seasonings you put in your mouth. Colostrum is one of the most highly researched/awarded foods out there. It is first MILK. Look at the warning letters issued for turmeric. People from India or those who love Indian cuisine should raise a ruckus.Many opposed ObamaCare because it only requires you buy one type of medical insurance. It is NOT health insurance. It is coverage for medical care which diagnosis and manages diseases, and not very well at that. It will NOT pay for naturopathic or alternative care. The type of care one chooses to seek should be a choice. To force people to buy something they will NOT use is wrong. Many will not use pharmaceuticals. Many cannot. Now what? If the FDA does not have an answer to this, they should bow out. They are abusing an authority they were never given. Someone posted physicians know next to nothing about natural supplements. They never studied this. They only know about natural/alternative care when THEY start to get sick and KNOW the poison they have been prescribing will not work. The natural recommendations for COVID from MD’s are a result of them desperately seeking to protect themselves. Natural supplements have a protective roll as well as a preventative roll but they only want to sell vaccines, Remdisivir, and Regeneron. Your money or your life! Some MD’s openly admit they had ZERO training in natural supplements. ZILCH. Why in the name of PEACE would someone ask their MD how much tulsi should they consume? You always read “ask your doctor before starting any supplement”. Why would you? They know no more about it than people who have used natural supplements for 40, 50, 60 years. How many people would not have succumbed to COVID or even contracted it had their MD KNOWN to check Vit D/Zinc levels. When they cry about the hospitals being overwhelmed, that is their fault. Further, the few who are bravely recommending supplements don’t know what they are doing. You never take Vit D without the correct amount of Vit K and extra magnesium. You never take zinc, except short term, without the proper corresponding amount of copper. This is a time to optimize nutrient levels, not overdose them. Neither the FDA nor anyone trained allopathically knows anymore about this then the people here. BUT. It is your body, your risk. The FDA only needs to regulate contaminates. They don’t do a good job with our food much less our supplements. America has got to stop voting people into office and then ignore what is going on for the next four years. Few attend precinct meetings, serve as poll workers, attend their county meetings, issue RECALLS of elected officials, or write their elected officials weekly. But they can sure spend a lot of time on Facebook, Twitter and the like. People don’t take our freedom, we give it to them. Starting with privacy which means you gave them your dignity. People sell their dignity (privacy) for a Facebook account, a smart phone, and the myriad of GPS junk in their homes. Heaven forbid anyone should vote with their remote or money. Heaven forbid anyone should refuse to donate blood, organs, or money to research groups UNTIL the federal government backs off and backs out and write to all off Congress, AMA, FDA, CDC etc. and anonymously tell them why. That would require growing a pair. Petitions and marching with little placards are useless. When you take what allopathy and research pharmaceuticals needs to function, then you will have their attention.

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