NDI Supplement Guidance is Just a Bait-and-Switch—and Time Is Running Out to Stop It!

October 25, 2011
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FDA LogoOnly 38 more days to tell FDA and Congress that the proposed rules for supplements could lead to the elimination of thousands of supplements and make the surviving ones much more expensive.

When FDA issued their draft guidance for New Dietary Ingredients (that is, supplements), the agency was perverting congressional intent—the congressmen who wrote the original legislation even told the FDA commissioner before the guidance was issued that it needed to be fully consistent with DSHEA! FDA was also attempting to circumvent the notification system Congress intended by instituting a scheme that mirrors the Waxman supplement pre-approval system, introduced in 1993, which DSHEA was intended to stop.

Here’s some important background for you.

Supplement and integrative medicine champion Sen. Orrin Hatch made this statement when he introduced the bill for DSHEA, the Dietary Supplement Health and Education Act of 1994:

In our free market society, consumers should be able to purchase dietary supplements and companies should be able to sell these products so long as the labeling and advertising are truthful, non-misleading, and there exists a reasonable scientific basis for product claims.

Unfortunately, not everyone in our federal government shares these views. For more than three decades, FDA has tried to restrict severely the ability of the dietary supplement industry to sell and market its products and, consequently, the ability of consumers to buy them. The agency has repeatedly attempted to impose unnecessarily stringent standards that would leave many if not most supplement companies with no practical choice but to close their doors.

In sharp contrast, Rep. Henry Waxman wanted dietary ingredients and nutritional supplements to be considered food additives and therefore subject to FDA approval—not unlike the system that is used for drugs. So Waxman introduced the Dietary Supplement Access and Claims Moratorium Act of 1993. This bill would have amended the food additive definition to include dietary ingredients (supplements)—thereby making supplements subject to the food additive approval process.

Happily, cooler heads in Congress prevailed. Sen. Hatch explicitly stated:

As you know, [DSHEA] makes clear that dietary supplements are not food additives or drugs, and that the burden of proof shall be on the FDA to prove that a product is unsafe.

Consequently, when DSHEA was passed, dietary ingredients were specifically exempted from the definition of “food additives,” making supplements not subject to FDA pre-approval. All that was needed was a simple notification.

Now FDA has offered its draft guidance—which attempts to circumvent DSHEA as it was passed and create a new pre-approval system. Everything about this proposal is a perversion of congressional intent, and will (as Sen. Hatch told the world eighteen years ago) severely restrict your ability to buy nutritional supplements and leave many—if not most—supplement companies with no practical choice but to close their doors.

Time is running out—the comment period ends on December 2! Help us protect your access to supplements. We need everyone reading this to send their message to Congress and FDA right now to make sure the FDA and Waxman don’t win! Take action today!

103 Responses to “NDI Supplement Guidance is Just a Bait-and-Switch—and Time Is Running Out to Stop It!”

  1. Mari says:

    This is terrible. The system is broken. Protect our freedoms!

       0 likes

  2. joan downey says:

    I have celiac sprue and if you people go through with this I will be in great danger, and so will many more people.
    Please work on keeping are food safe and label all food from can foods to all neats and vegies and fruits both in and out of cans. Meaning ALL FOODS OF EVERY KIND.
    Thank you for doing the right thing. Think of all the people you will save. We all trust that you will do the right thing.

       0 likes

  3. Ty Ingle says:

    Just another example of Congress being sold to corporations. They do not represent the people anymore. There is no logical way they can say they are trying to protect the consumer if they would just look at the CDC’s own website and check adverse reactions from supplements compared to prescription medicine. Prescription medicines kill more than heroin and cocaine combined. Look at all the news coverage of the oxy problem. We must R.I.O.T. in the next election. R.I.O.T. Now.

       0 likes

  4. Chris says:

    Good that you are covering this destruction of consumer choice and also the hinderence of so many suplement companies. Especially the small ones, without full legal divisions. Say good bye to some of the cleanest and best mom and pop suplement companies. Especiall the organic ones.
    Pretty scary!

       0 likes

  5. Dr. Manhattan says:

    Let’s thank government in big business for screwing up our food by not supporting small farms and changing things so it is robbed of all nutrients. My family had a farm where my grandmother grew up and they could eat pork and beef with no health problems. She said they even drank a tea with cow manure in it to cure colds and similar things. She is 80 and only started having bad health after taking prescription medicines. I gave her some cissus and curcumin and her energy improved and she lost weight.

    We require supplements to replace what no amount of food can give us anymore. The meats are processed full of steroids which are banned for use in athletes, and the vegetables are GMO. Even organics are not 100% great.

    We need to take our freedoms back. All of them. Or we are going to end up like the very nations that we went to war against. Except that ours is going to be undercover and subtle lies instead of outright force.

       0 likes

  6. It was stated in here that the FDA didn’t know what they were doing. I wish that were the case; it is chaired by a majority of ex-food industry and big Pharma CEOs. They are giving closer and closer to exactly what they are striving for: FULL CONTROL of food, water, medicine, drugs and ultimately wealth and power. Driven by a insatiable greed. In my eyes they all should be brought up on charges of involuntary manslaughter if not murder. The FDA I believe also knows what all that food additives and drugs are doing to the general public. It ought to be criminal in the first degree.

       0 likes

  7. Peggy Worley says:

    You know what I just can’t figure out is the FDA wanting to be so hard on supplements, but I could go across the street and buy a pack of cigarettes!!!!!!!!! Are they for real????? If they want to regulate something that could be harmful, regulate them.

       0 likes

  8. Ron Ritscher says:

    Please help reduce American healthcare costs that are beginning to skyrocket — Secure the rights of the American people to pursue healthy living by preserving the right to purchase and use proven dietary supplements (doing preventative, cost-cutting maintenance).

    Much more could be said but this is the kernel focus.

    Thanks, Ron

       0 likes

  9. Carole Ewald says:

    Idon’t want the government meddling into my right to take supplements. Leave the FDA out of
    our business and let us make the decisions.

       0 likes

  10. Please leave our vitamins and supplements alone! It is bad enough you allow harmful ingredients in our food and our water. GMO’s etc… poison toxic pesticides proven to cause birth defects are allowed to be used! Banned in other countries! I enjoy the option of choosing natural alternatives for my health! Thank You!

       0 likes

  11. Jack says:

    Those in the pockets of Big Pharma are promoting this as the supplement industry will then be taken over by B.P. where their greed for profit trumps all else. I’m not against profit – I’m against those lining their pockets at the expence of us who use vitamins to promote quality of life and health.

       0 likes

  12. majrianne shouse says:

    What are you people thinking?? It is a known fact that dietary and nutritional supplements are necessary as our food is so over factory farmed that the nutritional value is almost non-existent. To back pedal on a Bill passed in 1994 is the height of arrogance, stupidity and thoughtless waste of money in these trying times. This pre-approval system being introduced is nothing but a smoke screen to shut down reputable companies. When will you in Congress do your job as mandated by the people of the U.S.?? Enough – and I am a voter!

       0 likes

  13. Brenda Vargas says:

    Please leave my supplements alone. I depend on them to help me stay healthy.

       0 likes

  14. Yvonne Taylor says:

    Please stop the manipulative attacks on supplements. I am sure there is an ulterior goal by ruining businesses and our health, obviously to help Big Pharma make more money, both with supplemental sales and medicines when the public’s health goes further down hill.

       0 likes

  15. Anne Geren says:

    It is horrifying to think, that after successfully addressing joint pain, bone density, fulfillment of basic nutritional needs, i.e., a basic multi-vitamin/mineral, anxiety and depression successfully, with a disciplined balance of diet, exercise, meditation and carefully researched supplements, that I may lose that segment of my regimen. Traditional medications have co-pays that add up fast, and the side effects of medications that I have personally had prescribed for me in the past have been unacceptable. Please leave this alone, and redirect your energy to more pressing issues-illegal drugs, jobs, the economy, child abuse, violent crime, to name a few…..

       0 likes

  16. Andrea says:

    If someone in gov’t doesn’t share the view that citizens should be able to buy whatever supplements they want, maybe they ought to be recalled…….. This is still America. Make them regret taking kickbacks for removing our rights.

       0 likes

  17. Louise Cates says:

    Please don’t take away my nutrients. I have Celiac Disease. My digestive system is badley damaged because Several Doctors missed it over many years. I was not able to absorb nutiants from my food. The only teatment is to totally avoid Gluten and try to add nutients to build up my body. If you restrict my ability to buy my nutients I will be sicker. Medicare is not paying for medical cost on me now. If you take away my nutients, I may need expensive medical care. Louise Cates

       0 likes

  18. Robert Travis, Jr. says:

    Once again the corruption of our democratic processes is responsible for proposed legislation and FDA rules to protect the big drug companies. The revolving door between the FDA and the drug companies faux science labs and the executive positions presents a threat to the American citizens. I wish elected legislators and the FDA could abide by the law and the truth of science instead of pandering for money from those who distribute dollars for votes. Leave supplements alone—take a close look at drugs and the deaths and disabilities they cause.

    Dr. Robert Travis, Jr.

       0 likes

  19. Felix Renteria says:

    The government should let the american people choose to buy supplements on their own.They need to do a better job regulatimg big pharma oh thats right thats where they get all their dirty money from.People are tired of the government over stepping their authority.Supplements need to be left alone in a free market.They should get rid of the fda they are incompetent

       0 likes

  20. Arleen S. Wiley says:

    More people die from prescription drugs than have ever died from taking vitamin supplements. The Pharmaceutical Corporations wish to see vitamins labeled as drugs so that they may have control over the pricing, you would be required to obtain a prescription for higher dosages (another doctor bill) and right now the RDA for most supplements is sub-standard. Most prescription drugs advertised today have side effects far worse than the illness or disease for which they are being taken. Not so with supplements. Please do yourself a favor and obtain a copy of the book Prescription for Nutritional Healing by Balch and Balch. It will list ailments and diseases, tell which supplements will help, which NOT to take, which NOT to combine with other supplements OR prescriptions. This bill and others like it are NOT in the best interest of the people…it will take away the FREEDOM OF THE PEOPLE TO MAINTAIN GOOD HEALTH. Without supplementation, they will be forced into worse health situations which will bring greater profit to the already corrupt Pharmaceutical Corporations.

       0 likes

    • Terrie Branch says:

      Please stop the attacks on supplements. Americans should not be deprived of effective, low-cost means of staying healthier.

         0 likes

  21. James Green says:

    The proposed rules for supplements could lead to the elimination of thousands of supplements and make the surviving ones much more expensive.
    In our free market society, consumers should be able to purchase dietary supplements and companies should be able to sell these products so long as the labeling and advertising are truthful, non-misleading, and there exists a reasonable scientific basis for product claims.

    Please oppose FDA’s attempts to control the suppliment industry.

       0 likes

  22. Howard McCoy says:

    Just because you don’t choose to take vitamin supplements doesn’t mean you should remove them so that I cannot. My wife and I take a number of dietary supplements and wish to continue to do so. Give us that choice.

       0 likes

  23. Carol McWhirter says:

    In our free market society, consumers should be able to purchase dietary supplements and companies should be able to sell these products so long as the labeling and advertising are truthful, non-misleading, and there exists a reasonable scientific basis for product claims.

    Unfortunately, not everyone in our federal government shares these views. For more than three decades, FDA has tried to restrict severely the ability of the dietary supplement industry to sell and market its products and, consequently, the ability of consumers to buy them. The agency has repeatedly attempted to impose unnecessarily stringent standards that would leave many if not most supplement companies with no practical choice but to close their doors.

       0 likes

  24. James F Deuro says:

    For several years the pharmaceutical industry has been using their lobbyists in Washington DC to try to get our congress to give them the power to control supplements. This needs to stop!!! Using the spin that they will make supplementation safe for the American people is a lie. What they want is profits from the American people. What the average American can currently pay for safe supplements will no doubt increase tenfold or more once the pharmaceutical industry is granted control. Supplements will no longer be readily accessible to the general public without a prescription or some other type of approval process and those that do not follow the new regulations will become criminals. I urge all Americans to contact their legislators and put a stop to this nonsense. A true patriot protects their country from their government. Lon live the free people of the United States of America.

       0 likes

  25. John H. Nolan says:

    Gentlemen : I am very much in favor of the freedom to pick my own healthcare. I want
    and need alternative medicine. It is cheaper and more effective than that offered by
    traditional medicine. God has provided supplements in contrast to drugs and surgery
    that kill hundreds of thousands of Americans every year. This statistic does not compare
    to dietary supplements. Why are vitamins unsafe ? I have been using them for almost ten years.
    I have never had a problem with them. In fact my health has never been better than it is
    today because of vitamins. I want to be assured that I will be able to buy my supplements
    in the near future and for the rest of my life. If the federal government takes them away
    from me, then I may get sick and unable to pay for traditional medicine. With drugs and
    surgery I might die an early death. The FDA does NOT know what it is doing to us Americans.

       0 likes

  26. Isabella Iverson says:

    I am Sick and Tired if the FDA trying to take away my right and ability to purchase dietary ingredients and nutritional supplements which keep me and others HEALTHY.

       0 likes

  27. Stephanie Lawner says:

    As Senator Hatch stated when he introduced the bill for DSHEA, the Dietary Supplement Health and Education Act of 1994:

    In our free market society, consumers should be able to purchase dietary supplements and companies should be able to sell these products so long as the labeling and advertising are truthful, non-misleading, and there exists a reasonable scientific basis for product claims.

    Unfortunately, not everyone in our federal government shares these views. For more than three decades, FDA has tried to restrict severely the ability of the dietary supplement industry to sell and market its products and, consequently, the ability of consumers to buy them. The agency has repeatedly attempted to impose unnecessarily stringent standards that would leave many if not most supplement companies with no practical choice but to close their doors.

    I agree with his views.

       0 likes

  28. please stop FDA from having the general public from having access to supplements without restrictions. inposeing harsh requirements on those who manufacture them. SUPPLEMENTS ARE FAR FAR SAFER THEN PRERSCEIOTION MEDS. THANK YOU.

       0 likes

  29. celli says:

    You dont have the expertise or experience to promote such a bill that takes away MY CHOICES. no one has ever died from taking vitamins yet you will see all these disclaimers about Avandia, celebrex and so many other drugs which were approved by the FDA. i do not trust, i do not want my rights taken away from me to choose WHAT I DEEM PRUDENT. This is a blatant attempt to form a police state. i will call upon the thousands, millions of people in the holistic community and we are ever-growing exponentially and call upon the masses to fight this with every breath we collectively have. you will also not be re-elected……..

       0 likes

  30. Michaelle Robardey says:

    Consumers should be able to purchase dietary supplements and companies should be able to sell these products so long as the labeling and advertising are truthful, non-misleading and there exists a reasonable scientific basis for product claims.

    Please do not allow the FDA to restrict the ability of the dietary supplement industry to sell and market its products and, consequently, the ability of consumers to buy them. As you know, [DSHEA] makes clear that dietary supplements are not food additives or drugs, and that the burden of proof shall be on the FDA to prove that a product is unsafe. Consequently, when DSHEA was passed, dietary ingredients were specifically exempted from the definition of “food additives,” making supplements not subject to FDA pre-approval. All that was needed was a simple notification.

    Please do not allow the FDA to circumvent DSHEA as it was passed and create a new pre-approval system. Everything about this proposal is a perversion of congressional intent and will (as Sen. Hatch told the world eighteen years ago) severely restrict our ability to buy nutritional supplements.

    Thank you for preserving our ability and our freedom in this regard.

       0 likes

  31. NJ Brooks says:

    Leave our supplements alone! For many allergic persons these are our only resources!

       0 likes

  32. this is a clear cut case of corporate medicine and Big pharma imposing thier will on the american people.
    We have a supposed freedom of choice in America.

    If this is allowed to happen to yet another freedom. We will be a poorer nation for it.

    i

       0 likes

  33. Terasa Hild says:

    Please, vote against this. We need our supplements. So many people need them to keep good health. I know i really need my nutritional supplements. Nutrilite is the best and no other are like them. Every company should follow Nutrilites direction of product control and organic properties.

    All Congress Vote against this DSHEA bill Please!!!!

       0 likes

  34. su johnson says:

    I am a health care provider with 27 years in health care. By suggesting the use of effective, properly produced organic supplements, I have helped patients recover their health, when other physicians told them to go home and suffer and prepare to die. Supplements and clean food and water can reduce our health care costs and establish a healthy society. Take these away and we are forced to endure needless surgeries, useless dangerous pharmaceuticals and a crippled citizenry.

       0 likes

  35. Ann Schlueter says:

    Suppliments are very healthy for the human body.
    Please leave them alone. They are so very helpful to so many people.
    Thank You.

       0 likes

  36. David Hoffman says:

    Gipson Guitar, Boeing, the oil and coal industry, and now the supplement industry. The attitutude of these stateists in Congress seems to be seek and destry job producers!

       0 likes

  37. Terry L Gaedchens says:

    I have used supplements since 1974 and enjoy good health at 57.Supplements have been a significant contribution to my work stamina. My experience with supplements is they have continously improved on performance as science gained better understanding of the various forms which the body best utilizes. I have never experienced adverse reactions to supplements and wish to continue doing so. 37 years with no adverse affects is very good odds and speaks to the integrity of the nutritional supplement industry. Long live the gurus’ of health!

       0 likes

  38. Miriam Walton says:

    Stop this assault on our supplements!

       0 likes

  39. Randy Felder says:

    To the powers that be,
    Please do not cause natural cures to be taken from within my grasp. I have spent a small fortune over the years on pharmaceuticals via Doctors recommendations and prescriptions until in 2010 I nearly died from all the side effects. I decided to try natural cures and began eating a vegan diet and taking a few supplements and now my health is much improved. I have dropped over 12 inches in my waist line and about 60lbs and at 57 I feel 47or younger again. Pharmaceutical drugs are killing people every day. Don’t stop “we the people” from having our choice of how to be healthy. The AMA is certainly not interested in us being well, just in how much they can make off us before we die.
    That’s not nearly enough said but you get my drift.
    Randy Felder

       0 likes

  40. Douglas Kowalewski says:

    This is America. I have maintained my good health from dietary supplements. DO NOT limit my access to these important products. Pharmaceutical companies may not like the competition, but their products have had deadly consequences and supplements do not. Please do not take away my right to buy dietary supplements.We should be free to do what is right for us and not be controlled by the lobbyists that buy you off.

       0 likes

  41. Annice Estes says:

    Stay out of the nutritional supplement game and try to do better the things you are actually supposed to do. Why don’t you do current measurements of mercury in fish? How about more poultry plant inspections? ETC.

    Please do not subvert the Dietary Supplement Health and Education Act of 1994.

    Keep Pharmaceuticals off your board and make it easier for women to get beneficial bio-identical hormones—not the disastrous ones made from mare’s urine that increases the chances for heart attack and breast cancer.

       0 likes

  42. Colleen Pancake says:

    I have come to depend on supplements to keep myself healthy. Please don’t take away my right to choose supplements that I have come to depend upon. It does not keep me safe or make me healthier to deny my options to choose from. Supplement options that have a history of safety should be my right to purchase.

       0 likes

  43. Barbara Spector says:

    I like Senator Hatch’s statements and believe them to show that consumers can not be run over on
    the issue of thier taking food supplements that are valueable for good health.

       0 likes

  44. Barbara Spector says:

    In 1994 Senator Orrin Hatc stated the “In our free market society , consumers should be able to
    purchase dietary and companies should be able to sell these products so long as the labeling and
    advertising is truthful, non-misleading, and there exists a reasonable scientific basis for product
    claimes.” He further stated that “As you know (DSHEA) makes clear that dietary supplements
    are not food additives or drugs, and that the burden of proof shall be on the FDA to prove that a
    product is unsafe.”

    We consumers want Senator Hatch’s words to still be the standard of the FDA. Keep dietary supplements specifically exempted from the definaition of ‘Food Additives, keeping supplements
    not subject to FDA pre-approval..

       0 likes

  45. Ellen Hotz says:

    Supplement and integrative medicine champion Sen. Orrin Hatch made this statement when he introduced the bill for DSHEA, the Dietary Supplement Health and Education Act of 1994:

    In our free market society, consumers should be able to purchase dietary supplements and companies should be able to sell these products so long as the labeling and advertising are truthful, non-misleading, and there exists a reasonable scientific basis for product claims.

    I agree with Senator Orin Hatch, then and now. Help protect our access to supplements as a freedom of choice I believe all Americans should have. Thank you.

       0 likes

  46. Great website! I am letting all of my customers in the autism community know about what is going on and linking them to your action alerts. The future of individuals on the autism spectrum depends upon protecting the supplement industry. The vast majority of the 40% of individiuals who eventually lose their autism labels take supplements. Running an autism product website for almost 11 years now, I have heard story after story of children on the autism spectrum who have dramatically improved or have lost their autism spectrum labels after taking specific supplements or a implementing a supplement protocol.

       0 likes

  47. Alice Burkhart says:

    Add no new restriction on supplements. They are fine. It is prescription drugs that are killing people. Restrict prescription drugs.

       0 likes

  48. Deborah Corder says:

    My husband and I are in the natural health business and many people have “had it” with prescription drugs and their side effects. God gave us everything in nature we need to live healthy and prosperous lives. We are the ones who have polluted our soil, air and water. If this bill passes, people will not be able to afford supplements or will be afraid of reprisal from the government. What is this country coming to? What happened to our right to life, liberty and the pursuit of happiness. The side effects of FDA approved drugs are being made public almost daily and yet the FDA allows them to continue poisoning men, women and children without censure. Please continue to fight for the rights of the American people. Thank you for what you do. God Bless you

       0 likes

    • AJ Romeo Jr says:

      That couldn’t have been said any better. Nature is here for us to use as food and remedy. To manipulate nature more for money and power instead of the well-being of humankind is a disgrace.

         0 likes

  49. Allen Lankes says:

    Since the FDA is continually trying to impede our free choice in supplements it is long past time to get rid of the FDA! They do not have the best interests of the public in mind.

       0 likes

    • Gail Mosley says:

      AMEN! You said exactly what I was going to. The FDA needs to go away altogether.

         0 likes

      • David K says:

        Correct me if I’m wrong here, but I believe the FDA is a broken ineffectual agency who already has their hands full with unapproved prescription drugs flooding into the market.
        And of course, every couple of years the FDA seems to be pulling another FDA reulated approved medication
        off the shelves for harmful side effects.
        And this of course is after the damage has already been done on the unwitting ginuea pigs after the medication has already made millions or perhaps even billions of dollars for rthe companies and after they’ve all divied up their profits and walked away fat and rich from their latest oversight.
        It is no wonder people are turning to the more common sense approach of alternitive health care supplements. ” What ?” Now we want them taking away what choices we have because it is cutting into their profits… There is no other elegent way saying that this is nothing more than corporate greed reaching an all time low.

           0 likes

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