FDA Breaks Promise on Proposed New Supplement Rules

May 1, 2012
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Vitamin-Herbal-SupplementsFDA promised not to enforce the NDI guidance until it was final. Last Friday, they broke that promise.

The specific provision that FDA has decided to enforce is the one that says synthetic botanicals will no longer be considered New Dietary Ingredients and must never be sold as supplements, only as drugs. Last Friday, FDA issued a press release and sent warning letters to ten companies who sell supplements containing DMAA (dimethylamylamine), which is advertised to increase energy, concentration, and metabolism. The manufacturer says DMAA is derived from the Asian geranium—specifically, geranium oil.

In their warning letters, FDA said the supplements are technically classed as “adulterated” for two reasons: (1) DMAA has not gone through the NDI notification process, and (2) it is a synthetically produced botanical which, by definition, is not an NDI.

However, the claim that a synthetic botanical is not a dietary ingredient is nowhere to be found in the law governing supplements: the Dietary Supplement Health and Education Act of 1994 (DSHEA). This new distinction comes exclusively from the NDI draft guidance, which is one reason we called it a perversion of congressional intent.

For years drug companies have studied plants for medicinal uses. As we noted recently, if they find a useful plant, the next step is to try to create a synthetic analog of the natural plant substance—a new molecule that can be patented and then taken through the FDA as a new drug. With this provision in the NDI draft guidance, FDA is giving drug companies a monopoly on synthetics, knowing full well that, in general, natural products cannot be patented while synthetics can, and only patented substances can afford to be brought through the hugely expensive FDA approval process.

The worst part is that FDA is now treating the guidance as if it has been finalized—something they promised not to do. In February, FDA held a meeting with the Natural Products Association (NPA), and explicitly told the group that until FDA finishes reviewing comments and releases final guidance, it would enforce only DSHEA and not the draft guidance. Now they’ve gone back on their word.

In addition, we would point out that FDA has still not addressed the many formal comments that were submitted on the synthetic botanicals question. We, and many others, said that FDA’s claim that synthetic constituents of botanicals are not NDIs while synthetic constituents of any other substance are NDIs is a completely arbitrary distinction. Taking action when they haven’t reviewed any of the thousands of pages in public comments makes a complete sham of the formal comment period. Moreover, FDA shouldn’t be enforcing a guidance when it is still in the draft stages anyway—that’s the point of it being a draft.

Worse, by going outside the bounds of DSHEA, the NDI guidance is basically creating new law, which the FDA is not allowed to do. Instead of issuing proper regulations and going through the formal rulemaking process (as is required when creating a new law), the FDA sidestepped everything by issuing a guidance. Technically, a guidance is not legally binding—which makes lawsuits difficult—but as feared, the FDA is enforcing the guidance as if it were.

DMAA is not without some controversy. Last year, two soldiers died after having heart attacks during fitness exercises, and both happened to be taking supplements that contained DMAA, though as of this writing, DMAA has not been conclusively linked to the deaths. A spokesperson for the manufacturer said that “there have been over one billion doses of DMAA-containing products taken without a single corroborated serious” health problem among people who used the products as directed. Just to be safe, the US Army is investigating, and the Defense Department has removed all products containing DMAA from stores on military bases until the safety review is complete.

If DMAA is proven to be unsafe, it should be removed, plain and simple. If it is a New Dietary Ingredient, then by all means it should go through the NDI notification process as outlined by DSHEA. But let’s just stop this nonsense about it being illegal because it’s a synthetic botanical—that is not a requirement of DSHEA. That requirement comes only from FDA, and it is not supported by law.

Here’s the crux of the matter: If FDA fully enforces this guidance as drafted, we will likely lose up to 29,000 nutritional supplements  from the market, at an economic loss of between $5.6 billion and $10.5 billion; the nutritional supplement market could shrink by between 28% and 52.5%, producing an annual loss for the industry of between $7.84 billion to $14.7 billion; and between 55,720 and 104,475 jobs in the supplement industry could be lost.

Let’s be clear: this is not about DMAA. This is the FDA setting in motion its draft guidance, which threatens our access to more than half of the supplements we all need to stay and get healthy.

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169 Responses to “FDA Breaks Promise on Proposed New Supplement Rules”

  1. Suzanne says:

    The FDA must be reined in and better yet, disbanded as Ron Paul would like to do. We need him to get in to the White House. This country would have so much money if the FDA, TSA and such and all the NGOs were put out to pasture without a safety net or dissolved.


  2. Dawn says:

    The FDA is proving to be a rogue agency and needs to be stopped. I’m not sure why they haven’t been sued? They allowed unsafe GMO’s to contaminate our food supply and the American people have been consuming them unknowingly for years. Who knows how many health problems this has caused people. This alone is an egregious abuse of power and should be punishable. And now, our right to buy supplements is in jeopardy along with our health freedom and the freedom to choose what is best for ourselves and our families. Time to slay this beast. If we don’t firmly stand up to these unconstitutional acts with legal force then these bullies will win. Calling all kick-*ss lawyers. Your services are needed!


  3. Robert Morrow says:

    So what is new, the FDA aways sells out to the highest bidder. When I teach cooking classes I talk about the FDA (murder for profit Inc) The title of my classes are “how to cook and prepare meals out side the FDA’s poison box”. I point out just how much toxins are blessed by the FDA to be put in the processed food that you buy and eat. Just read the labels and then put it back on the shelve for it is deadly poison. The FDA is not there to protect us the people, but on there to protect the Corporation so the can received the 30 pieces of blood stain silver and use it to buy yours and mine corrupt elected official. I know my Senator has blood stained hands and I have told him so and that he should resign in shame Then there is the complaint about the oil companies profit of 6 or 7 %. But not a word of the Pharmaceuticals markup of 30,000% or higher on poison drugs that do not cure, but murder. Why, because the FDA like you so called representative is bought and paid for.,


  4. maureen says:

    I’m writing my congressman and asking him to help with thus problem. Hoping that will help because I take some very nice supplements and see new ones coming into the market from other countries that have been used fir thousands of years. This doesn’t seem right. We might just find the natural cure for cancer in one of these supplements. Think of all the medical visits we didn’t have to make and the money it has saved Medicare and insurance companies because we have taken these supplements that have prevented illnesses. It would be wrong to take these off the market or cause the prices to rise beyond our reach. We must do something.


  5. Jan Lindner says:

    This is as brainless as that moronic research taht used SYNTHETIC alpha-tocopherol and concluded that Alpha-tocopherol is not a good preventive against cancer. Sort of like saying a sandwich made from plastic cheese is a real cheese sandwich. It must be painful to have sold your souls to the corporate machine.


  6. Ellis Ring says:

    Please forward this information to my Congressmen.
    Rep Bass and Rep Guinta.
    Thank you.
    Ask them to stop FDA from regulating supplements. I use them to stay healthy.


  7. Welcome to harmonization via trade obligations with CANADA. Your supplement laws are beginning to smell of the same rot that invaded Canada some years ago. Only the wording is different… the intent, and the effect, are the same.

    Worse, you can expect further harmonization via Canada’s obligations via CETA, which will shove the EU’s THMPD up our Canadian noses. (You may recall we have for years called the EU Food Safety Directives, from which the THMPD emanates, “Codex Alimentarius’ Evil Twin”)

    THEN, you can expect that the USA, thanks to these overlapping trade obligations, which supersede ALL domestic law (and you can include your constitutional rights in that one) to also be harmonized with the THMPD… something that is happening, notice, with ALL former and present colonies of the British Empire at present.

    The elite/Pharma/governments are boiling the frog slowly. But meanwhile, DSHEA has pretty much been simmered out of existence. The NHF’s delaying tactic, H.R.3380 Dietary Supplement Protection Act (DSPA), would at least save thousands of products by moving the grandfathering date forward to 2007: not the perfect solution, no, but it would indeed put all those products brought to market over the period from 1994 to 2007 out of reach of the Draft Guidance. It deserves your support, if only to buy time.

    Do not look to permanent internal solutions. except those that address the international trade obligations: these are the “foreign entanglements” your Founding Fathers warned about, and here they are, coming into force. Your legislation is badly hampered in its ability to reflect Americans’ values and wishes, because it is directed offshore.

    Every time a trade agreement is signed, a foreign group takes control of your sovereign laws. This is the platform for the one-world government, and nowhere is it more obvious than in the health freedom issue.

    Our sovereignty, yours and ours, is what preserves our democratic rights and freedoms. By the back door, and cloaked in promises of prosperity for all because of “free trade”, our sovereignty is being deliberately eroded and destroyed. We are all in the same trouble.

    Are we having fun yet?


  8. Ava Ciliberti says:

    Pay attention, people. Do not be hoodwinked by the drug industry!
    Supplements have kept my cholesterol in check and contribute
    to a happier healthier life. Do let the government take them away
    from us!


    • Ava Ciliberti says:

      Do Not let these natural remedies be taken away from us.
      I, for one, am entirely convinced that supplements are
      required in a toxic environment


  9. Gentlemen:

    Sorry I used capitals, I just got carried away, and after all, it is telling it “as it is” of course those in “denial” will never accept that comment since their idea of the “humanity of man” is totally misguided since very few people on this egotistical planet are “enlightened” especially politicians who are clever ‘con” artists, swindlers of the highest order. Who says that? those that know of course, con artists spilling “the beans” as they say. It takes a crook to catch a crook, that s “if you want to check a crook” in many cases they “love their crook” and would definitely refuse “to catch him” of course.

    There are many crooks basically known politicians which a lot of people know but nevertheless agree to their thievery etc., why? perhaps they would also be thieves if they had the same opportunity. After all are we not all egos, and arent egos void of responsibility for egocentric behavior. Just protecting “my interests” If our government can do whatever they do even inmmoral acts, to protect their interests, why not me? After all, what’s good for the goose, is good for the gander as they say! Every man for himself isnt that the “way of the world” even if people die its OK , protecting our interests have a right to kill and injury innocent people, why?
    Because that is how the ego world operates; self interest allows a person to do anything that they can prove threatens their egocentric existence. Iis it morally wrong? of course it is, self interest, egocentricity is a negative view of the world; not a positive view of the world, but then we do live in an egocentric world, how can this hypocracy be resolved? It cannot be resolved unless the people become “more aware” of their hypocracy and stop their ego from dictating to them what is right and what is wrong.

    Dr.Maurice Rothman PHd


  10. Denise Earl says:

    Maybe, the revolution, that is brewing, will come to a head because of such FDA rulings about people being “allowed” to choose their own response to “health care.” When are we going to hear an adult dialog about weird concoctions, aka drugs, vs., natural supplements that cannot be patented and hence have no monetary value – but may just be bona fide treatments for certain conditions?


  11. mary dowling says:

    I always think that when some decision is made like this that there must be a financial element to somebody but certainly not to the regular people.


  12. Elke Blair says:

    It’s extremely disappointing that the FDA did this, but not at all surprising to me. They don’t want the population to have access to supplements because of big pharma. It’s all about money folks, and one hand (FDA) washes the other (big pharma). U.S.A. is becoming a fascists country in the name of money. All of us who take supplements for health problems, are on a bumpy ride for sure.


  13. Charlie NU says:

    hey, if the leader (para-phrasing) of this country can break all the rules, so can the lying fda…they work for pharmas and are probably getting kickbacks by doing this…they no more care about the health of Americans than does my dog…they just want the monies to go to them, not the manufacturers of supplements….guess we all will just have to buy up what we can while we are still free enough to do it….may not be that way after november…


  14. Jim Park says:

    The FDA is bought and sold by the drug companies. The corruption is really unbelievable; they at least used to pretend they had a modicum of honesty, but now, they are totally flagrant and blatant about it. The only way to get any justice from the FDA is to sue them on some of their obviously corrupt actions. The stupidity of selling your soul for a few buck is truly mind-blowing!


  15. Louise says:

    That is because some one did not get paid at the fda.


  16. Teri says:

    What can we do about this besides write our congress-people (which I’ve already done)? Can we create a petition? Thank you.


    • Gretchen says:

      A country can only be as mentally healthy as it’s sickest leaders. This sick control of supplements etc. does not bode well for oue country to remain mentally and physically strong with mentally and physically strong citizens


  17. Sherry says:

    I have been taking vitamins since my mother sold Shackley vitamins in the late 60’s. I was 10 years old when she started me on vitamin supplements. And for that matter, juicing and eating soups and stews all naturally derived. I still take vitamins still make soups and stews and juice all kinds of fruit and vegetables. The difference now I have taken the road to organic eating for me and my family.
    I am now 60 and no health problems so far. I contribute that to the vitamin and mineral supplements !
    The chemical companies have infiltrated everything we eat and drink with pesticides, preservatives and food colors. Dont forget there are other things in the air that are also pollutants. All altering our health and well being. I shutter to think about life w/out my vitamin and mineral supplements ! !


  18. Gentlemen:

    It all makes sense of course. People are coming to the realization of the danger taking prescription drugs; the internet is their means of accessing truth, not the controlled media from TV ads to magazine ads to whatever. The Facebooks and other social networking systems are the power today; people dont trust what they see, hear, read since as mentioned they are all controlled. Just a our governent agencies are unworkable, etc., the FDA is also unworkable they cannot control what’s happening in the fact that people want supplements rather than drugs which are dangerous and expensive, two facts that trouble our medical system particularly our governments heavy debt burden. However, the “fat cats” always “want more, just like any addict the more the better, lets destroy the firms that makes supplements, put them out of business by forcing the FDA to pass edicts that most if not all supplement makers cant fuilfill; its as simple as that, what to do, what to do? organize of course, pay bigger bucks to the crooked politicians, whoever pays the most gets their votes, its a simple as that. Greed always wins out from the beginning to the end, and that is worldwise of course, nothing talks like money and who knows that better than corrupt politicians! Even if and when they kill the golden goose that lays golden eggs, as long as they get their, truly egolovesof the highest order, money does all of the talking, and voting. So again “what to do” raise more money than the crooks out there, money for whom? the politicians of course and their lawyer “bagmen””

    Thats the solution of course, the highest bidder get the bid, and that is where it is right this minute, pay pay pay pay, that the clarion call in Congress, mone money money money, what’s more important than money? nothing of course, honesty? what’s that? humanity? whats’ that? morality? what’s that? what the hell are you talking about, what kind of a realist are you? dont you know the first and last word is mone]\

    Obviously there ar a lot misformed, dumb people out there who still believe in justice when they cant even spell the word correctly; it should be ‘JUST -IS, not justice since their aint none!

    What Just is, is and means “is” WHAT’S IN IT FOR ME, HOW MUCH? is there any “justice” with that demand? of course not, there is and never was any true Justice, why? Just-is wont let it happen, the metaphor for for Just is, “IS money , now before later and…


  19. The FDA is nothing more than a tax supported arm of the pharmaceutical industry. As such they are in charge of making us sick, and unable to treat ourselves with natural products so that their friends can sell us junk that alleviates symptoms temporarily while killing us in the long run. They have no moral high ground what-so-ever being gutless lackeys of the wealthy 1% who are really loathsome traitors.


  20. jason stuart says:

    I am sure as God makes little green applies I am not the only person in this country that is sick and tired of slowly but surely having their freedom and freedom of choice being squeezed out of them by boneheads who got all of the answers but none of them work…time to clean house we need men and women with brains and ability not self-consumed self-serving bureaucrats who sleep with the guy with the biggest checkbook


  21. Sparky Alfonzo says:

    I dont know which is worse the Big Pharma or the Big Supplement Industry. One highly regulated, one barely regulated, both focused mainly on their own bottom lines, and rarely focused on whats in the best interests of the consumer or the patient. Both make me ill. Got something for that?


  22. Joanne Schmidt says:

    Could the deaths of the two soldiers have ANYTHING to do with the insane amount of vaccinations and flu shots they are forced to have and nothing at all to do with DMAA?


  23. Doris says:

    When the animal rights shut down the equine slaughter plants, the horse industry lost 100,000 jobs and over 10 billion dollars a year and nobody cared. That was my industry. Why should I care about yours?


  24. I see the FDA’s persistence in this draft guidance issue as motivated by big pharma to put natural supplements out of business. This is because more and more people are looking to supplements, as they should, as a simple, inexpensive way of curing many, many diseases. If the FDA “wins,” this will mean, not only the severe pruning of the health food industry, but millions of deaths of people, like me, who depend upon supplements to stay healthy. The men and women in the FDA must be incredibly ignorant, or incredibly evil to do what they’re doing. It blows my mind when I think of what this actually means to me and to so many people that I know. This can’t be possible in our country, can it? Sign me, Horrified.


  25. Fred Fawcett says:

    More and more you just can’t trust what our government tells us, about anything.


  26. Alceon Jones says:

    I am truely fed up with the FDA. They are making and carrying out most of the laws in this country. That is not their job!!!!!!!!!!!!!!!!!


  27. America had the highest costs in the world. But does not rank in the top health nation.
    If the FDA was working for the people and not the drug companies wwe could be a healthyer nation with lower health costs. Be guided by the law instead of the drug companies.


  28. SONIA UNGER says:

    I would be so sad and disappointed if I were not able to purchase my supplements freely as I am today. This should not be taken away from the people we should have the freedom to supplement as we see fit.


  29. Monica says:

    The FDA sent me a letter about Merit “last year”, which I have found to be quite helpful with my weight problem, it has “all natural” ingredients, they told me it was an unknown substance, an “unknown” substance!! It had all the ingredients on the outside of the box, that can be found on the internet had they bothered to research any of it. So I lost my order and it was supposedly sent back to the manufacturer. About 6 months later they sent me “another” letter about the same product, telling me the exact same thing. I did waste money calling their number and after being disconnected and lost calls while being transferred I finally talked to someone who was so very ignorant and told me I was not allowed to have this product. This is what I pay taxes for?? It is not a drug, Merit is a dietary aid and it works for me quite well. I was told to take the dietary aids in the stores, well I tried everything and Merit was the “only” dietary aid that worked, probably because it was all natural ingredients. I think the FDA should not even exist if they are in the position to be nasty, rude, hateful, ignorant to anyone who calls them. By the time I got done it cost me approximately $20. to get through to the person I needed to talk to, they give you one number and then when you do get someone they tell you to call another number and don’t know how to transfer anyone correctly. And these people are in charge of our health?? I am sorry, but I hope this is not considered uncivil, I just wanted to share my experiences with the FDA last year. I am still upset about it.


  30. Robert says:

    FDA is one of, if not the most, abusive federal agencies and they run amok with no oversight.

    As we see above their word is not to be trusted, their intent is much like the EPA guy who likened enforcement to the Romans conquering villages by hanging the first 5 people they cam across then the rest meekly obeyed. That is certainly the intent and demonstrated action of the Hamburg led FDA along with the compliance/enforcement group.

    It is a travesty on American business, an afront to let them say they are protecting the public welfare, and a crime to allow them to assess penalties without legal authority. They make up rules as they go and in this case it’s not even a final rule. Bogus, bogus, bogus. The savor authority but shirk from culpability.


  31. E Tarver says:

    Just goes to show you, our government is for the corporation, not for the people.


  32. Jenifer Parker says:

    We expect them to “play fair”? It’s not gonna happen they need a class action lawsuit to m ake them pay attention. Or a Judge with the “you know whats” to enforce the current LAW!!!


  33. Simon Teolis says:

    Well what a surprise, the FDA has been corrupted! Now FDA can stand for “fully drug addicted”.


  34. judy miller says:

    It continues to bother me that we uananimously passed the DSHEA law in 1994 because people wanted to have the science behind safe and non-toxic supplements unlike pharmaceuticals that kill more than 100,000 per year. We have to continue to fight for our right to have these products that help our health and wellness.
    Please stop this nonsense. Judy Miller, Rph


  35. Cynthia Groves says:

    I am concerned about this if this is true.


  36. Daryl says:

    Pink Slime consumption is fine but not your vitamins. How does this fit into the health care bill?


  37. Heidi Watson says:

    Again, it is not about consumer safety, it’s about money. The FDA wants us all dependent upon their drugs. I cringe to think of the medical trap the FDA is trying to enforce upon all of us. FDA approved drugs lead to suffering and many times an earlier death. I saw it happen to members of my family. The FDA attacks our freedom to our health choices.


  38. Michele says:

    It would appear the FDA sets itself up for a lawsuit but by whom?
    Also the loss to the supplement industry is a gain to the drug companies. Drug companies will gain by filling a new supplement gap with synthetics but also patent the designated ingredient on trial.
    The FDA controls the market for the pharmacutical industry, a fact I object to my congressmen and President. This issue would nit be at the fire if supplements wete not big business.


  39. Steve says:

    This is why Europe & Asia are way ahead of us when it comes to natural & alternative therapies. The FDA is & always will be a CRONY to big government & just one more reason we the people need to take our country back. We need to shrink government & make a move back to self governance. Otherwise we will end up with pure ‘crony-capitalism’ or ’socialist-totalitarianism’.


  40. Terri says:

    This makes perfect sense in this screwed up world of 2012.
    Anything that works, could be healthy for you is going to be illegal or unable to be found…except in the black market.
    Just like illegal drugs, I guess “WE THE PEOPLE” will have to do this for supplements (food? water? baby formula?) also.
    Government, what a washout, waste of time and money and to the detriment to anything living, breathing or thinking about doing such, in this country or any other on this planet.
    I am completely and utterly disgusted with FDA, IRS, EPA …most everything now.
    I do not believe anything anyone in government says any longer. We are finished.
    Well, this is progress of the highest order. We “humans” have evolved into complete utter crap.


  41. Mike88 says:

    I have a problem with the FDA in general, I do not believe we need a Federal Government agency that is made up of unelected people that are not accountable to the citizens of this nation telling the citizens what foods, drugs, or herbal suppliments they can or can’t consume.
    Further more I have a problem with the FDA making the determinination as to what is and is not a drug, or an herbal suppliment. All drugs made by the Pharmnaceutical Industry are derived directly from plants, plant materials,or insect materials.The FDA should not have the authority to tell a private citizen what he/she can or can’t consume. We don’t need this agency to begin with as adults are able to make the determininationas to what they choose to injest into their bodies for their own safety or health needs.
    This Agency should be under strict control not just by the Congress but by the citizens as to the determininations they are allowed to make about our foods, and injestable plant material. The determininations that the FDA makes should also be subject to the concent of the citizens of this nation, and the FDA should not be permitted to make determinations without the concent or approval of the citizens.


  42. Jim H. Stevens says:

    I think it’s time that the FDA keep there hands off all supplements and quit trying to control everything and helping to enforce the money train for the pharmecutical companies. Enough is enough!


  43. Tonya Ryan says:

    Big business won’t be happy until they control everything!!


  44. Truman Berst says:

    I am suing the FDA& DOJ and getting very little help. None from the wealthy and a few hundred dollars from the poor.

    Please help the few of us that are willing to stand up for all of us.

    Rev. Truman Berst
    Founder/President/Master Herbalist – Good Shepherd Ministries/ALTERNATIVE Health & Herbs REMEDIES, a nonprofit. Founder/President of Americans for FDA Reform a nonprofit.


  45. We have been distributors of health supplements for almost 20 years. The efficacy of the quality products we have distributed is supported by countless testimonials of positive health changes. Government efforts, if any, should be aimed at assuring quality and not severely retricting an industry that makes a significant contribution to the health of the nation.


  46. It’s my opinion that we have too many supplements…often synthetic and they are harmful. DMAA is one of these.

    How about a good healthy normal diet. Let’s push that.



    • Debbie says:

      It would be great if we could get all the nutrients we need from the food we eat, but since that is regulated also and has the many preservatives etc in our food, we generally need the supplements since we DON’T get them in the food we eat. Unless you live on a farm & grow everything you eat including the animals, I wouldn’t trust anything they say about how healty our food is.


  47. Lily K. says:

    Where is the “Take Action” item for this!!!


  48. buck says:

    The FDA needs to be removed from the taxpayers payment system and put on the payroll of the drug companies that they support against the American taxpayers welfare .


  49. Charlie Hanna says:

    The best way to fight this outrage is to simply vote for Ron Paul. This is just one of the many freedoms he supports. Back him all the way.


  50. Dolores Sieg says:

    FDA promised not to enforce the NDI guidance until it was final. Last Friday, they broke that promise.
    So I do not trust or believe the FDA. All they want to do is let the Big Pharma rule. I use alternatives that got me out of a wheel chair. Western Medicine Put me in a wheel chair. Please leave my Freedom of choice alone.


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