FDA Breaks Promise on Proposed New Supplement Rules

169

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 This new distinction comes exclusively from the NDI draft guidance, which is one reason we called it a perversion of congressional intent.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 With this provision in the NDI draft guidance, FDA is giving drug companies a monopoly on synthetics, knowing full well that, in general, natural products cannot be patented while synthetics can, and only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group that until FDA finishes reviewing comments and releases final guidance, it would enforce only DSHEA and not the draft guidance.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.

If you enjoyed this article please join us on Facebook and Twitter
Share.
  • Dolores Sieg

    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.

  • Charlie Hanna

    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.

  • buck

    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 .

  • Lily K.

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

  • http://none Francille Willis

    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.

    Thanks

    • Debbie

      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.

  • http://joesbiz.vemma.com Joe Sustersic

    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.

  • http://www.healthherbs.com Truman Berst

    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.

  • http://[email protected] Tonya Ryan

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

  • Jim H. Stevens

    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!

  • Mike88

    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.

  • Terri

    Wonderful.
    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.

  • http://google Steve

    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’.

  • Michele

    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.

  • Heidi Watson

    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.

  • Daryl

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

  • Cynthia Groves

    I am concerned about this if this is true.

  • judy miller

    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

  • Simon Teolis

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

  • Jenifer Parker

    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!!!

  • E Tarver

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

  • Robert

    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.

  • Monica

    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.

  • SONIA UNGER

    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.

  • http://LencoLabs Leonard Austin

    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.

  • http://AllianceforNaturalHealth Alceon Jones

    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!!!!!!!!!!!!!!!!!

  • Fred Fawcett

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

  • http://www.booksforhomeschooling.com Leigh A. Arrathoon

    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.

    • Jermo

      Incredibly greedy, controlling, ignorant and evil – we must stand against them.

  • Doris

    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?

  • Joanne Schmidt

    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?

  • Sparky Alfonzo

    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?

  • http://yahoo.com jason stuart

    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

  • http://AllianceforNaturalHealth William McGuffey

    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.

  • http://akternatuveheakthresjourcenetwork maurice rothman

    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…

  • Sherry

    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 ! !

  • Teri

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

    • Gretchen

      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

  • http://anh.org Louise

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

  • Jim Park

    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!

  • Charlie NU

    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…

  • Elke Blair

    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.

  • mary dowling

    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.

  • Denise Earl

    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?

  • http://akternatuveheakthresjourcenetwork maurice rothman

    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

  • Ava Ciliberti

    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

      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

  • http://www.thenhf.com Dee Nicholson NHFCanada

    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?

  • Ellis Ring

    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.

  • Jan Lindner

    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.

  • maureen

    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.

  • Robert Morrow

    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.,

  • Dawn

    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!

  • Suzanne

    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.

  • Jason

    So where is the link to contact everyone to stop this nonsense? Why isn’t Obama included on all these action alerts.

  • annie steele

    One size does not fit all ! Supplements are like shoes must be in amounts that
    are appropriate for the individual. I am 118 pounds not 200 pounds my supplements
    have to tailored to fit me and my needs. Nobody in Washington,DC can set an
    arbitrary amount to fit the whole nation.

  • http://ANH-USA Gary Anderson

    Promises, only to be broken and prove the FDA’s word is not to be trusted. Why not get your “RX HOUSE” in order given the fact that they kill thousands more people annually than the supplement industry does. I’m personally quite fed up with the FDA’s constant meddling with supplements! Next thing you know we’ll need a prescription to purchase supplements like vitamin C. I’ve been taking supplements for over forty years and have benefited greatly from them. I am quite capable of researching and deciding for myself which supplements to take. I do not need or appreciate the FDA imposing “guidance” and thereby restricting my nutritional supplement choices. I’m amazed that given the potential public outcry that’s certain to come if supplements are overly restricted that the FDA continues along these lines.

  • Shirley Heisey

    Early in my life I learned that the FDA was established to protect consumers from snake oil charlatans and dangerous products peddled indiscriminately. Perhaps that once was true. Perhaps. But it has come a LONG ways from being the consumer’s advocate. Today the FDA protects BIG PHARMA , who currently are the “snake oil” marketers (I know; I was prescribed snake venom as medicine,) which has the potential side effect of affecting the kidneys. I have learned that there are safe foods that do the same without the dangerous side-effects. BUT, those are the things (competing substances) which they would keep out of our reach, if possible. Like SOUR CHERRIES, which have such high efficacy that orchards were forbidden to tell their benefits to the public who desperately need to know.
    The FDA is hopelessly broken, employing planted employees who favor industry over consumer.
    PLEASE do not let the FDA get away with the crimes against US citizenry!

  • RAY WEST

    may be some one should start an investgation into the finacial back ground of every person on the fda board check any and all money tranctions that each menber has ever had

  • http://ANH.com Jacque

    What did we really expect?? After all it IS the FDA! Isn’t this normal behavior for these people??!!
    It is It is high time to dismantle this agency or at least reduce their power to what is actually needed from them. How do we even keep up with all their devious stunts?

  • Bruce Stewart

    What’s next? Vitamin D, A, C? Someone died and they had been taking vitamin D!!! Let’s get it off the market!

    Maybe it all comes from this—“Cosmic Constitutional Theory-
    Why Americans Are Losing Their Inalienable Right to Self-Governance” by J. Harvie Wilkinson

  • Michael J Dorning

    It is obvious that Big Pharma has spent some Big Money to get this corrupt FDA decision.

  • http://AllianceforNaturalHealth Geraldine Young

    The choice to use supplements vs big Phama drugs should be left to the individuals. I prefer to use supplements that my body can “understand” vs poisonous synthetic drugs with side effects that are worse than the problem you take them for. I have medical and RX coverage that doesn’t cover any of my natural supplements, so I pay out of pocket for them plus the medical coverage, my choice and that choice to use supplements shouldn’t be taken away from me. The Government does more harm by making these across the board decisions, in the so called name of keeping the public safe, when we all knowTHEY operate the way the big Pharma pays them to do so. It is so sad that the almighty dollar has become more important than the citizens of the US! These are sad times and the Government just is so out of touch with the people and their wants and needs over the Politicians greed! Remember, what goes around, comes around!

  • Jonathan Crews

    Hands off our supplements!

  • Charles Kazer

    So What Now Can Any thing be Done???

  • Emily Scott and family

    We will not go away.

  • Bill Kornell

    Why are we not going to members of congress and getting the FDA in line.

  • Steven Bernhaut

    The push to dietary supplements, natural healing herbs is all about big pharma. This effort has been going on for 20+ years with codex. If you are so worried about “safety” at the FDA why not focus on the 70,000+ prescription drugs fatalities that occur each year in this country. How about vaccine safety? BGH, GMO’s, Antibiotics, irradiating our food and pesticides in our food chain. Follow the money. Just try regulating corporate interest instead of regulating for the corporate interest for a
    change.

  • http://[email protected] carolyn schaefer

    We must fight this. Thank you for your excellent article.

  • Charles Moore

    It is clear that we need to completely dismantle the FDA. While it is true that some form of regulatory agency may be useful to oversee the pharmaceutical industry, the current FDA is a sham, a fraud, and merely a trade organization to protect the financial monopoly that the drug companies have on “health care” in the U.S. And we are paying for it with our health and our lives. Time to ‘Throw the Bosteds Out!’ and start over. While we may need to continue to focus on specific “rulings” they put out in the mean time, the larger issue is putting THEM out – and prohibiting their participation in any aspect of government or agency ever again.

  • Fran Jean-Bart

    We shall overcome, not someday but soon.

  • Kevin Wally

    Since the Obama administration took office the federal agencies have been on a regulation binge. They have ignored congress, the people, and known law in an attempt to create a utopia. The alphabet agencies are stifling freedom to such a degree that almost any behavior can be punished by any and all of these agencies. They use the excuse of protecting us while they really destroy us. We need a return to constitutional limited government. These agencies should be dismantled at the federal level and let us return to the America that made us great.

  • http://healthy-life-vitamins.com Terry Beckham

    This is outrageous! The FDA needs to be put out of business or completely re-built from the ground up. We must find a way to get our political leaders on board to stop any further changes to the DSHEA law and any other changes that involve our freedom to buy and sell nutritional supplements.

  • Pat Schmeing

    SInce the L50 (lethal dose in 50% of subjects) of DMAA is much higher than that of caffeine, one could assert that caffeine is more deadly than DMAA. I can see it now: A pharmaceutical co. patents a breakthrough drug for ADHD or Parkinson’s.

  • http://ANH-USA Gretchen Artemis

    When President Obama was running for office in 2008, he promised to overhaul the FDA department, if he got elected. He has obviously has not kept that promise. In this election year, why can’t this be brought to his attention, and letters, emails, petitions etc. be directed to him to do something about this? This is ridiculous what the FDA is trying to do, but remember, we the people are the government, and only a massive outpouring from the people can change this. If he was made aware of the job loss that would occur, maybe that would make him take notice. The apathy of the American people is sometimes a reason these things are allowed to go through.

  • Veronica Roach

    oh don’t worry the supplements won’t disappear completely – they will reappear under new packaging from big pharma at a greatly inflated price !! It’s called fre enterprise – they are free to
    remove their competition by devious means !

  • http://[email protected] Carl Molitor

    I suffer from autoimmune problems, which doctors are inept at curing or treating effectively. I say this based on years of experience. Time and time again they appear dumb founded by my problem and either prescribe something with horrible side effects with little net benefit or ask me what I am doing and then signal concurrence with a nod without really endorsing or condemning my self treatment plan. I get along very without their help using anti inflammation supplements that I get through the internet without prescriptions or help from them. The mere idea that big brother in the name of meddling government, doctors and drug companies will now force me to get a prescription to accomplish the same thing that I now do for myself without their help is repulsive.

  • Diane Knight

    I take supliments for my heart. Having suffered a heart attack 3 years ago, I am alive and in one peace becaus of suppliments orderd by my Dr at the Whiticker Wellness instatute in New Port here in CAlifornia. I would apreciate it if you did not kill me.

  • Jan Phelps

    Is there a way we can advocate our feelings to the FDA for (at least) this instance of not keeping their word?

    If so, I would be happy to help in the efforts.

    Jan

  • http://n/a Dr. Elizabeth Martin

    I’d say it’s time to find a lawyer!!!! Now that corporations are “people”, the real people have few rights left- not even for clean air, water, food or vitamins. The law needs to be exposed if it exists only for corporate profit. The law needs to be upheld if it protects people. We, the people, are obviously having everything taken away by these monstrous government/corporate entities.

  • James Verry

    The FDA is influence too much by drug companies and the politicians who are on the payroll (i.e. bribed by lobbyists) and this stops the FDA from acting in the best interest of the American people.
    We must get the honest politicians to help stop this sell out.

  • http://www.LauraPower.com Laura Power, PhD, LDN

    Has anyone notified the Attorney General’s office about this outrageous FDA attempt at monopoly, and attempt to “make laws” instead of follow them?

    Laura Power

  • http://AllianceforNaturalHealth Lorrie Chloros

    This is outrageous! The FDA has been bought out by the pharmaceuticals. Those of us who have benefited from the supplements will be the losers!!!

  • Laura

    I’m done with the Pusherman (big pharma) and the Dealers (doctors) being the tail that wags the dog in America. They continue to infringe on our freedoms and liberties. I don’t believe for one second any of them truly care what happens to me when I ingest something. I do believe they only care that I bought it from the Pusherman.

    It says in the Bible, God gave me the herbs, plants, and animals to do what I want with. Well, FDA you are violating my Freedom of Religion rights! I think you and the rest of the Feds laugh that we think we have constitutional rights. However, We, The People don’t think it’s a laughing matter at all.

    You are public servants, you work for us, we pay your salaries, health care, pensions, and it’s high time you do what your real bosses tell you to do and that is Undo the Corporate Coup!

  • bonnie szalay

    What are we going to do about this? Start a petition!

  • Andy

    No surprise. The FDA is acting to protect its interests and not the public’s. The attacks on human health are so blatant now that even the blind should be able to see them. But when you have former industry executives like Michael Taylor at the helm of the FDA the results should be nothing short of criminal. One should not expect a lawful outcome from a lawless group of criminals. In short, concerned citizens need to realize that the system is lawless and therefore operating illegally and has no jurisdiction over individuals.

  • Luis Delgado

    As of today we must have millions of people using those supplements and we are getting better because them. I urge and demand FDA that stay away of anything that makes more difficult to us to buy a supplement of our choice.

  • Jerry

    This violation of the public trust is nothing new to this administration. How many more times do we have to be lied to by this government before we realize that we are not respected or viewed as competent enough to govern out own lives and make our own decisions?? This is despicable, and so very typical of this regulatory happy FDA and the controlling Obama administration.

  • Toni Francis

    What is ANH-USA doing in response to this illegal action on the part of the FDA? Can a court injunction be sought? If they are not stopped now, they will go forward with their plans to devastate the nutritional supplement industry and destroy our access to life-giving and life-saving nutritional supplements. In my opinion, this is a simple power grab by Big Pharma which is so cozy with FDA. This is restraint of trade, pure and simple, aided and abetted by an agency of the government. Unfortunately, there are senators and congressmen on both sides of the aisle who support and push this kind of oppression. We are in danger of losing our health freedom altogether. Please let me know what ordinary citizens like me can do – Is there a letter to sign, call to make . . ? .When all those supplements disappear from the shelves, it will take a very long time to get them back and many companies will go under, as you well know. We will all have to search for alternative, natural methods to maintain our health and prevent disease and hope that we find them.

  • Tru Luv Flo

    If you illegally attempt to manufacture law from your “guidance” civil suits and criminal charges will be brought, and then class action lawsuits. Since many companies are making lots of money and you are threatening their livelihood in an illegal manner, you may be repeatedly screwed in an unpleasant and embarrassing way. You have done a stupid , illegal thing in a stupid illegal way leaving you and your organisation vulnerable. I suggest you reformulate your tactics and their implementation, for the benefit of all concerned. Thank you.

  • Beverly Haynes

    Statements I have heard and read from the FDA are very frightening. It is a super-ego, beholden to no one. That has got to change to protect the freedom of people of this country to choose health over illness.

  • Barry Sherr

    It has been obvious for a long time that FDA stands for For Drugs Alone. While over 100,000 people die from drug side effects, and have serious long-term disability from others, the FDA pursues and persecutes safe herbs and nutriceuticals. Our healthcare system does not promote health, and doesn’t care, now forcing more than ever, pharmaceuticals on the American public. We are now unhealthy and broke thanks in large part to this convoluted system….drugs treating side-effects of drugs in a never ending spiral of masking symptoms instead of achieving true vital health. Shame on our FDA, and politicians who accept special interest money which allows this perverse system to monopolize our God given right to be healthy through supplementation and pure food.

  • Nancy Alfuth

    Leave my supplements alone!!!!! Supplements have not caused any deaths. Leave them alone!!!!

  • http://ANHUSA JEANNE BRANNIGAN

    FDA IS AN ABOMINATION!!! IF I had the power they would be summarily DISMISSED and all their operations would END tomorrow!

  • http://ANHUSA JEANNE BRANNIGAN

    IF I had my way the FDA would be out of business tomorrow!!!
    they are on the wrong side of almost every issue!

  • MARK

    This is down right immoral if we don’t have a choice in our own health we have “nothing” left
    This is all about $$$$ and all at the cost of human lives
    WE NEED REAL FOOD AND NUTRITION THIS IS OUR BASIC HUMAN RIGHT HEALTH IS OUR FIRST PRIORITY
    THIS MUST BE STOPPED NOW!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

  • M W Baumeister

    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 rule making process (as is required when creating a new law), the FDA has sidestepped everything by issuing a guidance.

  • Dave

    What the FDA is doing is forcing the Natural Supplement companies to develop a Black Market. I would lonly hope that these companies don’t give up. I’ll buy the stuff underground if I have to.Can you imagine having a prohibition era with natural supplements??? Count me in. If the government can over step their boundaries, then so can we!

  • EllenDiann

    When are the governors of the STATES going to back off the FEDERAL AGENCIES agains businesses. The Governors are allowing agencies such as the EPA and FDA to destroy business which is destroying our economy. We need to start taling to the governors of the STATE as they are being WIMPS in their job of protectiing the citizens of the STATE!. The Federal AGencies are unconstitutional and are NOT ELECTED officials who make up laws to rob businesses.

  • Jim L Adrian III

    The FDA is responsible for the health and well being of Big Farma, only, can be no other way.
    Many of the upper echelon of the FDA are ex-employees of drug companies. This makes the FDA and Big Farma married for sometime now and they do not want anything on the market that they do not control.
    I have been taking supplements all of my adult life and the supplement companies make fine products.
    When deaths occur, it is drugs, not supplements that are the cause. Along comes the FDA growing and growing right along with the drug companies and they tell us, that they are focused on supplements because of what? Supplements do not kill. What the married couple is saying is that they need to be off the market to make room for the inevitable drugs that will replace them that they produce.

  • Catherine Albers

    So what can the average pissed off American do about FDA slime? Who to contact that will give a dam?

  • http://AllianceforNaturalHealth Cynthia Wilson

    I really wish the FDA would stick to what they know best which is Nothing. They just want to make money off supplements. Please give us the freedom to choose. You the FDA have eough drugs on the market, most not tested properly. You the FDA allow drugs to be prescribed, then when they start damaging or killing people, youmay decide to remove it from the drug market, but you wait too late for many people. What is it all about. Money and Power? Guess so.

  • Cyndi

    “Do not post comments in all caps; it’s considered ‘shouting!'” So What? Our words fall on deaf ears anyway. The FDA and the pharmaceutical giants can now go about what they were doing all along — discrediting harmless, health-building nutritional supplements, while making their expensive versions that kill approximately 100,000 people and more per year.
    It’s time we put some strength into our spines, join together and back these bullies down. They have walked all over our rights while aggressively planning to take our health away from us. Their synthetic versions won’t contain the elements that the REAL herbs or botanicals do. A sick and weak public is much easier controlled. Do everything you can to raise awareness to the problem. Make phone calls to the appropriate offices, departments and leaders. Send faxes, cards and letters. Oh, by the way, please SHOUT; remember, they are hearing impaired.
    Another thing, don’t believe that the soldiers died because of DMAA. That information can be totally false. The truth will come out —- eventually — when it can be shrugged off and forgotten. In the meantime they will use the lie to confuse and scare the livin’ daylights out of the less suspicious among us. If you are mad, stand up and be counted! Hold the ground on the right to buy and use nutritional supplements. The government OF the people, BY the people, FOR the people! Don’t forget it!

  • Karen Graham

    The FDA needs to be fired! They are not for the people. Not the general public anyway!

  • Karen Graham

    The FDA is trying to kill us off. Or at least make us so weak that we will be unable to stand up for ourselves!

  • Joseph Nemchik

    FDA needs to back off anything that is not specifically given them by Congress to regulate. This is non-sense. We need less government, not more.

  • Renie Gadzinski-Giezyng

    This is a free country I should have the right to choose what suppliments not have the FDA dictate what I can take. How many people have died from addiction to legal prescription medications and vaccinations. Why dont you target the industry really causing all the harm the pharmacy industry. Of course most of the FDA are ex pharma employees. Shame on you all for the lies and corruption. The drug companies, FDA, senators corngressional members and state representitives. Shame on the greedy lying lot of you all!

    Renie Gadzinski- Giezyng

  • lisa alexander

    I work in govt and we are not allowed to enforce DRAFT policies or regulations, so why can the feds?

  • Ruth Herdt

    I don’t understand this. If it is not a law then how can the FDA treat it as though it is. There are drugs that the FDA has approved that are on the market that certainly cause serious side affects inclujding death, cancer, heart attacks, strokes, etc. Yet they continue to allow these drugs to be sold and that seems to be fine. I believe this all boils down to making money for certain professions in this country. While I don’t try to force my views on natural and/or organic foods and supplements, I don’t tell other people they can’t take prescription or chemical drugs. I think they are foolish, but it is up to that person not me.

  • Viviane Paolini

    ” If FDA fully enforces this guidance as drafted” Yes they want to take over and give everything to the big pharma so the money done by the vitamin companies go to the Big Pharma and then go to the FDA,
    The FDA have not right, but they take it and we must stop it. What is the gov doing for our health? and defending us against, grabbing power FDA. We need these vitamines , and we are millions that are counting on these lifesaving vitamins for our well being.

    Viviane

  • Doreen

    I find the article informative; but if I were to write to the FDA, the follwoign is what I would write to them:
    FDA Breaks Promise on Proposed New Supplement Rules; FDA why are you not good for your word and why do you refuse to allow our natural supplement healthy way of life that has been proven and working for millions of people and many supplements for thosands of years.
    The FDA and their supporting agencies want to turn God created natural medicinal plants/supplements into drug form and not allowing the public to have their natural
    Supplements that have proven beneficial for thousands or hundreds or years.
    Why do you, the FDA and your supporting agencies disallow us to be healthy and even stay alive.
    I am fighting cancer & Diabetes successfully with supplements and you will kill millions of people by your process via specific provision that you/FDA decided to enforce stating as a fact (false fact) synthetic botanicals will no longer be considered New Dietary Ingredients and must never be sold as supplements, only as drugs.

    Drugs have never been the answer for good health; drugs for the most part are destructive to the human body.

    Truth is: I ask you how do you have peace of mind removing our choice for our bodies, you are not doing this in the interest of the people that chose natural medicine/supplements; you are doing this for big business for your own financial gain.

  • Steven Duran

    Another Republican Taking Profit…Not, Making Profit. Taxs cut promises for the dim witted, only to close more American Industry and funnel profits to Republican Cronies in the Pharmaceutical Industry.

  • Michael Carpenter

    It’s time to go to the top of the FDA and 1 way or the other .maybe check their Bank Accounts and find Pharm money all over them.People can find that out,again 1 way or the other.

  • http://Alliancefornaturalhealth Leo Provencher

    Hi I have ulcerative colitis I am a male 30 years old who is very dependent on natural supplements because there is alot of things I cannot put in my body. I’m on a very strict diet and need my daily intake of supplements which is 5 to six different ones everyday. If this goes through this will really put a burden on my life. This is ridiculous FDA thinks they can do watever they want and need to be stopped! We as people need to stand up and say no!!! I think it is time to rally people!!!

  • pat Summitt

    I think the FDA should but out of regulating anthing sold as supplements,. If the public does not want it they won’t buy it. If they want it they should have access to it and the FDA has turned unto a NAZI agency that wants to controle every aspect ouf our lives. We all still have the Freedom of Choice and don’t need FDA telling us what we should and should not be able to obtain.

  • http://www.jam2day.blogspot.com Johann Mitchell

    The FDA enforces things that are harmful to me so consistently that I started to hate them long ago.

    They’re running a protection racket, not helping Americans be healthy or safe.

  • http://mercola.com Gerri Machin

    Is there something we (the consumer) can do?

  • GlennethLambert

    This new rulling classifying DSHEA as synthetic is completely OUT of established authority given to the FDA for identifying natural supplements!! IF there is concern over it’s safety then it should be held off the market ….until this is resolved …BUT you don’t make a unpredidented change in how supplements are classified WITHOUT normal protocall for such!!!

  • http://yahoo.com Vee W

    Posted by Vee W may1, 2012 at 12:32 am

    Why doesn’t the fda make those drug companies release cures for diseases
    people have in stead of treatments with medications that can cause other
    bad problems for them? ( You see the lawyer ads on t.v. every day ) wanting
    to go after the drugs companies.
    They can’t make as many billions off of the cures for different diseases,
    like they can with just the treatments. And they have the cures for them
    different diseases. Their just greedy that’s all.

  • Thomas Mueller

    President Barack Obama ought to stand up and oppose this and other FDA abuses of power, but apparently he is on the side of the pharmaceutical monopolists. We need a President who would stand up for civil liberties, like Ron Paul. I voted for Barack Obama once, but this time may vote libertarian if Ron Paul fails to get the Republican presidential nomination. Most other Republicans are just big-business stooges like most Democrats.

  • http://yahoo.com Vee W

    FDA gets paid off again!

    That’s why they’ve broken their promise on proposed new supplement rules.
    Drug companies can make more billions.

  • Rene DeMattei

    The FDA has a terrible track record on protecting us from bad drugs. They should clean up their process before branching out into an area they no nothing about. The only regulation supplements need is assurance that what the product contains what the maker says it contains and maybe some processing guidelines. Let us, the public, decide if we want to take the supplement. The FDA once again appears to be bowing to the wishes of Big Pharma. The drug companies already run the FDA since they are responsible for doing all the studies to get their product out for sale. Given all the drugs that make it to market and cause major health issues, I think it is that process that the FDA should be working on.

  • Naomi Cramer

    Is there some action that we can take to stop this and where can I see a list of supplements affected.

  • Angie

    This is a travesty. Many people in the U.S. need supplements to stay healthy, some to stay alive. This could amount to a death sentence for some of us who need these products. If they become unavailable or so expensive that very few can afford them then their deaths will be on the hands of the FDA and the U.S. government. I see some lawsuits coming!

  • David

    What do expect from an angency that has no respect for either the people or the constitution?

  • Douglas Michie Johnson

    We need to dump the FDA before they pontificate that only Monsanto can run the local grocery store.

  • http://www.petersonfamilychiro.net/ Les

    Interesting that the FDA is concerned about soldiers taking DMAA, a possible link to two deaths, yet military heath care givers pass out NSAIDs like candy to everyone suffering from the rampant overuse syndromes the troops are plagued with, despite the deaths that occur yearly from GI bleeding alone.
    Regarding heart attacks, a Danish study showed diclofenac (Voltaren and Cataflam) was associated with a 91% higher risk of death from all cardiovascular diseases, and Ibuprofen increased stroke risk by 29%.
    The public might be better served if the FDA focus on NSAID overuse, which may have been a contributor to these two deaths, not the DMAA.

  • dave connors

    If these FDA beaurorats took an oath to the US Constitution then they are guilty of a FELONY called PERJURY of Oath of Office and should be immediately prosecuted therefor . We the People need to take back control of the Grand Juries the main original purpose of which is to force the govt agents to obey their oaths!

  • blondie walker

    Please know these are the very supplements that have kept me in great health….saving of million of dollars for medicare, SS, and UnitedHealth Insurance….. Please know HealthCare and the freedom of “taking our health in our own hands” go hand in hand…we must have both.. Supplements work by for the good of keeping us healthy so that we will not be a burden on society . Please do the right things….Do not allow”it is all about the dollar” to be a reality especially when it comes to our health!!

  • Henry

    Seems like there are criminals in the FDA.

  • Jay Weeden

    I think it is about time we vote on taking the F.D.A. out of making our health care decisions for us !!!!

  • http://AllianceforNaturalHealth Matthew O. Fretz

    What has happened to the “Check and Balance System?” This system is set up to control each area of Goverment. Let’s get the FDA in complience with the LAW.
    If the FDA understood the human body, as they should, they would know that the body will not do well with synthetic materials. It will only build up in the body to create other health problems. Where as Natural plants were made by God for the body and it will accept it and heal.
    Get the FDA back doing what they were designed to do. They are like a camel, they get their nose in a tent and the next thing you know, they have taken over the entire tent.
    Let’s put a STOP to their antics.

  • http://www.distance-healer.com/Chemtrails.html Dr. Charles Morris

    Your Action Alert message (https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=833) needs to be updated to be more effective, in light of the new information in the article on this page; in particular, “I request that the FDA carefully review the draft guidance, and unless amended to reflect DSHEA (and Congress’s) stated values and goals, I request that Congress hold hearings to review FDA’s behavior at the close of the draft review process…” needs to be changed so that it tells Congress that the FDA did not amend the guidance and is now enforcing it as if it were, and that 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.

    In addition to asking Congress to uphold the landmark legislation it passed seventeen years ago, we need to also tell Congress, “Since the FDA did not carefully review the draft guidance and amend it to reflect DSHEA (and Congress’s) stated values and goals, and is now arbritrarily enforcing its draft “guidance” as if it were new law, I request that Congress hold hearings to review FDA’s behavior and to protect from being arbritrarily banned by the FDA, please propose legislation to modify DSHEA to include supplements developed and sold during the past 17 years.”

    • http://www.distance-healer.com/Chemtrails.html Dr. Charles Morris

      Also, please add a “Take Action” link for this page.

  • http://naturalformulations.net/ Sam Ziff

    Once again the FDA raises its ugly head in an effort to once and for all do away with nutritional supplements that are taking revenue away from their favored drug companies. Come November I am going to try aand see that the new president is aware of the problem

  • sara

    i personally think the key word here is synthetic. i dont want synthetic supplements any way why would you?

  • Oreste W. Lombardi

    It is high time for congress to assert its right of FDA oversight. FDA officials need to be reminded that the FDA is supposewd to serve the interests of the American people, not the industry that it regulates. Foot draging officials need to be shown the door.

  • kenny guillotte

    someone must have the power to reighn these guys in but WHO?????????

  • Debbie Bartelsmeyer

    Who has the authority to step in and make the FDA do the right thing? Is it Congress, law enforcement?

  • Marie Snavely

    How can we take action on this?

  • anita graham

    Why should anyone be surprised….we already have martial law; here is yet another example. The sheep-ish National Products Association deserves to be betrayed; they were happy to acquiese to the FDA……go along, don’t make waves. Unfortunately, we have all been sold down the river.

  • http://email Kathleen Kreiselmeyer

    This is another corruption of the FDA using unauthorized force ( most likely paid for by the pharmacy companies ) to take away another civil right of choice for the US Citizens. Hopefully, someone in a higher power position will stop these FDA people that my tax money pays for, the ones who make very poor decisions for We the People. I wonder what other countries think of the USA acting like a country without morals & ethics for the majority? What a role model for my children & grandchildren who will pay, not only salaries for the corrupt but for the “rules” they break at will that will cost the US Citizens a fortune in many ways.

  • http://None Phyllis A. Hannan

    The FDA and large drug companies have ever intention of taking all supplements off of the market. The Obama Healthcare Plan will not pay for major surgeries after the age of 75. It appears to me that the governement does not care about our health. We do require our supplements to maintain our health based on how the government no longer follows the guidelines or the constitution and makes rules of their own. When is someone going to stepuup and stop this madness?

  • Margi Wieber

    FDA:

    Please do not take away our rights as citizens to purchase dietary supplement by forcing non-patentable natural supplements to go through the same expensive and rigorous hoops you’ve created for the mega drug manufacturers. It is our right as American Citizens to choose which natural supplements we consume. Do not take our rights away!

  • Elaine

    The FDA is over stepping their mandate and attempting to write laws that will negatively impact the health and economics in the United States Truely this is short sighted foolishness that makes bad economic sence and contributes to the decline in health care in our country.

  • Doug

    The FDA is nothing but a group of paid whores who bend over for the drug companies!
    What a sham!

  • Chris C

    Our government…i.e. world leaders, want to control population growth in a more subdued way than that of the Chinese, who out right band children. Look who they start picking on first, the catholic church, many of which have large families. If our leaders can take a few of us out by not allowing these, so called dangerous supplements, the world will be a much happier place for the 1%. Big Brother will be our forever guardian….Sad future for mankinde…it is.

  • Tony Zitzelberger

    Is everyone asleep in government? You have created an agency the(FDA) that is working for the drug companies the same as the gestapo did in Auschwitz and 40 other concentration camps. The FDA is trying to take away all alternates that would keep us out of their death camps with no way for us to punish the drug companies for the killings that go on with what they are pushing. look at the side affects of those drugs advertised on TV for the death warnings for these things, and that only covers what they have not covered up.

    • TinaW

      No one is asleep in the government, they are on a power trip and taking money from all Pharmacy manufacturing businesses. They are all getting rich and they love it.

    • Jermo

      Yes, and note the disclaimers just after the drug advertisements on tv directing you to an attorney who will help you recover losses from problems experienced from FDA approved drugs. WHAT A SCAM WORKING HAND-IN-HAND!! Everything is coming to a head – American citizens will only take so much, then watch out.

  • Marge

    Here is my theory:I believe that long time ago, FDA has been purchased wholesale by Big Pharma. FDA will do whatever benefits Big Pharma, because when Big Pharma makes money, it will trickle some of it down to the FDA members. So, unless we un-corrupt FDA, there is no point in wasting our time by signing petitions, calling, writing personal letters etc. Now go ahead and prove me wrong.

  • Anne Zerrilla

    I take supplements. I don’t have any side effects. Yet, when I took medication/pharmaceuticals I had multiple side effects. My body belongs to me and I want to choose what I take to treat myselft. I don’t understand why you would approve drugs that have seriouse side effects. It seems like a double standard and implies that you are unduly influenced by big Pharma. I, as an Amercian, want more control over my life and less interference from big Government.

    • Kelly S

      FYI…The only reason this is happening, the governement is owned by the pharmaceutical company. Write your congressman, because elections are coming up …..we can make this an issue. I am a supplement user and have great health effects as a result. Can’t believe that the FDA supports medications that have killed people and been pulled from the market, but will then try to control the system on health supplements. Doesn’t sound like freedom to me!

  • Brian Taffe

    Seriously–who does the FDA work for? Why are these so-called federal jobs under the control of Big Pharma? The FDA needs to start working for the American people or be cut from the Federal payroll.

  • Laura Walls

    Fascist Dictatorship Administration

    Get rid of them

  • Gloria Jones

    It greatly saddens me to think that freedom of choice is being taken away from American citizens. If supplements work for a person, he or she should be able to use those supplements, and not have to resort to harmful, poisonous drugs. The only reason the FDA wants to put supplement manufacturers and sellers out of business, is because it doesn’t share in the profits, and can’t patent a natural supplement that, unlike a drug, can produce millions and millions of dollars at the expense of the lives and well being of the citizenry. This is the worst travesty I have ever encountered in my many years on this planet. Needless to say, if the FDA continues to dictate what a person can or cannot take for health purposes, there won’t be many of us left to fight. Does “weapons of mass destruction” have a familiar ring? That’s exactly what the FDA is trying to do by forcing us to take harmful drugs instead of Mother Nature’s cures. Thank about it!

  • Brodude

    The FDA is a corporate controlled criminal organization ! They do not represent we the people. They regularly support their constituents amongst big pharma and big ag . They do not care about our health or well being , rather they prefer us to be sick and dependent upon their brothers and sisters within the corporatocracy . All of this nonsense also coincides with a full implementation of the Codex Alimentarius. I am thankful we have outlets like ANH to provide us this information so we can alert our family and friends to the usurpious activities of these so called branches of govt.

  • Jermo

    The people have given our government away to the elites – $800K for GSA parties. Untold tax millions wasted on things we can’t see. SS agents committing adulterous acts on our dollars. We seek and destroy Osama Bin Laden, yet allow 1000 illegal immigrants per day to cross our borders without recourse, but with a wink and a nod. The problem is that our Nation has turned away from truth, “Love God with all your heart, soul and mind, and love your neighbor as your self.” What can we expect if we do not acknowledge that we are accountable to God Almighty! Corruption is rampant in our businesses and governments because leaders believe they can “Do what they want in their own eyes”.Our Nation has sown to the wind and the whirlwind is coming. Pray and act decisively if you want to see positive change in our future – and careful how you vote.

  • http://www.clicknbid.us Ron

    Bring on the lawsuit. Every company that uses DMAA should pull out their quality control specs on this product. Then SUE the FDA for breaking the laws set for them to function under.

    • http://www.doghappiness.net Elena Marcus

      One solution I see is to make people suspicious of all synthetic drugs to the point that they would not touch them and would break the trust between them and the unscrupulous drug-pushing physicians.. Less consumers and less sales will make it expensive for the Pharma to make new drugs. The ANH should spread the word on the adverse effects of drugs, including the physicians’ denials of them, and setup awareness opportunities for more attorneys to get on the wagon of fighting the Pharma, in the way they did with Fosomax and Vioxx.
      The ANH should spearhead a SSRI mass lawsuit – the adverse effects such as movement disorders (Parkinsonism and swollowing difficulties) are well established, accepted consequences by the medical communities, but the patients are being held in the dark by physicians (and given other noxious drugs to fix the symptoms — temporarily).

  • HS Incubar

    How much longer before we replace industry shills in the FDA, USDA, EPA, etc with people who are not beholden to the corporatocracy?

  • L.P.

    The FDA (Food & Death Administration) and the Obama Regime have a lot in common. BOTH break laws and BOTH have been given WAY too much power. BOTH NEED to go….permanently!!
    The FDA’s arrogance is UN-Conscionable. Corruption runs deep in the United States Government and in ALL entities within that government, but particularly the FDA. DISMANTLE ASAP!!!!

    • john639

      The FDA was just as corrupt under Bush as it is under Obama. The FDA is simply run by corporations.

  • chris

    i dont really care either way they will come out with something else for us to take but my problem with it what that . 1 it is a synthetic suppossidly and 2 i know several people that have had a false positive or this coming up as amphetamines and ruined there career . im millitary they are cracking down on us for pissing hot. studies done by a civilian lead resurcher show that 93% of hot urinalysis had dmaa in it that to much for me no thanx

  • http://www.naturalnews.com Steve

    It is common knowledge that the FDA is a rogue organization answering only to Big Pharma. The cited companies should send a link to this article back to the FDA informing them that they will take any necessary corrective measures when such regulations become law. I realize this may result in a SWAT raid, but a stand has to be made at some point to nullify the FDA.

    Meanwhile, for those supplement manufacturers who wish to continue supplying customers with quality products but want to avoid threats by the FDA, here is a method:

    A central database should be established to hold nutritional supplement product data for all manufacturers that wish to participate. The database would be hosted on a website by a third party, not any supplement manufacturer. By virtue of free speech, that site would allow consumers to find supplements with full truthful descriptions about the products; if it cures cancer then that may be stated. No FDA mandated labels apply here! There would be a link to the manufacturer’s website where the purchase may be completed. Since this third party site does not sell anything, any verbiage may be used to describe products; the FDA is powerless to regulate the site because no commerce is involved.

    Now, here is the tricky part. We know that the FDA is planning to do everything it can to effectively ban supplements by classifying them as “New Dietary Ingredients”. So the way around that is to stop selling supplements, and start selling decorations! Yes, simply sell the same nutritional supplement products, but package and label them as decorations that the consumer may wish to enjoy by looking at them. The FDA does not regulate the ornament industry, so they would be powerless to interfere. For example, if a company wanted to sell some tree bark as a nutritional product to make a tea with medicinal properties, the FDA has jurisdiction. But if that same company is selling that same tree bark as a decoration, the FDA has no jurisdiction.

    The central database on the third party website would match up generic product codes for “decorations” to the truthful nutritional info. There would also be a feature to print proper labels for the products so that the consumer could accurately keep track of the items they order, even across multiple vendors. Manufacturers could register on the site and obtain new “decoration” product codes and enter the corresponding nutritional product info.

    This is a rather convoluted…

    • http://www.naturalnews.com Steve

      … This is a rather convoluted method to ensure we have access to nutritional products without censorship and banning by the pharmaceutical industry, but it would certainly be effective and quick to implement. The site and database would be a sort of “open source” of information for nutritional products. The consumer could query on various ailments or desired outcomes and scan results filtered by cost, vendor, testimonials, etc. Let’s just quit playing the FDA’s games!

  • blue heron

    Y’all need to take under consideration that annual combined profits of Big Pharma are about 2x (double) those of all other major US industrial groups combined, making it so powerful that it may take a major public revolt to change the workings of the FDA, insurance companies in their pockets, and other govt. agencies that seem to listen only to Big Pharma and their myriad lobbyists.

    My suggestion is to educate your friends, family, and relatives, and keep talking to anyone who will listen about the false promises the FDA is making, and their numerous illusions that they are following any mandate to keep our food safe. Strip the veil at the local level and perhaps sooner than later, enough Americans will wake up to the damage done every day by this conspiracy of thieves and deceptions: Big Pharma, Big Ag and Big Insurance.

  • barry parks

    screw fda eat what u want.they r bought & sold they fool no one..buy organic buy supplements u have right 2 put what u want into your body.FDA can KMA!!! u r the resistance question authority its a democracy.november we throw them all out of office.send them a message!!!

  • http://www.justlivingbetter.com skin Care

    Excellent site. A lot of useful information here. I aam sending it to several friends ans additionally sharing
    in delicious. And certainly, thanks in your effort!

    Here is my web page … skin Care