FDA reverses itself—for now.
We have pointed out for months that the FDA’s NDI (new supplement) guidance threatens our access to supplements and indeed could destroy the industry, leaving drugs with a total monopoly.
After adamantly digging in its heels and refusing to reconsider, FDA has now at last agreed that the draft NDI guidance requires substantial revision. This follows a meeting between FDA Commissioner Margaret Hamburg and Mike Taylor, Deputy Commissioner of Foods, with Senators Harkin and Hatch, longtime champions of natural health.
According to our sources, the FDA stated in the meeting that the guidance would be revised to account for the numerous comments and concerns, and released in draft form once again, which will then be open for public comment. This is exactly what we asked for!
The FDA’s decision is a dramatic reversal of the position taken in an earlier meeting with the Senators’ representatives, in which they adamantly refused this very same request. While we may never know how or why the FDA changed their position, it is very likely that they were responding to our sustained public messages opposing the current NDI draft guidance.
ANH-USA has also been working closely with the Appropriations Committee that controls the FDA’s purse strings. We recently helped secure report language in the Appropriations Committee censuring the FDA for prematurely enforcing the NDI draft guidance while supposedly still in draft. The report goes on to further state: “The Committee urges FDA to withdraw the July 2011 NDI draft guidance and re-engage the dietary supplement community to develop a new guidance on what constitutes NDI.” This appears to be another reason the FDA is finally listening.
While the FDA has not yet agreed to a specific timeline for revising the guidance, nor indicated what exactly will be revised, they did commit to collaborating with the dietary supplement industry to create a list of agreed-upon “grandfathered” dietary ingredients (ie. supplements). A “grandfathered” dietary ingredient is an ingredient marketed before 1994 and therefore not considered an NDI (new). Grandfathered dietary ingredients are therefore not subject to the NDI guidance. Currently, there is no authoritative list of “grandfathered” dietary ingredients, leaving the legal status of many dietary supplements in limbo.
Although an authoritative list of “grandfathered” dietary ingredients could be useful to the supplement industry, we fear that the FDA will use this as an opportunity to knock out supplements that were indeed on the market before 1994 but may not meet the FDA’s idea of proof. This is precisely what happened to pyridoxamine, one of only three natural and bioavailable forms of vitamin B6. Although we know that pyridoxamine was on the market before 1994, the FDA determined that there was not enough of the right kind of evidence to conclusively prove so, and removed the ingredient from the market.
ANH-USA will participate in this process to try to ensure that the list of “grandfathered” dietary ingredients is inclusive in order to maintain your access to as many supplements as possible. We will also try to prevent the FDA from using the list as an excuse to delay indefinitely their promise to revise the draft guidance.
Our readers have sent hundreds of thousands of messages to the FDA regarding the NDI draft guidance issue. We have just won an important preliminary victory and it wouldn’t have happened without you! Now on to the next phase of the struggle. If we are patient and persistent, we will win.
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Wonderful news….we do not need more regualtions in our lives and suppllements have helped so many, including me
Thanks so much for all your hard work, ANH! I have called Senators Hatch and Harkin before to thank them for their work to keep supplements available (even though I’m not a constituent of either of them) and will do so again. They’ve both worked hard alongside ANH to fight the power-hungry FDA on this issue, and they deserve our thanks.
No, We don’t want anything “grandfathered in” we want the government completely OUT, this administration has over reached just about everthing it get’s it’s hand on and we ARE TIRED OF IT!!
Yeah! I am very happy to hear this! Thank you for all you do!
Warm regards,
Karen Harris
Audit the FDA!
What about things like astaxanthin and coQ10 which people haven’t been aware of until the past five or 10 years? These two are some of the most important ones I take every day.
thank you for all your hard work on this. getting these people to the table was a major event in itself. and getting them to back off, even somewhat is an accomplishment. but need to build on it, not sit back on our proverbial laurels.
i have to wonder if this draconian draft guidance wasn’t used in the destruction of private gardens such as the one recently reported. the woman was indigent and sick. she grew her own herbs and food trees/plants. the authorities, without legal basis, came on her property and destroyed everything. this was in ???ohio? a similar case was of a man who distributed his organic foods to neighborhood people. it devestated him. i think he committed suicide.
‘Substantial Revision’.. That means the snakes are preparing for yet another round.. Tell me I’m wrong.
” If we are patient and persistent, we will win.”.. Does this mean they actually have a ‘cut-off’ time where they must adhere to their responsibilities and stop being a usurper?
I certainly hope that you and your organization will continue to address this issue, provide as many petitions as you can and allow the people to continue to inform these bureaucrats that we will accept nothing less that what WE require of them.
So, thank YOU for being our advocate and our voice.
Why stop at grandfathering. Shouldn’t we have access to suppolements resulting from new research?
Although I am not connected in any way with any profession related to medicine, I am an individual who wants to keep the freedom to have access to any and all foods and supplements that I deem best for my body.
In that regard, true access to ALL nutritional supplements that were on the open market during any part of 1993 (equal to being available before 1994) must be included. To determine this may require more research than FDA has done in determining all the supplements that were available for those time periods, especially the different forms of B6.
I believe in taking true responsibility for my own health — which includes guidelines or rules or laws or directives that allow me to have accessto those supplements that I determine my body needs for better/best health.
B J Ward, PhD
Yes we must keep up the fight glad my voice was heard
I use several supplements and do not think the FDA has the right to take the product away unless they can prove its damaging to your health. The government should go with the will of the citizens.
God Bless you guys for fighting the FDA. We have not fully won the battle against them, we have won a major victory at this time. Almost everybody I have talked to, knew nothing about what the FDA was trying to do. Somehow we need to group together with more voice against them. I posted your article on my two blogs. I get almost 2000 readers a month. I have done my part to try and spread the word about your work.
Thanks for this good report. Keep doing what you do and we will keep supporting you!
I don’t believe many people are aware that Tom Vilsack (over the USDA) and Michael R. Taylor (Deputy Commissioner, Head of the FDA)–are both from Monsanto. Monsanto is so determined to force feed their GMO produce and pesticides and Agent Orange compounds down everyone’s throats, and the USDA is so eager to say that rBST meat is safe for consumption; so I can understand why these two federal entities want to get rid of vitamins and supplements. Getting rid of vitamins and supplements would put a stop to those of us who want to take care of our bodies and stay well. This is why there is a major resistance for the government to enforce labeling of food. Eliminating our choices of what we put into our bodies will help cause more disease. This is a nasty form of population control.
Thank You! Thank You! It is so hard to stay healthy and we are not on medication, so we eat
very healthy and take supplements! This is the greatest news. It pays to sign petitions!
Thank you ANH-USA for all of your hard work. This win could not have happened without your hard work.
Thank you all ,from the bottom of my heart, for being on top of controlling Bureaucracy…….I have and hope to always be able to have the right to consume healthy (non-chemical) supplements!!!! Hip Hip Hurray for this small but HUGE victory…..I will continue to support your choice for freedom….Again….THANK YOU ALL!!!!!
Congratulations on a battle patiently and consistently fought. Thank you for helping to preserve this important aspect of our health care. I look forward to supporting ANH in its continued efforts. May reason, not profit, prevail.
Best,
Catherine Gentile
how can we vote to get the bad guys out of government ? Why do we vote a president for 4 years at a time, and everyone else stays in till they die. Find a way to change that with a petition. We’re just wasteing time with every bill you and everyone else is trying to catch before it’s put into law. What a waste. Let fight the guys giving us the problems they need voted out NOW not later. Let us know who’s the problem makers and not moving us forward as a nation and hear what the people say with a vote on this . Find away we can vote for no more lobbyist in washington also. That’s a bigger problem. Lets get rid of them with a vote from us. Were just trying to stop problems they are making, Lets our votes on potitions make laws the people want…………………………………… How can I help with this sugestion? Can we do it some how ?
It should be easy to come to an agreement. Just add some aspartame, fluoride, mercury, and some GMO ingredient to every supplement and they will SAIL though the FDA process.
It should be easy to come to an agreement. Just add some aspartame, fluoride, mercury, and some GMO ingredient to every supplement and they will SAIL though the FDA process.
It should be easy to come to an agreement. Just add some aspartame, fluoride, mercury, and some GMO ingredient to every supplement and they will SAIL though the FDA process.
It should be easy to come to an agreement. Just add some aspartame, fluoride, mercury, and some GMO ingredient to every supplement and they will SAIL though the FDA process.
It should be easy to come to an agreement. Just add some aspartame, fluoride, mercury, and some GMO ingredient to every supplement and they will SAIL though the FDA process.
It should be easy to come to an agreement. Just add some aspartame, fluoride, mercury, and some GMO ingredient to every supplement and they will SAIL though the FDA process.
I am nearing 87 years of age. Other than organic food, I intake only supplements that are tailored to my body chemistry, maintaining excellent health. I am grateful to a remarkable Integrative M.D. who has kept me healthy for many years. I am grateful also to all the supporters of supplements who never gave up the fight with the FDA and their overwhelming pressure from the pharmaceutical conglomerate. thank you for must ering much of this support.
Thank you!
I am glad to know that they are considering looking into the importance of maintaining our access to supplements that have the essential dietary ingredients for the consumer. And keep our supplements as our freedom of natural health.
We know the supplements work better than Medicine you get form any Doctor. Please let us keep
getting supplements. Thank You Donna Rabe
Just let me be the one to choose what I put into my body, please.
Since it will become very difficult and expensive to keep fighting the FDA,
I think we should start a movement to abolish the FDA. We do not need an agency that is more concerned about profits, than the rights of the people to make their own decisions.
I have been taking supplements since I was 30 years old, I am now 66. I am basically very healthy. I do not have high blood pressure, diabetes, osteoporosis, weight issues, heart problems, etc. My doctors have many times commented on this fact. I feel that without thie vitamins and supplements I would not be as healthy as I am today. I also have cancer in my family and that was another reason for staying well with Vitiamns. I am against any regulations on supp, or Vitiamns. Why doesn’t. the powers to be understand that this helps people from long hospital stays and heavy expenses for insurance company’s . STAY AWAY FROM OUR SUPPLEMENTS!
THANK YOU,
J. DeLara
I have had many health issues and thanks to taking supplements I am managing quite well. I would be quite distressed if they were no longer available. I do take my medications also but these supplements have made a big difference. Please allow them to be purchased. Thank you.
“Although we know that pyridoxamine was on the market before 1994, the FDA determined that there was not enough of the right kind of evidence to conclusively prove so, and removed the ingredient from the market.”
How critically we need an HONEST FDA!
The FDA has “given” a natural form of B6 pyridoxamine to a drug company so this drug company can “patent” it for a drug use. This is such a DANGEROUS precedent it should shock us into action. Who the hell is the FDA to allow a natural substance to be “patented”???
The FDA is clearly beyond control and should be ABOLISHED. They have long ago turned on the people they claim to represent.
Yaaaaay… This is the best news we have heard in a long time!!! Keep us posted for sure on your great and effective efforts to keep us healthy.
Thanks for all the good work you do.
Power corrupts. Truth is wonderful.
Thank the Lord for the Victory!!!!!! I have useed supplements for many years and I am 67
years old and am in perfect health!! No perscription drugs in my body!! I have never had surgery
or been in the hospital except to give birth to 4 children!! Thank you so much for not taking our
supplements away! Thank you FDA!!!!!!!!!!
Dear FDA
Please continue to allow us the freedom to learn and make our own decisions about how we maintain our own health. It is only the American way. Freedom was bought by a lot of bloodshed.
Please help us stop those who would chip, chip, chip it away.
Thank you
James Riley
Finally this is a great preliminary victory for us!
i am very happy right now.
We must be vigilant and pay attention to everything thats going on.
Keep up the good work ANH and i will continue to back you up all the way.
I’m not sure if I know how to “not be abusive” when it comes to this topic. Any thought that the FDA will take away my right to purchase any vitamin I want, makes me very angry. If they take away any more vitamins, it will turn me into a drug smuggler, because I refuse to accept these NAzi TACTICS and I would like them to start investigating the real drug crimes committed by the pharmaceutical industry. This is what their agency was created for. Not to interfere with vitamin useage by Americans.
I went off 7 pharmaceutical prescriptions that a doctor had me on. I went off cold turkey. I had been taking some for over 30 years. They did absolutl NO GOOD, but caused a waste of 11 years of my life due to the depression they caused and the enormous amounts of weight gain. I was also on an acid inhibitor for over 30 years. my hair fell out and I only realized after using the Internet for a while, that those pills were what was causing my irratible bowel and blocking the absorption of many vital nutrients from my food, including B vitamins which was the main cause of the loss of my haif. I am female and live in Arizona and I don’t want to wear a wig. I feel so much better now. I refuse to take any Pharmaceutical drugs, both prescription and over the counter. Nothing but vitamns and herbs, spices and sprouts and healthy, organic foods, grown indoors if necessary, to avoid the pesticides and the chemtrails and the poison tap water. The FDA no longer works to help the american citizen. It is in the pocket of Big Pharma. I would like to see the entire agency dismantled.
How do I contact the FDA? How can people get their voices heard on this topic? How can we stop the slow accumulated deaths caused by all the other problems that the FDA chooses to ignore? I know you won’t post this. You are in the same pockets that they are.
Come on, Taylor — the ANH is doing its best to *stop* the FDA’s power grab. They are not by any means in the “same pocket” as the FDA!
This comment talks of Nazi tactics. Fascism is a form of government where industry controls policy. One could make the argument over and over again that The Pharmaceutical Empire has bought off the US government. I think Nazi tactics are exactly what we are seeing. We must recognize the threats that a thoroughly corrupt FDA pose to the American public. What they are trying to shove down our throats is not “Health Care” but instead is “Disease Care” and is so lucrative to Big Pharma that it is bankrupting the USA.
Never take time to take a breath with this vastly corrupted agency. They have something up their sleeve and we must be ready to blast them again. My congressmen are sick of hearing from me I am sure. You will only get my life sustaining supplements from me by showing decency and integrity in the process of fair and science based evaluation.
We are to be congratulated for the great job we are doing. It’s far from over, and may never be. We are fighting not only for our supplements, but for our freedom to choose.
How does one successfully counter this kind of money and corruption? There needs to be the kind of exposure of the FDA that would be on mainstream news as an investigation of a scandal. There needs to be a best selling book about it. Somehow it needs to be a huge exposure. Even tainted food from China didn’t stop them. This is so scary.
great news and a great birthday present!
Having worked as a Clinical Trials Monitor on behalf of a CRO/Big Pharma I have an entirely different view of the FDA. FDA Rules/laws are written by Big Pharma. Almost all FDA research on any drug is paid for by the Pharmaceuticals themselves. So, drugs are approved that turn out to be dangerous AFTER the fact, while Pharma knew this was the case during the Clinical trials. Information is kept from the FDA or is ‘doctored”. Drugs are allowed not when they have been shown to be safe but solely because they havewn’t killed anyone as yet. Splenda is anot allowed in Europe, the FDA is paid by the industry to allow it. Statin drugs are prescribed to people who dopn’t need them with terrible side effect including loss of memory. GM foods are allowed although there is a ton of evidence showing that it is causing cancer/infertility in animals. There is an epidemic of Autism with a 78% increase in Autism between 2002 and 2008 of children 8 years of age.
The FDA is no longer an advocate for the American population against unsafe foods/drugs.
It is funded by Corporations and Big Pharma. It cannot be trusted.
It should be exposed for what it is and a complete overhaul of the Agency is required.
Congratulations, Good Work.
Bev
Good News! Keep up the good work!
Rebecca Lang
Thank you, ANH-USA and Jonathan Emord! You guys are just absolutely wonderful! We really appreciate your very hard work. It’s so heartening to see how well it has paid off! Thank you again!
It is grossly unfair to deny the public alternatives to Big Pharma with its concocted drugs: to read the advertisements on tv and in print one has to wonder why one would take any of those drugs when there are natural and alternative cures and treatments. Granted they do not earn Big Pharma its millions but then what is more important: their millions or the public’s well being?
Congrats to you and all in your organization involved in this matter. Keep up the good work….it’s appreciated more than you realize or could know.
Jack Weinberg
The FDA is still a threat to our freedoms. Your example of pyridoxamine shows this. The fact that tryptophan is still banned is another. The FDA is still the greatest secondary cause of our increased healthcare costs (the primary one is the big pharma industry). The FDA needs to be reigned in much more than it already has been, not merely placated a bit. In fact, it is so much trouble that I think that we would be better off without the FDA to begin with. We shouldn’t have to fight our own regulatory agencies, supposedly set up for our well-being, for that very same thing.
Tryptophan is NOT still banned, just subjected to so much checking up on quality control as to make it cost about twice as much as it would without all that supervision.
Tryptophan is available now. I recently purchased some.
But that does not negate the fact that it was unavailable for so long.
glucosamine is keeping me from a knee replacement.
I celebrate this small, but significant, win. Let’s hope that all of our collective efforts can bring some form of sanity to the FDA.
There must be some way to give the BIG DRUG FIRMS their obscene profits AND give consumers the right to buy the products they want both at the same time. With money all fiat already and unemployment so high, it must be possible to just print enough money to BUY OFF BIG BUSINESS< get most of the 99% back to work and give consumers some semblance of a free market ALL at the SAME TIME.
I agree, but hoping only won’t do it. We cannot give up “bugging”them, agree?
I’m really happy to hear that FDA is moving in the right direction for people that want their voices heard, and brought to light for the right to choose between conventional or alternative medicine/supplements.
I’m proud to know I had a small part in getting the ball started in leading the FDA to make the right decision in giving all people the right to choose what they want to take in supplements or anything else.
Hear it but don’t believe it. Make sure Romney is with the program too. The issue is FREEDOM, and the pro-freedom individual is the one who will get my vote… party affiliation or not. Make it clear to your Senators and Congressperson Too. Don’t let them buy your vote with the big money ads.
Tell them to Get with the program of get out.
So …. finally a victory. The lobbyist/ regulators in Washington D.C. only know one language. That is the language of money. Take away their funding and they start to cry. It’s high time to get the Big Pharma lobbist’s OFF the FDA and replace them with people grounded in science and responsible NOT to Big Pharma and Wall Street but to the citizens of the USA who use supplements. It’s refreshing to see Mr. Hatch working for “people” instead of Big Business. I don’t expect to see this very often. Kudos mr. Hatch and Mr. Harkin.
I’m so pleased that the FDA appears to be “coming around” regarding our right to take the medicine of our choice. Natural remedies and therapies have been around for thousands of years, so I’m not sure why they are discussing grandfathering supplements since 1994…why not supplements prior to that? There are many good, reputable and helpful supplements that have been around a lot longer than that.
As always, consumers need to have their right to pick and choose what they will and won’t put in their body. As a Naturopath, people come to be on purpose so that I will recommend something healthy and natural for their body and their various symptoms. It should ALWAYS be an individuals right and choice if they choose to NOT take pharmaceuticals and instead, to take nutritional supplements.
Too many organizations like Monsanto, are pulling the purse strings with our government and our choices. This must stop. Thank you to your organization for helping to win this current battle!
One thing that concerns me is that Senators Hatch and Harkin, who seem to be the main Senators who fight for our right to have free access to supplements, are both getting older, and Senator Hatch is in the fight of his life to keep his Senate seat in Utah. If either or both of them leave the Senate, I’m afraid there will be no more champions of natural health in Washington to help us fight the FDA.
I called the offices of Senators Hatch and Harkin today to thank them for their tireless work to stop the FDA from taking away our right to buy supplements. Both staffers I talked with thanked ME for calling and said they rarely hear positive comments, and that they would definitely pass on my message to the Senator.
So I urge others here to call also. They deserve our thanks for standing up for our rights, and supporters of natural health in Washington are few and far between. I told the staffers I’m not even a constituent of either of them but just wanted to say thanks.
Senator Orrin Hatch: (202) 224-5251
Senator Tom Harkin: (202) 224-3254
Thank God for the ANH!! You make it possible to know what is going on in our huge federal government. Thank you, and keep up the great work!
Point one: We won NOTHING. Everyone please notice that the FDA still has the 1994 “grandfather” provision in place. Ask why. Why the 1994 date? Because most prescription drugs, from what I have read, have not been substantially altered since then, may be one reason. It would cost them almost nothing to duplicate any pseudo-“new” drugs they have come up with since then.
Why now? Because a lot of Big Pharma’s patents are due to expire pretty quick. And there is only so much they can do to label them as “new” by scratching an extra cut-line on tablets.
Point two–In Nazi Germany, the pogroms began with requiring Jews to simply “register.” Now FDA wants to make it mandatory for supplements to simply “register.” With whom? With FDA!
Point three–No supplement can possibly pass FDA’s required “protocols”, for 1,000 times normal dosage–of each ingredient or compound separately. Think of plain drinking water–no one could survive drinking 1,000 glasses of water a day every day for a year. Think of many supplements which, like whole foods, can NOT provide broken-apart individual segments and still get the same results. As one supplement maker pointed out recently, when you separate the ingredients in the natural product, all you get is a sticky mess! Further–FDA uses the “1,000X dosage” protocol for nefarious ends. When one FDA-favored commercial product came under fire for health risks–FDA’s answer was, eh, you’d have to drink a thousand of them a day to come to harm. And the dangerous product was allowed to remain on the market, for that reason. Despite evidence that even reasonable consumption levels had led to noticeable harm–and to the outcry.
Last point–which should be the FIRST point–It is NOT and never has been FDA’s responsibility to oversee, regulate, or otherwise govern in any way over nutrient supplements. We need to work toward laws to back off FDA from ANY such “Guidelines” –not just cheer because FDA agreed to wait a little longer to hammer down. From what I gather other places, FDA tried this same stunt twice already, and got shut down on it by Congress. This time FDA may succeed.
Congress–please shut FDA down on this new attempt to cut out competition from Big Pharma.
OKAY–the really last point–We can impeach presidents, but there is zero consequence for a government agency, such as FDA. FDA even wrote an applicant’s application for them, concerning GMO salmon–which the President of Consumers’ Union…
Gertrude, thank you for your comment. We agree with many of your points, but would like to respond to your mention of the 1994 date. The reason the date is set in 1994 is because this is when Congress passed the 1994 Dietary Supplement Health Education Act. In DSHEA, Congress declared that all existing supplements were considered untouchable unless a safety issue arose, and that any new dietary ingredients that would be introduced to the market after the passage of DSHEA should submit notification to the FDA along with evidence to support their safety. (Note that the bill required notification, not application for approval.) The legislation directed the FDA to work out the specifics of how companies should submit notices, and FDA waited 17 years to get around to it! The 1994 date and the NDI guidance both apply only to dietary supplements, not prescription drugs.
This is a basic freedom — One of the many — that the ELECTED LEADERSHIP(!) is trying to take from us. No wonder people are suspicious that there is a conspiracy under wraps!!! I have no doubt; how about you?
Vote with our MONEY: MONEY TALKS! When the last body dies, the gold and silver will be meaningless. One of these days it will be their own families, there own body. Wonder when they will think of that.
I do not understand how a free country (like the United States) can have an agency that wants to take the freedoms of its citizens away. What is even more disturbing to me is how many medical doctors from overseas have come to practice here, know about the benefits of supplements, yet are not allowed to use this knowledge within their practices because of the backlash they will get! My father had congestive heart problems and I asked his cardiologist when I saw him in the grocery store about coq10 to help out his condition. The doctor said it would be good to do if we were in another country, but he could not advise my father as his doctor in this country. Is this freedom? How those medical professionals must feel about themselves when their patients die before they needed to! This lack of freedom to discuss natural alternatives makes me and many others distrusting of the medical profession and that is a big shame for us all.
Thank you ANH-USA! We will continue to fight with you for our health and freedom.
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People that want to see less of their freedoms taken away had better start paying attention to which voting groups they want to aline themselves with. Less government control over ALL aspects of our lives is the only way to stop this power grabbing from those in office. And that crosses both parties. Pay close attention for those that want LESS government intrusion in your life and LESS government departments. And then VOTE for those people. Stop playing the “I always vote DEM/REP” game. Because it is just that. Time to wake up and smell the crap being fed to you.