“FDA is Violating Federal Law”—Emord
December 6, 2011
Bolstered by a massive outpouring of support from you, we are asking the agency to withdraw its New Dietary Ingredient (NDI) draft guidance completely!
The period for comments to the FDA on the draft guidance on NDI notifications closed on December 2. Along with the hundreds of thousands of messages you sent and the 20,000 phone calls you made to FDA and Congress, ANH-USA also submitted formal comments.
The problem with the FDA’s draft guidance on New Dietary Ingredients is that it allows FDA to arbitrarily deny the sale of any supplement created (or modified) in the past seventeen years. If you’re a supplement manufacturer or distributor or possibly even a health food store, and you don’t file a NDI “notification” (actually a request for approval) for each ingredient in each product developed since 1994 in just the way prescribed by the FDA, and the court later decides the FDA is right, then you are guilty of product “adulteration,” which is punishable by prison. With your favorite supplements off the market, it also would allow the drug industry to adapt and patent them, and sell them back to you—by doctor’s prescription only—for 10 or 100 (or even more) times what you’re paying now.
Our comments, drafted by acclaimed attorney Jonathan Emord on our behalf, show that the FDA is engaged in substantive new rulemaking, in violation of the federal Administrative Procedure Act (APA). “The APA says if an agency’s action is legislative in nature, that’s rulemaking,” explained Emord. “The guidance distorts the plain language of the laws that govern supplements. FDA needs to comply with the APA’s formal rulemaking requirements, not issue unilateral guidance as a deceptive means of creating new rules.”
We argue that the FDA is acting illegally. The FDA circumvented the regulatory process by issuing a guidance, which gives them cover and flexibility, instead of going through the rulemaking process, which is required when creating a new law—and we believe the guidance in fact does create new law. As a result, FDA’s actions leave interested parties little recourse within the regulatory system.
In technical terms, a guidance is supposed to be legally non-binding. It is meant to simply present the FDA’s interpretation of the rule. However, the NDI guidance goes well beyond an interpretation, and we believe it is in fact a legislative rule with legal implications:
- The NDI guidance is a departure from the FDA’s previous standards for NDI notifications. It alters and broadens the meaning of what qualifies as an NDI, and creates new—and very expensive—requirements to comply with the NDI notification process (creating what we would call a de facto pre-approval system), counter to what is outlined in Dietary Supplement Health and Education Act (DSHEA).
- Not fulfilling the NDI notification requirements outlined in the guidance ensures that the supplement will be considered adulterated and therefore illegal. This indicates there’s a clear, legally binding impact to the NDI guidance.
- Supplements that are considered illegal can be confiscated, and under the Food Safety Modernization Act, as we noted lasted week, can now be subject to administrative detention as well.
You may recall that Joanna M. Shepherd Bailey, PhD, professor of law and economics at Emory University, demonstrated that FDA grossly underestimated the economic cost of the NDI guidance. Her report found that:
- Up to 29,000 nutritional supplements would likely be removed from the market;
- 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.
FDA’s analysis did not take into consideration the costs of the expanded reach and requirements of the NDI guidance. The agency therefore misled the Office of Management and Budget, in violation of the Paperwork Reduction Act of 1996.
FDA has arbitrarily determined that supplement companies need to show at least “25 years of widespread use” in order it to meet the “history of safety” standard in NDI notification. In other words, only supplements on the market before October 1986 could be considered “safe.” This is patently ridiculous, since the cutoff date for grandfathered ingredients assumed to be safe, according to DSHEA, is October 1994.
The NDI notification system was intended to ensure safety. The very reason pre-DSHEA supplements were grandfathered is because they had proven themselves safe through years of use by hundreds of thousands of consumers! If safety is of utmost concern to FDA, why does the guidance document burden the supplement industry with regulatory requirements that have nothing to do with proving the safety of the supplements? It appears FDA is acting out of spite—and not in the public’s best interest. Moreover, many of the provisions in the guidance are totally unrelated to safety and serve only to limit consumers’ access to nutritional supplements.
We believe FDA will be unable incorporate enough changes to their draft guidance to bring it in line with existing law, preserve supplement access for customers, and remove needless regulatory hurdles for industry. Because of this, we asked FDA in our formal comments to withdraw the draft guidance at the earliest possible moment.
Now that the FDA’s comment period is closed, the agency is supposed to review the comments and prepare a final version of the guidance document—though they are under no legal obligation to do so. In fact, because it is guidance, they are under no legal obligation even to take public comments into consideration. Nor is there any timeline: the agency is still sitting on a guidance, now nearly three years old, that was meant to create a distinction between beverages and liquid dietary supplements.
Even worse, since this is presented as guidance and not formal rulemaking, the FDA is very likely to enforce the provisions in the draft guidance as though they were final—with limited legal recourse for affected parties!
We believe FDA’s actions require them to follow the Administrative Procedure Act, which calls for a formal rulemaking procedure. Under this law:
- FDA will be forced to have a formal comment period, and to review and consider all comments before they issue a final rule. This includes a rulemaking record that shows the data and analysis behind a proposed rule, and sometimes even public hearings.
- If the result is not to the liking of interested parties, “Each agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule.” This means, that unlike a guidance, it is possible to challenge a rule in court. It is very likely that FDA conveniently issued a guidance, instead of going through the rulemaking process, to avoid this very outcome.
Now that the NDI comment period is closed, we will start implementing the next phase of our strategy—which will include both legal and legislative components. We will, of course, keep our supporters and allies in the loop.
Thank you all again for your tremendous outpouring of letters and phone calls! It has laid important groundwork for our next actions.
The FDA is no longer a Protection Agency “of or “for the People”, they have been Hijacked by Big Pharma which makes more money than all of the Fortune 400 on wall St. combined in a year.
We The People need to dissolve, Close the current FDA and make a new Protection Agency: Peoples Food and Drug Agency The PFDA.
I am 59 and this is the first time since the Vietnam war, that I have seen U.S. citizens amass in public groups to continually protest things about our government which they do not like. Although these groups are still not very organized, it at least appears possible that maybe something can be done to get beneficial change to occur. . The people have the ability to make our legislators effect changes in government and in regulations. The FDA is one of the better examples of where significant changes are needed so that they will be required to do what they were designed for, and NOT what big business interests want them to do. Most voters continue to be stupid enough to not vote for the candidate who they believe will do the best job, and instead to either vote “their” party line, or the lesser of two evils of the two useless major parties. This can never send the message that we are fed up, since the two major parties still know that they can do whatever they wish and yet we will still vote one of their candidates into office. Until the voters understand that both parties represent mostly a continuation of the status quo, we will keep going in the wrong direction. In the past few elections, the only candidate whose views represented health freedom has been Ron Paul and so I will most likely vote for him once again as I continue to fight for my health freedom rights and the rights of my patients, students, family and friends
Hello,
I am in favor of all your comments, I totally agree with everyone here. The Govt., including Big Pharma, Big FDA, and Big CDC along with Big Agra are all corrupt equally. I really think and believe that our supplements should be overseen and managed by a totally different department, one that is managed by someone who believes in taking supplements for good health. Someone like a naturopathic physician, a homeopathic specialist, doctor of oriental medicine, or a professional nutritionist who is a certified practitioner. The FDA has no right whatsoever to manage or oversee our supplements, they just do not know what they are doing and do not know anything in regards to supplements, they have no knowledge how they function.
If the public cannot have access to their supplements, people will become sick and die as a result of the FDA’s doings and therefore there will be less people on the planet earth, I guess that is the FDA;s and Big Pharma’s plan and goal. Well, I have a lot of faith that this whole thing will just collapse in the FDA’s lap and make them look completely embarrased and will have egg on their face.
To Jonathan Emord: I really hope and pray that with his expertise, he can work real hard to help keep our supplements where they should be, in the hands of comsumers who believe in taking them to prevent illness and for good health maintenance. When you really think of it, taking suppelments should not ever get in the way of the FDA or Big Pharma, but they do somehow. We should be able to take whatever supplements we want whenever we want, without disrupting the FDA or Big Pharmas workings. Who are they to control our supplements. I am really getting tired, if I am not at that point now, of the Big Govt. wanting to control our lives. After all, this is America, the United States, we should be enjoying our freedoms, not be afraid that someone or something is going to take them away. We sure live in crazy, crazy times anymore, I don’t even know from one day to the next what will happen, need to keep abreast and up to date anymore what is happening or else we will lose out and get caught off guard. And anymore I sure want to know what is going on in our messed up world we live in.
Congratulations to us all!
The FDA seems to have been revealed as EVIL. Not mistaken, not inappropriate, not unbalanced, not misdirected but EVIL. EVIL in that it blatantly is promoting an anti-Americian murderous agenda.
IMO this is the first and REQUIRED step in regaining our freedom.
Please spread this far and wide and CONVINCE your immediate circle of friends of this CRITICAL truth.
There are many supplements that literally keep people alive. My own family’s lives were saved MRSA and Lyme by using powerful natural antibiotics. MRSA and Lyme are drug resistant and these diseases would have killed us since the medical industry couldn’t help us.
I believe that millions will lose their lives if the health supplements are taken away by the FDA. It is all about money not about the value of life. FDA, you will have the blood of millions on your hands!
Want to kill the monster? Don’t do any drugs. Where we spend our dollar will make a difference. This is how this monster has grown out of control. Our society has surrendered it’s health to the medical industry. Take back control and run from the seduction of the media and your doctors who say that you need drugs. We need to get back to the basics of good food and food supplements. Drugs are poison!
Well said to all who have posted a comment. I would also like to say that my supplements, and natural medication has never sent me to the hospital with liver failure, a heart attack, blood clots, etc.
I have a vote of no confidence in the FDA or their antics towards public safety. These killer pills that they deem safe to the public at the cost of human life for the sake of corporate greed in nothing short of murderous acts on the people of this nation. But as Wall Street had a play in the demise of the financial system of this fine country and not 1 person has been convicted so too will no one be punished for the murders of American’s trusting in their Dr’s to give them safe medications to help their ailments.
My wife and I are near 70 and in great health. We attribute our health to supplements. We hardly spend any money on prescription drugs which more than likely will have side-effects. We are the type of people that Big-Pharma is trying to target so they can milk even more money. The FDA is their agent. It is hard to prove but we suspect that FDA people take bribes to do Big-Pharma’s work. Certainly, many FDA people “retire” to cushy jobs with Big-Pharma once they leave FDA. No wonder people are getting fed up with government corruption. Is the US any better than Russia or third world countries far as corruption?
I was going to say that I cannot believe that this is happening but I really can..Our freedoms as we know it are being taking away, thanks to our wonderful president. If it is not broke why try to fix it, this is working just find, I feel that they just need to leave well enough alone..The government is corrupt and it is all about the money that they are not making off of the people for drugs. People are staying healthier longer and they don’t like it..There is big money in sickness..
To ANH good job in representing the people..It will work out somehow..
Cannabis should have been Grandfathered in too….5000+ years of use and NO HARM!
Mother Earth is fast becoming a battleground for good and evil with FDA (Fascist Drugging Association) and CDC (Center for Deceitful Communication) leading the evil. Sure wish I could say, “Forgive them Father for they know not what they do”….but they DO know and the world is waking up, Thank God.
FDA- Hitler comes to mind.
I find it rather amusing that the FDA continues to allow deadly drugs which are about as safe as having a ticking time bomb in the basement, and at the same time are targeting our supplements as being unsafe. How ridiculous is that? I think the families of people who have died as a result of Big Pharma’s poisons should get into a class action suit against the FDA, Big Pharma, and other proponents of drugs for profit. And that’s all it’s about. I don’t feel sorry for those killers who profit from people’s misery and death. How dare they attack supplements and natural foods that have cured people and kept them healthy. And the only reason they’re doing this is because they might lose some of their almighty bucks. They should hang their heads in shame, because they are putting a pox on this country. People will die in epidemic numbers because of their greed. I certainly hope God is keeping track of these monsters and will punish them accordingly.
If there were a class-action lawsuit against Big Pharma, I’m in, They killed my father and then my mother. My father was killed with the blood-thinner Warfarin, which is one of the top 3 killers of all pharma drugs. The doctor’s defense would be that it was administered in accordance with AMA standard of practice. So, the AMA should be sued as well, for recommending deadly drugs instead of non-toxic alternatives. Blood can be thinned safely with garlic, cayenne pepper, or simply drinking more water.
As usual, the FDA has demonstrated it has about as much interest in protecting the public as the proverbial fox has in protecting the chickens it is about to kill and eat. The only thing I can see that the FDA is interested in protecting is the profits of their drug company overlords.
If the FDA were truly interested in protecting the public, they would have never allowed Aspartame to be approved, and would have quickly banned it once its toxic effects became known, rather than stalling all efforts to have it removed from the market. Same for bad drugs, which have been allowed to remain on the market until they have killed tens of thousands of people unnecessarily. Instead they focus on staging armed raids on natural food stores, supplement makers, cherry growers and the like who have done no harm, and coming up with all sorts of stealthy schemes for outlawing natural supplements whose only possible damage has been to drug company corporate profits.
It’s high time to dump the FDA and their drug company lobbyist buddies and other cronies, and replace them with disinterested parties who will truly have the public’s safety in mind.
What we are witnessing is the beginning of the end of world governments.
The foundations of the gov’t are immoral, corrupt, and diabolical. When a foundation of a
building (gov’t) is so decayed and rotting, its not long before it crumbles and falls
to the ground. That time is coming very, very soon.
There’s no leaders, if there’s no followers—we need to pull back the curtain, like in
the Wizard of Oz, and expose them for the greedy, corrupt cowards they really are.
To ANH, I’d like to say, KEEP UP THE GOOD WORK!! We will win.
“The foundations of the gov’t are immoral, corrupt, and diabolical”
IMO this is all being done by intention. These same corrupt governments have allowed and HELPED a pandemic plague to be created in their bio-weapons labs. This plague may be released this year.
The “vaccination” they will attempt to force into your body and the bodies of those you love CANNOT be the solution as BOTH the plague and the “vaccine” are created by the criminals running this sorry world.
http://healthyprotocols.com/2_pandemic_update.htm
What a bunch of prostitutes we have in our government! They sell us out to line their own pockets. It’s disgusting. We need to oust the vast majority and find some people who actually value our country and its people. This “hyper-greed” is ruining a once great country.
Debbie,
That will take lots of us getting organized and acting to choose people who will work for us and work and organize like hell to elect them to Congress, throwing out the incumbents who don’t. Look around locally, join Occupy and the organizations who have been trying to get this to happen: Progressive Democrats of America, Alliance for Democracy, maybe Working Families Party, Jobs with Justice, and whoever is hot where you are.
We recently elected a bunch of representatives who profess to belong to the “Tea Party” and who espouse a smaller government and an objection to the “Nanny State.” The FDA is the worst possible example of the Nanny State, protecting us from making decisions about our own health care, or even getting the information we need to make those decisions. Contact your representatives and senators, and urge thm to live up to their campaign promises by eliminating the FDA.
VOTE RON PAUL!!!!
There’s another interesting note to support what the FDA and Pharmas are doing. I have a horse and she’s 22 years old. She has Cushing’s Disease and I’ve been giving her Pergolide which is compoounded (I pay $25 a month). I went to renew this with my vet who told me that Pergolide can no longer be used per the FDA and that using it would violate the vet’s license. Instead I will now have to get a drug called Prascend and that is the only thing I can give her at $65 a month.
There is a company in California called Great Life Pet Products PH # 805-529-3647 I contacted them in 2006 about a Beagle I had which I suspected of having Cushings. They had a product which they used in a trial to eliminate Cushings in a pony or horse. You might give them a call and see if they are still making the product.
Sorry you cannot get the product you were getting from your vet.
Vicki Hcks
Nikki, would you be willing to try an organic herbal formula on your horse? Cheaper and safer.
If so, contact me.
Blessings!
The FDA should simply be declared a terrorist organization. They are far worse than Al Qaeda.
Bingo!
Far, far worse.