New FDA Food Detention Powers Could Endanger Your Access to Food and Supplements

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FDA Food DetentionThey no longer need evidence that a product is harmful. Just a suspicion that there’s an error in the paperwork.

The Food Safety Modernization Act (FSMA) was signed into law on January 4 of this year. For the past several months we’ve been sharing our concern over one of the FSMA’s mandates that eventually developed into the disastrous NDI draft guidance. There are only a few days left to tell the FDA what you think about these new anti-supplement rules—FDA’s public comment period ends this Friday, December 2. Please take action today, if you haven’t done so already!

There is another rule mandated by the FSMA, which is currently being implemented, that we also want to highlight. It gives the FDA wider authority to detain food products, including supplements. Under the previous law, in order to administratively detain food, the FDA had to show “credible evidence” that a food presents “serious adverse health consequences or death to humans and animals.” The new rule gives the FDA enhanced authority to detain any food or supplement they have “reason to believe” may be “adulterated” or “misbranded.”

Using the vague terms “misbranded” and “adulterated” as a standard to detain food is extremely problematic. It gives the FDA too much discretionary power against small food companies and dietary supplements and potentially allows the agency to detain food and supplements on even minor violations. Under the “adulterated” or “misbranded” standard, a farmer’s paperwork error could be treated just as harshly as a multinational corporation that knowingly sells tainted food.

As we’ve reported previously, a food or supplement may be considered “adulterated” under the Federal Food, Drug, and Cosmetic Act if some vaguely written FDA rule is deemed to have not been followed. “Misbranded” can mean that the producer makes a completely true statement about the product but without FDA permission. A cherry producer who cites peer-reviewed scientific research from prestigious universities on the health benefits of cherries would, in FDA-speak, have engaged in “false” and actionable “misbranding” which suddenly turns the cherries into drugs. Producers, of course, have the right to take cherries through the vastly expensive new drug approval process!

“Administrative detention” means that the FDA can now act without judicial oversight. It doesn’t even have to be true, since the FDA merely needs “reason to believe” that the product is misbranded or adulterated. This makes it an extremely subjective process. By its own admission, the FDA estimates that up to 48% of food detained could prove not to have been adulterated.

The food or supplement can be held for up to twenty days, with a possible ten-day extension if FDA wishes to initiate legal action. Many food products are perishable in that amount of time, which would have a severe impact on business, especially small businesses that could not cope with the loss.

This new, broader FDA food detention authority opens the door for the FDA to abuse its power and hold any supplement they believe has not filed an NDI notification. If the proper notification paperwork has not been submitted and officially accepted by the FDA, the agency considers them “adulterated” supplements—even though FDA’s interpretation of what a New Dietary Ingredient actually is and what the NDI notification process is supposed to entail are clearly contrary to what Congress intended when they passed the law. It also flies in the face of common sense.

This makes it extremely important that the NDI guidance be revised. As it stands now, the rules ensure that most dietary supplements will be found in violation of the FDA’s ludicrous interpretation of the NDI notification process.

There are only a few days left to make your voice heard on this absurd NDI guidance. If you have not done so already, please send the FDA your comments today!

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  • jamea mcenaney

    i served in nam & my dad in wwii,we need more freedom not less.
    allow people freedom of choice, jimmy mack

    • Tenaya

      The current NDI guidance allowing the FDA’s authority to detain food products, including supplements, appears clearly contrary to what Congress intended when the law was passed. It is imperative that the NDI guidance be revised.

      Please stop this over-reaching use of authority and use better judgment addressing the concerns of public health. Natural supplements have been shown to have huge benefits and undue regulation flies in the face of much needed access to health care in this nation. While many FDA-approved drugs have tremendous negative affects on people at a huge cost to pocketbook and health, it is essential that natural supplements are affordable and accessible to the general public. Do not cater to the special interest drug manufacturers who truly only have their profit margins at interest, not the public welfare.

      Your help in correcting this egregious oversight will be greatly appreciated.

      • Please do not take this freedom to use natural products instead of the many drugs with all their possible serious results from taking them. We have been helped over the years with many good herbs and are very happy our country still allows this freedom.

      • Tracie Brown

        This is suppose to be American. Why are would the FDA do such a thing. Our freedom for life, liberty and justice are being violated. We have the right to good health. FDA should be helping our citizens not hurting them.

      • Rosemary Pustak

        IT’s not just happening in the USA, the Therapeutic Goods Adminstration (TGA) here in Australia, has banned apricot seeds for human consumption and a herbal remedy Black Salve, which can be used to treat skin cancers and other known cancers. Although it can be legally given to treat cancers in horses, cats and dogs. The TGA is the little brother of the FDA ( Fatal Drugs Allowed) and they too, have allowed dangerous pharamaceutical drugs to be administered to our population. Vioxx for example was proven to be safe by the FDA and then later proven to cause heart attacks and strokes. My father used Vioxx and he suffered from several strokes, just before he’s death in 2008. I have been fighting breast cancer since May of 2007. I had refused chemo and radiation and have been using Natural Treatments since. At every turn they have tried to blocked my path but I have managed to get around it. I have had enough! Lets all make a stand together, like previous and current wars fought side by side, we can join forces to STOP the continual GENOCIDE our two peoples.

      • Gloria Mitchell

        This Dick Durbin and is at it again. Disrespecting the people he was hired to work for. I believe he thinks he owns us and that we are his stupid lackeys. This man has to be voted out. Please stop this over-reaching use of authority. Natural supplements have and do help me. The FDA-approved drugs have tremendous negative affects on me and other peoples health. The natural supplements has corrected the damages FDA-approved drugs did to me. It is essential that natural supplements are affordable and accessible to the we the people. Please do not cater to the special interest drug manufacturers who truly only have their profit margins at interest, not the public welfare.

      • JOANN

        EVERY AMERICAN NEEDS TO STAND UP FOR OUR RIGHTS!

      • Sweet V

        I agree; this is rediculous and needs to be revised. I wish they would take these steps with pharmaceutical companies in regards to prescription drugs and immunizations. Most of the ‘new’ drugs are toxic and are proven to. The HPV vaccine should be completely taken off the market as well; in the first year it came out it cause over 3000 severe reactions such as permanent disabilities, hospitalizations, and other similar reactions. Many don’t know, unless they do their homework that your body naturally will fight an STD and take care of the issue on it’s own within a short period of time. It also only covers 3 HPV’s for which not all of them are found in the area/part of the country. Yes, HPV’s can cause abnormal pap smears and in some cases can eventually cause cancer. However, the harm the vaccine causes far outweighs the risk of contracting an STD as well as getting cancer. This should definitely be taken off the market!

        If they want to keep this law into place, there should be a stipulation that the FDA is required to monetarily reimburse the farm or supplement company for any losses incurred if their allegations are proven false and if someone places scientifically proven data, there should be a clause preventing the FDA from false allegations of stating facts. We now live in an information world and posting factual data about anything should not be something that the FDA has any control over as well as them not being able to have a say. I can understand if someone was posting falsified or misrepresented data like most commercials on TV, that would constitute an investigation.

        This is just wrong on so many levels!

      • kathy smallwood

        i am 70 years old and take a lot of supplements. i am much more active now than before i started them and feel 100% better please do not restrict them

      • Rob

        Under the previous law, in order to administratively detain food, the FDA had to show “credible evidence” that a food presents “serious adverse health consequences or death to humans and animals.” The new rule gives the FDA enhanced authority to detain any food or supplement they have “reason to believe” may be “adulterated” or “misbranded.”

        This is not logical, who would want the FDA to not use “CREDIBLE EVIDENCE”

        Is the FDA accepting funds from pharmaceutical companies – those whom they should be governing?

      • Jency Griffin

        I really due like having access to whatever supplements and vitamins that I need! I’m so much healthier because I take them. It’s hard enough to stay healthy and make good choices without restrictions from the FDA. America is a free country. Let’s keep it that way. – Jency

      • Donna Alucard

        My feelings exactly…couldn’t have said it better myself! Thank you, Tenaya!

      • MARTHA VANCE

        to whom it may concern….
        that would be me and my family! we live in a country that gives us the freedom to choose our method of getting the proper healing in our bodies. if conventional medicine does not work but only mask and rob our pocketbooks, then god gave us the sense to discern when we need to return to nature and to rely on reliable people to bring to us the most inavative products. don’t take away from us what insurance does not pay for, and dr. don’t prescribe……allow us to continue to heal and be whole through the natural way of life. the supplements many of rely on to comfort and heal us….need to be widespread knowledge so that everyone has the same advantage that some of us have already found. don’t destroy what we have waited a lifetime to rediscover and make life better. i stand with those who fight for the right to keep the supplements and foods that we benefit from. thank you for your time.

    • Eva

      The current NDI guidance allowing the FDA’s authority to detain food products, including supplements, appears clearly contrary to what Congress intended when the law was passed. It is imperative that the NDI guidance be revised.

      Please stop this over-reaching use of authority and use better judgment addressing the concerns of public health. Natural supplements have been shown to have huge benefits and undue regulation flies in the face of much needed access to health care in this nation. While many FDA-approved drugs have tremendous negative affects on people at a huge cost to pocketbook and health, it is essential that natural supplements are affordable and accessible to the general public. Do not cater to the special interest drug manufacturers who truly only have their profit margins at interest, not the public welfare.

      Your help in correcting this egregious oversight will be greatly appreciated.

    • The FDA needs to leave the Vitamin and Health Industry ALONE. They need to spend their time policing all those horrible drugs that have ads on television for which drugs they have already “given the nod” – where they have some “syrupy” voice talking in a low soothing tone telling how the drugs can kill you. Do something about that !

    • i want to express my mad as hell opinon on my behave,who gives the fda the right to tell me what i can take and not to take,if yous stop me from buying my vitaims that my body needs. then i have the right to stop taking my medication too.if you pass that law on supplements,then i will no longer buy anymore medication drugs for my debetes.or any other kind of drug store over the counter too.i will go on medication drug on perminent on strike from the drug companies who are running the show.the FDA should be watching our interest not the drug best interest.but the citizens of the of usa should protest and throw out all drugs from companys,like when the women burn all the Bras in the 1970s

  • Charles James

    Revise the DNI! I want my supplements!

    • No one, and I mean No One has the right to make my choices on what I choose to eat or drink. It’s my right to choose to take vitamins or eat whole foods etc. What the FDA should be doing is knocking on the doors of all these Fast-Food Chains that are poisoning so many Americans these days! This is just yet another way to keep us sick and dependent on drugs! Food Will Always be My Medicine!!

    • I agree we need more freedom not less freedom let us make the choice what foods and supplements
      we want to use. It is diffidently wrong for FDA to tell us what we can or can’t do. We need our supplements !

  • Jerry Irwin

    The current NDI guidance allowing the FDA’s authority to detain food products, including supplements, appears clearly contrary to what Congress intended when the law was passed.

    Therefore, it becomes imperative that the NDI guidance be revised , otherwise we stand the risk of finding most dietary supplements to be in violation of the interpretation process. And since, by your own estimates, up to 48% of the food detained could prove not to have been adulterated in the first place, this means the process is far too subjective.

    I am forwarding my and my fellow voters’ concerns, along with supporting documentation, to Senator Roy Blunt and asking for his support of our position.

    Your help in correcting this egregious oversight will be greatly appreciated.

    • http://www.govtrack.us = you can research any legislature and any/all bills that they have been a part of. The best thing is to rally all fellow people in IL and get them to change. I vote that we the people vote out everyone asap and try some new blood. If the new blood doesn’t work, next election votem out and try again. We the people do the power if we work as one.

    • helen

      This is not handy or time efficient at all. Do it the way so many others are doing it, by enclosing a form that is PRE-ADDRESSED TO YOUR POLITICAL REP, which also contains a place for your name/address etc. and a has a pre-written form letter (for those who are REALLY stressed out for time). Also include a space for those who can to add their own personal comments to the form letter. You will get a tremendously higher rate a responssem and your recipient/s will be impressed.

      • Helen, please click either of the links – in the first paragraph to “Please take action today, if you haven’t done so already!” or in the final paragraph to “please send the FDA your comments today!” There you will find a pre-addressed, pre-written letter where all you have to do is add your own name and optionally, modify the letter with your own comments.

        • Health by choice

          Let us be free!!! Free to choose our own food. Free to take charge of our own health. Free to take our own supplements. If pharmacetical companies are free to peddle their wares (which sometimes end up being “poison”), let us choose Health Food companies “natural” substances. Please don’t take my freedoms away!!

    • Duke

      Jerry, if you go to the petition link, at the bottom of the text above, you can hit all of your congress critters in one fell swoop. You can use the text provided, modify it, or compose your own. It is then automatically sent to all of your state’s Senators and House members.

      Good on you for standing and being counted.

      • It is appaulling our own Government is not listening to the people of this nation but to creedy monopolies of their lobbyists control freaks. THIS CAN NOT STAND everybody get on your keyboards and express your concern don’t just sit there!! Do it now!

    • Jill Kreutzer

      The only thing that should be changed is GMO labeling in the food supply. Do not limit access to supplements for the general public.

  • robert seaton

    Every time one of these anti -suppliment bills comes around,you can bet the name dick durbin is at the.top… We know he’s in someones pocket. But who ? I really wish we had a way to DIG into the money trail. We could stop him and his buds permanently, by exposing them as the crooks they are.
    Any surprise he’s from Illinois ?…The home of political corruption in the US. And a Democrat.!

  • AnneOnymous

    The FDA is nothing more than a hand puppet to the big pharma.. Eliminate vitamin supplements (through years of tests and study) forcing the mass to depend on prescription meds that HAS been known to create even more problems up to and including death.. As a citizen of the U.S.A. I am getting tired of the feds trying to run our lives for our own good. Whoever reads this plea, stand up for your citizens.. DO NOT allow this travesty to blossom into a big pharma windfall.

    • Ethel

      If you think big pharma involve, consider big agra! Genetic Engineered Food which is going to be one huge health problem probably will be excempt from this

  • Janet Bauml

    I say NO to the NDI draft guidance. FDA has far too much control over our supplements, especially given they cannot be counted on to adequately judge risk to the public… they do an awesome job of protecting corporations though!

  • shirley huss

    I do not want the government or any so called “health agency” that does more harm than good to control what I take. The organic suppliments and foods are better, leave them alone. If the public has any complaints they will tell you. Stop playing god and trying to control everyones lives. Your system is becoming more hazardous for the public than if we didn’t have any control. Butt out!!!

  • Jason Nicoloff

    Please stop your over-reaching use of authority. Your degree of special interest alignment is atrocious. If you were so concerned with the public’s health and safety, then revisit your own FDA-approved drugs, which have caused far more negative effects on society, and all in the name of a special interest payout. Shame on you.

    • trina taylor

      This does’nt shock me at all this is down rigt greed this show has saved my life and other who i know Mr Kaufman u continue doing what is right at least you can rest good at nite not worry about the lives was taken over the chemicals that is prescribed daily they are no better that the drug dealers on the street WOW i suport you Mr kaufman continu Saving lives love and support trina

  • I am completely shocked and disgusted with this NDI guidance being proposed. It goes against the original purpose of why the FDA was created to begin with. The health and well being of the American citizens is the only purpose of FDA. The profits of the pharmacuetical and big aggiculture industries are not your puroose or your duty. The actions taken by the FDA are hostile to the health and well being of AMERICAN citizens. If you cannot serve America then this agency needs to be completely overhaled so it can get back to the original purpose for its creation. I wonder if you people at the FDA have any conscience at all. Do you not care about the American citizens?

  • This is nothing more than another abuse of power which is thoroughly disgusting. I am an 85 year old physician/surgeon who still has his volunteer license to practice, helping out friends and the indigent, having been to this date on thirty-six medical missions worldwide to the poorest of the poor rendering medical care as required. I have also taught alternative as well as traditional medicine to interested groups since the early 80’s.I so disgusted with the abuse of power of the FDA. Anything that can be done to avoid such control would be a welcome step forward. Thank you for whatever you and related groups or organizations could do to stall or prevent such happenings would be more than welcome

  • Jill Warga

    Leave my supplements and food alone. We are all trying to keep ourselves healthy in spite of US health care. Your pharmaceuticals are killing people and your food is harmful and full of GMO products, mercury filled corn syrup, hormone and antibiotic filled meat and dangerous alternative sweetners. And many of the AMA’s treatment protocols do more harm than good. We have enough problems in this country. Try to make things better instead of worse.

  • Alan Rose

    Stop the attack on small farms and natural supplements. It’s clear that this initiative benefits big food and Pharma companies at the expense of everyone else. If you are really concerned with public health then you should be more closely watching the use of GMOs and pharmaceuticals which kill hundreds of thousands every year.

  • The FDA has a history of top officials moving to well paid jobs in the drug companies whose products they have been regulating. How much more evidence is needed to show that the FDA has become a disaster for public health? Many of the drugs it approved have had to be banned. New Mexico tried to sue the FDA over Aspartame. The New Mexico legislature must surely be very interested in this latest development.

  • Jean Leclair

    Keep hands off. There is too much government in our lives. The FDA is a pawn for the big (grubby picking, money grabbing) FDA All the pharm can do is try to make our lives miserable and to bow down to their lousy drugs.

  • Jim Park

    You think Durbin and his ilk are in the pockets of big pharma? Nah, couldn’t be. After all, they took an oath to protect us and they certainly wouldn’t go against their oath! Congress people are like shining knights! Sorry to be so sarcastic, but they obviously don’t believe that what goes around, comes around. Be happy you don’t have the karma that’s coming up for them!

  • Dr. Richard Edlich

    The New Dietary Supplements Ingredients laws must be revised so the consumer can buy supplements if they want to. It’s an emergency!

  • Rebecca

    Big Pharma is in this, you can bet the farm!

  • Laura Borst

    I tried to search for the form on the web site regulations.gov to comment on it. But the comment form was not available, even though the comment period is supposedly to Dec. 2. I was doing this tonight, Nov. 29. I wonder if the government just wants to avoid having the people comment.

  • Here is another website to track what the elected officials of our country are up to. This one shows the committees that they are sitting on, PAC contributions, office locations etc..
    http://www.capwiz.com/military/bio/fec/?id=210&cycle=2011-2012 this one pulls up the PAC on Mr. Durbin. Hope this helps you out!

  • wvhillbilly

    You think sending comments to the FDA is going to have any effect? It’ll have about as much effect as telling a fox to stop stealing your chickens: exactly none.

    The FDA is beholden to no one but the big corporations like Monsanto and big pharma with whom they have been in bed for years. Better to tell your congressmen, I believe that would have at least a chance of getting some response, though I doubt they will do much of anything. I wrote mine about the Rawesome raid a while back and the only reply I got was mostly trying to justify it.

    The whole system is corrupt to the bone.

  • Nancy Hicks

    I cannot believe the direction that this country is headed!! Where is the common sense with our people in charge? They have lost site of what is good for the people and are looking out just for themselves. I vote that we get rid of all lobyist and make it a crime for any politician to even talk to one!!! How absurd is it to put regulations on natural products and supplements. I for look for natural alternatives to maintain my health and not take medications if I can avoid it. What a trap so many people have fallen into taking so many drugs. I am in the medical field and see and hear of how many drugs people are on. It is frustrating because I know there are alternatives out there that work. I want to maintain my freedom to have a choice!!!!!

  • Suzanne Jenkins

    While creating a “safety” issue with supplements, politicians and the FDA are ignoring the FDA’s Adverse Events Reporting System (AEFS), which contains over 4 million adverse events reported from 1969 to the present for FDA approved drugs. From 2000 to 2009, the FDA AEFS system reported 370,056 deaths and 2,5,066 serious patient outcomes from FDA approved drugs, NOT from dietary supplements. Eleven years ago on July 26, 2000, the Journal of the American Medical Association (JAMA) reported that behind heart disease and cancer, American medicine was the 3rd leading cause of death.
    Unless this country wakes up and institutes publicly funded elections without exception, this insane power grab will continue because our elected prostitutes are returning “favors” and using their alphabet agencies to carry out their objectives. Keep your paws off of our dietary supplements and quit trying to decimate DSHEA.

  • clark r

    We need to start rising up like the ones of occupy wall street. We need on web site one clear leader to cut through our voices with one intention, to speak for us. We also need to raise money to lobby (pay off) the politicians. First start with campaigning against drug companies advertising, cut them off at the knees and the networks that feed off them. Protest the networks, the shows and their fan base show them what harm and rights the FDA and networks like ABC, CBS (in with web MD, Pharma spokes company) etc. When the fans walk away from shows and the networks, you cut off the money. Go after the celebrity facebook pages, post what you know bring to light of this and what they do. Hold they stars acountable and the networks. When a drug ad is shown 5 times an hour and it is from a company that recalled that and other drugs than say this is what you are taking money from. Turn them down or we tune you out!

  • The pharmaceutical power grab is a strategy to impoverish the middle class and send it back to feudalism. By hijacking nutritional substances and making them accessible only by RX, prices will be increased 600 to 1000 percent. This power grab has key players all tracing upwards into the ruling body of these United States—not Congress, the President or the Supreme Court, but the hidden Senate of the super rich—The Pilgrims Society, which always has top Pharma execs from Pfizer, Warner Lambert, Eli Lilly and others in its ranks. The organization was founded to “seize the wealth necessary” (American Review of Reviews, May 1902, pp 557-558) and was conceived by Cecil Rhodes, South African diamond cartel organizer. The same interests who corrupted the money system are out to control us by cartelizing the realm of health and treatment. Henry Kissinger, former Secretary of State and Paul Volcker, former chief of the Federal Reserve System, are VP’s of The Pilgrims Society.

  • Robin

    You are clearly working for the drug companies, who stand to benefit from sales of drugs if natural supplements are taken off the market. We’re not interested in you catering to drug companies. We are interested in our own health and having self-determination, so get out of our lives and leave our supplements alone.

  • Lisa

    I think that the FDA is working with the big pharmaceutical companies. Dietary supplements do not need to go through the stringent premarket approval process like other drugs do. So, the FDA believes they have every reason to reject dietary supplements, and get them off the market. I am sure that there will be inspections that are biased, and people may get shut down because of personal reasons. This is ludicrous, and definitely needs to be revised.

  • Andy Humelsine

    Leave our organic food and vitamin/mineral supplemnts alone NDI …. you have no right to play God with citizens health throwing them onto meds with side effects saying our food is compromized …. saying its bad for our health & that we need meds that only make the big Pharma more wealthy to our health hazards …. this is an outrage in the face of normal cognative sense …. how stupid do yu think we are anyhow . This is just another atempt fot Gov. to interfere with our lives and line the pockets of the greedy elite to the siad reversed detriment to our health …. what a travisty and insult to intelligence of caring American ciizens & their constitutional rights …. OUTRAGEOUS !

  • Suzanne Abboud

    We already live in a cesspool of man-made poisonous chemicals that is getting more toxic by the day. There are toxins in our food, our drinking water and the air we breathe…leading us to all kind of sicknesses and diseases. What’s left?

    “Woe to the shepherds who mislead and scatter the flock of my pasture, says the Lord: You have scattered my sheep and driven them away. You have not cared for them, but I’ll punish your evil deeds. I will appoint shepherds for them who will shepherd them so that they need no longer fear and tremble; and none shall be missing.” Jeremiah 23:1-6

  • Gloria Jones

    The FDA wants to kill us all. Eventually that will happen, since there are many who depend on supplements for their lives and health. The only reason the FDA is doing this is the almighty buck! They not only try to kill the supplement industries, but also continue to produce deadly poisons at ridiculously high prices, and expect us to use those instead so they can continue to fill their pockets with our blood money. Stockpile your supplements now, and if we have to purchase them underground, then so be it.

  • joanna

    The FDA approves medication that can kill you, get you addicted and has terrible side affects… They don’t want people to know the truth about healthy alternatives because it would run the drug companies out of business. Its a-shame…

  • Mary Chapman

    I always thought this was a free country and that people died to keep it that way but I guess I’ve been wrong all these years and so were my dad and brothers who fought for the same freedom of choice that it seems as tho you want to take away from us….leave my supplements alone! Why don’t you focus on cures for diseases ? I don’t understand why you think you have the right to decide what is best fo ME……there’s that freedom of choice again but apparently you seem to think that you are the only ones entitled to that. Mrs. Chapman

  • Time to get rid of Durbin and that vestige of the Nanny-state, the FDA

  • Kay Caringi

    Please leave our supplements alone.

  • Kris Leveque

    Why don’t you (the Goverment) leave us along, and let us buy what we want.

  • Linda N

    We write, we fax, we email, all, it seems to no avail. The FDA does not listen to us. Give us something with real teeth please! The ANH did not think the bill proposed by The National Health Federation was strong enough and I agree. Draft a law that will really protect our supplements and organic food from the FDA, and we will sign it. All those commenting are screaming that we need our freedom and our supplements but posting all that here does not good at all. PLEASE ANH give us something to do that has teeth! (Not that I have not signed all of your previous alerts.)

  • macrobin

    FDA should not have the right to delegate what we Americans have as one of the few freedoms left in this country! We should not have to be told what we are allowed to take for our health and what we are not allowed to take. This is a country founded on freedom and many of those freedoms are already taken away by our government. We all must stand up for our rights and not allow this to happen!

  • Darlene Delco

    This is terrible. When did we need someone telling us what to eat and how to live? There are a lot of people that are healing themselves and want a healthy lifestyle. We don’t need the FDA making choices for us. We need to retain the freedom of choosing for ourselves what healthfoods and supplements to take or not to take. These companies are trying to make money like everyone else. That’s called free enterprise! Isn’t this why our ancestors left the other countries? This will not help the economy by trying to close down businesses that make these products. Shame on those trying to force others to live by their standards. This almost looks like a take over because these smaller businesses are being successful. We deserve the rights as American Citizens to live as we see fit and use the products we want to use. And these businesses have the right to stay in business without being discriminated against. This is wrong to let it happen.

  • I am totally against the FDA having any control of the supplements purchased at Health Food Stores. Please stop this action. It’s the many many side effects from chemical drugs that are harming a lot of people…even death.

  • SuzyQue

    I am sorry but please tell me if I understand the proposed regulation!

    For example:
    1) Cherries are found to contain a chemical “X” that was found to lower blood pressure in a peer-reviewed scientific study.
    2) A cherry producer advertises his cherries as healthful due to the presence of chemical “X” without first asking the FDA for permission to make the claim.
    3) the producer is fined (bc he did not ask FDA for permission to make the claim first).

    What is wrong with this rule? Doesn’t this prevent unproven claims about the healthful benefits of foods/supplements?

  • Donna Gilley

    Stop the attack on small farms and natural supplements. It’s clear that this initiative benefits Pharmaceutical companies at the expense of everyone else. If you are really concerned with public health then you should watch pharmaceutical companies which kill hundreds of thousands every year.
    I manage my own health with food supplements not drugs from doctors. Less government more freedom to choose what’s right for me and my family.

  • Tony Montileone

    When the FDA can prove that the “natural supplements” kill people like the prescription counterparts ,then they would have a valid reason to screen the supplements.But they know,like I know that they only help us!!!Leave the Natural Health Industry alone.

  • Tony Montileone

    When the FDA can prove that the “natural supplements” kill people like the prescription counterparts ,then they would have a valid reason to screen the supplements.But they know,like I know that they only help us!!!Leave the Natural Health Industry alone.

  • Tony Montileone

    When the FDA can prove that the “natural supplements” kill people like the prescription counterparts ,then they would have a valid reason to screen the supplements.But they know,like I know that they only help us!!!Leave the Natural Health Industry alone.

  • Tony Montileone

    When the FDA can prove that the “natural supplements” kill people like the prescription counterparts ,then they would have a valid reason to screen the supplements.But they know,like I know that they only help us!!!Leave the Natural Health Industry alone.

  • Tony Montileone

    When the FDA can prove that the “natural supplements” kill people like the prescription counterparts ,then they would have a valid reason to screen the supplements.But they know,like I know that they only help us!!!Leave the Natural Health Industry alone.

  • Tony Montileone

    When the FDA can prove that the “natural supplements” kill people like the prescription counterparts ,then they would have a valid reason to screen the supplements.But they know,like I know that they only help us!!!Leave the Natural Health Industry alone.

  • Rachel

    our government is broken and corrupt…this legislation is another proof of the absolute corruption that special interests like big pharma has created hand in hand with greedy, self-serving politicians.

  • Burdell Walth

    The FDA is over reaching its bounds. The NSI guidelines for supplements set up by congress was not intended to be used this way. There are far more life treating Pharmacuetical drugs that any over the counter supplements or vitamins. Natural vitamins and minerals have been life saving when Pharmacuetical Drugs did nothing but give undesireable side effects. This must be stopped. I should have freedom of choice. My freedoms are being taken away.

  • Shawn

    Please leave our organic food and our supplements alone! Please leave us alone and let us buy whatever we want! We know what’s best for us, not you! Stop trying to control our lives, let alone what we want to buy. If the role were reversed you would feel exactly the same way! You’ve got friends and family of your own and you would do almost anything for them, so please leave our organic food and our supplements alone! Not only for our sakes, but for theirs as well!

  • Tom Sheltron

    Keep approving deadly drugs with killer side effects and leave our supplements alone.

  • Mel Duarte

    Mel says:
    Observing through the years, in pharmacy’s and clinics I’ve worked in, is that drug wars are not about the nations borders. Drug companies go to dangerous lengths to put their products in the #1 sales spot. It is all about money. Much advertisement goes into the propanganda adds to gain public trust. Dr.’s get “kickbacks” for writing for drugs that the companies pay/push. The FDA, like many instituions founded on good intentions has long past failed the mission. Finding new ways to get a piece of the pie (and to own it) is what is being done in the name of protection. We need an FDA protection agency like “Judicial Watch” to nail the corruption. The only way to fight this NDI revisement is with our purchase power and voting. Please leave our freedoms alone. You do not know what is best for us, statistics don’t lie. A mass group of public is seriously watching you. Develope a conscience, please.

  • Vicki Causby

    I have been using health products for 20 yrs with no adverse effects. Do not limit my rights by
    not allowing my a choice about my health.

  • Mona

    I am greatly concerned about the FDA accepting funds from pharmaceutical companies. The FDA are supposed to be governing the pharmaceutical companies, not accepting money to sway opinions concerning laws. This is a blatant conflict of interest. Now we find out that you are considering imposing legislation against the freedoms we enjoy in health food stores!

    Remember that in America we must keep the freedom of choice that our families have fought and died for. Please keep the FDA an agency of integrity. We, the public, are watching what you do.

  • Eunice Alfred

    VItamins and supplements are just that food supplement due to our busy lifestyle we need them, so now they are trying to tell us what to eat? whats next? they are going to tell us when to sleep? or turn the lights off? is this america or what?

  • Joanne Scruggs

    This is an clear attempt for the goovernment to continue to line the pharmaceutical companies pocket. I thought in this great United States of America people had the free choice to buy what they wanted in this area of supplements/food. I know for a fact the drugs the doctors had me on for 2 1/2 years did me no good (narcotics) & I was headed for an early grave. I had so many complications during that time. I was told I had M.S. & had a spinal tap that left me disable. It was only after I was fed up with the 2 narcotics I was taking I choose to start supplement. I had gone to a 3rd or 4th opinion only, to find out it was not M.S. but a low magnesium level I had all along. Therefore, It was my choice to take the supplements I am now on. If the FDA would choose instead to be a watch dog on the many narcotics &
    other medications & how they effect people and how they are dispersed today rather then try to regulate supplements. You can not overlook something that is bad while in bed with what you are over looking for the good of the people!

  • Glen

    Not allowing people to make informed decisions ties our hands as individuals. As a society, people have been making up their own minds for centuries, even before science or religion. It’s an unfunny joke to allow this corporate mindset to drive our ideals and feelings towards the planet and each other.

  • Jean Spella

    NO! to NDI draft guidance. NO! to FDA excepting funds from pharmaceutical companies.

  • C.A. Clark

    Please, please, leave our supplements alone!

  • Liz Leach

    I feel better by the choice of my supplements, etc. Please do not regulate what that choice is.

  • Cia

    Are you seriously thinking this is a good move? You approve GARBAGE food for us to consume that have almost NO nutritional value and you want to take away what we can take/do to help us get the nutritional value we should have??? PLEASE tell me where does this make sense????!!!!!

  • Doug Hauswirth

    I find it laughable that the FDA is going to start quashing supplements yet allows the massive pharmaceutical machine to continually advertise to sell drugs most don’t need and often have side effects that are worse than the original problem. If the FDA were truly serious about protecting the public’s health, they would have banned tobacco decades ago. Leave my supplements alone and re-regulate drug advertising!

  • shannon

    We have a right to protect our families from what the government allows to be placed in our food and our bodies. PLEASE STOP THE GOVERNMENT FROM CONTROLLING OUR SUPPLEMENTS AND OUR HEALTH !!!! Please our families fought all these years for our freedom. Then have those very freedoms that they died for striped away from us? This is so sad no words for this at all. This is USA this stands for freedom !!!!!!!!!!

  • Lisa

    i should,in this country be able to buy supplements,herbs and any other food product that comes from the earth!Instead it seems i have the right to buy chemical compounds that may harm me over time becuase there is more of a profit to be made ,this is sad.We should at least have the right to choose which to buy chemical or supplements/natural holistic products or not.It should be our choice not yours.

  • Lindsey

    People have the right to take care of themselves and eat healthy and be proactive in their mind/body health. We have the right to choose.

  • Rob Nichols

    I do not want the government or any so called “health agency” that does more harm than good to control what I take. The organic supplements and foods are better, leave them alone. If the public has any complaints they will tell you. Stop playing god and trying to control everyone’s lives. Your system is becoming more hazardous for the public than if we didn’t have any control.
    I am completely shocked and disgusted with this NDI guidance being proposed. It goes against the original purpose of why the FDA was created to begin with. The health and well being of the American citizens is the only purpose of FDA. The profits of the pharmacuetical and big aggiculture industries are not your puroose or your duty. The actions taken by the FDA are hostile to the health and well being of AMERICAN citizens. If you cannot serve America then this agency needs to be completely overhaled so it can get back to the original purpose for its creation. I wonder if you people at the FDA have any conscience at all. Do you not care about the American citizens?

  • I don’t want the FDA telling me what supplements I can take and what to do and what not to do. We need our Freedom and where are our rights? We want our supplements and to choose which ones that will help our health.

  • do not take away our freedom to purchase healthy vitamin supplements and food instead of forcing us to use pharmaceutical drugs. do not take away our choices, we want to live healthy lives.

  • Gayle Snyder

    Remember the saying not broke don’t fix it? This is worse than before. Giving this much power to an agency starts always has grave consequences. Unfortunately, it is going to be the health of the people in the United States of America that will suffer. People are smart. We can make good decisions on what we need. We don’t need the FDA making those decisions for us. Putting a Big Brother watch is going to limit our freedoms. This new, broader FDA food detention authority opens the door for the FDA to abuse its power and hold any supplement they believe has not filed an NDI notification. I see abuse of power coming up. Lets stop this abuse of power before it actually happens.

  • robert luongo

    HERE IS A SIMPLE REPLY. As John Lennon wrote,” Give power to the people”. We know what’s best for us AMERICANS,more than the government beaurocracies, including now the marriage of the FDA and the pharmeutical industry. A courtship that has been going on for years, and now are ONE. All their interested is, power and money, and not the public’s interest and well-being. That is not democracy, it’s socialism.

  • amy

    God placed all we need in natural form to nourish our bodies. I don’t understand what the FDA are trying to do allowing the drug companies to over flow us with chemicals. Get off our backs and let us take charge of our own health. I’ve been on different meds for blood pressure. Nothing works,you know I am going natural now.

  • Patti Woods RN

    Where has our rights as Americans gone? Is is sad that we are becoming less of a democracy and more of a dictatorship. Some of our elected officials are swayed by large companies with highly paid lobbyist and lawyers who not only dictate and mandate laws but make it criminal to do otherwise. This type of mandatory dictatorship first started with the small mom and pop farmers as oppose to the mega ranchers. Now the FDA and the large pharmaceutical companies are doing the same thing….WHY, because people who are informed, who take control of their lives and health are contagious. We share our knowledge. We seek out alternative methods to maintain our longevity and health. We don’t blindly believe all the hype that is printed in the media and advertised on TV regarding the latest ‘WONDER’ drug. We the informed consumer are hurting the pharmaceutical companies wallets, which is why they are in alliance with the FDA. If our concerned elected officials continue to allow the FDA to legislate, regulate and mandate the use of natural vitamins and supplements, while allowing unsafe medications flourish, healthcare will truly become a crisis EPIDEMIC.

  • Laurie Hoag

    Why don’t you (the Goverment) leave us alone, and let us buy what we want.

    The FDA approves medication that can kill you, get you addicted and has terrible side affects… They don’t want people to know the truth about healthy alternatives because it would run the drug companies out of business.

  • Donna Forbes

    Please leave our supplements alone.

  • darlene

    I agree with all of the above. I also believe that the silly, stupid, rediculous, insane, unscrupulous, dumb, dam, idiotic law that states that only a drug can treat or cure a disease must be struck down. If a food is deemed a remedy or cure, it can then be classified as a “drug”. A food is a drug? That is senseless. But big pharma can take that food and tweak it and make it into a pharmaceutical medicine complete with nasty side affects and charge an outrageous price for it, in the the complete confidence that the puppet FDA will approve it. Not only that, just think of all the poor animals that suffer needlessly in the name of research.

  • I am most concerned as I watch our rights being stripped from us that now nature itself is coming under “attack”. I have turned my health completely around by making my own personal decision to stop catering to the alopatchic approach of treating a symptom. I research everything thoroughly, use herbs and other holistic means of taking care of myself. No one talked me into it – it was MY OWN personal decision. This is supposed to be a country where you have the right to choose. Everyday more and more people are waking up and taking responsibility for their bodies and their health. We do not need anyone to do this for us.

  • Pre-market safety of food is not the FDA jurisdiction. I believe the FDA should be challenged on this legally. This is the USDA mandate. The FDA should not censor foods or dietary ingredients just because they are presented in different packages, quantities, or combinations. This is onerous.
    The FDA approves drugs which cripple and murder millions around the world. This tax-payers supported institution wishes to protect the interests of Pharma, working, more or less behind our backs to turn supplements known to work into expensive drugs. The pharma has been heavily involved in pulling extracts out of herbs and foods and giving them different names. These products will be very expensive, and it will never be as good as the entire plant.

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