FDA Again Ignores Instructions from Congress

starch-wheat-flourAnd turns a blind eye to allergic reactions from Big Farma’s favorite foods. Action Alert!

In 2004 Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA), which required that food labels state clearly when any of eight “major food allergens,” are present in the product.

These eight foods or food groups are milk, egg, fish (e.g., bass, flounder, cod), crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, pecans, walnuts), wheat, peanuts (which are not true nuts, but legumes in the same family as peas and lentils), and soybeans—or an ingredient that contains a protein derived from one of these foods.

Why these eight? Because they account for 90% of the most obvious allergic reactions to food. They produce classic, immediate allergen responses, such as a closing of the throat, sneezing, an asthma attack, or hives. These are all caused by the reaction of an antibody called Immunoglobulin E (IgE). The medical establishment is not taking into account the internal and often silent IgG or IgA immune responses like those to gluten, which can create inflammation or intestinal permeability, not to mention irritable bowel syndrome. It’s not just a matter of discomfort: our immune system “resides” in our gut. When the small intestine is damaged, our entire immune system is vulnerable.

Gluten should technically be in the big eight anyway, since it is a protein found in wheat, but is not included in the labeling scheme. The list also fails to mention allergenic effects from flavoring, preservatives, additives, etc.

Despite this emphasis on the Big Eight, when Congress instructed FDA to determine threshold levels of allergens that must be labeled, it also required threshold levels for gluten, mainly so that some products could safely call themselves “gluten-free.” In another “here we go again” moment, FDA is working on the labeling thresholds for the eight “major allergens,” but is choosing to ignore the gluten issue—probably because gluten is in so many foods, and the food industry won’t like it.

A maximum threshold of 20 mg of gluten contamination per kilogram of food marketed as gluten-free has been successful in protecting celiac consumers in Europe, according to a new study published in the American Journal of Clinical Nutrition. We are not always a fan of international standards, but in this case agree that the US threshold should be consistent with them.

Gluten is not an issue to be swept under the rug in order to please industry. A shocking number of people have an allergic immune reaction that causes damage to the inner surface of the small intestine whenever they ingest it while eating bread, pasta, cookies, pizza crust, and many other foods containing wheat, barley, or rye. The intestinal damage causes an inability to absorb nutrients, depriving the brain, peripheral nervous system, bones, liver, and other organs of vital nourishment. It can also cause abdominal pain and diarrhea. As we reported previously, severe cases can infertility, as well as an increased risk of osteoporosis and certain cancers, particularly colon cancer.

One in 133 people have celiac disease, the most dramatic form of the food allergy. But researchers say between ten and thirty percent of Americans—up to 100 million people in our country—have non-celiac gluten sensitivity, with more subtle immune reactions, like dermatitis herpetiformis, a skin rash often confused with eczema or psoriasis. They suffer intestinal damage and Leaky Gut Syndrome but may experience no intestinal distress. Gluten sensitivity may be responsible for a number of chronic illnesses, fatigue, arthritis and other immune system reactions, and brain and neural network malfunctions.

Interestingly, given the FDA’s obsession with developing and approving weight loss drugs, a new study has just determined that wheat gluten may promote weight gain. The researchers found that mice fed a gluten-free diet showed a reduction in body weight gain and body fat percentage when compared to mice fed a diet containing gluten—with no other changes in the amount of food they ate or the number of calories they consumed. This indicates that gluten disrupts endocrine and exocrine processes within the body, and directly modulates nuclear gene expression in such a way as to alter mammalian metabolism in the direction of weight gain.

Ignoring Congress’s instructions about gluten is bad enough. But this is not the only other major allergen being ignored. A study in the New England Journal of Medicine showed that genetically modified soybeans can cause an allergenic response. Allergies have already skyrocketed in the US, and with the introduction of GE soy in the UK, soy-related allergies rose by 50%. GMOs also cause immune system dysregulation, with changes in the number of immune response cells showing up in the gut, spleen, and blood of mice—all of which points to an allergenic and inflammatory response to GMOs.

At minimum, GMO versions of the “big eight allergens” need to be considered when setting threshold levels because triggering levels are lower for GMO foods. This is just one more proof that GMO foods are materially different from non-GMO foods—a fact that the FDA consistently ignores. If they admit there is a difference between GMO and non-GMO foods, GMO would be considered “materially different” from other foods, and could legally be required to be labeled.

Action Alert! The FDA is asking for comments on establishing thresholds for food allergens for labeling purposes and enforcement action. Please tell the FDA that they should broaden their scope to look at gluten, in addition to the so-called “major” food allergens. Ask them to consider the exacerbating effect that GMOs have on food allergies (e.g., the threshold level for GMO soy might be different than for conventional soy). And tell them to consider IgA and IgG allergenic responses in addition to the more dramatic IgE responses. Long-term but health-damaging allergic responses are as important—and far more widespread—than reactions to the “big eight.”

Take Action!


  1. Being food sensitive and an American I expect the FDA to protect Americans and their chioldren from adverse food reactions and increasing medical expenses by FDA slacking!

  2. Looking at this from the perspective of 75 years I have come to the conclusion that just about all of these immune responses and allergies are from man modified and processed food. Real food does not produce these reaction to shut down the natural systems of the body. What we read on the labels and what we are never suppose to read on labels is really no help. If we read something like tomatoes on the label that is what it container should contain-not man made chemicals or man modified foot that other animals immediately smell and not eat.

  3. I have food allergies. I was tested for all kinds of foods and showed no kind of reaction. when I questioned the doctor he said it wasnt’ really the food I was allergic to….it was the chemicals in the food. I have 1 son and 2 grandchildren with food allergies. its awful to live with. we all need and deserve to have food without chemicals. FDA is not an independant government agency that should be allowed to act against the governing body of this country. nor should it be allowed to act on behalf of corporations. its suppose to be an agency that acts on, and protects, the american people.

    Why are you ignoring Congressional instructions and giving those GMO pushers free rein?
    If you want a job with Big Pharma, go work for them and stop sucking up taxpayer money. Your job is to protect us, not to protect those who are exploiting and endangering US citizens with Frankenfood.

  5. By not doing what congress has decided you are betraying and harming every us citizen

  6. FDA Folks:
    Although no one in my immediate family has gluten sensitivities, I personally know 7-8 people who are mildly allergic or have celiac disease or anywhere in between. It is a rising epidemic and should be included in the list of 8 legally required on labels. In fact, I know more people with gluten issues than I do the other 8 on the list – combined!
    Please broaden your scope to include gluten.

  7. I have so many food allergies from what is being done to food. If I get vegetables from a garden I don’t react to them. I can’t eat corn. The list goes on and on. I have severe asthma and get very ill and have asthma attacks.
    I also think chlorine should be listed. I’m very allergic to chlorine and that is the manufacturing process with Splenda. That stuff about killed me and I only used a packet a week. The doctors thought I had stomach cancer or colon cancer because I had such severe stomach pains.
    I can’t even begin to list how many problems I have because of the food we are able to buy. It is so hard to even eat meals because of it. The only good thing is it sounds like I’m far from the only one.
    Isn’t the Food & Drug supposed to be working for the people? It appears as though they are trying to satisfy everyone but who they should be.

    1. The FDA is NOT an elected entity. It is an out of touch agency – like many of the regulatory agencies who have been hand fed bad science and false information and just perpetuate it – (also they don’t want to lose their jobs or suffer professional criticism. I wrote to my congressman here in Wisconsin about GMO’s and he sent me a letter, the same FDA approved blah blah that I got from the other state senator who just left office.
      The people in Washington for the most part, do not have adequate information – unless they have a family member who suffers from food allergies. What the Jeff Smith of the Institute of Responsible Technology has to say about GMO’s in the 2012 documentary titled Genetic Roulette. (available online FREE online to watch – for now) gives a pretty “interesting” take on the introduction of GMO’s in American Diet and the increase in all kinds of diseases – And everywhere the diet is taken, Europe, Asia people get sick – just like here in America. There is LOTS of money already spent by the US taxpayers to approve this bio/chemical/agricultural monster and while Europe has already banned GMO stuff, it is being pushed in Mexico, Central and South America. Already, Canada is already on board with the vast amount of rapeseed -( canola ) another genetically modified item. Better living through chemistry.

  8. Myself and all three of my children have Celiac disease which has caused irreparable damage to
    all of us. I now suffer from siezures from even trace amounts of gluten and can go into anaphylaxis from wheat, gluten and other grasses if ingested. My daughter ingested wheat flour through inhalation at a school baking project and had her immune system attack her brain so bad it took a week to get over the damage. These are only a few very acute problems that have happened to our family. We were very fortunate to discover what was going on and have been able to re-balance the over active immune response through working with qualified nutritional experts at a large teaching university that has a comprehensive program for such problems. The FDA needs to stop dragging its feet. I work in a health related field and speak to parents all day long about the lack of any kind of standards for Gluten labeling and the potential harm it could do to a child who is severely affected. As for the GMO’s the FDA has allowed the food industry to play blind Russian Roulette with our health. The fact that these foods have been allowed into restaurants, packaged foods in school cafeterias, convenience stores and in supermarkets without labels is fraud.

    1. Can you tell me the name of the program that helped you and your family? I would like to get my immune system back in balance too! I suffer from multiple food and chemical sensitivities and have ‘brain allergies’ perhaps similar to what you described. I am always looking for ways to overcome these challenges….

      1. I don’t know if the brain allergies are the same as mine, but I will tell you what was happening to me. I had been taking “soy lecithin” as a supplement for about 3 years, because I was told by a friend, that it was good for the brain.
        I also ate chocolate pretty regularly, and cookies and snacks with it in them. One Sunday a year and a half ago, after eating lunch with friends, when we arrived back home, my husband sat me down on the couch and asked me “Honey, why did you act so stupid while we were out with our friends?” I was shocked, becaue I didn’t know what he was talking about. I asked him, “What did I do?” He explained simply, that I had stood up and said some silly things, and was waving my arms, and he just couldn’t believe it. I was not aware that I had done this, and it was hard to realize that I had done it, but that night before I went to sleep, I asked God in my prayers, “Father, what is causing this?” The first thing that came into my mind was, “brain fog”.
        The next morning I got on the computer, and looked up, “brain fog”. There were many places that had explanations, and I read several, but the one that really explained what was happening to me was the one that focused on “soy lecithin”. It expalined that nothing soy is good for us, unless it has been fermented, like soy sauce is. It explained that “soy lecithin” can cause “brain fog” and that it was not good for the brain. It explained that soy lecithin has been in our food since the 1930’s and it is NOT good for us. It is in almost all of the candies, cookies, chocolates, and could cause “brain fog”. I immediately had to give up my favorite chocolate, and have been watching everythin that I eat, to make sure that it is not in anything I eat. I have felt better, and more alert, since. I even found out since, that the “jelly beans” that our wonderful President, Ronald Reagan loved to eat, also contain soy lecithin! To me that is proof enough!
        I believe that it is the cause of Alzheimer’s disease, because it builds up in the brain over periods of time, and then people who have the problem, are not even aware that they have the problem. I am so glad that my husband was kind enough to present the proablem to me, and that the Lord answered my prayer.
        I present this, because I believe that everyone should know about this problem, and as with so many of the problems presented in this article about gluten, and all, it…

  9. The FDA us a marketing arm of big business, not a government agency protecting the welfare of American citizens.

  10. Dear Sirs, After years of suffering from “irritable bowel” syndrome, which left me unable to leave home for more than 30 min. at a time, i was diagnosed with gluten sensitivity and within 3 days of eliminating all wheat products was relieved of symptoms that had plagued me for 30 years! Require gluten labeling for my health and sanity because less than 1/8 teaspoon of wheat sets me back 30 years. I have also become allergic to soy and possibly dairy products that I am now being tested for. I currently have a 3 month case of hives that we cannot cure that I can only hope is not GMO related but my doctor believes is. I will have to be on an even stricter diet. Keep labeling of all proteins and help Americans function at their best.

  11. I am old enough to remember when allergies were rare, the change started when GMO’s were put on the market without telling anyone. I cannot eat the GMO foods whether plant or animal, or animals that are fed GMO grains and foods. If I eat the same in organic form I have no problems. If I eat the GMO and toxic chemical junk I get sick and feel miserable. As I said I am old enough to remember when food did not cause so much illness and cancer. We need to go back to the natural way of doing things like my grandfather who was born in 1889 believed in. He was active until he died. Excellent example as far as I am concerned. The modern diet is horrible and is killing people.

  12. FDA & FCC are a very grave disappointment for us. Just who are they serving. Certainly they have neglected to protect the public and not big corporations & industries or moguls. What an absolute monstrous disaster to have such inept people whose agenda is not what they have been appointed to do

  13. The FDA has a duty and a responsibility to protect the American people from food which will harm them. So why are dragging your feet, Michael Taylor?

    1. For that matter, why are “former” Monsanto employees like Taylor running the FDA and USDA? After all of Obama’s talk about GMO labeling during his original campaign, he sure was quick to promote Monsanto insiders straight into positions of extreme power over our food safety. Talk about letting the foxes take over the hen house…

  14. Really, if you were doing your JOB, we wouldn’t be having this little discussion! You would have outlawed GMO products and already labeled all allergens, as well as eliminating aspartimene.
    The FDA should broaden their scope to look at gluten, in addition to the so-called “major” food allergens. Consider that the exacerbating effect that GMOs have on food allergies (e.g., the threshold level for GMO soy might be different than for conventional soy). Also consider IgA and IgG allergenic responses in addition to the more dramatic IgE responses. Long-term but health-damaging allergic responses are as important—and far more widespread—than reactions to the “big eight.”

  15. Hi,
    I have been diagnosed with multiple disorders, including Celiac disease, Why would any government agency not want to deal with a serious issue that can lead to death and serious disability. It is so hard to eat and without proper labeling, it makes it harder. Congress passes laws for a reason. I would hope the gov’t can see the serious issues those of us with allergies that are life threatening face every day. We can’t eat out normally. Please let us shop normally at least.
    Thank you,

  16. I have Celiac and must avoid gluten. But, I’ve been allergic to corn for all of my life. Corn allergy is very common, but it is totally ignored, except by us victims. The corn industry is very powerful, and the food industry surely won’t be bothered to label the origin of all the ingredients and additives that are made from corn. Such as, citric and lactic acid, xanthan gum, ascorbic acid. These are just a few of the additives that are usually made from corn, but not labeled as such. For all of us who are severely allergic to corn, we are finding it impossible to avoid all the hidden corn in or on food products. Processing and packaging aids that use corn-derivitives are never labeled to warn us, so we can avoid getting sick. Contacting companies to ask them about corn in their products is risky. The customer service often doesn’t know, or gives us the wrong information. We are sick of the FDA, USDA, FANN and other agencies ignoring corn allergy, despite our many complaints. Do a google search for ‘corn allergy’, and you will see what I mean, about corn allergy being a serious and very common problem for many of us.

  17. please save our children, seeing the pres. making a big deal about the guns when he allows the gmo’s favored over real food???? that’s what will kill our children, they’ve become another way to support monsantos and the big pharmas. we have the right to know what we’re eating, i do not like to see the pres. using children to his advantage. oh by the way, nobody in washington deserves a raise, spend my money like it’s the last dime in your pocket!! we,ve got a pres. that’s spends our money like he’s the king. he needs to pay taxes on alll these perrsonal trips same as we do, it should be considered an income just like us. remember united we stand divided we fall, this pres. takes every oppertunity to to allways blame and divide, someone out there raised a very bad child, but we still want to know who this man is, he seems to hate a free country. he’s slowly gutting the constitution, not something you should be proud of. you’ll all go down in history for what you’ve allowed to happen to the most amazing country in the world. god help you.

  18. Excuse me, but what gives you people the right to just ignore laws? If you’re required to make companies list allergens in foods, then DO IT!!!

  19. Your “facts” are wrong. Gluten may or may not be an allergen. Gluten makes up the majority of the protein in wheat but it is yet to be determined as to what protein creates an allergic response to wheat. Sue Hefle and Steve Taylor(University of Nebraska) submitted an argument for celiac interests to include celiac disease as an allergy. It is not a because it is not the result of the body’s histamine response. Those people who have celiac disease (less than 1%) know to stay away from gluten and they know the various places to find it in foods. Your attempt to dumb it down is painting with a broad brush and smacks of special interest lobbying to influence uninformed consumers. If this is not the case then please make sure you have the facts straight before you take a position.

  20. FDA please uphold your requirements and list all allergic foods. It makes me and I know a growing number of people ill. I have severe reactions if I ingest Gluten or Soy. I have Celiac Disease and Gastroparesis. Please help!!!!

  21. I am severely allergic to corn and corn derivatives–I am anaphylactic to ingestion of these ingredients. I am petrified that I will unknowingly eat something with an unlabeled corn derivative
    (for example, beautiful 100% grass-fed beef is typically sprayed with a non-disclosed corn-based lactic acid or vinegar during processing, which means I can’t eat it). I also worry that, in a medical emergency, my medic alert bracelet or necklace will be overlooked or ignored and I will be given a dextrose IV or other corntaminated pharmaceutical. What corn-allergic people don’t know CAN kill us! Please research the increasing number of reported corn allergies, and add this to the list of allergens that need to be labeled on our food.

  22. The simple truth is the FDA works for the eugenic Rockefeller clan and NOT the American people. This truth is hard to accept but once you do many of your very puzzling health questions will become crystal clear.

  23. You have helped me figure out my dermatitis herpetiformis condition… I have finally figured out exactly what it is…and, what it is related to… Thank you so much…

  24. I agree with what you’re saying here, but I don’t think Celiac is actually an allergy…
    also I agree with the commenter above that corn allergy should be included.

  25. This is a very poor and out of date list, but then again, the FDA/ media is full of misinfo.
    In H R Clark’s The Cure and Prevention of All Cancers, 2007, you will find a list of 27 allergens, the precisely identified body parts they inflame, and the identified foods etc that contain each one. Dr Clark, PhD ND based her works since 1995 on over half a million repeatable so scientifically valid bio-resonance tests.

  26. What ever happened to msg?! It seemed that we all ranted & raged against it, but it just fell to the wayside. My feeling is that there was too much money/power behind that conglomerate to crack it. So, is that one just dead in the water? Also, i do not hear anyone talking about carmine (the red coloring made from crushed beetles). It has been shown to be an allergen to people who are allergic to shellfish & everyone that I have told about it was disgusted by the fact that they were eating beetles, regardless of what the end product looked like or tasted like.

    1. Msg myseriously turned into all natural “sea salt”.. Considering msg is somewhat derived from seasalt, it is still there, butt with a different name.r,

  27. FDA has been ignoring the gluten issue for too long. Last year a group of Gluten-free bloggers petitioned Congress to get this issue resolved and we’re still no closer to a label. Then again everything regarding food in this country is determined more by corporations than anything else. I am allergic to wheat and corn. Corn allergies are growing, and since corn goes under over 150 different names in our food, I would love to see it clearly labeled. But that will never happen. The people with the money don’t want us to know how much of our food is nutritional devoid, genetically-modified junk. We fight back the only way we can – buying CSA shares, dairy, eggs, and meat from a local farm, and minimizing use of anything commercially produced. Fortunately we live in a part of the country where we have these options. If we didn’t, I don’t know what I’d eat.

    1. It’s hard to understand if corn is as “harmless” as all the manufacturers claim it is, why should they care if its presence gets pointed out on a label. I go around feeling terrible quite a bit of the time, and I am confident it has to do with the hidden corn everywhere. (I was diagnosed 30 years ago).

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