Government Agencies Agree to Undertake Research on Folic Acid Risks

May 12, 2015

Will this convince the FDA to drop its proposed folate ban?
Last year, we reported on a proposed rule coming out of the FDA that would ban the word “folate” from Supplement Fact labels. Only “folic acid” could be listed on the labels.
We noted that the FDA’s maneuver would result in natural folate disappearing from the market entirely. If a product can only list “folic acid” as an ingredient, it would be fraudulent for it to contain anything else, even natural folate.
Folate is incredibly important to human health. Our bodies need it to synthesize and repair DNA, to produce healthy red blood cells and prevent anemia, and to support many other vital functions. Folate supplementation in pregnant women has been shown to protect against neural tube defects like anencephaly and spina bifida in children.
What we refer to as folate is the naturally occurring form of the water-soluble vitamin B9, while folic acid is the biologically inactive, synthetic form of folate. This distinction is crucial. Most people can convert folic acid to the folate that the body needs, but it is estimated that about a third of the human population cannot efficiently convert synthetic folic acid into folate. For these people, too much unmetabolized folic acid can build up in the blood, which could lead to an increased risk of prostate, lung, and colon cancer, or worsen already present cancerous lesions. This refers to very large amounts of folic acid, much larger than in current supplements, but more research is needed to account for individual differences.
In response to the proposed rule, ANH-USA submitted a formal comment to the FDA pointing to these concerns and laying the groundwork for future legal action if the agency did not change its approach. We also encouraged ANH-USA members to weigh in and demonstrate the widespread public opposition to such an action. We are happy to report that our concerns appear to have been heard!
After ANH-USA, our members, and other concerned stakeholders expressed their concerns about the FDA’s action, the National Toxicology Program (NTP) and the Office of Dietary Supplements (ODS) announced they will be conducting research into the potential adverse health effects of ingesting high levels of folic acid. ODS serves as an advisor to the FDA on issues relating to dietary supplements. NTP and ODS asked for public input on what specifically they should look into, and ANH-USA’s scientific director, Dr. Robert Verkerk, supplied a number of suggestions, such as the need for research into how much unmetabolized folic acid persists in the bloodstream in people consuming large amounts of folic acid. He also discussed the need for a better understanding of the effects of multiple genetic polymorphisms that effect the conversion of folic acid into folate.
We hope this research will cause the FDA to abandon its proposal to ban the use of the word “folate” on supplement labels, an action which could put the health of millions of Americans in jeopardy.
We will continue to monitor the situation, and will notify ANH-USA members of any further developments.

35 responses to “Government Agencies Agree to Undertake Research on Folic Acid Risks”

  1. Folate is converted into folic acid, not the other way around. Furthermore, folic acid does not cause cancer.

    • Ellie Crawford says:

      The body needs the enzyme MTHFR to convert the synthetic form, folic acid, (invented in 1946) into the bio-available form of B9, called Folate. For those of us with the genetic version of C677T or A1298C cannot complete this conversion. The build-up of folic acid triggers blood clots, heart attacks and strokes as well as birth defects and miscarriages.
      Up-to-date cardiologists and obstetricians may be aware of these problems.

    • Linda N says:

      No, . Synthetic folic acid is converted to Dihydrofolate which is the dietary form of folate, then Tetrahydrofolate, than in a few more steps converted to 5-methyltetrahydrofolate. And one of those intermediate forms. folinic acid, is also used in another pathway.

    • Bruce Stewart says:

      Through a genetic defect I have trouble converting folic acid to folate, that is, methyltetrahydrofolate (MTHF). Your body produces methyltetrahydrafolate reductase (MTHFR) to convert folic acid or plant folates to MTHF. The term folic acid has become a generic term for B9.
      I think I smell a rat at the FDA. Yes you need to be educated to take many supplements but there is very little risk. You may feel bad for a few days if you over do it but then back off or better yet see an informed doctor. Genetics is tomorrow’s medicine.

  2. Aweston says:

    Suzanne, from my years of research, I feel you have the conversion backwards. Folate is technically a general term for methylfolate, folic acid, etc, but is used nowadays as a term to refer to bio active folate, which folic acid is not. Your body must convert synthetic folic acid to bio active forms of folate in order to be used. Nowhere in my years of research have I ever seen that your body converts methylfolate to folic acid.
    If you have information to the contrary, please post sources, as I would like to know.
    Thanks

  3. Sandi Hornsby White says:

    I read this, this morning and it sent me into a rant. I also spent the day calling numerous CA State Senators for my “no vote” on mandatory vaccines. We are starting Recalls here in CA of Senator Pan….and The Senate Pro Temp and the “unethical” Senator Bill Monning for “rigging the votes.” My Amendment for Antioxidants was ignored. Senator Pan received $350,000 Pharma and AMA donations and takes orders from them. He and several other Senators . The push is on in Congress and State’s to force vaccinations and will be an issue in the GOP election. Anyway, I have been concerned with how the AMA and Big Pharma play this nutrient. Blocking it until they can get a synthetic chemical version. They are directly responsible for poor brain and fragile nervous system health. It has taken years to raise the dosage in prenatal and after birth children’s vitamins. And, this proves dangerous stupidity.

    • Linda N says:

      The pharmaceutical companies already have a patented pharmaceutical version of of the active form of folate. But mostly it is sold to high end supplements companies. Changing the Guidance to read that only folic acid is allowed to listed on a supplement label will force those of us with Gene defects that code for the MTHFR enzyme (and other methylation defects) to pay huge prices to get this supplement as a prescription. And even then it will not do most of us any good 1: because of the massive amount of toxic “inert” (cough cough!) other ingredients like toxic dyes and what not, and 2: the ridiculously high doses that are over kill, not necessary and will cause us to over methylate. I am sick over this!. Having lots of methylation defects and having to take both 5-mthf, high doses of methyl B12, methionine and other supplements to bypass defects, getting a prescription will be impossible. The FDA will, as always, limit the uses for the drug so most people will not be able to get it anyway even if they could afford it, and, as stated above, the toxic version will be full of crap at too high a dose.

  4. BIOCHEMICAL FUNCTIONS
    Basic Functions
    *Folic acid is a water soluble B vitamin derived from its conjugates, folate polyglutamates, found in foods such as organ meats, dark green leafy vegetables, and citrus fruits. Food folates are broken down in the small intestine to form folic acid and then converted in the liver and plasma to form tetrahydrofolate (THF). THF is then converted into two active and medically important coenzymes, methyl-THF and methylene-THF. Methyl-THF is more concentrated in blood plasma and represents short-term stores (called “plasma folate”). Methylene-THF is higher intracellularly and represents intermediate stores (Ma, J, 1997, Scott JM, 1994). Folic acid is concentrated within erythrocytes where it binds with glutamates and iron to form hemoglobin (called “red cell folate”) (Benesch RE, 1985, Lucock MD, 1996). Reserves are stored in the liver but become exhausted quickly (within three days). Both methyl-THF and methylene-THF play critical roles in methylation—the donation of methyl groups (single carbon fragments–CH3), in the synthesis of amino acids, and DNA and RNA nucleoproteins. These methyl groups attach to sections of the genetic code, preventing DNA damage and chromosome breakage, protecting our genome integrity by disallowing the expression of inappropriate developmental and disease causing genes (Blount BC, 1995, Fenech M. 2001). Folic acid also works indirectly with tRNA,
    helping to transport specific amino acids to their appropriate locations in the chain of forming protein molecules (Kelly GS, 1998).

  5. It is the lack of folic acid which causes all the problems with birth defects and heart disease and that is because it is needed to recycle homocysteine back into the most limiting essential amino acid, methionine. If this is not done, homocysteine accumulates in the blood causing plaques in the arteries and NTD related birth defects and heart defects in the developing fetus. B9 is just another name for folic acid or folate. Folates in food must be first converted into folic acid which only occurs in the intestines. Then it can be converted further into the important medical enzymes. Don’t blame high folic acid, it is low folic acid that is the problem.

    • Reality of Truth says:

      Is this what the ADA/Big Pharma taught you in their fake indoctrination classes?
      Clearly, one must take folate by your own statement, for it to be converted into the “required” folic acid. So, by taking folic acid you are defeating that requirement and thus MUST eat folates in food for it to be converted properly. Therefor, by your own statements, suggesting to take folic acid is not practical because it will not be converted properly (especially if it is synthetic).
      How about we just get rid of the folic acid and only use folates? Hmm?
      We could also, you know, stop fighting the natural world and just accept that humans are stupid and will always be inferior to the world that provides them their existence. You cannot defeat nature, not with toxic chemicals, so stop trying!

      • No, I am a cytologist, CT (ASCP), and cancer and nutrition researcher with a masters certificate in holistic health. Folates are bound together in food (primarily in plants) and must be broken down in the body to elementary folic acid. Then folic acid can combines to form 5-MTHF.
        Ascorbic acid (vitamin C) can be made in the lab just as folic acid can. It doesn’t mean it’s bad. It’s just not as good. However, it is better to have some than none or very little. Each time we cook our food we destroy both folic acid and ascorbic acid as they are heat sensitive. Also, many medications deplete folic acid. Therefore we are always running into a deficit. Birth defects can be prevent in women with MTHF enzyme deficiencies if they are given much more than average of folic acid (eg: 5 mg). Now that there are supplements of 5-MTHF this is even better.

      • 5-MTHF supplements are actually synthesized in the laboratory.

  6. Richard Smith says:

    The FDA, the wonderful people who brought us Aspartame, will not listen to the truth no matter who presents it. Why? Because our current government of occupation by the globalists has three main purposes:
    1. To rob us of our money and property,
    2. To control and/or imprison us, and
    3. To kill us.
    This fits in neatly with #3.

    • Nancy says:

      100% agreed with you!!
      We need to live our comfort zone and get together and fight for our rights…
      Thank you for your great work.

    • MountainKiddo says:

      The FDA does not set goals to rob us of our money and property, control or imprison us or kill us. The FDA does however listen to organizations who present logical arguments with consumer support behind them just like they did with ANH as is explained here in this status summary. Many times the FDA makes the mistake of listening to the wrong organizations such as big pharma and then ANH needs to step in with our voice behind it and attempt to make changes.
      It’s important to keep the right attitude towards our government. It is made up of people who are also eating aspartame just like you and I – their decisions effect them as well as you. And thankfully we have a choice (not to eat the aspartame) and we have a voice to influence the government and FDA to do the right thing and with ANH’s support our efforts have a chance of having an effect. If you feel so strongly against the decisions FDA makes, it is wise for you to continue to watch the posting here on ANH so that you can be a part of the changes they are trying to make.

      • Reality of Truth says:

        Keep living in your dreamworld where the government really does care, where the corporations have your interest at heart and where regulatory agencies really do their jobs! Haha!
        The reality is the FDA doesn’t give a single crap about the health of anyone except the corporate goons it serves. It cares about the health of their profits, not the citizens. To the US incorporated government, we are nothing but an enemy populous to poison, abuse, maim, and murder. The sooner you realize this, the better off you will be. Those that work in the US incorporated “government” are not even human, they are lizards wearing human skins which explains why they intentionally and maliciously poison all life on the planet. No human could be so soul-less, so heart-less and so mind-less as to maliciously poison their own home world and all life on it. “MountainKiddo” You’d have to be a kid to think that the government or regulatory agencies have any legitimacy to them what-so-ever. Grow up kid, the government poisons you and they do so intentionally.

      • Richard Smith says:

        “The FDA does not set goals…” But our bought-and-owned officials who tell the FDA what to accomplish DO. The FDA is just another alphabet agency doing the bidding of the collaborators posing as our representatives, whose goals are exactly as I stated. And are you unaware that the head of the FDA is the former head attorney of Monsanto? We can certainly trust him to do what is right for us, can’t we? LOL!

    • Reality of Truth says:

      Completely agree.
      The US incorporated “government” is nothing but a sham system of abuse, deceit, and death.
      Do not trust them, the regulatory agencies are in the pockets of the companies they are suppose to regulate. Regulatory companies have actually HURT more people on this planet than they have protected, thus defeating the very purpose of their existence.

  7. Wendy Allen says:

    Thanks for your help! I am glad you are working hard to help correct this. Folate..not Folic acid may cross the placenta into the baby an article said. Folate makes my toes have more circulation compared to folic acid when taken with Vit B12 methylcobalamin.

  8. Abresh Arquah says:

    I did not know that some people could not metabolize folic acid. Learn something new every single day.
    That said, this sounds like another case where the FDA is trying to regulate natural supplements out of the market by having a too small definition of X and Y or saying that X is acceptable but Y is not.

  9. tbran10 says:

    Why don’t we do research into the nutrient depletion caused by the majority of prescription drugs. It would be much more productive. Misdirection is a basic tenent of the current allopathic model.

  10. Reality of Truth says:

    “Food fortification was deemed mandatory due to overwhelming evidence for
    the protective effect of folic acid supplementation before conception
    and during early pregnancy on the development of neural tube defects
    (NTD) in newborns.”
    I don’t like this part though, to me it just says they are poisoning the food.
    If synthetic folic acid is bad why are they “fortifying” the food with it?

  11. Reality of Truth says:

    Humans will never defeat nature, because the day that you do, you will have merely defeated yourselves.

  12. tbran10 says:

    I have learned a third of the US population has trouble converting folic acid to methyl folate.
    It is becoming clear to me that Type II diabetes is caused by the nutrient deficiencies of methyl folate and Vitamin D. Boost both nutrients and decrease sugar consumption and you reverse the condition. Unfortunately, the drug manufacturers don’t make any money if the truth was known.

  13. To thoroughly understand folic acid and 5-MTHF supplementation visit the Point Institute and read Dr. Thomas Guillian’s position paper on the subject. He also has a two part video interview on the subject.

Leave a Reply

Your email address will not be published. Required fields are marked *