ANH-USA Submits Formal Comments on FDA’s Latest Attempt to Ban the Natural Form of a B Vitamin

52

Healthy living.We’ve joined with two natural health powerhouses to argue that this action is illegal. Urgent Action Alert!

We have been telling you about the FDA’s latest sneak attempt to ban another B vitamin—natural folate. Folate is the naturally occurring form of the water-soluble vitamin B9. It is found in foods such as black-eyed peas, chickpeas and other beans, lentils, spinach, turnip greens, asparagus, avocado, and broccoli, and is also currently available as a supplement. According to the FDA’s 109-page proposed guidance, the word “folate” will be banned from the Supplement Fact labels, and only the term “folic acid” will be allowed. Since it would be fraudulent for the supplement to list synthetic folic acid among its ingredients but to use natural folate instead, this is a backdoor way of banning folate.

This week, ANH-USA, together with the Organic Consumers Association and the Weston A. Price Foundation, have submitted formal comments to the FDA. Our comments contain forty pages of analysis. The scientific analysis was done by our scientific director, Dr. Robert A. Verkerk, who is also the executive and scientific director of ANH International; the legal analysis was done by Ze’eva Kushner Banks, ANH-USA’s staff attorney, and Gretchen DuBeau, Esq., ANH-USA’s executive and legal director. The legal analysis is important, because it will lay the groundwork for future legal action if FDA does not heed our concerns.

In our comments, we explain how banning the word “folate” and allowing only the term “folic acid” will have a number of dire consequences:

  • Many individuals have a genetic defect that prevents them from producing the enzymes needed to convert synthetic folic acid into the active form of the B vitamin that our bodies need. This includes up to 44% of North American Caucasians and over 50% of Italians, and over 90% of patients who are predisposed to diseases such as cancer, heart disease, and autism.
  • The new rule is illegal for a variety of reasons. For example, by treating those who cannot convert folic acid properly and banning the supplemental folate that would otherwise be available to them, the FDA is violating the Equal Protection clause.
  • Supplement companies currently using dietary folate in their products will either be forced to remove the ingredient or incorrectly label the folate ingredient as “folic acid.” Not only would they knowingly mislead their customers. They would also risk enforcement action for misbranding or false advertising under the Food, Drug, and Cosmetic Act (FD&C). Moreover, the rule fails to advance the FDA’s interest in encouraging truthful labeling and helping consumers maintain healthy dietary practices. By limiting what ingredients can be mentioned on a label, the FDA may also be violating the First Amendment.

In our comments, we also address the fact that the FDA set the Daily Values for most vitamins and minerals far too low and, as we reported recently, the changes of unit of measure are also problematic. These concerns feed into the public policy argument: because amending the labeling regulations has a major impact on every consumer, the FDA’s new labeling scheme should address, and attempt to correct, the substantial nutritional deficiencies most Americans now face. Proper nutrient recommendations could also have an impact on the nation’s obesity levels and other poor health choices; not addressing them means our economy will continue to be seriously burdened by costly, chronic health problems.

On June 26, ANH-USA attended the FDA’s public meeting on the nutrition and supplement fact panel, and we were the only organization to bring up the folate provision or to discuss the impact of the low daily values and the changes of the units of measure. There were a number of Big Food groups represented at the public meeting—the National Confectioners Association, the Grocery Manufacturers Association (GMA), etc. Their biggest concern was the provision that would reveal added sugars on labels. For example, sugar found in an apple would be considered “naturally occurring,” but agave—a sweetener isolated from cactus— would be considered an “added sugar” and would have to be listed as a subsection of total sugars). This is one of the few actual improvements in the new labeling rule.

Urgent Action Alert! The deadline for receiving comments is August 1, so there are only a few days left. Please don’t wait a moment longer—send your comments to the FDA. We need consumer support for our formal scientific and legal comments! (Please submit BOTH Action Alerts!)

Folate/folic acid:

Take-Action11

Daily values:

Take-Action11

Share.
  • If you don’t have a lobbyist, you ain’t in the game.
    Because we have ANH, we have a lobbyist in DC.
    HOORAY for ANH-USA.

  • Veronica Roach

    Please do not start interfering with what we as consumers are allowed to consume – you are NOT protecting us from the big food lobby and the very suspect creations they call ‘food’; WE as consumers have the right to eat what we discover to be natural, you cannot be trusted to leave our food alone, but obviously are bent on controlling what we – the public – wish to consume. Natural substances were never and still are not NOW your area of business – stick to controls on man-made substances, which we are in danger of having thrust down our throats by the big-food lobby – namely big business – and guess what their modus operandi is !!
    WE – the public – are watching what you are doing.

  • John (Action) Jackson

    It is not only illegal, it is evil, how can you even think that you could get away with this. When this information is circulated as it is now, it is time….

  • Josie Arballo

    Thanks for the continued efforts on behalf of all those that believe in natural forms for health.

  • Laura Boojwa

    It is ridiculous to control any vitamin at all, especially the essential B vitamin which is a naturally occurring substance and has been around forever! Why is it that you want to continue making people sick? Oh, the drug companies control. I almost forgot! Please STOP letting them control you for the greater good of health, for a chance. After all, that is your job and responsibility. Let us take our B vitamins in whatever form WE choose. I don’t think anyone is going to overdose on it like all the prescription drugs you approve daily where thousands of people are sick and dead as a result. Just let B vitamins remain.

    Thank you.

  • SHW

    Considering we have a mass epidemic of American babies that American’s have not awakened to, yet, with brain cancer. Decades of children are at the fate ADD and ADHA and Autism because of the gross stupidity of FDA and the AMA. Prenatal Vitamins and minerals are severely lacking, especially folic acid. These same children would not be suffering if both omegas and b vitamins where give on daily bases…..feeding the brain what it needs to thrive needs to be in every diet and especially children. Shame on the FDA! And, the MD’s who refuse to learn the benefits of long term health benefits of B vitamins. ….instead of pushing legal drugs with shared profits.

  • David C. Osterhoudt

    Banning the word “folate” and allowing only the term “folic acid” will have a number of dire consequences:

    Many individuals have a genetic defect that prevents them from producing the enzymes needed to convert synthetic folic acid into the active form of the B vitamin that our bodies need. This includes up to 44% of North American Caucasians and over 50% of Italians, and over 90% of patients who are predisposed to diseases such as cancer, heart disease, and autism.

    The new rule is illegal for a variety of reasons. For example, by treating those who cannot convert folic acid properly and banning the supplemental folate that would otherwise be available to them, the FDA is violating the Equal Protection clause.

    Supplement companies currently using dietary folate in their products will either be forced to remove the ingredient or incorrectly label the folate ingredient as “folic acid.” Not only would they knowingly mislead their customers. They would also risk enforcement action for misbranding or false advertising under the Food, Drug, and Cosmetic Act (FD&C). Moreover, the rule fails to advance the FDA’s interest in encouraging truthful labeling and helping consumers maintain healthy dietary practices. By limiting what ingredients can be mentioned on a label, the FDA may also be violating the First Amendment.

    The FDA’s new labeling scheme should address, and attempt to correct, the substantial nutritional deficiencies most Americans now face. Proper nutrient recommendations could also have an impact on the nation’s obesity levels and other poor health choices; not addressing them means our economy will continue to be seriously burdened by costly, chronic health problems.

  • Marcia Hempel

    Folate is such an important nutrient. I’m one of those people with an MTHFR gene mutation, and folate is important to my health, as well as P-5-P.
    Thanks for the opportunity to make my feelings known about this. No one should have a right to legislate these kind of changes. It’s important for us as consumers to know what we are taking. Now that people are getting educated about the differences between folic acid and folate, this kind of legislation comes up. It seems like whoever has been selling folic acid is feeling threatened because folate is better and people are starting to know that! Both methylfolate ans folinic acid are both superior to folic acid. for someone like me, folic acid is dangerous and builds up in my body.And additionally, P-5-P is an important type of B6 that needs to be available. I take both P-5-P and B6, and both are important.

  • Peter Freer

    The FDA’s policy regarding natural products, in this case natural folate, aligns itself with big pharma and away from the consumer. This is not the purpose or mission of the FDA in its original form. It is through corruption that non-ethical practices such as the backdoor attempt to ban natural folate occur. Let’s get back to your original mission and protect the public rather than favoring your friends in big pharma.

  • Normajean Bowen

    I am shocked that anyone would even consider taking away my access and choice to a natural substance. Remember that our nation was founded on FREEDOM OF CHOICE!
    This is my body, my health, and it’s my choice what I put into it.

    If you want to legislate away any of our choices, let’s start with high-fructose corn syrup and GMO’s. How about if you remove access to those before you start on the vitamins?

  • Susan

    People with MTHFR can not process folic acid and are advised NOT to use any supplements containing it. This also applies to foods that are fortified with folic acid. MTHFR complicates folate nutrition and the function of the methyl cycle. This is a serious health issue that affects a great many people. Who came up with the idea to ban “folate”????

  • Jan Emerson

    Please do not block my access to natural vitamin B in order to give control of a vitamin supplement to any drug company and force me to take a synthetic (and possibly carrying side effects) version of what is safe and available in natural form.

  • kerry

    The GOV. needs to stay out of Americans business…..

  • Andrea

    Stop banning natural supplements! Allow the public to make their own educated decisions on B Vitamins!!

  • Many individuals have a genetic defect that prevents them from producing the enzymes needed to convert synthetic folic acid into the active form of the B vitamin that our bodies need. This includes up to 44% of North American Caucasians and over 50% of Italians, and over 90% of patients who are predisposed to diseases such as cancer, heart disease, and autism.
    The new rule is illegal for a variety of reasons. For example, by treating those who cannot convert folic acid properly and banning the supplemental folate that would otherwise be available to them, the FDA is violating the Equal Protection clause.
    Supplement companies currently using dietary folate in their products will either be forced to remove the ingredient or incorrectly label the folate ingredient as “folic acid.” Not only would they knowingly mislead their customers. They would also risk enforcement action for misbranding or false advertising under the Food, Drug, and Cosmetic Act (FD&C). Moreover, the rule fails to advance the FDA’s interest in encouraging truthful labeling and helping consumers maintain healthy dietary practices. By limiting what ingredients can be mentioned on a label, the FDA may also be violating the First Amendment.

  • Angela

    Our Representative and Senators, here in Kansas, are traitors to the American people, endangering them, as make deals with Big Pharma, Big Ag, Monsanto, FDA, and any Lobby that lines the pockets of the Washington Insiders. I hope and pray their time is waning as the people begin to wake up.

  • Elizabeth Maupin

    Because of a homozygous mutation in gene MTHFR (A1298C) I cannot process folic acid properly–I must have folate. Therefore, I need proper labeling of the different forms of this B vitamin.

    This is a very common variant, although most people with it have only one copy (heterozygous), which allows a little better processing, not great, but better. However, many of us have two copies (homozygous), and folic acid compromises our health.

    Please live up to your stated purpose, keeping us healthy.

    Sincerely,
    Elizabeth Maupin

  • Charles Weber

    The FDA’s proposal to bann the word “folate” and allow only the term “folic acid” will have a number of dire consequences, including the following:

    1) Many individuals have a genetic defect that prevents them from producing the enzymes needed to convert synthetic folic acid into the active form of the B vitamin that our bodies need. This includes up to 44% of North American Caucasians and over 50% of Italians, and over 90% of patients who are predisposed to diseases such as cancer, heart disease, and autism.

    2) The new rule is illegal for a variety of reasons. By treating those who cannot convert folic acid properly and banning the supplemental folate that would otherwise be available to them, the FDA is violating the Equal Protection clause.

    3) Supplement companies currently using dietary folate in their products will either be forced to remove the ingredient or incorrectly label the folate ingredient as “folic acid.” Not only would they knowingly mislead their customers.

    4)These supplement companies would also risk enforcement action for misbranding or false advertising under the Food, Drug, and Cosmetic Act (FD&C).

    4) Furthermore, the rule fails to advance the FDA’s interest in encouraging truthful labeling and helping consumers maintain healthy dietary practices. By limiting what ingredients can be mentioned on a label, the FDA may also be violating the First Amendment.

    The FDA’s proposed is flagrantly ill-advised and wrong on many counts. Do not defer to the megavitamin manufacturers.

    Do not institute this proposal.

    • Jazz Apple

      I think you mean, “Do not defer to the pharmaceutical industry.”

  • To Whom This May Concern,
    Corruption from and within the Federal government and specifically the FDA is tending to the destruction of America as it was once known.
    When the FDA oversteps the boundaries it was originally given only harm will result. If the FDA insists in going in this direction it will only result in hurt. Unfortunately, the tree of liberty has to be refreshed with the blood of patriots.
    So the FDA gets to decide on which side of liberty it will stand. Ultimately there is one judge that all men will stand before and give an account of himself or herself.
    Andrew Dickens NMD

  • Sharon Morin

    Tell the FDA and others to Leave our natural food supplement sources alone. I depend on my natural B vitamins and if it works I say LEAVE IT ALONE. We are not as dumb as the government think we are. Most have done their homework and find it to be safe.

    Thank You

  • Lorna Paisley

    I know ANH-USA cares about people and OCA is definitely about people so you need to do as they advice. They are not out to control human needs or make as much money as possible.

  • kathleenhunter

    Don’t fall prey to the drug companies. We as a nation have the right to have this information and for gosh sakes its in the food. NO BAN!!!!!

  • Stephen Pflanze

    I am opposed to banning the word folate from ingredient lists. There is no benefit and only harm in doing so. The FDA has a long history of attempts to eliminate the freedom to consume supplements of the consumer’s choosing. The effort to make the vitamin pyrodoximine a prescription drug for the benefit of the pharmaceutical industry, and to the detriment of the consumer, is an example. Now folate is just one more of those attempts.

    Leave us alone!

  • Virginia W Hulbert

    I listened to Deb Ray when in FL in the 80″s and 90’s and “til 2006. I’m 90 years old now. I was a dietitian in my youth. Now try to be a vegan. John Douiillard grew up in our neighborhood in Valhalla NY with my five daughters!

  • Joseph Battaglia

    Let’s keep the vitamins, and lose the corrupt FDA.

  • mike

    I don’t understand why people who know little or nothing about such topics are allowed to make laws and decisions like the one proposed here. And, if these people do know what this legislation will do and still support it, then they don’t deserve to hold public office. I don’t know why there isn’t a requirement for elected officials to bow out of votes on topics that are beyond their boundaries of knowledge. If an official relies on what a lobbyist tells her or him to determine how to vote because she or he has no expertise on the subject then that person should be forced to sit out the vote. I would like to see some prerequisites for holding office since we have proven that people who are thoroughly incompetent and unfit to hold any office can make it all the way to the white house–like W. Surely we can adjust our process of electing people to protect us from the intelligence deficits we have and continue to experience. is it not a threat to our country that palin was a possible vp and came so close to the presidency? Don’t we have some responsibility to not unleash more bushes and palins on us and the world? Are we not smart enough to demand certain proof of intelligence and decent behavior in our candidates? Are we just stuck with the twisted (and now proven by bush jr.) mantra that anyone can become president while we digest the bile covered sauce of the other unfortunate mantra of money controls elections?

  • Stop insulting the Founding Fathers and cease obstructing “life, liberty, and the pursuit of happiness.”

  • d. koenig

    Please do not ban the natural form of vitamin B9 (folic acid) currently available in supplemental form.

    Thank you for protecting our rights against the rapacious greed of the Pharmaceutical industry whose real concern is profit, profit and yet more profit.

  • lois schreur

    I really don’t understand why you would put people’s health at risk by eliminating access to natural Vitamin B. For many people this is an essential vitamin for their health. The only reason I can think of is that there is some financial interest at stake here for some corporate entity. Please do not do this. Please do not limit choices and options that people need for their health and well-being.

  • Eliot

    We need proper labeling of food so we know what we are eating!

  • Lee Johnson

    The more emails I receive regarding programs that are SUPPOSED to be watchdogs and champions for the common good of those of us they were charged with protecting the general public, the more laughable the articles. The FDA, EPA NSA, etc. are just a sample of a waste if our tax dollars and they are, in essence, useless and ineffective. Actually, they may very well be considered enemies of the people?

  • Larry Holman

    Do not ban the Natural Form of Vitamin B9.

  • Brad Frederick

    Feed us garbage so we won’t eat healthy and there can be more for the elite. You folks are out of your minds along with the rest of the power hungry,

  • Leroy Frankel

    Banning the word “folate” and allowing only the term “folic acid” will have a number of dire consequences:

    Many individuals have a genetic defect that prevents them from producing the enzymes needed to convert synthetic folic acid into the active form of the B vitamin that our bodies need. This includes up to 44% of North American Caucasians and over 50% of Italians, and over 90% of patients who are predisposed to diseases such as cancer, heart disease, and autism.
    The new rule is illegal for a variety of reasons. For example, by treating those who cannot convert folic acid properly and banning the supplemental folate that would otherwise be available to them, the FDA is violating the Equal Protection clause.
    Supplement companies currently using dietary folate in their products will either be forced to remove the ingredient or incorrectly label the folate ingredient as “folic acid.” Not only would they knowingly mislead their customers. They would also risk enforcement action for misbranding or false advertising under the Food, Drug, and Cosmetic Act (FD&C). Moreover, the rule fails to advance the FDA’s interest in encouraging truthful labeling and helping consumers maintain healthy dietary practices. By limiting what ingredients can be mentioned on a label, the FDA may also be violating the First Amendment.

    Additionally the FDA set the Daily Values for most vitamins and minerals far too low and, the changes of unit of measure are also problematic. These concerns feed into the public policy argument: because amending the labeling regulations has a major impact on every consumer. The FDA’s new labeling scheme should address, and attempt to correct, the substantial nutritional deficiencies most Americans now face. Proper nutrient recommendations could also have an impact on the nation’s obesity levels and other poor health choices; not addressing them means our economy will continue to be seriously burdened by costly, chronic health problems.

  • kendra heiss

    i am one of the 50% of americans that has the MTHFR gene mutation and i have both of the possible gene mutations and have to eat folate not synthetic folic acid. i cant function onit. my brain is foggy, and i feel sluggish. FDA needs to butt out of peoples lives and stop making everything about money. i would not have a live child if it werent for folate supplements. they dont have anyones interests at hand except their pocket book and that needsto change.

  • joe

    do not ban any words, or a vitamin that the human body needs.

  • T.

    For the FDA to protect and serve the Public, it requires preserving the availability of non- synthetic forms of supplementation of all vitamins and minerals. Anything less then the freedoms of liberty to purchase & utilize all natural forms of plants, herbs, mineral, vitamins, is a blatant totalitarian stand against the people. The FDA should not exalt itself over God and the people of this country. Our strength and power come from a true desire to do what is right, not what stuffs the pockets of Drug Corporations at the expense of our lives.

  • Suzanne Hachey

    Comments on FDA’s Latest Attempt to Ban the Natural Form of a B Vitamin- What are you guys doing????? We need protection from GMOs and unproven synthetic products!!!! Leave the natural already used products alone!!!!! Please bring your brain to work and treat the public like your own children.

    • Alice

      Nice! LOVED your comment, bring your brain to work, lol!

    • Jazz Apple

      “We need protection from GMOs “. Agreed, FDA = Fatal Defects Allowed. But who are you addressing? This is like saying, “We need protection from YOU”! Or the ultimate pathetic absurdity, “Please protect us from you”.

  • David E. Levy

    Why does the FDA want their lower level workers to be indited for conspiracy and other illegal activities and probably closed down if the Republicans take over both houses? Banning the word folate will guarantee that! Although my wife campaigned for Hillary and is on her email list, why is your agency trying to ruin it for the Democrats by doing this! Everone knows that Folate is the naturally occurring form of the water-soluble vitamin B9 found in black-eyed peas, chickpeas and other beans, lentils, spinach, turnip greens, asparagus, avocado, and broccoli, and until this lobby interest-group plan passes it is still currently available as a supplement.

    According to the FDA’s 109-page proposed guidance, the word “folate” will be banned from the Supplement Fact labels, and only the term “folic acid” will be allowed. Since it would be fraudulent for the supplement to list synthetic folic acid among its ingredients but to use natural folate instead, this is a backdoor way of banning folate.

    Banning the word “folate” and allowing only the term “folic acid” will have a number of dire consequences:
    “•Many individuals have a genetic defect that prevents them from producing the enzymes needed to convert synthetic folic acid into the active form of the B vitamin that our bodies need. This includes up to 44% of North American Caucasians and over 50% of Italians, and over 90% of patients who are predisposed to diseases such as cancer, heart disease, and autism.
    •The new rule is illegal for a variety of reasons. For example, by treating those who cannot convert folic acid properly and banning the supplemental folate that would otherwise be available to them, the FDA is violating the Equal Protection clause.
    •Supplement companies currently using dietary folate in their products will either be forced to remove the ingredient or incorrectly label the folate ingredient as “folic acid.” Not only would they knowingly mislead their customers. They would also risk enforcement action for misbranding or false advertising under the Food, Drug, and Cosmetic Act (FD&C). Moreover, the rule fails to advance the FDA’s interest in encouraging truthful labeling and helping consumers maintain healthy dietary practices. By limiting what ingredients can be mentioned on a label, the FDA may also be violating the First Amendment.”

    It is common knowledge in the teaching hospitals that the FDA’s Daily Values for most vitamins and minerals far too low. These concerns will…

  • israel

    Please dont make it illegal to use folate on the label…i cant and wont buy things that say folic acid on them because i have mthfr. My body cant metabolize folic acid. Please require truth in labeling…in this case it seems like hair splitting but i can assure you in this case it is absolutely necessary.

  • Gene Moore

    Thank you for very valuable work! Your work unknown to the majority of Americans is critical to all of our health including mine as I’m predisposed to cancer. The FDA’s proposed ruling is troubling to me. It seems government is no longer our ally but our enemy coupling their over-reaching rules, laws, regulations and practices with the interests of big business and old money for the sake of a few at the peril of the majority. Thank you so much for your concerted work and efforts.

  • Albert Haines

    This is not helpful to anyone that takes vitamins.

  • Elizabeth Maas

    I am very concerned as to why, what clinical evidence is prompting the FDA to consider restricting access to folate, a B-vitamin that is available in foods? In my ignorance, I can only suspect that the pharmaceutical industry stands to profit from restricting access to Folate in light of clinical evidence that is undergoing substantiation. http://ods.od.nih.gov/factsheets/Folate-HealthProfessional/

    • It’s not about clinical evidence, it’s about the drug carte’ s control.

  • Linda Pleasant

    Please do not remove FOLATE from the supplement list. It is a natural form of B vitamin that needs to remain.

  • Carole Dallek

    All B vitamins are important to our health. We do not want B vitamins or any other vitamins taken away from us. We have a right to be healthy and strong and to make our own choices in matters.

  • Rose Jenkins

    Let’s not play games with nomenclature, e.g., “folate” vs “folic acid.” The proposed change reveals a dark and devious nature — and ultimately is not in the best interests of our people.

  • Wayne Robey

    I submitted a comment on this to regulations.gov in June then discovered that the FDA dose not make comments from the public available to the public. The Microsoft Word file is 41 KB so It won’t fit in the 2500 characters provided here and contains subscripts. If anyone wants to see it, contact me at the address shown in the submission info for this post.

  • Wayne Thrash

    Actually, dihydrofolate is the “natural” form of folate found in foods. This form of folate, like folic acid (synthetic folate) has to be converted into L-methylfolate before it can be used by the body for the many critical biological functions that folate is necessary for. The genetic variant that was cited in the complaint to the FDA, the MTHFR T or T/T variant, interferes not only with the conversion of folic acid, but also of dyhydrofolate into L-Methylfolate. Consumers who learn they have this genetic variant should absolutely be supplementing their diet with L-methylofolate to bypass the conversion process that is being impeded by their genetic issue. They may mistakenly see “folate” or “naturally occurring folate” on a label and think they are taking the supplement they need, when in actuality they are NOT getting what they need unless it is L-methylfolate. While I do not put it past the FDA and big pharma to manipulate regulations to increase the financial take of pharmaceutical companies, in this instance I believe that there should be more accurate labeling that distinguishes between synthetic folic acid, naturally occurring dihydrofolate, and the more expensive to produce, but necessary for some individuals, L-methylfolate. Different labeling actually is in the consumers best interest.