You can’t live without this vitamin. But the FDA wants to reserve the natural form for monopoly drug companies, leaving only the synthetic form for supplements. Urgent Action Alert!
The FDA has just released a new 109-proposed rule on the revision of nutrition and supplement labels. (You can read more about the implications of the new labeling rules in our other article this week.)
On page 69, the agency slipped in two little paragraphs that could risk the health of millions of people who desperately need folate. It’s a sneak attack so quiet and unobtrusive that few people will even realize it’s there.
According to the guidance, the word “folate” will be banned from the Supplement Fact labels—only the term “folic acid” will be allowed.
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, but is also available as a supplement.
The human body needs folate to synthesize and repair its DNA. It’s especially important during the kind of rapid cell division and growth seen in infancy and pregnancy. Children and adults both require folate to produce healthy red blood cells and prevent anemia among many other vital functions
Folic acid, on the other hand, is synthetically produced, and refers to just one member of the folate group: pteroylmonoglutamic acid. While folic acid occurs only rarely in whole foods, it’s extremely stable, which is why it’s widely used in dietary supplements and to fortify processed foods.
The important thing to remember is that folic acid is not itself biologically active, though for most people the liver can convert it to the folate we need. Most, however, does not mean all. It’s estimated that 30% to 40% of the population can’t efficiently convert synthetic folic acid into folate.
In other words, about a third of the human population has two potential problems: a deficiency in folate (because it is hard to get enough from a diet full of processed foods), and possibly even an excess of folic acid (because their body can’t metabolize what could become an overabundance of folic acid present in “fortified” foods):
- According to Dr. Jonathan V. Wright, folate deficiency is one of the most dangerous medical conditions, leading to Alzheimer’s and other brain diseases. If pregnant women are deficient in it, it can also lead to spina bifida and other neural tube birth defects in their children.
- On the other hand, 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 large amounts of folic acid, larger than in current supplements, but more research is needed to account for individual differences.
Note that the FDA is not exactly banning the inclusion of folate and requiring the inclusion of folic acid in supplements. As usual, it is playing a much more subtle insider’s game. It is simply banning supplement producers from using the word folate on their labels and conversely only allowing the word folic acid on their labels. But it would of course be fraudulent to put folic acid on your label and then use something else. The FDA understands that perfectly.
So on what grounds is the agency banning the use of the word folate on the label? Believe it or not, it is arguing that folate can only be found in “conventional” (whole or minimally processed) foods.
Before we examine this absurd claim, we must first explain that limiting a folate claim to food would not prevent drug companies from becoming the only source of folate outside of food. Drug companies don’t care what a chemical is called so long as they can create a high priced monopoly in it. Ironically, the FDA’s position that folate can only be used to describe what is in food would still turn folate over to the drug companies—so long as supplement labels can only use the term folic acid.
So what about the agency’s assertion that “folate” can only be found in food? “Folate” is actually a term for a whole B vitamin group. The term “folate” we see on dietary supplement labels refers to “dietary folates,” members of the folate group that can be naturally found in foods. Folinic acid (5-FTHF), calcium methylfolate, and various other tetrahydrofolates can be found in dietary supplements. Many brands feature dietary folate. It would be completely inaccurate and misleading to refer to these dietary folates as “folic acid.” Legally, it would be fraudulent.
Why did the FDA do this? One can only guess. But it would not be surprising if it eventually turns out to be a blatant attempt to reserve for drug companies the use of dietary folates. After all, B vitamins are not only essential for life. They are also proven therapeutic agents. Drug company research programs have been coming up short for years; new drug therapeutic agents are in very short supply.
Moreover, the drug company Merck already holds patents on Metafolin, which the body recognizes as a bioavailable dietary folate. Metafolin is licensed by dietary supplement companies for some of their products.
If, according to FDA “logic,” dietary supplements can’t contain folate like Metafolin, it would only be available from whole foods…or drugs, and only from drugs in higher doses. Since Merck would have exclusivity for a Metafolin “drug,” our guess is that they would make billions. And other forms of patentable folate could then follow.
Sound unlikely? It’s not—both forms of fish oil and vitamin D have already been turned into patented drugs. Imagine if competition from supplemental forms of fish oil or D could be wiped out at one stroke by saying no supplement label could use the term!
Let’s also keep in mind the case of pyridoxamine, one of the natural forms of vitamin B6, another B vitamin critical to human health. In 2009, Biostratum, the manufacturer of a proposed pyridoxamine-based drug called Pyridorin intended to prevent the progression of diabetic nephropathy (kidney disease), filed a petition with the FDA asking to ban the natural form. The agency agreed to do so. It announced that pyridoxamine dihydrochloride was a “new drug”—which means the FDA effectively prevented any substance containing pyridoxamine from being marketed as a dietary supplement.
Never mind that the fish on your lunch salad and the chicken on your dinner table both contain pyridoxamine, as does brewer’s yeast! Never mind that vitamin B6 in general has been in supplements for decades and therefore ought to be grandfathered under federal supplement legislation. The agency simply stated that because supplement bottles in earlier decades had not distinguished between the particular type of B6 included, they could ban it
The natural alternative to pyridoxamine, one with similar health and anti-glycation properties, is another B6 compound called pyridoxal-5′-phosphate, or P5P. This is the only form of B6 that can be used directly by the body without conversion. While everyone needs B6 to live, some people have difficulty converting other forms of B6 to P5P.
P5P exists in food, and has been available as a supplement for years. But even P5P has been under threat! The FDA has a petition from Medicure Pharma to ban P5P. Thanks to grassroots activists like you, the FDA hasn’t acted on that petition yet—but if the petition is approved, we will have to wait until we get sick enough to obtain a prescription for the drug. We’ll no longer be able to maintain good health and prevent aging and diseases like cancer by proactively keeping P5P at the optimal level. It would be a complete travesty if P5P disappears from the market as pyridoxamine did.
The attempt to ban folate is being done differently, through a proposed FDA rule, which carries the full force of law. So it’s critical that we stop this now.
All of these attacks on your access to B vitamins are scandalous. Natural vitamins belong in food and supplements. Banning them in order to potentially benefit drug companies is just another egregious example of the crony capitalism that infests the FDA.
Please take immediate, urgent action on this. It may have to go to court. In the meantime, we lay the groundwork for court action by sending our complaints to the FDA. We need a lot of responses on this one to get the agency’s attention.
URGENT Action Alert! The FDA must not be allowed to implement this change in its Supplement Facts rules. It will in effect ban folate and allow supplement producers to use only synthetic folic acid. Consumers who are less able to convert folic acid to the safe and bioavailable folate we need will have no choice. For women of childbearing age, folate is recommended by the CDC, WHO, and most practitioners as an essential tool in preventing neural tube defects—and supplementation with folate is vital, since women may not be able to get enough folate in their diet. Send your message to the FDA today, and tell them not to convert a critical, natural B vitamin from a supplement to a drug through bureaucratic labeling sleight-of-hand!
 At press time, we have been able to confirm that the following companies have dietary folate (not folic acid) in their nutritional supplement products: BioGenesis, Complementary Prescriptions, Daily Essentials, Designs for Health, Doctor’s Best, Douglas Labs, Europharma, Innate Response, Jarrow Formulas, Kirkman Labs, Life Extension Foundation, MegaFood, Mercola, Metabolic Maintenance, Metagenics, Physician’s Preference, Priority One Vitamins, ProThera, Pure Encapsulations, Solgar, Thorne, Vitacost, and Xymogen. This is not intended to be a complete list.
68 thoughts on “Breaking News: FDA’s Sneak Attempt to Ban Another B Vitamin”
Tell the FDA to quit interfering with natural vitamin sources! Big Pharma has no ones interest at heart except for their stock holders and related persons with a financial interest. I am sick and tired of their intent to prevent the public from having access to viable food supplements except through Big Phama where they can attempt to synthesize something that they can exploit the American people by charging exuberant prices for. Synthetic OTC vitamins and minerals are a prime example.
Please allow food supplement companies to properly carry and label whole food supplements. Do NOT turn natural supplements over to drug companies! These are FOODS, not drugs. Best to keep that in mind and leave the supplement world alone. We don’t need anymore GOVERNMENT REGULATION!!!
Who do you think makes the supplemental folate? Merck does. Nothing that comes made from a company is food. And “natural supplement” is an oxymoron. You want a natural source of Folate, hit up your grocery store and eat some leafy green vegetables. Stop wasting money on vitamin supplements and eat unprocessed, whole foods. Also, FDA stands for “Food and Drug Administration.” Which makes them regulating food completely in their jurisdiction.
Synthetic vitamins are not real vitamins. The body cannot use them. Do you care or are you supporting the drug companies? Don’t ban natural folic acid (folate) or anything else!!!!!!!! Even to have to ask this is outrageous. Shows how much money talks!
Please o not take away my ability to purchase folate. I need B9 for my health.
Food supplements are intended to supplement are food intake. Our food
intake is woefully inadequate in nutrition because the nutrients because it is
missing from the farmers soil. Synthetic fertilizers contain from 3 to 8
From Food Labeling: Revision of the Nutrition and Supplement Facts Labels
2. Folate and Folic Acid
a. Units of Measure—The RDI for “folate” is listed in “micrograms” (§ 101.9(c)(8)(iv)). Folate represents the sum of naturally occurring folate and synthetic folic acid that has been added to foods. In 1998, the IOM set the RDA for folate expressed as mcg Dietary Folate Equivalents (DFE) (Ref. 141). The IOM Labeling Committee recommended that the units used for folate (mcg) in nutrition labeling should be consistent with the units in the new DRI report (mcg DFE) (Ref. 25). In response to the 2007 ANPRM, in which we asked for comment on this issue, a few comments supported retaining the current units (mcg) for folate and one comment noted that the use of the term DFE on the label would be unfamiliar to consumers and could be confusing (Ref. 47). The IOM developed the new term, DFE, to account for the greater bioavailability of synthetic folic acid that is added to fortified foods or dietary supplements than folate that occurs naturally in foods (food folate). As defined by the IOM, mcg DFE is equivalent to mcg food folate + (1.7 × mcg synthetic folic acid) (Ref. 141). The current unit of measure (mcg) does not take into account the difference in the bioavailability of folate and folic acid. In addition, mcg DFE declaration would provide a more accurate representation of the amount of folate in foods that contain both naturally occurring folate and added folic acid. For example, the standards of identity for certain enriched foods require the addition of folic acid (21 CFR parts 136, 137, and 139) and, these foods contain both food folate and synthetic folic acid.Show citation box
Therefore, we are proposing to amend § 101.9(c)(8)(iv) such that mcg DFE would be used to declare the amount of total folate (food folate and synthetic folic acid) on the Nutrition Facts label. Section 101.36(b)(2)(ii)(B) for the labeling of dietary supplements includes a reference to § 101.9(c)(8)(iv), which, as proposed, designates the units of measure for declaration of folic acid as mcg DFE units (see section II.L.).
Please don’t restrict our choices.
Are you doing the people’s business by making it possible for commercial companies to have a monopoly over certain supplements necessary for life? I think NOT and shame on you!
to FDA: if folate is in our food why are you trying to take it away from us? do you want to take away our food. that is the natural way to get our nutrients (to live). i do not understand!
Enough with trying to ban nature!
The FDA Should be supported by the government for the good of the people. (instead of drug companies who make synthetic vitamins so they can patent them and make big profits) Synthetic vitamins or supplements should be banned as it has been proven that they don’t work like natural ones. Some are dangerous such as synthetic progestin which causes cancer. Natural progesterone prevents cancer and osteoporosis as proven by Dr. John Lee and John Hopkins in 1981. The warning label should be removed on natural progesterone as they used synthetic progestin in the test.
If folic is not such a big deal, then why are you trying to ban it? Why do you want to make our lives so bad that we will die sooner than we should. You people only see money to be made. Why don’t you just eat cardboard and see how long you live. Or you could revive the biggest dumb quote I ever heard, which was vitamin C doesn’t cure nothing. Ever hear of scurvy ? We don’t need vitamins? Go back under your rock and leave our food supply and supplements alone. You’ve done enough damage. With all the crap you’re allowing in the food supply there won’t be anybody to buy your junk or pay for government or defend your. Put that in your pipe and smoke it.
It is immoral to restrict anything that is naturally in my body or needed by it.
I insist on my right to purchase any vitamin I want.
They want to make real vitamins prescription so that pharma mafia can further dominate the skincare system. They should never be allowed to use natural vitamins in prescription.
Big PHRMA rips us off enough as it is. We’re the only country in the world who pays such high prices for pharmaceutical crap that does nothing but destroy the immune system from side-effects of these drugs. We have been using the natural B vitamins for yrs., that doctors discouraged patients from taking and now, Big PHRMA wants to make money from a natural B vitamin so it can call it a drug and cash in on it’s health-properties. It’s all about making BIG PHRMA richer and stripping us of inexpensive vitamins that heep us healthier than their deadly CRAP. NO!!!!!!!!!!!!!!!
This is supposed to be a free country,we should have a choice as to what we put in our bodies,and not have a big pharma paying off politicians to force us to take their deadly products.Every other commercial on tv is for another drug,none considered safe when there are 20-30 deadly side effects for each condition it is supposed to help.we should have a right to choice of treatment and if we all ate organic foods we probably would not be sick in the first place.
It’s the “right” thing to do!
Thank you so much for this–and all alerts–message. It is becoming more distressing all the time how the US govt. is undermining the citizens of taking care of ourselves. The pharmaceutical companies’ profits are all that matter, not the health of humans. Save the rich, get rid of the rest. Resources, you know, are getting scarce.
Lelt’s not leave “folate” out of the supplement fact labels. Don’t reserve the natural form for monopoly drug companies, leaving only the synthetic form for supplements. Thanks.
Don’t change Vitamin B from a supplement to a drug. Government needs to keep their hands off of this. This is a safe vitamin and most people don’t get enough anyway through diet or vitamins that are on the market. If you get too much you urinate it out. If you don’t have enough it can cause real problems. some people’s bodies can’t convert the synthetic form so it is not used properly anyway. just another ploy to ruin our health? Sounds crazy-actually the government just wants the money it can bring in. Please don’t do this.
Anything to take control of our Lives……….our health and our Religion. What kind of supplements are the misfits taking themselves and what are they giving their families?
Gentlemen: I am also very concerned about the actions of the FDA. as well as all of the other government agencies. My husband and I are both senior citizens, and do as much as we can to protect ourselves nutritionally, but who knows what’s in the future? I appreciate all of your hard work, and try to stay abreast of all of your news, as well as spread it to anyone else who will listen. I always want to sign your petitions, but don’t do it, because everything I read warns that it does not help influence any of these governmental agencies, as well as most of the large corporations. I’m very frustrated, but I tend to believe this. I’m sorry.
I want folate to remain as a supplement. Let Big Pharma have the inferior synthetic variety. It will fit in well with the toxicity of many of their products.
Even though I take a supplement that has 100% of the US RDA of folic acid, I have noticed that this isn’t enough to prevent a sort of roughness and chapping of my lips. Eating spinach (very rich in folate) does prevent it, so I eat some fresh raw spinach once a week. For several months, I ate a spinach salad every day and gave myself a small kidney stone that passed without too much pain. Spinach is rich in oxalic acid, which causes kidney stones. Now, I am more cautious with spinach, but a little spinach does seem necessary to prevent deficiency. Of course, there are other sources of natural folates, but spinach is much richer in folate than all of them.
Folate/folic acid is one of two vitamins that are seriously degraded by heat (vitamin B-12 is the other one, however the semi-synthetic form cyanocobalamin is heat-stable). The cartoon character Popeye the Sailor was originally created as part of a campaign to get people to get more folate from food — but the campaign was wrong in showing him eating canned spinach. The folate content is greatly reduced by canning. Raw or frozen spinach are reliable sources of folate.
Note that vitamin C is metabolized to oxalate, so it also contributes to the risk of kidney stones. There was a study which found little benefit to taking more than 400 mg of vitamin C daily, because the body limits the amount of vitamin C present in the bloodstream.
I take 1000 mg daily just to be sure. This study does show a slight increase in vitamin C in the bloodstream at 1000 mg and 2500 mg. If you really want a higher level of vitamin C in your blood, you have to get it by the intravenous route. I prefer not to override my body’s limits because I suppose there must be a good reason for such limits.
Please do not ban folate.
According to Dr. Jonathan V. Wright, folate deficiency is one of the most dangerous medical conditions, leading to Alzheimer’s and other brain diseases. If pregnant women are deficient in it, it can also lead to spina bifida and other neural tube birth defects in their children.
On the other hand, 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 large amounts of folic acid, larger than in current supplements, but more research is needed to account for individual differences.
disgusting false attack!
It’s time the federal govt allows the American public to stay out of our decision making on our health. It’s becoming more clear the govt wants to kill us slowly.
Knock it off and get your BigPharma backed hands off my vitamins.
I use capital letters for emphasis.
Give us a break-stop trying to ban vitamins and supplements that are good for so many. Stop trying to make vitamins labeled as pharmaceuticals.
Let us have our folate please!!!!
Someone from another listserve posted this comment from Dr. Ben Lynch on his MTHFR.net site. He seems to think that Banning all forms of folate supplements is not what the FDA is trying to do. All the FDA is trying to is clarify what is on the label – accurately.
The Federal Register states here:
“Therefore, proposed § 101.9(g)(10) would require manufacturers to make and keep records to verify the amount of folic acid added to the food and folate in the finished food, when a mixture of both naturally occurring folate and added folic acid are present in the food. (See section II.N.) We invite comment on available scientifically valid methods that are capable of measuring folic acid and folate separately.
c. Terms to Declare Folate—”Folic acid” or “folacin” are identified as synonyms of folate and can be added in parentheses after folate or can be listed without parentheses in lieu of “folate” on the Nutrition Facts label (§ 101.9(c)(8)(v)) or in the Supplement Facts label (§ 101.36(b)(2)(B)(2)).
Consistent with the proposed amendments related to the units of measure for folate that take into account the differences between folate and folic acid, we are reconsidering appropriate terms for declaration of folate content in foods and dietary supplements.
We are proposing to (1) eliminate the synonym “folacin” specified in §§ 101.9(c)(8)(v) and 101.36(b)(2)(B)(2); (2) require, in proposed § 101.9(c)(8)(vii), that the term “folate” be used in the labeling of conventional foods that contain either folate only or a mixture of folate and folic acid; and (3) require that the term “folic acid” be used in the labeling of dietary supplements only. As proposed, conventional foods would not be permitted to use the term “folic acid.”
So Dr. Ben is saying that the term folic acid can only be used on Supplement labels but not food labels, as: ”Folic acid” or “folacin” are identified as synonyms of folate and can be added in parentheses after folate or can be listed without parentheses in lieu of “folate” on the Nutrition Facts label (§ 101.9(c)(8)(v)) or in the Supplement Facts label (§ 101.36(b)(2)(B)(2)).
So is ANH’s take on this right or is Dr. Ben’s?
Hi Linda: Thank you so much for your very thoughtful comment. Unfortunately, the link you provided to Dr. Ben’s website is broken, and we haven’t been able to find the article on his website. We would be very interested to read it, so please email me at [email protected] if the article comes back online.
Under the new rules, supplement manufacturers would only be permitted to use the term “folic acid” on supplement fact labels. So, even if they would, under the new rules, be permitted to use dietary folates in their dietary supplements, consumers wouldn’t be able to tell the difference between products containing folic acid and products contain folate. This is vital information that consumers need to know.
Thanks again for sharing your thoughts!
Stop being the schill for the corporations! Leave our vitamins alone!
Thank you for the information. I will send it on to my entire mailing list and post it on my Facebook and LinkeIn pages.
Martha M Grout, MD, MD(H)
Your article provoked quite a scare in the MTHFR community yesterday. After having time to read the language of the directive, I wonder whether the author of this article is perhaps misinterpreting the wording and that this may actually be a good thing. As Dr. Ben Lynch has explained here(http://mthfr.net/folic-acid-labeling-on-nutrition-and-supplement-facts/2014/03/12/) – is it not preferred that synthetic folic acid is disclosed to us?
Still confused on this… why is this paragraph contradictory to the rest of the folic acid disclosure changes: “We are proposing to only allow the use of the term “folic acid” for the labeling of dietary supplements. Folate is a nutrient found in conventional foods, whereas folic acid is the synthetic form of folate that is added to fortified conventional foods and dietary supplements. As discussed in section II.J.2., “folic acid” or “folacin” are identified as synonyms of folate and can be used on the Nutrition Facts label (§ 101.9(c)(8)(v)) or in the Supplement Facts label (§ 101.36(b)(2)(i)(B)(2)). However, because of the difference in bioavailability between naturally occurring folate, and synthetic folic acid, we are proposing to amend § 101.9(c)(8)(v) such that the term “folate” would be used in the labeling of conventional foods that contain either folate alone or a mixture of folate and folic acid. As discussed in section II.J.2.c., we consider only the term “folic acid” to be appropriate for use in the labeling of dietary supplements. Therefore, we are proposing to amend §§ 101.36(b)(2)(i)(B) and (b)(2)(i)(B)(2) to specify that “folic acid” is the term used to declare folic acid content of dietary supplements; and to remove “folate” and “folacin” from the list of synonyms that may be used to declare folic acid on the Supplement Facts label.”
Hi Andrea: The sentence “As discussed in section II.J.2., “folic acid” or “folacin” are identified as synonyms of folate and can be used on the Nutrition Facts label (§ 101.9(c)(8)(v)) or in the Supplement Facts label (§ 101.36(b)(2)(i)(B)(2))” refers to current rules. The rest of the paragraph discusses the new proposed rules, which would only allow “folic acid”–and not folate–to be used on dietary supplement labels. Does this answer your question? Thanks again for commenting!
Thanks for your response =) I’m just wondering how it is legal for them to force a company manufacturing, for example, L-5-MTHF, to call that substance “folic acid.”
Hands off our nutrients you dark kabal. we see you. Do not step over the line of our RIGHTS.
Yahoo is sabotaging your petition. When I pressed “Take Action” the page appeared, but before I could write on it, a new page appeared, “Sorry, the page you requested was not found.”
Hi Maria–Thank you so much for bringing this to our attention! Could you please email me at [email protected] with what browser (i.e., FireFox or Chrome) you were using at the time? We need this information to fix the glitch. Best, Liz @ ANH-USA.
we need more nutritional freedom not less.i served in nam as a medic,do your part for freedom!!! best jimmy mack
Thanks for serving!! These attacks on our freedom are disgusting and very upsetting. it is hard to see what we can really do about it, besides sign petitions. It’s horrible that “they” have so much power over what we have access to for health.
Why is our government depriving us of a natural vitimin? Folate is particularly important during a woman’s pregnancy for the development of her child. My 35 year old daughter needs every chance to have a normal baby.
Please do not ban folate from supplements.
This ban is likely due to Pamlab, LLC making a prescription form of l-methlyfolate called Deplin; “a medical food” used to treat depression; intended to be taken along with your antidepressant. Cost is around $125.00 – Yes I did say $125.00! Check out http://www.deplin.com After all you can’t have patients just going to the health food store or their alternative practitioner and spending all of $12 when we have this spiffy new “medical food” available.
well the old saying…”money talks and bulls..t walks” comes to mind…this has always been about money…and to the pharm companies, that don’t give a rat’s butt for any of us out here that is the norm…and the congressman and senators that go to office with little or nothing and leave millionaires…and the FDA that was bought out a long time ago…and the fact the US uses over 80% of the psychotropics made in the world says one thing—most of the people doing this must be whacked out on meds…note that the top grossing pysch med in the US last year was an antipsycotic–Abilify which grossed over 6 billion dollars in revenue…why is this happening?…well we’ll start with the possibility that the FDA employees and the the congress and the Senate must be getting their free samples from the drug companies…
thanks for doing the homework on this one barbara. goodonya!
Take Government hands off of natural supplements.
All these pharmacuticle companies don’t care about us, they care for money. They all should be sued for their lack of honesty and professionalism and helping us get sicker. And the FDA is in their favor. Sue the FDA.
Also, buy all the vitamens you can afford now and don’t buy your doctors vitamens, they are worthless.
especially avoid vitamin D-2 ,often ordered by ignorant doctors. it can be harmful, although in a completely D-starved person, it can seem to work wonders at first. Teach your doctor about D-3, and substitute D-3 if he/she orders those green 50,000unit D-2 pills for you. be kind though, at least he ihas entered this century and has tested for D level. now if we could just get them to wash their hands…
This is insane. Consumers should be fully informed of what is contained in supplements, and the various forms of folate be fully disclosed. Why would it be otherwise? Why is this even happening? It makes no sense.
Its dr that are on rhe FDA board. Its doctors that organize and order deficientcies in vitamins so they can keep the rewards of having more patients. Its DOCTORS THAT ORDERED CHLORINE TO BE USED IN THE WATER SUPPLY TO KILL BACTERIA. GUESS WHAT ELSE IT KILLS…….OUR OWN BACTERIA!!!!
it’s time to end the government as we know it that wants mostley to say no to darned nearly any and everything.
We need the FDA to stop taking away our free choices. We live in a country where our ancestors fought for our freedoms. We won’t stand for our Government taking away our rights and choices. Stop making ridiculous decisions FDA. We are sick and tired of you choosing things that harm the general public, and supporting corporations and pharmaceutical companies. We won’t stand for it anymore.
In our ever changing world of communication, it is time that you realize that the word is out. No longer are you going to be able to secretly numb the masses…we are on to you! If corporations and amalgamations want to appeal to the masses, instead of manipulating them with lies and deceit, restructure your products to conform to the new consciousnesses that exists today. Buck up big business.. time you realized that this is a country that is a democracy… and the people have a voice…familiarize yourself with it….because it is going to get a lot louder!
Do not remove the right for small, people supporting, business to provide us with the products that we really want… and need!
The FDA needs to go! A shining example of being in Big Pharma’s pockets. The word corruption does not even come close to describing them. And shame on all the Senators and Congress for lining their pockets and voting like the useless puppets they are. Pay attention to who votes yes for this and vote their sorry out in the next election cycle.
“Please correct this egregious error immediately. Or drop dead in the process you money grubbing!”
Okay, I really did not send it like this, but I am posting it here… 🙂
you got that right!
Although I 100% agree that the FDA doesn’t exist for our benefit, I also disagree with allowing the term “folate” to be used in supplements that have folic acid. Of course, labelling 5-MTHFR or folinic acid as “folic acid” would be just as inaccurate. But the FDA is for once not wrong in not allowing the term “folate” to be used in supplement.
The solution would be to list the actual form provided: 5-MTHR, 5-FTHF, folic acid, etc. “Folate” on a supplement bottle is a term that is vague at best and dangerous at worst, especially for people that have an active MTHR gene mutation and should NEVER use folic acid (a fairly large percentage of the population, actually).
From what I can tell of the legal mumbo jumbo, it sounds like the FDA is saying that dietary supplements can no longer list any other form of B9 than folic acid, so the other forms could no longer be sold.
The verbiage…. My read is that they are not banning the use. They are banning the use of the synonym.
2. Folate and Folic Acid
We are proposing to only allow the use of the term “folic acid” for the labeling of dietary supplements. Folate is a nutrient found in conventional foods, whereas folic acid is the synthetic form of folate that is added to fortified conventional foods and dietary supplements. As discussed in section II.J.2., “folic acid” or “folacin” are identified as synonyms of folate and can be used on the Nutrition Facts label (§ 101.9(c)(8)(v)) or in the Supplement Facts label (§ 101.36(b)(2)(i)(B)(2)). However, because of the difference in bioavailability between naturally occurring folate, and synthetic folic acid, we are proposing to amend § 101.9(c)(8)(v) such that the term “folate” would be used in the labeling of conventional foods that contain either folate alone or a mixture of folate and folic acid. As discussed in section II.J.2.c., we consider only the term “folic acid” to be appropriate for use in the labeling of dietary supplements. Therefore, we are proposing to amend §§ 101.36(b)(2)(i)(B) and (b)(2)(i)(B)(2) to specify that “folic acid” is the term used to declare folic acid content of dietary supplements; and to remove “folate” and “folacin” from the list of synonyms that may be used to declare folic acid on the Supplement Facts label.
My question is this: If folate (the most bioactive form) is naturally in food, why not just buy food rich in folate. It is, after all, the best way to obtain your nutrients, through whole, unprocessed foods. It is in many foods including fruits and vegetables. Everybody wants to be healthier and not take any medications or anything, then don’t. There is nothing fundamentally different between a supplement and a drug. Yes, prescription drugs are more expensive and require a visit to your physician. But you’re still taking pharmaceutical agent either way. So, just eat a well-balanced meal and you should be fine.
The standard American diet (SAD) is deficient in many, many vitamins. While it would be great to think that we could just snap our fingers and change our diets, but there are many, many barriers in the way. In this particular case, folate (B9) is critical to the development of every fetus. So, we all have a stake in having women able to get a quality supplement (which aren’t the same as drugs in many cases – anything that is patented by a drug company cannot exist in nature… it must be modified from it’s natural form. Supplements have no such restriction). There are many reasons a person might choose to get nutrients from supplements, including calorie restriction, economic reasons, food availability, metabolic disorders, food allergies, and philosophical choices. Restricting supplements could increase the health problems of all of them.
The footnote lists vitamin manufacturers that “have dietary folate (not folic acid)” in their supplements.
Solgar, Douglas Labs, Mercola, ProThera and Pure Encapsulations use Metafolin (L-methylfolate), which is NOT naturally-occurring “dietary folate”, but a manufactured chemical compound patented by the giant pharmaceutical company Merck.
Jarrow Formulas, BioGenesis, Designs For Health, Doctor’s Best, Life Extension Foundation, Metabolic Maintenance, Priority One, Vitacost and Xymogen use Quatrefolic, a.k.a. “Extrafolate-S”, which again is a manufactured chemical compound patented by Gnosis, an Italian pharmaceutical corporation, which describes Quatrefolic as a “folic acid derivative”.
Complementary Prescriptions uses generic 5-methyltetrahydrofolate glucosamine salt, which is identified on the product label as “Folic Acid 800 mcg” — NOT labeled as dietary folate.
Thorne Research uses equal amounts of generic L-5-methyltetrahydrofolate and “folinic acid”.
Innate Response and Megafood use “FoodState” folate (a trademarked product of their parent company FoodState), which is sourced from broccoli, and may be the closest thing to “dietary folate” available in supplement form — although their labels and websites give no information about the bioavailability of this trademarked form of folate compared to L-methylfolate or folic acid.
So, based on the list you have provided, it seems clear that the great majority of supplement manufacturers who might have an issue with the FDA’s proposed labeling rule are in fact using the trademarked, patented products of the pharmaceutical corporations Merck and Gnosis in their so-called “dietary folate” products.
So, whatever the merits of the proposed rule, to claim that it represents a “sneak attempt” by the FDA to “ban” natural folate in the interests of establishing a “monopoly” for Big Pharma makes no sense, given that Big Pharma (represented by Merck and Gnosis) already has a virtual monopoly on the so-called “dietary” form of folate (L-5-methyltetrahydrofolate) that commenters mistakenly believe would be “banned” by the labeling rule.
If the FDA wanted to give some advantage to Big Pharma, they would have to do the OPPOSITE of what this rule proposes, and only allow supplement manufacturers to use the Merck or Gnosis patented versions of L-5-methyltetrahydrofolate, and “ban” the use of inexpensive, generic folic acid (which cannot be patented).
I can;t take fake anything so I have to any vitamin company’s productws who has changed to comply with the FDA artificiality.
This article is very misleading and the journalist who wrote this does not understand the issue. Allowing manufacturers to use the word folate allows them to confuse customers and be less than honest about what type if folate is in their supplements. which is not a good thing.
To understand how and why manufacturers of whole food supplements are able to fool customers so easily, one needs to understand 1) that the names of the four different types of folate contribute to the confusion, and 2) the labeling requirements.
folate: folate (this is what you get in whole foods)
folate: folic acid
folate: folinic acid
Knowing this, you can see that allowing a manufacturer to say “folate ” is meaningless. Therefore, the proposal to disallow the use of the word folate is a very good thing!
No where does the proposal say they hope to ban the inclusion of folate. It says it will ban the word folate from labels, which would be a wonderful thing, in my opinion. Using the word folate only serves to confuse the consumer and it allows makers of whole-food supplements to be less than honest about what consumers are ingesting when they use their products.