If you missed our urgent Action Alert on the attempt to ban folate from dietary supplements, please take action now!
Last week we told you about FDA’s sneak attack on folate, the B9 vitamin essential to human life. This week, we tell you why the drug industry may want folate all to itself: it could be a ploy to make billions on a new, patented SSRI/folate combo drug.
Under the FDA’s new rules, Supplement Fact labels would only be allowed to list the term “folic acid” as an ingredient; the word “folate” would not be permitted. Oddly, this contradicts another FDA regulation that allows supplement producers to list sourcing ingredients next to nutrient names—for example, “Folic Acid (Folate).” Is the FDA attempting to overrule this old regulation via the new labeling rules?
This wouldn’t be a small labeling tweak: banning folate from the label is a sneaky way of banning it in the bottle, as it would be completely inaccurate and misleading to refer to dietary folates like folinic acid (5-FTHF), calcium methylfolate, various tetrahydrofolates, and other “whole food” folates as synthetic folic acid.
Why ban folate? Well, according to FDA “logic,” if dietary supplements can’t contain any folates except folic acid, all other folates would only be available from whole foods—or drugs. As clinicians learn more about genetic defects in the genes responsible for the fifteen or so enzymes needed to convert folic acid to the reduced forms of folate the body can use, drug companies have been dreaming of the billions they’d make by turning folate into an expensive patented drug. Now it looks like the FDA is trying to hand it to them on a silver platter.
Much of the population benefits from taking folate—as distinguished from folic acid—in dietary supplements. There are two key things to bear in mind: how much dietary folate you consume, and how much active folate you have available.
If most of your folate is coming from folic acid supplements rather than from food, you may still be gravely folate deficient because of the big variations in how efficiently folic acid is converted to the bioactive form in different people. Even if you got your folate from foods, it will depend not only on what leafy greens, beans, oranges, and other folate-rich sources you eat, but also on how you prepare your foods. Dietary folates are very sensitive to heat, so a lot is destroyed by cooking.
These days, many of us get most of our folate from supplements or fortified foods. We know a lot now about defects in two DNA sequences responsible for producing enzymes needed for the final stage of conversion of food folates and folic acid into the active form your body needs. These defects relate to an enzyme called MTHFR and are very common, though they vary enormously between ethnic groups and regions. The defects can be found in as many as 44% of North American Caucasians and over 50% of Italians. They are also more common among those predisposed to diseases such as cancer, heart disease, and autism, where the mutation frequency can exceed 90% of these populations. And that’s before you’ve even looked at mutations in other genes involved in folate metabolism such as DHFR, data for which has only been emerging recently.
Individuals with mutations affecting MTHFR or other genes relating to folate metabolism could suffer from an unhealthy buildup of unmetabolized folic acid if they have inadvertently taken too much folic acid for their own metabolism. Unmetabolized folic acid, as it turns out, is an emerging risk factor linked to increased risk of cancer, heart disease and stroke.
Researchers have also found a strong link between folate deficiency and depression. This is particularly interesting when you consider research showing that 70% of patients with major depressive disorder (MDD) carry the MTHFR mutation. Importantly, L-methylfolate, which completely bypasses the “damaged” MTHFR conversion step and delivers a “finished” folate the body can immediately use, has been proven to safely treat major depressive disorders with few to no side effects. L-methylfolate is readily available in some dietary supplements especially those supplied by practitioners—at least for the time being.
Of course, a gentle, natural, and cost-effective vitamin isn’t safe from drug companies: Merck, a Big Pharma heavyweight, holds the patents to Metafolin®, the “finished” and stabilized form of L-methylfolate. In addition to licensing Metafolin® to dietary supplement companies, Merck has worked with a Nestlé subsidiary to create Deplin®, a Metafolin® pill marketed as a medical food. Deplin® is designed to be taken in conjunction with SSRIs—a risky class of antidepressants linked to suicidal and violent behavior—for the treatment of depression.
With folate dietary supplements out of the way, Deplin®—which, as a medical food, is exempt from the FDA’s looming folate ban—could be in high demand, especially while folate based drugs are in the FDA pipeline. Merck clearly sees that it has something very valuable in its form of folate, as evidenced by their lawsuits to stop perceived patent infringement on Metafolin®. Additionally, Merck may see a Metafolin®/SSRI drug as a ticket to the golden days of blockbuster SSRI drugs like Prozac, Zoloft, and Paxil, all of which recently sailed off the so-called patent cliff.
Taking an old drug, combining it with another ingredient, and convincing the FDA to grant a monopoly on the “new” combo drug is a well-known Pharma trick: in 2013, Merck combined Zetia, its LDL-cholesterol lowering drug, with the generic version of Lipitor. Despite the fact that this drug did not reduce patients’ chances of developing heart disease, it was granted market exclusivity by the FDA.
What’s in it for the FDA? Thanks to user fees, much of the FDA is funded by Big Pharma—so when the drug industry’s coffers are threatened, so are the FDA’s.
URGENT Action Alert! The FDA must not be allowed to implement this change in its Supplement Facts rules. It will in effect ban the natural B vitamin folate and require supplement producers to use only the synthetic, oxidized form of folate, folic acid. Consumers who are less able to convert folic acid to the safe, reduced forms including the bioactive folate (5-MTHF) our bodies so badly need will have no choice but to use the drug version or die. Send your message to the FDA today, and tell them not to turn a critical, natural B vitamin into a drug through bureaucratic labeling sleight-of-hand!
There is no scientific reason for folate to be taken off the market in health supplements.
Big Pharma is just so incredibly greedy and doesn’t care how they hurt people. That history goes way back and they try to keep it going. They must be stopped.
that’s our great fda…………what else is new……..the fda does more wrong than right.
This is a dumb idea. It is anti-consumer. Why should we make vitamin B into a drug? So the drug companies can get Rich off of us?
I am someone with multiple genetic defects in folate metabolism and the methyl cycle. And until I found out what I had, I made only so much progress with my conditions, even with extreme changes in diet and environment, and natural supplements. It was like my physician and myself were both working blinding with our hands tied behind our backs. I even went back to school to take courses in nutrition, biochemistry, herbalism and more. And I could never figure out why I could only make so much progress.
Until I found out about methyl cycle defects and had myself tested. Suddenly it was like a lightbulb going off. Here was a big missing peace.
I currently take 600 mcg of 5-mthf and 400 mcg of folinic acid daily along with supplements to help by-pass other defects. And they are helping.
Even if my physician could write me a prescription for Deplin or any other pharmaceutical brand of methyl folate (and I would need folinic acid as well), the dosage of these drug forms is way too high for me and most everyone, and they are full of garbage ingredients to which most of us with severe allergies and chemical sensitivities would violently react.
How healthy do these “inactive’ ingredients look to you?
Dibasic Calcium Phosphate Dihydrate, Silicified Microcrystalline Cellulose 90, Opadry II Orange 85F43102, (Polyvinyl Alcohol, Titanium Dioxide [color], PEG 3350, Talc, FD&C Yellow #6[color], FD&C Yellow #5[color], FD&C Red #40[color] and FD&C Blue #2[color]), L-methylfolate Calcium, Magnesium Stearate (Vegetable Source), and Carnauba Wax.
Several of these directly interfere with the methyl cycle as well, e.g. Polyvinyl Alcohol.
This product would do me no good at all because I would be unable to take it!
Unbelievable. I am so discussed with the FDA. When I think they can’t go any further with they attack on nature’s food I am hit in the head with a wake up call that says my head is in the clouds.
This is asinine. Time for the FDA to pull their heads out their as and fight corporate control of drugs, not vice versa.
When are we going to be allowed to live our life our way, without paying 80 dollars per pill for what we should be able to get for 10 cents? Aren’t they rich enough already?
Why does the FDA work against the little people and For “Big Pharma”?
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
I think this is to much how the athority are trying to manopulat us. I any way.
I’m darned tired of the pharmaceutical industry trying to own our lives. There is NO excuse for this criminally stupid move and the USDA should stop acting as corporate to the drug industry.
Protect the consumer’s right to healthy affordable B vitamins. This protects our health and keeps medical costs down. Thanks, Kit Zak
We request that folate be left on the market available in vitamin health food stores, it’s naturally occurring, it is in food and it’s not a drug.
This is an important issue . The FDA thinks no one cares and everyone is stupid . They must be the stupid ones since they will just let the little guys suffer .
To them the whole folate issue is a non-issue .
Grab the bucks anyway you can.
I’ve been Lucky enough to find the right supplements in time before they ban them from the market.
My eyes have been opened since I tested positive for the gene variant. After starting the correct protocol; I’ve been feeling great with no depression and more energy.
This reminds me of the thyroid issue where you can’t be treated for low level hypothyroidism because it doesn’t show up in blood tests.
I’m too old to have children but this explains my pre eclampsia. If I had known about my gene situation earlier I may have avoided it with the right supplements.
Apparently we are smarter than they think we are, so hopefully we can stop this nonsense in its tracks.
STOP! !!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Stop doing the bidding of the corporations. They are doing enough to undermine our health already.
So believable that our health & safety institutions coppted by Big Pharma. May you get a Big Pharma !
I received this in response to one of the letters I sent at your request.
Is this old news? 2007? Made me feel a bit foolish.
**
Thank you for your recent correspondence regarding the dietary supplement, Pyridoxal 5′-Phosphate. Your taking time to contact me is appreciated.
On November 28, 2007, Medicure Pharma submitted a citizen’s petition to prohibit the marketing of dietary supplements containing Pyridoxal 5′-Phosphate (P5P), the bio-active and natural form of vitamin B6.
I understand that dietary supplements are an important part of the health and wellness of many Americans. They are often taken to accelerate the recovery period after strength training as well as to increase vitamin and mineral intake. Should legislation regarding P5P come before the Senate, I will be sure to keep your thoughts and views in mind.
Sincerely,
Senator Saxby Chambliss
Big Pharma and the FDA do not care about you and I and what we need for good health only about the money, that’s it, money money and MORE money.
When will WE THE PEOPLE matter to our government? Stop being controlled by pharm companies!
I do not believe there is a sneak attack on folate, the B9 vitamin and posted the relevant part of the proposed regulation last week. There is only a calculation of B9 potency that recognizes different forms.
This isn’t working correctly. When I fill out the two petitions and click SEND nothing happens!
You need to see what is going on.
Marianne
www(dot)ThePeoplesBranch(dot)org
Wake up or die asleep – it’s up to you! Reasonable, responsible and conscientious people are choosing to wake up! You too can Wake-Up to the only non-violent way to take your government back.
Only when everyone has a direct input in government concerning matters that affect them will your and your loved ones issues (political, freedoms, rights, financial, health, justice and security etc.) truly have a chance to be properly addressed.
Your and others direct input on matters that concern you and your loved ones is paramount!
A People’s Branch creates the best way to check and balance government! If SPECIAL INTEREST continues to have its way then you too will lose much. Why not help us help you?!
Every Reasonable, responsible and conscientious person should be asking themselves – WHY DOES BOTH MAJOR PARTIES HATE THE IDEA OF A PEOPLES BRANCH?
Michael Talor once VP at Monsanto was appointed by Obama as the Senior Advisory to FDA…
http://www.washingtonpost.com/blogs/blogpost/post/monsanto-petition-tells-obama-cease-fda-ties-to-monsanto/2012/01/30/gIQAA9dZcQ_blog.html
This should be considered conflict of interest and/or criminal.
and The USDA etc…
http://hubpages.com/hub/The-Revolving-Door-Between-Monsanto-the-FDA-and-the-EPA-Your-Safety-in-Peril
This is ludicrous and must be audited and addressed.
I know this is a bit old news but it is important.
Big Pharma is all about greed and money. I could say so much here but it’s best I keep it short. It always has been and always will be about money in their very deep pockets until the American people stand up for what they want and believe. There are so many good products out today that are drug free and help with many diseases but the money used to purchase them does not go in Big Pharma’s pockets. They are so greedy and they have no interest in the health welfare of the American people. Pass this along to everyone you know because they need to know that we do not want them taking away our Vitamins and Supplements. I recently went to the Doctor and with an on going lawsuit with a drug that has caused more damage than good in the news, she prescribes me the drug…….No I didn’t take it. But the Drs. get samples from drug companies and they all operate on a buddy system. Why would a Dr. prescribe a medicine that was very controversial?……..money. It’s a shame the way they tend to overlook the fact that most many drugs the FDA has approved are killing people daily!!! Time for us to take things in our own hands and start asking questions about the meds that they give us. Let the FDA know that we do not approve of such measures.
Just to be fair, Merck actually discovered l-methylfolate and patented it long ago. We are lucky that they did so! It is the best form of folate for those who have MTHFR. You can say all you want about big pharmacy, but when you get really sick and need a pharmaceutical drug that they researched and produced, you will be very thankful. Injectible insulin was discovered by a pharmaceutical company. Every Type 1 diabetic would be dead without it. Every American has their right to voice their opinion, but I know that most researchers at pharmaceutical companies only want to help people.
I have been nutrient and supplement for apx. 40 years and have protested just about every cause in regards to health and environment. In all that time, I have seen about a 50% success rate. The ones that won for benefit of the general public, were the ones that had the most out-cry and public demonistrations (as far as volume of participants. The battles are won by long and LOUD protest. Keep the pressure on for things you truly believe in.
Wishing you success!!!