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!