The FDA has just released a new 109-proposed ruleon 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.