WASHINGTON — An essential “B” vitamin which prevents certain birth defects and helps adults with a host of medical problems would disappear from the vitamin market under an inexplicable Food and Drug Administration labeling proposal that’s drawing fierce opposition from many quarters.
The vitamin at issue is B 9 – a group of compounds known collectively as folate. The FDA proposes banning the word “folate” from the ingredients label on nutritional supplements and requiring manufacturers to replace that word (but not necessarily the ingredient) with “folic acid.”
Under the FDA’s proposal, which addresses a host of labeling issues besides folate verbiage, manufacturers would not be prohibited from including folate in their supplement products. However, if manufacturers announced its inclusion on the ingredients label, the FDA could declare those products “misbranded” and order their withdrawal from the marketplace.
Folate deficiency can cause neural-tube and spinal defects in a developing fetus. In adults, folate deficiency has been linked to anemia and atherosclerosis. At the same time, the vitamin is believed to help prevent some forms of cancer and possibly inhibit Alzheimer’s disease while potentially easing depression, as well.
“Synthetic folate” – also known as folic acid – has played a crucial role in elevating public awareness of nutritional strategies against birth defects. The March of Dimes has long promoted folic acid for precisely that reason, and its advocacy helped to persuade the FDA to issue a 1996 regulation requiring the addition of folic acid to cereal grains.
Folic acid, however, is not synonymous with folate. Folate occurs naturally in certain fruits, vegetables and beans; and it’s believed to be more bioavailable, and more medically effective, than folic acid – which is a synthetic copy of only one of folate’s constituents.
Emerging science, moreover, indicates that some people are unable to process folic acid because of a genetic defect. For example, says a scientific paper published in 2004, and referenced by the Alliance for Natural Health in its comments on the FDA proposal, over 40 percent of “North American Caucasians” (along with people in other groups) have this genetic defect.
The research has spurred nutritionally-focused groups like the ANH, and physicians such as Dr. Ronald Hoffman, to warn that the FDA proposal could place a greater number of Americans at risk for preventable health issues – including the potential increase in birth defects among infants born to women unable to process folic acid as effectively as folate.
Folate proposal blasted as “insidious”
Dr. Hoffman, who practices complementary medicine in New York City and serves as an ANH board member, told MintPress News that, “At best, the FDA proposal is ill-considered. At worst, it is insidious because, given the absence of any logical basis for this proposal, it seems like FDA is just protecting the turf of pharmaceutical manufacturers who might be telling FDA, ‘Hey, we spent millions of dollars to research folate – and the supplement companies are selling it for pennies.’”
A keyword search on any supplements website quickly reveals that folic acid supplements are much cheaper than folate supplements. The principal ingredient in many folate products is Metafolin, a type of folate patented by Merck & Cie (which didn’t submit a comment on the FDA’s folate proposal).
However, the price difference between products containing folic acid versus the cost for Metafolin supplements is trivial in comparison to what Metafolin would cost if it were available only as a pharmaceutical drug, not as a nutritional supplement.
“Billions” in potential profits
In fact, as complementary physician Dr. Joseph Mercola points out on his website, banning folate from supplement labels could enable Merck “to make billions of dollars in profits [from prescription sales of Metafolin].”
“Of course,” Dr. Mercola adds, “other drug companies would surely follow suit with their own drug versions of patentable folate.”
There’s an infamous precedent for the scenario described by Dr. Mercola, and it arose after studies on red yeast rice – a fermented rice popular in Asia as a medicinal herb – revealed that monacolin, a compound in the rice, was practically identical to lovastatin: a naturally occurring compound that Merck eventually patented as a cholesterol treatment.
In 1998, the FDA concluded that that – because of the lovastatin patent – red yeast rice had become a drug by virtue of containing monacolin. Consequently, the FDA announced that U.S. sales of red yeast rice would be prohibited unless manufacturers extracted monacolin from any product containing the rice.
Could folate follow monacolin into the jaws of a “Big Pharma” patent? The answer might depend on the legal future of the FDA’s labeling proposal.
The FDA proposal is “unconstitutional”
The ANH addresses the legal issues raised by the proposal in a joint response with the Organic Consumers Association and the Weston A. Price Association.
In their comments, the groups argue that the folate piece of the FDA’s proposed regulation would violate the Equal Protection Clause of the Constitution’s Fifth Amendment because it would discriminate against people who, because of a genetic defect, are unable to process and fully absorb folic acid.
Additionally, the joint response argues, the folate piece would violate the Constitution’s First Amendment because – as established by case law – the government has to show a “substantial interest” in any proposed restriction on free speech (such as a ban against the word “folate” on supplement labels). But a close reading of the folate proposal doesn’t clearly explain what the government’s “interest” in that proposal really is.
In fact, says the joint response, the FDA’s reasoning is “arbitrary and capricious” because the department claims to base its proposal on the bioavailability differences between folate and folic acid without identifying the scientific studies that establish those differences – and without mentioning any of the research indicating that some people are unable to process folic acid because of a genetic defect.
Do the legal concerns described in the comments suggest that the ANH and its co-respondents will file suit if the proposal is issued as an unrevised final rule?
“At this point,” Ze’eva Kushner Banks, a staff attorney for the ANH, told MintPress, “I can say that we will absolutely consider a legal response if the proposal is promulgated without revisions which mitigate our serious concerns. But it’s impossible to predict what kind of response it will be. We’ll just have to wait and see what they do.”
That wait could be a long one. Or, as sometimes happens in the world of federal agencies, the proposal could simply wither and die after a period of years.
Yet, it seems unlikely in this case that this particular proposal will die, as it addresses a host of important nutritional and public health issues in addition to folate labeling — it also proposes labeling for trans fats and added sugar, for example.
Unfortunately, there are doubts about the FDA’s sincerity in addressing these issues. For example, the FDA repeatedly says in its proposal that it’s trying to “assist consumers in maintaining healthy dietary practices.”
“How does banning the word ‘folate’ from nutritional labels help consumers maintain healthy diets?” Banks asked.
“And how,” Banks continued, “does allowing a food manufacturer to say their products contain ‘zero trans-fat’ as long as the amount of trans-fat doesn’t exceed half-a-gram per serving promote dietary awareness? If we don’t have the [laboratory] methods necessary to measure trans fat below half a gram, as FDA says we don’t, it’s not a justification to re-define the meaning of the word ‘zero.’”
Doctors as teachers
Dr. Hoffman, whose website and weekly radio program are branded as “portals of ‘Intelligent Medicine,’” says he has long sought “the best and latest information for my recommendations – whether they’re traditional or complementary – because I think it’s really a physician’s mission to teach and inform. I enjoy the interventional aspect of my work, but informed patients are, in a sense, the best patients.”
In that regard, Dr. Hoffman says he “absolutely” recommends folate supplements to all his pregnant patients. He worries that pregnant women who consume large amounts of folic acid while lacking the ability to fully process the nutrient will have “too much” folic acid circulating throughout their bodies (as well as those of their unborn babies).
“The research to establish the effects of excess folic acid is sketchy, right now,” Dr. Hoffman said, “but if excess folic acid is proven to pose real risks, I think you’d want the folate option available, wouldn’t you? And you’d want to know which product contained folic acid and which one contained folate. That’s just one the reasons we need informative labels on these products, but it’s an extremely important one.