You can’t live without folate, a B vitamin. Now the FDA plans to ban it in supplements so drug companies can have exclusive use of it.
Under new rules, the word "folate" will be banned from “supplement fact” labels; only "folic acid" will be allowed. Folate is the natural form of the vitamin, while folic acid is synthetic—and up to 40% of the population may have difficulty processing folic acid efficiently. Banning folate from the label is a sneaky way of banning it in the bottle.
All of us need folate, but it is especially important to prevent birth defects. Given folate’s popularity, drug companies have been dreaming of the billions they’d make by turning it into an expensive patented drug—now FDA is trying to hand it to them on a silver platter.
Don’t let FDA ban an essential vitamin for drug company profits—please act now!
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Subject: Docket No. FDA-2012-N-1210
As a concerned consumer, I am furious about your plan to ban the word “folate” from dietary supplement fact labels. According to your guidance, the word “folate” will be banned from “supplement fact” labels -- only the term “folic acid” will be allowed. To ban folate from the label is an underhanded way of banning folate from the bottle.
The FDA must not implement this change. There is no rational basis for limiting supplement makers to the synthetic form only.
The agency claims this is because folate can only be found in “conventional” (whole or minimally processed) foods, while fortified foods and dietary supplements can only contain “folic acid.” This is nonsense. Folinic acid (5-FTHF), calcium methylfolate, and various other tetrahydrofolates -- all of them dietary folates, not synthetic folic acids -- are commonly found in dietary supplements, and for a good reason.
It is estimated that up 30% to 40% of the population (125 million Americans) cannot efficiently convert folic acid into bioavailable folate. This unusable folic acid can build up in blood, which could potentially lead to an increased risk of prostate, lung, and colon cancer, and may worsen already present cancerous lesions.
For women of childbearing age, folate is recommended by the CDC, WHO, and most practitioners as an essential tool in preventing neural tube defects. Availability of supplementation with folate (not just folic acid) is vital, since women may not be able to get enough folate in their diet, and up to 40% of them cannot easily convert folic acid into folate.
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 your agency’s “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. Folates should not be banned from supplements and thus converted into expensive drugs through this back-door action.
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Please correct this egregious error immediately.