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ANH-USA Submits Formal Comments on FDA’s Latest Attempt to Ban the Natural Form of a B Vitamin

For related articles and more information, please visit OCA's Health Resource page.

We’ve joined with two natural health powerhouses to argue that this action is illegal. Urgent Action Alert!

We have been telling you about the FDA’s latest sneak attempt to ban another B vitamin—natural folate. 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, and is also currently available as a supplement. According to the FDA’s 109-page proposed guidance, the word “folate” will be banned from the Supplement Fact labels, and only the term “folic acid” will be allowed. Since it would be fraudulent for the supplement to list synthetic folic acid among its ingredients but to use natural folate instead, this is a backdoor way of banning folate.

This week, ANH-USA, together with the Organic Consumers Association and the Weston A. Price Foundation, have submitted formal comments to the FDA. Our comments contain forty pages of analysis. The scientific analysis was done by our scientific director, Dr. Robert A. Verkerk, who is also the executive and scientific director of ANH International; the legal analysis was done by Ze’eva Kushner Banks, ANH-USA’s staff attorney, and Gretchen DuBeau, Esq., ANH-USA’s executive and legal director. The legal analysis is important, because it will lay the groundwork for future legal action if FDA does not heed our concerns.

In our comments, we explain how banning the word “folate” and allowing only the term “folic acid” will have a number of dire consequences:

  • Many individuals have a genetic defect that prevents them from producing the enzymes needed to convert synthetic folic acid into the active form of the B vitamin that our bodies need. This includes up to 44% of North American Caucasians and over 50% of Italians, and over 90% of patients who are predisposed to diseases such as cancer, heart disease, and autism.
  • The new rule is illegal for a variety of reasons. For example, by treating those who cannot convert folic acid properly and banning the supplemental folate that would otherwise be available to them, the FDA is violating the Equal Protection clause.
  • Supplement companies currently using dietary folate in their products will either be forced to remove the ingredient or incorrectly label the folate ingredient as “folic acid.” Not only would they knowingly mislead their customers. They would also risk enforcement action for misbranding or false advertising under the Food, Drug, and Cosmetic Act (FD&C). Moreover, the rule fails to advance the FDA’s interest in encouraging truthful labeling and helping consumers maintain healthy dietary practices. By limiting what ingredients can be mentioned on a label, the FDA may also be violating the First Amendment.

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