FDA is trying to ban natural Folate?!?!

[sregan]

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

Take Action:
http://www.anh-usa.org/anh-usa-submits-formal-comments/

http://www.organicconsumers.org/articles/article_30588.cfm

"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."

 

[ahmo]

Oh No, Not AGAIN!

 

[ljimbo423]

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

Take Action:
http://www.anh-usa.org/anh-usa-submits-formal-comments/

http://www.organicconsumers.org/articles/article_30588.cfm

"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."

Hello sregan- Here is a quote from the FDA's food labeling revision letter dated 3-3- 2014.

They want to "specify that “folic acid” is the term used to declare folic acid content of dietary supplements; and to remove “folate” and “folacin” from the list of synonyms that may be used to declare folic acid on the Supplement Facts label."

I could be wrong, but it sounds like they are removing the terms folate and folacin as they apply to folic acid only, not food folate or methylfolate.

 

[sregan]

Hello sregan- Here is a quote from the FDA's food labeling revision letter dated 3-3- 2014.

They want to "specify that “folic acid” is the term used to declare folic acid content of dietary supplements; and to remove “folate” and “folacin” from the list of synonyms that may be used to declare folic acid on the Supplement Facts label."

I could be wrong, but it sounds like they are removing the terms folate and folacin as they apply to folic acid only, not food folate or methylfolate.

Jimbo, this comes right from the OCA which is a consumer group I have followed for at least a decade. When they sound the alert I listen. I added my comments using those links. Better safe than sorry.

http://www.organicconsumers.org/articles/article_29498.cfm

 

[ljimbo423]

Jimbo, this come right from the OCA which is a consumer group I have followed for at least a decade. When they sound the alert I listen. I added my comments using those links. Better safe than sorry.

http://www.organicconsumers.org/articles/article_29498.cfm

SREGAN- It was the "109-proposed rule" link on the first page of the link you gave, that I got the quote above. : ) Am I misunderstanding the quote?

 

[Lynn_M]

I clicked on the link for FDA's 109-page proposed guidance in SREGAN'S original post in this thread: https://www.federalregister.gov/art...-of-the-nutrition-and-supplement-facts-labels. This is the section "2. Folate and Folic Acid" from that document:

"We are proposing to only allow the use of the term “folic acid” for the labeling of dietary supplements. Folate is a nutrient found in conventional foods, whereas folic acid is the synthetic form of folate that is added to fortified conventional foods and dietary supplements. As discussed in section II.J.2., “folic acid” or “folacin” are identified as synonyms of folate and can be used on the Nutrition Facts label (§ 101.9(c)(8)(v)) or in the Supplement Facts label (§ 101.36(b)(2)(i)(B)(2)). However, because of the difference in bioavailability between naturally occurring folate, and synthetic folic acid, we are proposing to amend § 101.9(c)(8)(v) such that the term “folate” would be used in the labeling of conventional foods that contain either folate alone or a mixture of folate and folic acid. As discussed in section II.J.2.c., we consider only the term “folic acid” to be appropriate for use in the labeling of dietary supplements. Therefore, we are proposing to amend §§ 101.36(b)(2)(i)(B) and (b)(2)(i)(B)(2) to specify that “folic acid” is the term used to declare folic acid content of dietary supplements; and to remove “folate” and “folacin” from the list of synonyms that may be used to declare folic acid on the Supplement Facts label."

While recognizing the difference in bioavailability between naturally occurring folate and synthetic folic acid, it does sound to me that the only permissible proposed labeling in dietary supplements would be for folic acid. Meaning folate could not be sold as a dietary supplement, IMO, if this guidance is approved.

 

[ljimbo423]

Hi Lynn_M- You are quoting section J. I think this section is why people are confused, it is hard to understand. If you scoll down the page to "Folate and Folic acid" under section L."Dietary supplements" it says- Quote-

"Therefore, we are proposing to amend §§ 101.36(b)(2)(i)(B) and (b)(2)(i)(B)(2) to specify that “folic acid” is the term used to declare folic acid content of dietary supplements; and to remove “folate” and “folacin” from the list of synonyms that may be used to declare folic acid on the Supplement Facts label."

https://www.federalregister.gov/art...-of-the-nutrition-and-supplement-facts-labels

This seems pretty clear that they are talking about not using the terms "folate" and "folacin" instead of folic acid on supplement labels like they do now. Instead they would have to use the words "folic acid". All the best- Jim

 

[TigerLilea]

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

Take Action:
http://www.anh-usa.org/anh-usa-submits-formal-comments/

http://www.organicconsumers.org/articles/article_30588.cfm

Did you actually go to the document and read the proposed changes? I'm pretty sure that the ANH-USA didn't, either.

c. Terms to Declare Folate—”Folic acid” or “folacin” are identified as synonyms of folate and can be added in parentheses after folate or can be listed without parentheses in lieu of “folate” on the Nutrition Facts label (§ 101.9(c)(8)(v)) or in the Supplement Facts label (§ 101.36(b)(2)(B)(2)).

Consistent with the proposed amendments related to the units of measure for folate that take into account the differences between folate and folic acid, we are reconsidering appropriate terms for declaration of folate content in foods and dietary supplements. We are proposing to (1) eliminate the synonym “folacin” specified in §§ 101.9(c)(8)(v) and 101.36(b)(2)(B)(2); (2) require, in proposed § 101.9(c)(8)(vii), that the term “folate” be used in the labeling of conventional foods that contain either folate only or a mixture of folate and folic acid; and (3) require that the term “folic acid” be used in the labeling of dietary supplements only. As proposed, conventional foods would not be permitted to use the term “folic acid.”

 

[Hip]

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

What a totally wrong and misleading title. Shame on ANH-USA (Alliance for Natural Health) and shame on the Organic Consumers Association.

 

[Lynn_M]

ljimbo423 and Hip,

I disagree with your interpretations. Section L reads about the same as section J. They're proposing that dietary supplements can only list folic acid in the labeling, not folate or folacin. If the labeling only permits the words folic acid, that seems to me that they are precluding the use of folate in dietary supplements.

It would be commendable if the FDA was saying that the words folate or folacin can't be used on the label to describe folic acid. But that's not what they are saying. The wording in the guidance is that the only words permitted on dietary supplements are folic acid. In readings sections J and L, they make no exception for the labeling as folate in dietary supplements as folate.

Hi Lynn_M- You are quoting section J. I think this section is why people are confused, it is hard to understand. If you scoll down the page to "Folate and Folic acid" under section L."Dietary supplements" it says- Quote-

https://www.federalregister.gov/art...-of-the-nutrition-and-supplement-facts-labels

This seems pretty clear that they are talking about not using the terms "folate" and "folacin" instead of folic acid on supplement labels like they do now. Instead they would have to use the words "folic acid". All the best- Jim

 

[adreno]

It means that you can't label your folic acid as folate, as they are not the same.

 

[Valentijn]

Folate and folic acid are the same thing, chemically. We just use the different terms to specify if we're talking about the active or inactive from, as a matter of convenience. The supplement industry doesn't observe any such niceties, and something labeled only as "folate" is probably what we would call "folic acid".

Unless there's some indication that it's active folate, such as by using the full name (levomefolic acid, 5-MTHF, l-methylfoloate, etc), plain "folate" is currently meaningless and deceptive anyhow. I'd have no problem seeing that term go, so long as the other terms describing the active form accurately can remain.

 

[sregan]

For me I don't really care, if there is a chance this may restrict any use of supplements. I've already signed the thing and sent my statement to the FDA. Tryptophan was coincidentally pulled as soon as Prozac hit the market. An active form of B6 has already been restricted (Pyridoxamine ). Statins cannot be sold if they are standardized. You got congressmen like Durbin introducing the same sneaky legislation every year trying to restrict supplements (http://articles.mercola.com/sites/articles/archive/2013/06/19/durbin-supplement-bill.aspx).

If we don't pay attention we're going to end up like Canada and have to get a prescription for vitamin C! (probably an exaggeration

 

[PeterPositive]

Folate and folic acid are the same thing, chemically. We just use the different terms to specify if we're talking about the active or inactive from, as a matter of convenience. The supplement industry doesn't observe any such niceties, and something labeled only as "folate" is probably what we would call "folic acid".

That's true but to make a proper distinction we should call the synthetic folate, often referred to as "folic acid", with one of its technical names such as pteroyl-L-glutamic acid, which sucks

Probably it would be best if the labeling was more precise and indicated the form of folic acid all the times. At least it would put an end to this confusion.

 

[Hip]

The difference between folic acid and folate is that the former is an acid, and the latter part of an acid salt. This is standard chemical terminology for acids and their salts.

An acid salt is formed when an acid combines with a metal such as sodium, potassium, calcium or magnesium, or with non-metals such as ammonium.

For example, vitamin C can come as an acid (ascorbic acid), or in acid salt form (ascorbate). There are various different vitamin C acid salts, including sodium ascorbate, potassium ascorbate and magnesium ascorbate.


Other examples of acids and their salts include:

Malic acid, and malate (eg: magnesium malate)
Citric acid, and citrate (eg: sodium citrate)
Sulfuric acid, and sulfate (eg: magnesium sulfate, aka: Epsom salts)


All the FDA are doing is stipulating that the correct labeling is used, so that people know whether a product contains folic acid, or a folate.

You'd think that the Organic Consumers Association would actually know a little bit about chemistry, but it appears they have no training in that area.

 

[Snowdrop]

While there are plenty of restricted substances here in Canada vitamin C isn't one of them.

 

[Freddd]

I want to mention how some of the restrictions of Canadian supplements. The one I know best is carnitine because I read everything to do with it at the time. The restriction came about because of one person's report of "terrible" side effects. The person was taking a lot of meds including Klonopin. Their overall profile would look very similar to many of ours here. The person had a hyper response of what looks like a damaged limbic system to carnitine. I could see MeCbl being banned there because somebody reports overwhelming side effects like hypokalemia and donut hole paradoxical folate deficiency only they don't call them that. I would say that one needs to understand the nature of the "side effects" to know what is going on.

The misuse of "folate" to disguise the presence of folic acid is dangerous to a lot of us. Forcing the supplement makers to explicitly label folic acid is a good thing. They know quite well that "folic acid" is something millions of people are now avoiding. It is easier and cheaper to change the labeling to "folate", "calcium folate" and so on and remove those poison words "folic acid" than it is to change to l-methylfolate.

Folic acid has been a disaster for millions of us. For millions of us it may be an originating cause for CFS/FMS and related diseases.

 

[TigerLilea]

I disagree with your interpretations. Section L reads about the same as section J. They're proposing that dietary supplements can only list folic acid in the labeling, not folate or folacin. If the labeling only permits the words folic acid, that seems to me that they are precluding the use of folate in dietary supplements.

They are saying that food products can no longer list folic acid as an ingredient. The term folic acid can only be used for supplements. However, it does not say anywhere that folate cannot be listed as an ingredient in supplements.

 

[Leopardtail]

I clicked on the link for FDA's 109-page proposed guidance in SREGAN'S original post in this thread: https://www.federalregister.gov/art...-of-the-nutrition-and-supplement-facts-labels. This is the section "2. Folate and Folic Acid" from that document:


While recognizing the difference in bioavailability between naturally occurring folate and synthetic folic acid, it does sound to me that the only permissible proposed labeling in dietary supplements would be for folic acid. Meaning folate could not be sold as a dietary supplement, IMO, if this guidance is approved.

I can't work out whether this applies only to mislabelling of folic acid as folate, or a general ban.

 

[Lynn_M]

"We are proposing to only allow the use of the term "folic acid" for the labeling of dietary supplements"

.

Does this say that the only allowable place for the term "folic acid" is in dietary supplement labeling? Or is it saying that dietary supplement labels are restricted to saying "folic acid". Where do 5-MTHF and l-folate fit in? Are they still permitted or not?

I think there is a lot of ambiguity here.