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New FDA Rule Proposal Will Ban Methylfolate from Supplements.

Ema

Senior Member
Messages
4,729
Location
Midwest USA
Time to write the FDA...all you have to do is follow the link and fill in a form.

http://www.anh-usa.org/fdas-sneak-attempt-to-ban-another-b-vitamin/

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.[1] 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.
 
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PennyIA

Senior Member
Messages
728
Location
Iowa
This sure seems to be pretty horrible if this were to succeed. I followed the link and sent an email off along with a personalization around how much these supplements have been able to help me recover from my 'undiagnosed' condition.
 

Martial

Senior Member
Messages
1,409
Location
Ventura, CA
I have signed it and a equally outraged by this very greedy and selfish act they have commited. One thing I do not understand is how they would have the power to ban all methyl folate supplements though, as supplements for the most part fall far out of regulation and control if any at all by the FDA.

Having Metafolin as a Merck product and claiming patent could be a huge issue though...

Man seriously such a low blow, and sadly I hate to admit it but with that much potential revenue I doubt they would listen to any reason disputing the matter.

I will definitely sign and spread this though as best I can!
 

Sushi

Moderation Resource Albuquerque
Messages
19,935
Location
Albuquerque
I wonder if this is related to Deplin which is a prescription, isn't it? Don't they have to license methylfolate production even now? Or whatever company is behind Deplin?

Sushi
 

Dreambirdie

work in progress
Messages
5,569
Location
N. California
Yup, Deplin is what came to mind for me too, @Sushi

I have signed the petition and will post it on my FB page.

I will definitely be stocking up on methylfolate. At the slow rate I go, it will take me at least 3 years to finish a bottle.
 

*GG*

senior member
Messages
6,389
Location
Concord, NH
I have signed it and a equally outraged by this very greedy and selfish act they have commited. One thing I do not understand is how they would have the power to ban all methyl folate supplements though, as supplements for the most part fall far out of regulation and control if any at all by the FDA.

Having Metafolin as a Merck product and claiming patent could be a huge issue though...

Man seriously such a low blow, and sadly I hate to admit it but with that much potential revenue I doubt they would listen to any reason disputing the matter.

I will definitely sign and spread this though as best I can!

I agree, but what I find laughable is that we, for the most part, think the gov't is going to help solve our medical dilemna, they seem to only muddy the waters! (IOM contract to define CFS via nonn-experts of our illness).

Yes, the money for more research would be nice, but lets not hold our breath!!

GG
 

barbc56

Senior Member
Messages
3,657
While I don't think there are nefarious motives, if I understand correctly, it looks like this is more about labeling than banning? But my knowledge about the difference between the two, is limited.

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
 
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Ema

Senior Member
Messages
4,729
Location
Midwest USA
While I don't think there are nefarious motives, if I understand correctly, it looks like this is more about labeling than banning? But my knowledge about the difference between the two, is limited.
If you can't put it on the label, you can't put it in the product.

It's a tricky way for the FDA to ban something (folate) from supplements without saying so outright. Seems nefarious to me.
 

beaverfury

beaverfury
Messages
503
Location
West Australia
Son of a gun. Is this even possible?

This effects us in Australia too. Our equivalent agency TGA (Therapeutics goods agency) loves spooning the FDA.

http://www.pharmacydaily.com.au/news/tga-works-with-ema-fda/4231

"WORLD regulatory collaboration is one step closer, following the successful conclusion of two pilot programs of collaboration on inspections between the European Medicines Agency, the United States and Australia. The aim of the programs was to enhance global drug safety and quality via increasing international regulatory collaboration."

Oh goody, they left out India and Mexico, my drug suppliers of choice.
 

peggy-sue

Senior Member
Messages
2,623
Location
Scotland
Thank-you!:hug:
I tend to trust Solgar - but my local health food shop, which does have Solgar, didn't know anything about it.
On-line it will have to be.:(
 

whodathunkit

Senior Member
Messages
1,160
[Mods merged Ema's thread and a thread I started to create this one big thread. Apologies for the redundancy of posting the link to the petition--whodahunkit]

Found this on another board I go to.

http://www.anh-usa.org/fdas-sneak-attempt-to-ban-another-b-vitamin/

One thing in this write-up that doesn't make sense to me is the assertion that Merck would make millions by patenting metafolin (if it's not already patented) and making it a drug. They're already there, I think, by licensing the rights to make Deplin.

Point being, I'm not sure how Merck could make *more* money off of metafolin by putting up gatekeepers (i.e., pharmacies and doctors) between consumers and folate supplements. It's more likely they'd *lose* a bunch of money, if for no other reason than most doctors don't understand when or how to prescribe folate. Sales volume of metafolin would likely go so far down that they wouldn't be able to make up the profit even with an insane price hike on the prescription form. So if Merck is smart (big if, I know), they'll help keep metafolin on the free market where the real money is to be made.

But if it's about control by agencies other than the actual ingredients manufacturers, the profit motive doesn't even enter into it.

</editorializing>

Anyway, this could be overblown, but sounds concerning enough to get a little riled up.
 
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PeterPositive

Senior Member
Messages
1,426
So we can look at this from the bright side, most healthy people by producing l-methylfolate in their bodies could be sued by Merck for infringing their patents :D "Luckily" I am not among those ... as I am MTHFR C677T++ and I have no traces of methylfolate in my blood if I don't take supplements, so I won't have to appear in court. That's encouraging! :lol: