FDA BANS Vitamin B6

Have you guys heard about this? There was a forum about it over and mindandmuscle.net What the hell is next, banning Whey protein?

I doubt this is true. Sounds like it would have made some headlines.

Not B6 in all forms, but in a newly available form with great benefits and perfect safety, pyridoxamine.

[quote]Bill Roberts wrote:
Not B6 in all forms, but in a newly available form with great benefits and perfect safety, pyridoxamine.[/quote]

what was their reasoning on this ?

Why would they ban Vitamin B6? If anything, why ban a Vitamin in the first place? Seems strange to me.

They claim it is a drug. Regardless of being naturally occurring in food.

I don’t know the reasoning.

Most likely the reason is because it is feared to make economically unviable some potential billion-dollar pharmaceutical. Not that the FDA would admit such as the reason.

It sounds too crazy, it must be a made up rumor.

[quote]Bill Roberts wrote:
They claim it is a drug. Regardless of being naturally occurring in food.

I don’t know the reasoning.

Most likely the reason is because it is feared to make economically unviable some potential billion-dollar pharmaceutical. Not that the FDA would admit such as the reason.[/quote]

Fair enough.

I found this. Pharmaceutical nonsense indeed.

n response to a citizen petition filed on behalf of a pharmaceutical company…

…FDA has determined that products containing pyridoxamine (a form of vitamin B6) are not dietary supplements within the meaning of FDC Act § 201(ff) and ?may not be marketed as such.?

Although pyridoxamine is a dietary ingredient within the meaning of § 201(ff)(1), FDA determined that pyridoxamine is excluded under § 201(ff)(3) because:

(1) pyridoxamine is authorized for investigation as a new drug for which substantial clinical investigations have been conducted and their existence made public; and

(2) there is no ?independent, verifiable evidence? of prior marketing of pyridoxamine as a food or dietary supplement. Among the conclusions reached by FDA:

* an ?article authorized for investigation as a new drug? includes not only the active ingredient (i.e., pyridoxamine hydrochloride), but also the active moiety (i.e., pyridoxamine);
  • consistent with the position taken by FDA in Pharmanex v. Shalala, 2001 WL 741419, the ?mere presence? of a substance in the food supply, even at high levels in foods, does not alone constitute marketing within the meaning of § 201(ff)(3)(B);
    • affidavits, without more, are insufficient to support a claim of prior marketing.

FDA further states that “the marketing of pyridoxamine in a dietary supplement is essentially equivalent to the marketing of an investigational new drug as a dietary supplement.” Thus, it appears that FDA regards products containing pyridoxamine as drugs subject the new drug provisions of the FDC Act.

The implications of FDA?s § 201(ff)(3) analysis could be significant for the agency?s interpretation of § 301(ll). As we have discussed in prior postings, § 301(ll) was added to the FDC Act by the FDA Amendments Act of 2007.

In relevant part, § 301(ll) prohibits the addition to food of an approved drug or a ?drug? for which substantial clinical investigations have been instituted and their existence made public, unless the ?drug? was first ?marketed in food.? We have noted that there are differences between the text of § 201(ff)(3)(B) and that of § 301(ll).

Whereas the former refers to an ?article? that is ?marketed as a food or dietary supplement,? the latter refers to a ?drug? that is ?marketed in food.? These differences are among the issues on which FDA requested comment to gauge the potential impact of alternative interpretations of § 301(ll).

Notwithstanding these differences, the rationale expressed by FDA in support of its determination with respect to pyridoxamine suggests that FDA is likely to adopt an interpretation of § 301(ll) that is much more favorable to the pharmaceutical industry than what many food and dietary supplement manufacturers have advocated

Weak.

could be that B6 temporarily boosts metabolism but leads to down regulation of regular thyroid activity with long term excessive supplementation. And if its marketed as a supplement people may overdose and hurt themselves.

I don’t know who’s reaching more: the FDA so as to pimp for the pharmaceutical companies so one of them can charge $100 or more for something that now costs about $8/month to use, or you with this argument.

Evidence?

[quote]Bill Roberts wrote:
I don’t know the reasoning.
[/quote]

I’m disappointed that you would associate the word ‘reasoning’ with any government agency or official.

I should have said “the provided reasoning” or perhaps “alleged reasoning.”

[quote]Bill Roberts wrote:
I don’t know who’s reaching more: the FDA so as to pimp for the pharmaceutical companies so one of them can charge $100 or more for something that now costs about $8/month to use, or you with this argument.

Evidence?[/quote]

This is about half-way down the page.

"In someone suffering from Hypothyroidism and low sodium, Vitamin B6 supplementation on a long-term basis has the potential to eventually lower thyroid functions even more, although a brief boost will still take place every time Vitamin B6 is injected or taken orally.

In addition, Vitamin B6 will only affect
T4 (thyroxine) levels, but no conversion to T3 (triiodothyronine) takes place - causing a T3 / T4 thyroid ratio conflict, so rather than trying to boost thyroid functions with Vitamin B6 injections for weight loss purposes, iodine, as well as selenium and tyrosine status should be checked and corrected instead."

I found one study but the abstract doesn’t show up, just title and researchers name.
Another:
http://articles.webraydian.com/article1593-Treatment_of_Thyroid_Problems_As_Easy_as_BBB.html

"Vitamin B6 is important in keeping the lymphoid glands healthy. Lymphoid glands produce white blood cells, which are responsible for fighting infection and protecting the body from harmful germs and bacteria. So far, so good for Vitamin B6 being helpful in the treatment of thyroid problems.

Vitamin B6 is also responsible for protein metabolism and cellular growth, all of which are important for the growth of a healthy the immune system; and healthy immune system means a thyroid without a problem."

So where from this do you get anything against pyridoxamine supplementation with reference to people not suffering from hypothyroidism and low sodium?

Ok…so it turns out I am an idiot…Brain farted on the fact that it was about Pyridoxamine and not Pyridoxine(B6).

I blame it on the fact that my boss brought ‘special/magic’ brownies to work today.

Nothing strange. The FDA is corrupted to the marrow. The agenda is to ban from the market all natural potent compounds. You’ll still be able to purchase some, but you’ll need a prescription from the doc, and of course at much higher price.

Codex Alimentarius:

http://video.google.com/videoplay?docid=-5266884912495233634&ei=h0eWSavmOIqGjQLysInCCw&q="codex+alimentarius"+laibow

Nutjob conspirationists? Wait and see!

There is nothing dubious here.

Congress in conjunctions with the FDA intentionally create acts with vague wording.

Like any statute written by government, the vagueness is justified by the alleged need to accommodate unforeseen circumstances.
Of course, the real motivation is to create an illusion of structured boundaries where none exists.

Whatever is convenient and/or popular WILL be the position taken by the agency. The proper conjectures and careful omissions will be made to “fit” the position taken.

So…
The faction with the appropriate power(pharmaceutical company in this case) exerted it’s influence as was sufficient to make the ban of this “drug” convenient.

Bill Roberts and those whose reasoning is counter to the “alleged reasoning” of the FDA did not exert sufficient influence.
Of course, i’m not saying this was in any way the obligation of Bill or of anyone(or any group) exclusively.

Unfortunately this is how government works.
A moving and changing sea of Faction.

Right or wrong?
I don’t know.

I hope to have a part along with people like Bill Roberts to DO SOMETHING about it in the future.

Oh, I don’t have the ability to do anything with regards to the government.

The example really showing that is the attempts of the USFA to lobby Congress against making prohormones controlled substances or at least to limit it.

While the House and Senate staffers treated us nicely and gave us time and listened and had reasonable discussion with us, it was obvious that nothing we could say, no facts of any kind other than if there were vast dollar figures involved that were somehow tied in with political influence, could possibly make any difference.

The only success I ever had with the government was on a specific compound (not a prohormone) once. But there were no big commercial interests involved or any political ones either. In that case the agency in question did listen to the science, fortunate to say.

[quote]Bill Roberts wrote:
…no facts of any kind other than if there were vast dollar figures involved that were somehow tied in with political influence…[/quote]

You seem to believe that money and political influence are illegitimate tools for persuasion.
I would imagine you would have to accumulate political incentives to be able to entice the appropriate committees to act.
I have some ideas…

It’s not in the interest of the cereal companies to have people consume their carbohydrate rich foods in large amounts(per the FDA, USDA recommendations).

They just can’t see that yet.
The argument, like any good argument, is elegant yet simple.

You can springboard from one lobby to another to work your way toward a political scene more friendly to pro-hormones over time.
Along the way, you can utilize the T-man(and woman) community as a base of support.