FDA Vitamin Shenanigans

Grandfathered list may lose some supplements permanently ,or be put under big pharm monopoly .
Vitamin B6 and E ,first in the crosshairs .
Media ,nothing,as per usual .



Supplements not on an FDA “approved” list could disappear.

The NDI guidance interprets the rules for new supplements. After your protests got the first draft scrubbed, work on a second draft continues at FDA. A second meeting between FDA and “stakeholders”—mostly trade groups, with ANH-USA once again the only grassroots consumer group present—took place on October 16.

As we reported after the first meeting, the New Dietary Ingredients guidelines still pose a major threat. This is because FDA is trying to reaffirm the policies of the original guidance, particularly the elements that could remove huge numbers of supplements from the market.

Much of the meeting was dedicated to a discussion about how to create a list of “grandfathered” dietary ingredients (supplements). These supplements would have been sold prior to 1994, the year the underlying law, DSHEA, was passed and therefore would not require jumping through further regulatory hoops before being sold. The question was: what evidence would be required to show that a supplement was sold prior to 1994?

FDA says such a list won’t necessarily be final, and won’t be the only supplements allowed to be sold. But we could easily conceive of that being the outcome if left to the agency. We are also concerned that FDA wants to set the evidentiary bar so high that many supplements which were definitely sold prior to 1994 still won’t pass.

According to FDA, any of the following is sufficient to prove that a supplement was marketed before DSHEA was passed: an invoice, a bill of lading, a product label, or a catalog, provided it clearly indicates a date. But many companies don’t have this kind of documentation from eighteen years ago! For example, pyridoxamine (a B6 vitamin) was marketed before DSHEA, but no one in the industry has been able to provide the documentation required by FDA. Even signed affidavits from industry members have been inadequate in FDA’s eyes.

What if a dietary ingredient is, and has always been, in our food? Doesn’t that mean it was “marketed” before 1994? Not to the FDA. The supplement must have been separated out of the food, and sold for its own properties. Human beings have consumed the antioxidant resveratrol for millennia because it’s found naturally in the skin of grapes. But no one in the industry has yet been able to prove that resveratrol was marketed as a separate ingredient or was found on the label of a

The problem is a little different with P5P. P5P is the only form of vitamin B6 that the body can use directly. It’s produced naturally in the body: all other forms of B6, whether in food or in supplement form, must be converted to P5P first; without it we die. Most of us don’t get enough B6 in our diet, and some people lack the enzymes needed to convert pyridoxine into P5P.

There shouldn’t be any problem grandfathering P5P since there is no question that B6 was sold prior to 1994. But the FDA says no. If the form of B6 sold earlier was not P5P, if the label didn’t say

As we have previously reported, a drug company, Medicure Pharma, wants sole use of P5P and has petitioned the FDA to ban its use as a supplement entirely. Although Medicure has yet to market a drug made from P5P, it has already petitioned FDA to have the supplement banned now.

This idea of taking what we cannot live without and turning it into a controlled prescription drug is shocking. But this could only be the beginning. We are concerned this new “approved” list of supplements will be used by drug companies to knock out competition from other supplements

For a supplement to get on the grandfathered list, the FDA says it cannot be “chemically altered”—and the definition of that term was another bone of contention at the meeting. Many grandfathered ingredients, because they now go through different (and often safer) manufacturing processes than they did before 1994, could therefore be considered “chemically altered” by the FDA. So either supplement producers would have to revert to pre-DSHEA manufacturing processes, or else they would no longer be on the grandfathered list! Consumers would get the short end of the stick either

As we pointed out when the first draft of the guidance was issued, FDA’s stance is so extreme that a ripe apple would be considered “chemically altered” when compared to an unripe apple! Logic would suggest that the production process should not matter if the end ingredient is basically the

In all of this, FDA seems to be targeting new, improved, or technologically advanced supplements, presumably because they see them as potential competitors to drugs. If they keep cutting-edge supplements off the market, drug companies can also make big money by selling the older version of the supplement, as Pfizer does with its Centrum multivitamin that we discussed last week.

Here’s another example of why this question of a grandfathered list is so important. Vitamin E is a powerful antioxidant that prevents cell structure damage, boosts the immune system, reduces cholesterol, lowers the risk of developing cancer, thins the blood, helps skin repair itself, and even strengthens your hair. And everyone “knows” that vitamin E was sold prior to 1994. It currently appears on a trade association’s list of grandfathered dietary ingredients. However, this has not yet been vetted or approved by the FDA. If the proper documentation can’t be found, either vitamin E would be off the grandfathered list, or else some forms of E might be listed and others might not. This is important because different forms of the vitamin work very differently. Vitamin E in the form of mixed tocopherols may prevent breast cancer, among other benefits, whereas the common alpha-tocopherol form may not. Some researchers and integrative doctors actually warn against taking alpha-tocopherol alone because it may interfere with the body’s use of the other forms of

Unfortunately, this information has been buried by the media. All of the research on vitamin E that the media has been reporting—and badmouthing—has used alpha-tocopherols instead of mixed tocopherols, as Dr. Jonathan Wright points out in the current issue of his Nutrition and Healing

We are pleased that the FDA is including stakeholders at the NDI guidance redraft meetings. We are pleased that consumers were included by inviting us. But there are reasons to be very watchful. We don’t want a grandfathered list that will not only exclude many supplements actually sold before 1994, but will also make it easier to reject all newer supplements. With vigilance and your help, we won’t let that happen.


Read more here :
www.anh-usa.org...


Legal shenanigans :
www.law360.com...

Basically says it is putting the onus on the supplement companies to prove their worth .

So basically if they pass all this stuff, than in the near future "drug dealers" could actually mean some guy who is selling old GNC merchandise before the laws got passed on the "new black market for supplements"?

Our society is so screwed.
It's because we have too many complete idiots voting complete tyrants into power.
Well that's one of the many, many reasons.

They cannot eliminate a chemical though, that's not logical.

Look at "illegal drugs", they are manufactured or grown all the time everywhere almost.

All one needs to refine these things into supplement form is the know-how, some equipment, and some time.

This is for all supplements .
I use,in my house, things like 6 hour colostrum ,chaga mushroom ,and macela herb .
Macela and chaga definately are not on the list before 1994 .
Ergo,they are not eligible to be grandfathered in .
Colostrum ,is now going to be filed under the Nestle Monsanto breast milk patent ,which means they own it .
6 hour colostrum is bovine ,not human ,but given how they have labeled it ,I think this will put all colostrum under their control as well.
This is not ridiculous anymore . It's dire.
I use almost 90% herbals in my house . I will use prescription meds for a last resort ,and usually for the animals ,if herbs are ill advised .

This is part of the ,we MUST use their system ,or no system at all .

It's nuts . I literally hope I'm dead before it all happens ,because if im not ,I will be . I won't take their poisons ,or go to their hell hole hospitals . Period

I did some fact checking, and it seems to be bunk.
First, your source is laughable. The second one isn't even a full article...and surely doesn't say what you are saying.

I can't seem to find anywhere the FDA has proposed such a list....I clicked the links on the first article and their sources were a joke. The links did not link to pages that made the claims they were making....

After the stuff you wrote yesterday, I'm not surprised to see a thread like this.

Found the actual list, in their last link, see below:

Here's what the FDA actually says:

The Dietary Supplement Health and Education Act (DSHEA) established conditions under which a "new dietary ingredient" could be used in a dietary supplement . According to DSHEA, a "new dietary ingredient" means "a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994 ." By this provision, dietary ingredients already in use as of October 15, 1994, were "grandfathered ."

There's no ban on new dietary supplements...they're saying the ones on the "grandfathered list" don't have to go through a certain process to enter the market. That's all.

Your entire post is basically paranoid conjecture.

reply to post by Ghost375


Umm hmmm,and all the supplements not on the grandfathered list ...that's the point of my post .
And as I have said repeatedly ,I believe nothing on any official source . They're are the ones that are laughable ,as they do nothing but lie.
They want complete jurisdiction over all supplements ,and they are already in the process of doing it actively in the case of Chinese herbs .
Spare me your condescention ,as its just shill rhetoric .

reply to post by Ghost375


It doesn't say there's a ban at all,as the second,obviously too complicated legal article states .
They're still working on it . And they won't be banned,they will taken over by pharm ,and you will need a prescription to get them ,so they can milk insurance some more.

In regard to the OP on P5P

Citizen Petition Asks FDA to Pull From the Market All Dietary Supplements Containing a Form of Vitamin B6

Medicure Pharma submitted a citizen petition to FDA that asserts that all dietary supplements containing pyridoxal 5’-phosphate (“P5P supplements”) are adulterated under FDC Act § 402(f). The petition asserts that P5P (a form of vitamin B6) is a new dietary ingredient which has neither been present in the food supply as an article used for food in a form in which the food has not been chemically altered, nor has it been the subject of a new dietary ingredient notification. The petition further asserts that those supplements were therefore not lawfully marketed prior to the date on which the investigation of P5P as a drug triggered the dietary supplement exclusionary clause in FDC Act § 201(ff)(3)(B)(ii). The petition asks FDA to remove all P5P supplements from the market, or in the alternative, to initiate rulemaking under FDC Act § 201(ff)(3)(A) to exclude them from the statutory definition of a dietary supplement. Medicure Pharma is investigating a drug product under an Investigational New Drug Application that contains P5P as its active ingredient, and the company contends that marketing of P5P supplements undermines the company’s incentive to continue developing its drug product.

The success or failure of the petition will turn on a few issues. First, the petition contends that P5P is a new dietary ingredient because it was not marketed before October 15, 1994. This is certain to prompt a thorough search on the part of P5P supplement manufacturers for evidence of marketing prior to that date. Second, the petition contends that P5P has not been “present in the food supply as an article used for food” within the meaning of FDC Act § 413(a)(1) because the presence of P5P in foods is “incidental.” However, the Institute of Medicine recognizes that P5P is one of the major forms of vitamin B6 in animal tissues, and that animal tissues are a source of vitamin B6. Third, the petition contends that even extensive marketing of a dietary supplement does not forestall application of the dietary supplement exclusionary clause if the supplement was marketed unlawfully. Although the petition acknowledges that a plain reading of the exclusionary clause does not support this view, the petition asks FDA to read the term “lawfully” (as in “lawfully marketed”) into the exclusionary clause on the ground that not doing so would yield absurd results. Finally, the petition contends that, even if P5P is lawfully marketed as a dietary supplement, FDA can prohibit any further marketing under section 201(ff)(3)(A) to help preserve incentives for new drug development. In doing so, the petition fails to acknowledge that FDA’s rulemaking authority under FDC Act § 201(ff)(3)(A) is tied to a finding of adulteration under § 402(f), a finding that could be difficult to support in the case of a form of vitamin B6.



www.fdalawblog.net...

And it seems at least one House speaker got involved on behalf of the supplement company Jarrow (I actually buy a lot of their stuff)
That's rather extreme for something that wasn't really happening *coughs* ,isn't it ?
If you found nothing on this,you obviously ,as per usual ,didn't look very hard .

www.nutraingredients-usa.com...

Jarrow calls for Congressional hearings to address NDI guidance woes

By Elaine Watson , 19-Jun-2012

Related tags: NDI draft guidance, Jarrow Formulas

Related topics: NDI draft guidance, Manufacturer insights, Regulation, Probiotics and prebiotics

Jarrow Formulas has raised its concerns about the FDA’s draft guidance on new dietary ingredients (NDIs) with House Speaker John Boehner as part of its campaign to alert members of Congress to the dangers the “fatally flawed” document presents to the supplements trade.

One of the most vocal critics of the NDI draft guidance, California-based Jarrow has repeatedly called on the FDA to ditch the controversial draft guidance, which it argues is “already being used as a hammer to blunt the industry”.

It has also called for Congressional hearings on the controversial document, which it describes as a “blatant attempt to regulate and indeed legislate via a guidance document”.

‘We urge you to convene hearings or an inquiry’

In a 15-page letter to Boehner dated May 21, Scott Polisky and Dr Susan Brienza - regulatory attorneys for Jarrow - wrote: “We urge you to convene hearings or an inquiry into the FDA’s handling of dietary supplements.

“In particular, the FDA should be required to withdraw the current guidance and produce a new draft guidance for comment that is truly consistent with and harmonious with the purpose and intent of Congress in DSHEA [1994 Dietary Supplement Health and Education Act].”

reply to post by PtolemyII


First of all Ghost is a gov't shill - look at all his posts -

Second - I was afraid to even open up this thread because I've known for years now - this is in obozocare - They are going to make you get a prescription for vitamin C.

Look at the thread about doxyciclin (an antibiotic) recently going from $6.00 a 10 day prescription = to $60.00 a 10 day prescription.

Look at elton john playing for the walmart shareholder's party at 3 million dollars - walmart- the only place you can buy food and toiletries (and prescription supplements and drugs?)

It's coming quicker and quicker.

And they are going to make us criminals, or kill us through GMO foods.

Look ,5 supplement companies got together and petitioned the FDA to review ingredients to be grandfathered in closely . I wonder Wwwhhyyyy ???

www.npainfo.org...

reply to post by Happy1


I already made a bunch of posts like this. No one said anything,because everything I said is provable .
The shills on that other forum learned fast ,I will debunk their debunking ,before you can say BOO .
My alleged "paranoia" always seems to come out on the news ,as fact ,sooner or later


Feel free to post on my threads .

reply to post by PtolemyII
I believe the big overall scheme is to force people to get a doctor's prescription in order to purchase supplements, allowing the big pharmaceutical companies to raise the costs of them to an obscene price. Some people have no choice but to take supplements as certain prescription drugs that they need to live counter act certain vitamins that no amount gleaned naturally from foods can replace.

This would also force people who self-treat with supplements to go to a doctor and be prescribed pharmaceuticals for conditions that are more safely (and cheaply) treated with herbs and vitamins. Instead they will be forced to pay for doctor visits, probably lab testing and expensive (and often harmful) drugs instead of being able to choose what they feel is right for them. Big Brother and Big Pharm think they know what is best.......best for their bottom lines anyway!

The United States can print money until infinity, it can't create drugs.

Look at the FDA busting all those companies shipping out of India into the US......

Initial ingredients come in from poor countries, "Compounding Pharmacies" operate underneath FDA eyes to make Generic drugs.

The companies in India were exporting poison and dirt to the US claiming it was "ingredients" for medicine we make. They've been ripping us off since 2006 from what the FDA found out, and just fined 1 company $500 Million in India.

The FDA can write all the laws they want......the truth is right now there is a massive drug shortage in America.

They can print money, write hundreds of billions of new laws.......America's been failing in making drugs and regulating that market. The worlds been poisoning us the past few decades and laughing while accepting our dollars.

FDA=Fail.

reply to post by littled16


That is the goal. As far as I can see,they want it all in place over the next ten years,and WHO is behind it .