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Old 05-25-2012, 10:20 AM #11
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Originally Posted by Sallysblooms View Post
Supplements after 1994 would have been off the shelves within 30 days. So it was a good outcome. FDA has already taken fish oil to make money, good grief. Thankfully, we can still buy it. Also, the vitamin they took that you cannot buy now. I do not want to become the countries with no free will.
I am sorry I don't quite understand this post.

What vitamin did the FDA take off the market?
The FDA PASSED a form of RX fish oil, called Lovaza which allowed it to be covered by RX insurances. That did not do anything to OTC fish oil, which has always been available.
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Old 05-25-2012, 10:37 AM #12
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Yes, that is right, thankfully we can still get the Fish oil of our choice.

The other one is a Bvit and I cannot remember the name. No longer on the shelves. Money is the issue.
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Old 05-25-2012, 10:40 AM #13
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Natural form of B6 Pyridoxamine is the vitamin.

http://www.anh-usa.org/alert-protect...e-vitamin-b-6/
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Old 05-25-2012, 11:01 AM #14
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Default Big Pharma (FDA) vs. Big Supp

There are multiple sides to this issue, as there are to everything. I don't feel I have enough information to form an opinion on this one yet, and I've got some other priorities at the moment, but I have some observations...

First, defeat of the legislation may have had nothing to do with the ammendment/rider itself. I don't know what legislation Durbin ammended, or the merits thereof, but sometimes legislation is ammended to existing bills because the main bill is likely to pass, and sometimes it's ammended to existing bills because the main bill is likely to be defeated. Ain't politics a cuss?

Quote:
Originally Posted by Sallysblooms View Post
It is up to the consumer to be smart. I never take supplements from other countries.
Under the current system, I don't know how a consumer could ever know regardless of how smart/savvy they are. The way many laws (or in this case, unenforced existing guidelines/rules/suggestions) are written, what constitutes "origin" of a product is highly subjective and arguable.

Does "Made in U.S.A." mean every step in the product chain, or could it mean packaged here? Is it mfd. here from raw/processed materials from other sources (which could be contaminated/impure)? What about the capsules/coating (if applicable)? The facts, as I've been able to ascertain so far, are there's no way to tell, regardless of what the label/package states. In many industries, a product can be labeled "Made in U.S.A." if the final product rolls off the assembly line here, even if 99+% of parts & processes are done elsewhere. Some industries/products differ, depending on industry regulation, but there is almost no regulation for supplements, and what is there isn't enforced.

I found this article from earlier this year a VERY interesting read on Big Pharma vs. Big Supp: (N.B. Caution MrsD - your head may explode. )
Quote:
Rep. Burton has introduced H.R. 3380, the “Dietary Supplement Protection Act of 2011.”

The meat of the bill, in Section 3, is short and straightforward. It creates a “new dietary ingredient definition” by amending the provision of DSHEA that grandfathered in all new dietary ingredients existing prior to October 15, 1994. By changing that date to January 1, 2007, it grandfathers in another 12 plus years of new dietary ingredients, thereby wiping the slate clean on all those new dietary ingredients the industry didn’t provide safety information for, in violation of the law.
While the above article really has nothing to do with the Durbin Ammendment per se, I think it furnishes a broader perspective on the industry as a whole.

Another observation is that while Big Supp supporters claim no one has died from supplements (in 2010?), the only evidence proffered are statistics from the American Association of Poison Control Centers; nobody else (mentioned by either side) is tracking deaths from supplements. That seems a bit sketchy (at the least) to me, and I'm dubiouis about it reflecting the whole picture. Poison Control centers are contacted in the event of accute episodes; the data is not likely to include longterm effects. Also, Poison Control is usually contacted before, and in hopes of preventing, fatalities, so they may not include data about people who have already succumbed - long or short term.

I agree with MrsD that, on it's face (what's been outlined in this thread) the Durbin Ammendment sounds reasonable, but at what price? I also agree with Echo's comments.

Sally implies that there is a difference between good and bad supplements, which is MrsD's concern as well, and I wouldn't disagree either. I think the Bill's intent is to help consumers differentiate. It may be up to the consumer to be smart (caveat emptor) but we must also consider that half the population is below average/median intelligence.

As usual with politics, there seems to be a lot of dis/mis-information and fear mongering at work (not by anyone here).

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Old 05-25-2012, 11:21 AM #15
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Lightbulb

I believe this is old news. P5P is still available OTC. P5P works well for us.

Pyridoxamine does not come up on FDA RX Orange Book list either. Sure is taking a long time to be approved.
The drug is still not available...

More about its complex journey here:
http://en.wikipedia.org/wiki/Pyridoxamine

IMO pyridoxal 5 phosphate is still OTC and available and reasonably priced.

Thanks for the details.
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Old 05-25-2012, 11:28 AM #16
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Quote:
Originally Posted by Sallysblooms View Post
Natural form of B6 Pyridoxamine is the vitamin.
Another version: http://en.wikipedia.org/wiki/Pyridox...atory_Activity

This is a really bad precedent. IF...
Quote:
there was an "absence of independent, verifiable evidence that the substance was marketed as a food or a dietary supplement prior to its authorization for investigation as a new drug."
IBID.
...THEN somebody really dropped the ball, or this particular vitamer was not being marketed as a supplement at the time (I don't know that it was or wasn't). However, if it was not being marketed as a supplement at the time, then it could not have been "yanked off the market" as alleged, and would/should have no bearing on supplements we (collective "we") are taking currently.

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Old 05-25-2012, 11:52 AM #17
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Yes, FDA is still trying to get to that vitamin I think.

They really do want to control our choices. They prove it daily.
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Old 05-25-2012, 12:27 PM #18
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Back when the first drug company started, very little was known about "active" forms of B6. I started posting about a decade ago on another forum venue for PN about it. Only one or two companies even made it OTC (P5P). I used Solgar for years because it was one of the few and enteric coated.

NOW also makes it still.

The research into activated forms of vitamins is pretty new. And this pyridoxamine was not common back then, and I never saw it etc. It is also not the most active form of B6 anyway... P5P is.

I suspect this drug is not going to pan out profitably for the NEW owner of the version. This is basically not a big issue, as P5P remains available and useful. In the past some "coenzmated" forms of B6 were sold as mixtures (in other words not purified out). Once making P5P became easy and inexpensive, P5P became more commonly seen and began to attract attention of the OTC public.

The "medical food" industry, subcategory at the FDA... never really took off. Most insurances didn't accept them (like Metanx) and doctors did not understand most of them. Limbrel was one other failure in this category. These failures rather illustrate that Big Pharma won't eagerly try to make their own supplements, IMO.
http://www.pdrhealth.com/drugs/limbrel

What this amendment was trying to address were:
1)Adulterated herbal products containing dangerous RX drugs like digoxin, phenylbutazone, estrogens, etc.

2)Anabolic steroids and steroid precursors abused by body builders and teens working out.

3) OTC erectile dysfunction herbal mixtures that contained Viagra as an illegal additive.

4) diet pills with dangerous drugs added.

Things like this list.
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Old 05-25-2012, 12:44 PM #19
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They just need to concentrate on the drugs that have done so much to so many people. The numbers are staggering. SO many things to address, they need to move on.

http://www.naturalnews.com/035976_**...ts_Senate.html
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Old 05-25-2012, 04:38 PM #20
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i think this is exactly what government should be doing. requiring the listing of ingredients is the only way that consumers can make a rational informed choice. i fail to see what freedoms are being given up because of a listing of ingredients.
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