FDA Trying to Outlaw Supplements

Now I read OP’s post.

Yeah it still sucks. Won’t make much difference for me since every supp I buy over here comes from Europe, but still…

Anyone know off-hand how many people big tobacco kills every year?

Or misused pharmaceuticals?

OOH OH! How about drunk driving or all the health complications from alcoholism!

I’ll just ballpark it and go with, “a shitload.”

How many people died from OTC supplements? A lot less than a shitload.

Priorities.

[quote]kaisermetal wrote:

[quote]roybot wrote:

[quote]randman wrote:

The FDA has just issued a proposed mandate that will enable the government to ban the most effective dietary supplements you are now taking.

If this proposal is enacted, many fish oil formulas and natural plant extracts will be removed from the market until so-called safety testing is done. The FDA wants each nutrient company to force-feed laboratory animals the human equivalent of up to 240,000 milligrams a day of certain fish oils. This outlandish dose will injure the test animals and give the FDA an excuse to outlaw the supplement.

How can the FDA do this? They are seeking to reclassify the natural supplements you now take as “food additives.” This gives the FDA power to mandate outrageous safety thresholds that have no relationship to the scientifically validated doses of nutrients you take every day.

Why are they doing this? Because these natural products work too well. Take curcumin as an example. It has been shown to inhibit a deadly transcription factor in cells called nuclear factor-kappa beta (NF-kB) that is responsible for immune system regulation. Over-expression of NF-kB is linked with tumor cells that resist normal cell growth and maturation, as well as inflammation.

Pharmaceutical companies want to own the exclusive rights to these kinds of plant extracts that are freely sold on the market today. They don�?�¢??t want consumers to be able to obtain these biological benefits in low-cost supplements. Instead, they want to patent synthetic versions as high-priced prescription drugs!

What is being done to Stop This Travesty?

To give you an idea about how dangerous these draconian proposals are, Life Extension helped organize a conference call last week. Dozens of health freedom organizations participated and agreed to coordinate a massive consumer revolt.

The official start date of this uprising is Thursday, September 8, 2011, but you can take preliminary action today to thwart the FDA�?�¢??s latest attempt to steal your supplements and make them the exclusive domain of Big Pharma.

We ask that you forward this e-mail to everyone you know so they can understand the precarious state their health will be in when the FDA bans their most effective dietary supplements.

Then, use our convenient website to e-mail letters to the White House, your Representative and two Senators by clicking on the links below:

* Send a letter to your Representative and two Senators (http://www.capwiz.com/lef/issues/alert/?alertid=51641606&type=CO) demanding the FDA immediately withdraw their oppressive proposed guidelines pending rational discussions with those who depend on dietary supplements to protect their health and livelihood.
* Send a letter to the President�?�¢??s Office of Management and Budget (http://www.lef.org/featured-articles/0719_Letter-to-the-White-House.htm) as the FDA�?�¢??s proposed guidelines on new dietary ingredients directly conflict with an Executive Order issued July 11, 2011 (http://www.lef.org/featured-articles/0719_Executive-Order-Letter.htm), that orders the FDA to streamline and repeal burdensome regulations that interfere with job creation, economic growth, and innovation.

[/quote]

Relax. They can’t ban naturally-derived dietary supps like curcumin and fish oil and replace them with synthetic alternatives, for the simple reason that they can’t do it. They can’t ban something that can’t be patented then reverse engineer a patented alternative.[/quote]

mm what? i haven’t understood nothing.
[/quote]

The article is bullshit. Assuming pharmaceutical companies could patent and produce an alternative to fish oil and curcumin, they’d have to ban us from eating oily fish and tumeric to bring the patent into effect.

Water is toxic if you drink enough of it. They could ban that as well.

I completely fail to see the point in replying to a thread with an opinion that is generated WITHOUT READING THE ORIGINAL POST. These responses are always so incredibly helpful, topical, and thought provoking…

As a matter of fact they can ban just about anything they want that was formulated after 1994.

Link: FDA unleashes end game scheme to outlaw virtually all dietary supplements formulated after 1994 - NaturalNews.com

[quote]In 1994, after years of armed raids, oppression and censorship by the FDA, Congress passed a law known as DSHEA. This is the law that essentially forced the FDA to stop regulating dietary supplements out of existence, and groups such as the Life Extension Foundation (www.LEF.org) were instrumental in helping get this law passed in 1994.

But one of the little-known sections of the law required dietary supplement manufacturers to “notify” the FDA any time they used a new ingredient in their formulations. However, the details on how supplement companies were supposed to abide by these notification guidelines (called “NDI” or New Dietary Ingredient rules) were never published by the FDA, and since 1994, this entire section of DSHEA has remained essentially unenforced (or selectively enforced).

Now, suddenly, the FDA has decided it wants to enforce NDI, and its enforcement of this technicality would essentially amount to the FDA denying permission to use nearly all dietary supplement ingredients introduced since 1994. So last Friday, the FDA proposed its new rules on NDI – on the Friday before a long weekend, no less, which is a common tactic government uses when it wants to do something that nobody notices – and these new rules run the risk of being adopted as active regulations, threatening virtually the entire dietary supplement industry with an eventual shutdown.

Why did the FDA wait 17 years to take action on NDI rules? Believe it or not, this was mandated under the new Food Safety Bill (S.510 remember?) that Congress passed into law late last year without even reading the bill (The world's top new source on natural health - NaturalNews.com…). So now, the FDA has been forced into issuing these new guidelines, and it obviously is going to take every opportunity it can to destroy the nutritional supplements industry (and thereby protect the profits of Big Pharma).[/quote]

A quote from ANH (Alliance for Natural Health):

With regard to:

[quote]roybot wrote:
Relax. They can’t ban naturally-derived dietary supps like curcumin and fish oil and replace them with synthetic alternatives, for the simple reason that they can’t do it. They can’t ban something that can’t be patented then reverse engineer a patented alternative.[/quote]

I give you the following:

If you think it can’t happen:
Link: EU ban on top herbal supplements signifies crackdown on natural health - NaturalNews.com
Link to BBC news story: New EU regulations on herbal medicines come into force - BBC News

Full story from Alliance for Natural Health
Link: http://www.anh-usa.org/fda-new-sneak-attack-on-supplements/

[quote]roybot wrote:
The article is bullshit. Assuming pharmaceutical companies could patent and produce an alternative to fish oil and curcumin, they’d have to ban us from eating oily fish and tumeric to bring the patent into effect.

Water is toxic if you drink enough of it. They could ban that as well.

[/quote]

I assure you it isn’t.

They don’t have to ban fish or tumeric to ban it in supplement form. Two years ago there were attempts by two different companies to ban a form of VITAMIN B-FUCKING-6 because a pharmaceutical company was seeking approval for a drug that was based on it.

The difference is that now they have the power to make things like this much more of a reality.

They tried to do the same thing with red rice yeast:

[quote]From Wikipedia:
The Food and Drug Administration (FDA) position is that red yeast rice products that contain monacolin K, i.e., lovastatin, are identical to a drug and, thus, subject to regulation as a drug. In 1998, the FDA initiated action to ban a product (Cholestin) containing red yeast rice extract. The U.S. district court in Utah allowed the product to be sold without restriction. This decision was reversed on appeal to the U.S. District Court. (Moore, 2001) (see Further Reading: PDRhealth). Shortly thereafter, the FDA sent Warning Letters to companies selling red yeast rice. The product disappeared from the market for a few years.

In 2003, red yeast rice products began to reappear in the U.S. market. As of 2010, there are at least 30 brands available. Many of these avoid the FDA restriction by not having any appreciable monacolin content. Their labels and websites say no more than “fermented according to traditional Asian methods” or “similar to that used in culinary applications.” The labeling on these products often says nothing about cholesterol. If they do not contain lovastatin, do not claim to contain lovastatin, and do not make a claim to lower cholesterol, they are not subject to FDA action. Two reviews confirm that the monacolin content of red yeast rice dietary supplements can vary over a wide range, with some containing negligible monacolins.[5][6] In 2007, the FDA sent Warning Letters to two dietary supplement companies. One was making a monacolin content claim about its RYR product and the other was not, but the FDA noted that both products contained monacolins. Both products were withdrawn.[7][8] The FDA also issued a warning press release (see Further Reading; FDA 2007). The crux of the release was that consumers should “â?¦not buy or eat red yeast rice productsâ?¦may contain an unauthorized drug that could be harmful to health.” The rationale for “â?¦harmful to healthâ?¦” was that consumers might not understand that the dangers of monacolin-containing red yeast rice might be the same as those of prescription statin drugs.[/quote]
I know wikipedia is not the best source, but the information is accurate and boiled down sufficiently to allow brevity.

Incidentally, all of the “statin” drugs are derived from monacolin in red rice yeast. So tell me Big Pharma can’t synthesize natural compounds.

[quote]devilmanVISA wrote:
I completely fail to see the point in replying to a thread with an opinion that is generated WITHOUT READING THE ORIGINAL POST. These responses are always so incredibly helpful, topical, and thought provoking…

[/quote]

I did read the original post, mega-pendant, and responded to it succinctly and with plain English. Your direct rebuttal to me only means that they are allegedly replacing natural molecules with synthetic ones. Which isn’t what was said in the OP.

[quote]devilmanVISA wrote:

[quote]roybot wrote:
The article is bullshit. Assuming pharmaceutical companies could patent and produce an alternative to fish oil and curcumin, they’d have to ban us from eating oily fish and tumeric to bring the patent into effect.

Water is toxic if you drink enough of it. They could ban that as well.

[/quote]

I assure you it isn’t.

They don’t have to ban fish or tumeric to ban it in supplement form. Two years ago there were attempts by two different companies to ban a form of VITAMIN B-FUCKING-6 because a pharmaceutical company was seeking approval for a drug that was based on it.

The difference is that now they have the power to make things like this much more of a reality.[/quote]

Were they successful in banning it? I thought not.

Fuck it. After reading to Roybots post I’m moving to Europe.

[quote]roybot wrote:

Were they successful in banning it? I thought not.[/quote]

Be thinking again:
Link: FDA Determines That Pyridoxamine Is Excluded From the Definition of Dietary Supplement Under FDC Act § 201(ff)(3)(B); Implications for FDA’s Interpretation of § 301(ll) Could Be Significant

and

The ban was not on B6 itself, but on a form of B6. Now there is a petition to patent the most bioavailable form of B6 pyridoxal 5-phosphate, or p5p.

[quote]HoustonGuy wrote:
Fuck it. After reading to Roybots post I’m moving to Europe. [/quote]

You can take that stray ‘to’ with you while you’re at it.

[quote]roybot wrote:

I did read the original post, mega-pendant, and responded to it succinctly and with plain English. Your direct rebuttal to me only means that they are allegedly replacing natural molecules with synthetic ones. Which isn’t what was said in the OP. [/quote]

If you read everything I’ve posted about the ban on a form of B6, you’ll see that this fact gives the FDA everything they need to ban natural supplements. If a natural supplement is in a drug or in an investigational drug, the FDA equates that with selling a pharmaceutical product without a prescription or doctor’s guide, or with selling an unapproved pharmaceutical product.

The only way they pulled this off with pyridoxamine (form of B6) was that it was not marketed as being present in food, regardless of it being a form of a basic vitamin. Primarily because it is the rarest form of B6. Surprise, its also the most potent and the easiest broken down into the most bioavailable form, p5p.

That was 2 years ago. Now they have the power to ban anything that hasn’t adhered to the same formulation since the DSHEA was passed in 1994. How many supplements do you think have not changed in any way shape or form since 1994?

[quote]devilmanVISA wrote:

[quote]roybot wrote:

Were they successful in banning it? I thought not.[/quote]

Be thinking again:
Link: FDA Determines That Pyridoxamine Is Excluded From the Definition of Dietary Supplement Under FDC Act § 201(ff)(3)(B); Implications for FDA’s Interpretation of § 301(ll) Could Be Significant

and

The ban was not on B6 itself, but on a form of B6.[/quote]

So after all that preamble, it turns out they haven’t banned it at all.

[quote]HoustonGuy wrote:
Fuck it. After reading to Roybots post I’m moving to Europe. [/quote]

Incidentally I think it was his inability to correctly separate the HTML tags of my post that made it appear as his own. Perhaps it was inherent laziness, which is ironic given that he corrected your typo.

He may be a grammar Nazi, but his HTML is quite poor.

EDIT: But props to you for actually reading a post.

[quote]roybot wrote:

[quote]devilmanVISA wrote:

[quote]roybot wrote:

Were they successful in banning it? I thought not.[/quote]

Be thinking again:
Link: FDA Determines That Pyridoxamine Is Excluded From the Definition of Dietary Supplement Under FDC Act § 201(ff)(3)(B); Implications for FDA’s Interpretation of § 301(ll) Could Be Significant

and

The ban was not on B6 itself, but on a form of B6.[/quote]

So after all that preamble, it turns out they haven’t banned it at all.
[/quote]

Clearly you are an idiot, or you’re making a serious attempt at being “holds on to a tenuous argument just to avoid feeling as if he was proven wrong” guy. There are many different forms of B6. I offer you a philosophical question then. If they ban the most effective ones, such that people cannot get equivalent therapy from those remaining, have they not, in fact, banned B6 itself in supplement form?

[quote]devilmanVISA wrote:

[quote]roybot wrote:

[quote]devilmanVISA wrote:

[quote]roybot wrote:

Were they successful in banning it? I thought not.[/quote]

Be thinking again:
Link: FDA Determines That Pyridoxamine Is Excluded From the Definition of Dietary Supplement Under FDC Act § 201(ff)(3)(B); Implications for FDA’s Interpretation of § 301(ll) Could Be Significant

and

The ban was not on B6 itself, but on a form of B6.[/quote]

So after all that preamble, it turns out they haven’t banned it at all.
[/quote]

Clearly you are an idiot, or you’re making a serious attempt at being “holds on to a tenuous argument just to avoid feeling as if he was proven wrong” guy. There are many different forms of B6. I offer you a philosophical question then. If they ban the most effective ones, such that people cannot get equivalent therapy from those remaining, have they not, in fact, banned B6 itself in supplement form?
[/quote]

I don’t know. Have they?

[quote]devilmanVISA wrote:

[quote]HoustonGuy wrote:
Fuck it. After reading to Roybots post I’m moving to Europe. [/quote]

Incidentally I think it was his inability to correctly separate the HTML tags of my post that made it appear as his own. Perhaps it was inherent laziness, which is ironic given that he corrected your typo.

He may be a grammar Nazi, but his HTML is quite poor.

EDIT: But props to you for actually reading a post.[/quote]

Meanwhile, back in reality - and in spite of my “inherent laziness” and “inability to correctly separate HTML tags” - I was forced to remove all the irrelevant parts of your post (namely, most of it) because your linking blitzkrieg screwed up the quoting function.

Not that I have to justify anything I do to you.

[quote]roybot wrote:

[quote]devilmanVISA wrote:

[quote]HoustonGuy wrote:
Fuck it. After reading to Roybots post I’m moving to Europe. [/quote]

Incidentally I think it was his inability to correctly separate the HTML tags of my post that made it appear as his own. Perhaps it was inherent laziness, which is ironic given that he corrected your typo.

He may be a grammar Nazi, but his HTML is quite poor.

EDIT: But props to you for actually reading a post.[/quote]

Meanwhile, back in reality - and in spite of my “inherent laziness” and “inability to correctly separate HTML tags” - I was forced to remove all the irrelevant parts of your post (namely, most of it) because your linking blitzkrieg screwed up the quoting function.

Not that I have to justify anything I do to you. [/quote]

But you did all the same. What’s that about?

Also, a wee bit slow on the draw here aren’t we?

Both questions are hypothetical and require no response. E-fencing with you serves no purpose at this point and will only further detract from the topic.

[quote]Ghost22 wrote:
Anyone know off-hand how many people big tobacco kills every year?

Or misused pharmaceuticals?

OOH OH! How about drunk driving or all the health complications from alcoholism!

I’ll just ballpark it and go with, “a shitload.”

How many people died from OTC supplements? A lot less than a shitload.

Priorities. [/quote]

THIS!

More deaths are caused each year by tobacco use than by all deaths from human immunodeficiency virus (HIV), illegal drug use, alcohol use, motor vehicle injuries, suicides, and murders combined… about 443,000 in the USA alone. The US is the most overly prescribed country in the world.

USA Today reports that prescriptions are now the biggest cause of drug overdose (22,000 per year).

Alcohol related deaths come to 75,000 per year.

[quote]devilmanVISA wrote:

But you did all the same. What’s that about? [/quote]

When two posters - who strangely seem to be hyper-attuned to every one else’s faults but blind to their own -team up to make patronizing jibes directed at me, I have every right to respond … That’s what it’s “about”.

Glad you brought up hypothetical questions, but you forgot to include that whopper above where you claim B6 has been banned, when your own sources say no such thing. What they do say is that pyridoxamine has been withdrawn as a supplement based on it’s status as “an investigational new drug”. I can quote your own sources back at you if you want.

You substituted “banned” for “withdrawn”, a subtle but significant semantic switch, to make your argument stick.

In response to that same hypothetical question, I asked you to provide me with an answer, and you didn’t, because they haven’t banned it.

So yes, I know exactly what you were trying to do there (which is why I gave you a rhetorical answer that sent the question with no answer right back at you), and despite what you think you know about me, I do read, comprehend and absorb posted material before forming an opinion. We done?

[quote]Ghost22 wrote:
Anyone know off-hand how many people big tobacco kills every year?

Or misused pharmaceuticals?

OOH OH! How about drunk driving or all the health complications from alcoholism!

I’ll just ballpark it and go with, “a shitload.”

How many people died from OTC supplements? A lot less than a shitload.

Priorities. [/quote]

We all know their priorities are to make as much money as possible. They really don’t give a shit if something is safe or not.