4

votes

Do you use supplements with your diet? If so you may want to read this and do something about it.

Answered on September 12, 2014
Created July 06, 2011 at 6:04 PM

http://www.naturalnews.com/032912_FDA_dietary_supplements.html

I have spoken with my pen and met with my congress person today.

What will you do PaleoHackers?

1568416ef28477d1fa29046218d83ddd

(6235)

on July 07, 2011
at 02:22 AM

Well either some safety research would have to be done, perhaps just into historical uses and reports of adverse effect to file any of these. It seems like some manufactures might create co-op research given that some limited protection might be offered by the barrier of this requirement along with a protection of the formulations.

Medium avatar

(4878)

on July 07, 2011
at 01:37 AM

Vrimj, I still don't see how this is going to promote research. Since BigPharma controls the education and research system, how will funding be provided for low cost solutions with no patent protection? I see this ENDING if not decreasing research funds, not providing more.

1568416ef28477d1fa29046218d83ddd

(6235)

on July 07, 2011
at 01:16 AM

Supplements as regulated by the FDA includes vitamins and herbs like valarian. Also fish oils would probably be included. I don’t know when each of these reached the market in my perfered formulation but it seems likely I will at least be inconvenienced if this rule were to pass.

1f96ce108240f19345c05704c7709dad

(1061)

on July 07, 2011
at 12:59 AM

It would have helped had you said wrote what you now say you meant!

Aead76beb5fc7b762a6b4ddc234f6051

(15239)

on July 07, 2011
at 12:27 AM

thank you for being a voice of clarity and reason. i appreciate the links to the actual proposal.

9aa2a816c61170cc0183a68be0386ba5

(1702)

on July 07, 2011
at 12:27 AM

Vitamins are not "supplements" I was more talking about the Green Tea weight loss pills and the Acai Berry MEGA-DO-EVERYTHING-YOU-EVER-WANTED pills. Vitamins are a whole different thing, please be rational.

A8d95f3744a7a0885894ee0731c9744c

(3761)

on July 06, 2011
at 11:29 PM

Thanks, all :-) Wish it was a real answer ;-)

1568416ef28477d1fa29046218d83ddd

(6235)

on July 06, 2011
at 10:09 PM

Looking at the requirements for showing safety it is going to require either book research and ethnobotney or more usual sorts of trial to show safety (but there is no requirement for showing effectiveness)

Medium avatar

(4878)

on July 06, 2011
at 09:58 PM

Vrimj, Why do you believe it will increase research? Will the future supplements be patentable, and therefore producing a positive return on the investment of research?

50637dfd7dc7a7e811d82283f4f5fd10

(5838)

on July 06, 2011
at 09:29 PM

+ 100 if I could, Ben

696079a860ef54810406ae25e4650863

(1623)

on July 06, 2011
at 09:08 PM

And another one for Ben.

Cc7381bd787721575ea9198048132adb

(5541)

on July 06, 2011
at 08:46 PM

The main impact would be on the people that need the few supplements that actually do a lot of good

531db50c958cf4d5605ee0c5ae8a57be

(8878)

on July 06, 2011
at 07:50 PM

+1 for Oranges--don't agree 100% but this is a valid discussion point. The tone of the article is weirdly hysterical. Most supplements are unnecessary and it's a ridiculous--and disingenuous--claim that health and life expectancy will decline precipitously if this bill is enacted. All supplements could be wiped off the face of the Earth tomorrow and the main impact would be on...people who make supplements.

Af1d286f0fd5c3949f59b4edf4d892f5

(18472)

on July 06, 2011
at 07:31 PM

plus another one Ben

Ed71ab1c75c6a9bd217a599db0a3e117

(25472)

on July 06, 2011
at 07:18 PM

plus one Ben....

Ed71ab1c75c6a9bd217a599db0a3e117

(25472)

on July 06, 2011
at 07:17 PM

JAMA is run by the drug companies so I'd expect that. The real issue is that the lay public does not know what I just told you. What gets published in peer review journals these days is owned by pharma. They are the Monsanto of medicine.

1568416ef28477d1fa29046218d83ddd

(6235)

on July 06, 2011
at 07:08 PM

I am sort of mixed. On one hand it will slow supplements to market. On the other hand it will mean that more actual research might be done on supplements, herbs and the like. Right now I mostly have to rely on Germany's Commission E Reports for that sort of thing. The big down side and what might tip the balance for me is that I don't see any way that manufacturers can comply with the evidence of safety requirements without costs going up quite a lot. Some of this also just seems petty, like the requirement for the author citation for the binomial name.

1568416ef28477d1fa29046218d83ddd

(6235)

on July 06, 2011
at 07:01 PM

Oh and here is the link to submit an comment as part of the official administrative law record. http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0376-0001

A8d95f3744a7a0885894ee0731c9744c

(3761)

on July 06, 2011
at 06:58 PM

This is unreal. Thanks, Quilt.

A8d95f3744a7a0885894ee0731c9744c

(3761)

on July 06, 2011
at 06:57 PM

Here comes the libertarian in me...People should be allowed to create and sell whatever they desire. That's the point of having a free market in a free country. Companies aren't directly responsible for the actions of those who buy their products. Do they market inappropriately? Sure. Is it wrong sometimes? Sure. BUT, it's their right, and it's up to the people to educate one another and shut down said businesses by NOT BUYING THE PRODUCT, not passing laws against freedom.

B1859f696e88d25460a6b8a333412ea3

(837)

on July 06, 2011
at 06:55 PM

How about JAMA? Their take is different, of course: http://jama.ama-assn.org/content/early/2011/06/30/jama.2011.982.full

1568416ef28477d1fa29046218d83ddd

(6235)

on July 06, 2011
at 06:55 PM

I am sort of mixed. On one hand it will slow supplements to market. On the other hand it will mean that more actual research might be done on supplements, herbs and the like. Right now I mostly have to rely on Germany's Commission E Reports for that sort of thing. The big down side and what might tip the balance for me is that I don't see any way that manufacturers can comply with the evidence of safety requirements without costs going up quite a lot. Some of this also just seems petty, like the requirement for the author citation for the binomial name.

Ed71ab1c75c6a9bd217a599db0a3e117

(25472)

on July 06, 2011
at 06:52 PM

So vitamin D 3 and K2 are do nothings? Minus one.

Ed71ab1c75c6a9bd217a599db0a3e117

(25472)

on July 06, 2011
at 06:52 PM

Then contact LEF.org Bill Falloon is working like mad on this now. Its for real.

Ed71ab1c75c6a9bd217a599db0a3e117

(25472)

on July 06, 2011
at 06:51 PM

I have shared this with my fellow professionals and not one is happy about it. It will have huge implications for my patients and practice. They are trying to dictate care.

A089b683ee0498f2b21b7edfa300e405

(3895)

on July 06, 2011
at 06:34 PM

Wonder what the professional medical community, doctors et al, think about this..??

50637dfd7dc7a7e811d82283f4f5fd10

(5838)

on July 06, 2011
at 06:15 PM

Unreal! Thanks for posting.

  • Ed71ab1c75c6a9bd217a599db0a3e117

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4 Answers

5
1568416ef28477d1fa29046218d83ddd

(6235)

on July 06, 2011
at 06:42 PM

Here is the actual proposed rule

The bulk of it is rules for when a notification containing the following things must be sent before a supplement is marketed:

  • The name and complete address of the manufacturer or distributor that is submitting the notification.
  • The name of the NDI that is the subject of the premarket notification. For botanicals, the Latin binomial name must be given, including the author citation (the name of the scientist who gave the botanical its Latin binomial name).
  • A description of the dietary supplement that contains the NDI, including: the level of the NDI in the dietary supplement, and the conditions of use recommended or suggested in the labeling of the dietary supplement, or if no conditions of use are recommended or suggested in the supplement's labeling, the ordinary conditions of use of the supplement.
  • The history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended in the labeling of the dietary supplement, will reasonably be expected to be safe.
  • The signature of a person authorized by the manufacturer or distributor to sign the notification on its behalf

for supplement new to supplements (even if present in the food supply) since 1994. Then the FDA has 75 days before the supplement is on the market to object to the safety of the supplement or to object the sufficiency of the evidence of safety that was offered.

They have gotten 700 such notices since 1994. If you don't comply with these rules when you should they can remove the product from the marketed as adulterated.

1568416ef28477d1fa29046218d83ddd

(6235)

on July 06, 2011
at 07:01 PM

Oh and here is the link to submit an comment as part of the official administrative law record. http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0376-0001

1568416ef28477d1fa29046218d83ddd

(6235)

on July 06, 2011
at 06:55 PM

I am sort of mixed. On one hand it will slow supplements to market. On the other hand it will mean that more actual research might be done on supplements, herbs and the like. Right now I mostly have to rely on Germany's Commission E Reports for that sort of thing. The big down side and what might tip the balance for me is that I don't see any way that manufacturers can comply with the evidence of safety requirements without costs going up quite a lot. Some of this also just seems petty, like the requirement for the author citation for the binomial name.

Medium avatar

(4878)

on July 06, 2011
at 09:58 PM

Vrimj, Why do you believe it will increase research? Will the future supplements be patentable, and therefore producing a positive return on the investment of research?

1568416ef28477d1fa29046218d83ddd

(6235)

on July 06, 2011
at 07:08 PM

I am sort of mixed. On one hand it will slow supplements to market. On the other hand it will mean that more actual research might be done on supplements, herbs and the like. Right now I mostly have to rely on Germany's Commission E Reports for that sort of thing. The big down side and what might tip the balance for me is that I don't see any way that manufacturers can comply with the evidence of safety requirements without costs going up quite a lot. Some of this also just seems petty, like the requirement for the author citation for the binomial name.

Aead76beb5fc7b762a6b4ddc234f6051

(15239)

on July 07, 2011
at 12:27 AM

thank you for being a voice of clarity and reason. i appreciate the links to the actual proposal.

Medium avatar

(4878)

on July 07, 2011
at 01:37 AM

Vrimj, I still don't see how this is going to promote research. Since BigPharma controls the education and research system, how will funding be provided for low cost solutions with no patent protection? I see this ENDING if not decreasing research funds, not providing more.

1568416ef28477d1fa29046218d83ddd

(6235)

on July 06, 2011
at 10:09 PM

Looking at the requirements for showing safety it is going to require either book research and ethnobotney or more usual sorts of trial to show safety (but there is no requirement for showing effectiveness)

1568416ef28477d1fa29046218d83ddd

(6235)

on July 07, 2011
at 02:22 AM

Well either some safety research would have to be done, perhaps just into historical uses and reports of adverse effect to file any of these. It seems like some manufactures might create co-op research given that some limited protection might be offered by the barrier of this requirement along with a protection of the formulations.

2
215d3126214343a5760316f195a06b97

on July 06, 2011
at 06:31 PM

Ok, I personally take anything from naturalnews.com with a grain of salt. Also I've been hearing about variations of this for YEARS now, and nothing happening yet. I really doubt this would go through. But maybe I'm an optimist lol.

Ed71ab1c75c6a9bd217a599db0a3e117

(25472)

on July 06, 2011
at 07:17 PM

JAMA is run by the drug companies so I'd expect that. The real issue is that the lay public does not know what I just told you. What gets published in peer review journals these days is owned by pharma. They are the Monsanto of medicine.

Ed71ab1c75c6a9bd217a599db0a3e117

(25472)

on July 06, 2011
at 06:52 PM

Then contact LEF.org Bill Falloon is working like mad on this now. Its for real.

B1859f696e88d25460a6b8a333412ea3

(837)

on July 06, 2011
at 06:55 PM

How about JAMA? Their take is different, of course: http://jama.ama-assn.org/content/early/2011/06/30/jama.2011.982.full

1
66974b2cb291799dcd661b7dec99a9e2

(11121)

on July 06, 2011
at 06:15 PM

That is just obscene! Can we say socialist? Think I'll just move to Mars.

I am in Canada but every person in the US needs to fight this BS.

-1
9aa2a816c61170cc0183a68be0386ba5

on July 06, 2011
at 06:48 PM

Considering that most of these "supplements" do nothing and are only in existence to pray on people's pocketbooks, I don't see how this is a bad thing.

1f96ce108240f19345c05704c7709dad

(1061)

on July 07, 2011
at 12:59 AM

It would have helped had you said wrote what you now say you meant!

Ed71ab1c75c6a9bd217a599db0a3e117

(25472)

on July 06, 2011
at 07:18 PM

plus one Ben....

Cc7381bd787721575ea9198048132adb

(5541)

on July 06, 2011
at 08:46 PM

The main impact would be on the people that need the few supplements that actually do a lot of good

696079a860ef54810406ae25e4650863

(1623)

on July 06, 2011
at 09:08 PM

And another one for Ben.

Ed71ab1c75c6a9bd217a599db0a3e117

(25472)

on July 06, 2011
at 06:52 PM

So vitamin D 3 and K2 are do nothings? Minus one.

Af1d286f0fd5c3949f59b4edf4d892f5

(18472)

on July 06, 2011
at 07:31 PM

plus another one Ben

A8d95f3744a7a0885894ee0731c9744c

(3761)

on July 06, 2011
at 06:57 PM

Here comes the libertarian in me...People should be allowed to create and sell whatever they desire. That's the point of having a free market in a free country. Companies aren't directly responsible for the actions of those who buy their products. Do they market inappropriately? Sure. Is it wrong sometimes? Sure. BUT, it's their right, and it's up to the people to educate one another and shut down said businesses by NOT BUYING THE PRODUCT, not passing laws against freedom.

9aa2a816c61170cc0183a68be0386ba5

(1702)

on July 07, 2011
at 12:27 AM

Vitamins are not "supplements" I was more talking about the Green Tea weight loss pills and the Acai Berry MEGA-DO-EVERYTHING-YOU-EVER-WANTED pills. Vitamins are a whole different thing, please be rational.

A8d95f3744a7a0885894ee0731c9744c

(3761)

on July 06, 2011
at 11:29 PM

Thanks, all :-) Wish it was a real answer ;-)

531db50c958cf4d5605ee0c5ae8a57be

(8878)

on July 06, 2011
at 07:50 PM

+1 for Oranges--don't agree 100% but this is a valid discussion point. The tone of the article is weirdly hysterical. Most supplements are unnecessary and it's a ridiculous--and disingenuous--claim that health and life expectancy will decline precipitously if this bill is enacted. All supplements could be wiped off the face of the Earth tomorrow and the main impact would be on...people who make supplements.

1568416ef28477d1fa29046218d83ddd

(6235)

on July 07, 2011
at 01:16 AM

Supplements as regulated by the FDA includes vitamins and herbs like valarian. Also fish oils would probably be included. I don’t know when each of these reached the market in my perfered formulation but it seems likely I will at least be inconvenienced if this rule were to pass.

50637dfd7dc7a7e811d82283f4f5fd10

(5838)

on July 06, 2011
at 09:29 PM

+ 100 if I could, Ben

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