FDA NDI Draft Guidance Document: PP Article

ma70

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The end of supplements? PP Article Inside.

https://blog.priceplow.com/industry-news/2016-fda-ndi-draft-guidance

TL;DR

The FDA’s proposal is nothing short of a multi-pronged attack on the entire dietary supplement industry, and reaches much further than the bodybuilding or sports nutrition sectors.

It does not address the core problems that consumers face, which occur due to the FDA’s lack of enforcement of existing laws. Instead, the FDA is attempting to add mountains of costly and unnecessary bureaucratic processes that are literally impossible to achieve the remaining good actors of the industry.

No Reaction… Because Nobody Read It?

Despite the lack of reaction from industry insiders thus far (likely due to the fact that few people have actually read this monstrous document), there is much to be alarmed over.

This document represents an extreme amount of executive overreach from the federal government, and is purposefully vague yet simultaneously filled with hostile legal traps aimed towards damaging American businesses and limiting consumer choice.

Worse, we do not believe it represents the spirit of DSHEA 1994 as enacted into law some 22 years ago.
Ingredients That Could Become Illegal

The following ingredients are just a few that could become illegal for use in dietary supplements if this document is enacted “as is”:
Molecularly Distilled Fish Oil
Fish Oils with Unnaturally High EPA:DHA Ratios
Hydrolyzed Whey Protein
Ubiquinol
Ashwagandha
Resveratrol
Bacopa monnieri
Theanine
Yohimbe
Synephrine
Octopamine
Hordenine, and
N-Methyltyramine

…amongst potential others, despite each of these ingredients having a true basis in nature and being used in the dietary supplement marketplace with a high degree of safety for decades.

Increasing costs: Other ingredients such as Taurine and Vitamin C from Rose Hips could become monumentally more expensive, and this may subsequently have a profoundly negative effect on neighboring industries such as pet food products.

These ingredients are used by tens of millions of people in the United States each year – with most usage entirely unrelated to sports nutrition and bodybuilding.
The Ramifications: Yet Another Industry Sent Overseas

If passed, the American dietary supplement industry could forever be ruined, shifting more economic and labor resources overseas where such bureaucracies do not occur.

Further, the writing of such vague, byzantine laws will likely create unintended consequences that we cannot even begin to imagine today, much of which will be fueled by more intra-industry & class action lawsuits that will only benefit tort lawyers.
Get involved! Our Call to Action

As such, we urge our readers to click here to write your representatives in Congress, sign our White House Petition, and leave commentary for the FDA.
Hmmm....thoughts? Not trying to spam or anything, but I think this calls for some forum attention too (mostly the signing of petitions/etc)

If you want to support the cause:
https://blog.priceplow.com/industry-news/2016-fda-ndi-draft-guidance/how-to-help

You can sign the petition to the white house and also send comments to your congressman through that link. You should also probably send it to all of your gym bros (or even people who just take random stuff like Fish Oil) to sign!
 

enraged_chris

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It will be a significant blow on the industry. I've already called,emailed and written my local state representative regarding this. I recommend everyone does the same or the supplement industry (in the form we know it) could be done for.
 

ma70

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It will be a significant blow on the industry. I've already called,emailed and written my local state representative regarding this. I recommend everyone does the same or the supplement industry (in the form we know it) could be done for.
I wrote to the representative and signed the petition as well.
 

ma70

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I'm guessing my thread title sucked. Maybe it should have been more dramatic, haha.
 
muscleupcrohn

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I'm guessing my thread title sucked. Maybe it should have been more dramatic, haha.
Haha, dramatic and sensational titles/headlines always get attention. Perhaps you could have went with "THE END OF THE (SUPPLEMENT) WORLD IS COMING!"
 

ma70

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Haha, dramatic and sensational titles/headlines always get attention. Perhaps you could have went with "THE END OF THE (SUPPLEMENT) WORLD IS COMING!"
True, but I find them pretty obnoxious so I can't bear to do that. I guess while you're here, here's to hoping you sign the petition! Haha.
 
muscleupcrohn

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True, but I find them pretty obnoxious so I can't bear to do that. I guess while you're here, here's to hoping you sign the petition! Haha.
Of course; it's pretty ridiculous. Ashwagandha and bacopa? What the f**k man, does pharama want ashwagandha and bacopa now?
 
smith_69

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True, but I find them pretty obnoxious so I can't bear to do that. I guess while you're here, here's to hoping you sign the petition! Haha.
ma70 is there a universal link that you can put here so people can read what to do and how to do it
 

ma70

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Of course; it's pretty ridiculous. Ashwagandha and bacopa? What the f**k man, does pharama want ashwagandha and bacopa now?
I really, really would be angry if they messed with my beloved Ashwaghanda. It does EVERYTHING for me.
 

ma70

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ma70 is there a universal link that you can put here so people can read what to do and how to do it
I actually just posted PP's petition/help guide in the original post. Also trying to get the topic renamed to gather more attention, because I actually think this is worth a look. Imagine Whey Protein, Fish Oil, and Ashwagandha being banned...LAME. There are a lot of supplements I don't give a crap about, but let me keep my damn staples!
 
muscleupcrohn

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I really, really would be angry if they messed with my beloved Ashwaghanda. It does EVERYTHING for me.
Exactly; now imagine if you had to get a prescription from your doctor for it (and basically everything else). Ashwagandha and bacopa are effective, safe, natural, and cheap, so I don't think it's out of the question that there's some ulterior motives at play here.
 

ma70

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Exactly; now imagine if you had to get a prescription from your doctor for it (and basically everything else). Ashwagandha and bacopa are effective, safe, natural, and cheap, so I don't think it's out of the question that there's some ulterior motives at play here.
Not that I use the other stuff, but let's not forget Berberine ("the herbal Metformin") and of course, I like my Curcumin and all those small other goodies when my joints are hurting.
 
smith_69

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the only way to say this correctly,

this is fycking stupid

i can go to bar every night or drink a 6 pack, become an alcoholic and have all the negatives that come with alcoholism but taking fish oil and protein is deemed to be possibly banned. WTF - what country are we living in
 

ma70

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the only way to say this correctly,

this is fycking stupid

i can go to bar every night or drink a 6 pack, become an alcoholic and have all the negatives that come with alcoholism but taking fish oil and protein is deemed to be possibly banned. WTF - what country are we living in
Yeah, when a friend of mine sent me the original link, I was just dumbfounded. You can buy cigs, alcohol, and all this crap.....but Fish Oil will be illegal? Wow.

Also, Kratom becoming scheduled is another big pile of crap
 
muscleupcrohn

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Yeah, when a friend of mine sent me the original link, I was just dumbfounded. You can buy cigs, alcohol, and all this crap.....but Fish Oil will be illegal? Wow.

Also, Kratom becoming scheduled is another big pile of crap
It's insane; I do think that there's something to be gained by someone with influence (pharma?) here; we know that ashwagandha, bacopa, and fish oil aren't a danger to people's health in the slightest, but lots of these ingredients are actually pretty effective for certain things (either as alternatives or adjuncts). I don't want to get a script for bacopa, theanine, and amino acids; at that point just get a script for armodafinil and test. This whole thing is a joke.
 

ma70

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It's insane; I do think that there's something to be gained by someone with influence (pharma?) here; we know that ashwagandha, bacopa, and fish oil aren't a danger to people's health in the slightest, but lots of these ingredients are actually pretty effective for certain things (either as alternatives or adjuncts). I don't want to get a script for bacopa, theanine, and amino acids; at that point just get a script for armodafinil and test. This whole thing is a joke.
I'm surprised the petition hasn't gotten more signatures. You'd think all the supplement vendors, and possibly companies would try to notify people of this. Or is there some rule against that? (I don't really know the ins and outs of the industry like that)
 
muscleupcrohn

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I'm surprised the petition hasn't gotten more signatures. You'd think all the supplement vendors, and possibly companies would try to notify people of this. Or is there some rule against that? (I don't really know the ins and outs of the industry like that)
This is just speculation, but considering that the battle for DMAA went to court, I can't see someone(s) not taking this there if it gets that far, considering it encompasses just about every ingredient in every category of supplement, not just one ingredient that's pretty much only used in pre-workouts and fat burners. Only time will tell though.
 

ma70

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This is just speculation, but considering that the battle for DMAA went to court, I can't see someone(s) not taking this there if it gets that far, considering it encompasses just about every ingredient in every category of supplement, not just one ingredient that's pretty much only used in pre-workouts and fat burners. Only time will tell though.
Let's go Hi-Tech Pharma! Attack!!!
 
Jiigzz

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This is ****ed. If I read this right, the FDA is saying ingredients needed to be called dietary ingredients before 1994 to be sold as dietary supplements after 1994 without an NDI. However prior to '94, it wasn't legally require to label them as such and so many were not. How can you preemptively label something a particular title for something that hasn't occurred yet?

The petition only has sub 300 signatures in the 10 days the article has been up, however it needs ~100,000 more in a matter of weeks to be considered. Get behind this!

https://petitions.whitehouse.gov/petition/reject-fdas-new-ndi-draft-guidance-dietary-supplements-which-will-endanger-consumers-and-american-jobs
 

enraged_chris

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Basically it allows the fda and pharma companies to have a monopoly over any compound found in an herb. Or any derivative of any compound found in an herb. It's ridiculous.
 
ryane87

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Thank you and I just signed. Some company with influence and wealth has to feel threatened, otherwise healthy supplements such as bacopa and ashwagandha are going to be illegal but I can still have my cancer sticks and be a drunk, which actually take lives. This country is so, so effed up sometime s
 
Brandinooooo

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Depending on the loosely worded paper, this could effect soda companies and energy drink companies as well because of the yohimbe.
 
ryane87

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Depending on the loosely worded paper, this could effect soda companies and energy drink companies as well because of the yohimbe.
They would just put caffeine only in energy drinks...mainstream companies don't really use yohimbine
 
Brandinooooo

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True but its gonna effect more than they realize if they try to push it.
 
jaredmus

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hyrdo whey- I can see optimum going to battle for that along with many other companies hopping on board.

in for pre workouts with 6 grams BA and 500mg caffeine if this BAN happens
 

ma70

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This is ****ed. If I read this right, the FDA is saying ingredients needed to be called dietary ingredients before 1994 to be sold as dietary supplements after 1994 without an NDI. However prior to '94, it wasn't legally require to label them as such and so many were not. How can you preemptively label something a particular title for something that hasn't occurred yet?

The petition only has sub 300 signatures in the 10 days the article has been up, however it needs ~100,000 more in a matter of weeks to be considered. Get behind this!

https://petitions.whitehouse.gov/petition/reject-fdas-new-ndi-draft-guidance-dietary-supplements-which-will-endanger-consumers-and-american-jobs
Yeah, honestly, something tells me we really aren't going to get 100,000 signatures. There seems to be a difference between the general supplement community and the Kratom community.
 
The_Old_Guy

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Sounds like how Gun Control legislation is written.

Somebody call Orin Hatch!

Remember - Gov't employees are generally stupid.

I'm going to sign and call and whatever - they prolly figure since Kratom was so easy to go after (because they hid it and didn't allow the public to comment...) let's try for more.

Thumbs up ma70 !
 

ma70

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Sounds like how Gun Control legislation is written.

Somebody call Orin Hatch!

Remember - Gov't employees are generally stupid.

I'm going to sign and call and whatever - they prolly figure since Kratom was so easy to go after (because they hid it and didn't allow the public to comment...) let's try for more.

Thumbs up ma70 !
Thanks man, but of course, thank priceplow and whoever wrote it. I thought Jiigzz or someone from SNS wrote it?

It's sad though. I wouldn't care if they ban hammered/slammed 90% of the supplement companies out there, but getting in the way of my health staples is way too far.
 
justhere4comm

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Signed. Now 322 of 100,000. Only 99,678 more to go. :/
 

ma70

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Signed. Now 322 of 100,000. Only 99,678 more to go. :/
We only have until October 11. Something tells me even the entirety of this site will get nowhere near that....and outside of this forum, I don't really think it's being spread anywhere.
 
ryane87

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This should be on all the forums. Otherwise, this will probably be very bad news for the supplement user. It takes like 2 or 3 minutes to sign...it is mind-boggling that there aren't more signatures
 

Rob1882

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Just wow sad and pathetic but who didn't see this coming?

Big Pharma wants in on that $$$
 
ryane87

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Just wow sad and pathetic but who didn't see this coming?

Big Pharma wants in on that $$$
Yep....they want to be our pusher
 

Rob1882

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Yep....they want to be our pusher
inb4 prescription Yohimbe 800$ a bottle gotta make payments for them McMansions and private jet fleets breh ;)

Big Pharma don't care... right :p like that prescription THC and their lobbying against the evil's of pot with leaked documents of them claiming it will hurt their $$$$ of prescription THC lol

BRB can't afford to live if I get stung by a bee either my mortgage payment in injections or die.. :|
 
ryane87

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inb4 prescription Yohimbe 800$ a bottle gotta make payments for them McMansions and private jet fleets breh ;)

Big Pharma don't care... right :p like that prescription THC and their lobbying against the evil's of pot with leaked documents of them claiming it will hurt their $$$$ of prescription THC lol

BRB can't afford to live if I get stung by a bee either my mortgage payment in injections or die.. :|
This....I understand research goes into products, but after your patent runs out, and more than likely before, you have made your money back then some....
 
justhere4comm

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This....I understand research goes into products, but after your patent runs out, and more than likely before, you have made your money back then some....
Or when a potential cure for cancer comes up but is not patentable no research is ever done.
 

Rob1882

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This....I understand research goes into products, but after your patent runs out, and more than likely before, you have made your money back then some....
Well a LARGE amount of cutting edge research on drugs/ medication is funded by the public through tax money were being robbed with lack of regulation look at the wealth disparity and the salaries involved... follow the money in the case of the epipen look who her father is and the kickbacks I mean come the **** on lol

This happens on a daily basis..





http://www.alternet.org/news-amp-politics/fda-now-officially-belongs-big-pharma

http://www.forbes.com/sites/johnlamattina/2013/08/07/is-the-fda-being-compromised-by-pharma-payments/#26e75c887908

http://rense.com/general72/fdasown.htm

http://truthinmedia.com/big-pharma-influence-over-fda/

https://zcomm.org/znetarticle/you-wont-believe-the-outrageous-ways-big-pharma-has-bribed-doctors-to-shill-drugs/

https://chomsky.info/199804__-2/
 
ryane87

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Oh yeah man...our system is 100% set up to keep the money where it is
 
GreekTheBrick

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Maybe they should ban training. Greedy ****ers that want to control every aspect of our lives.
 
justhere4comm

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Well a LARGE amount of cutting edge research on drugs/ medication is funded by the public through tax money were being robbed with lack of regulation look at the wealth disparity and the salaries involved... follow the money in the case of the epipen look who her father is and the kickbacks I mean come the **** on lol

This happens on a daily basis..





http://www.alternet.org/news-amp-politics/fda-now-officially-belongs-big-pharma

http://www.forbes.com/sites/johnlamattina/2013/08/07/is-the-fda-being-compromised-by-pharma-payments/#26e75c887908

http://rense.com/general72/fdasown.htm

http://truthinmedia.com/big-pharma-influence-over-fda/

https://zcomm.org/znetarticle/you-wont-believe-the-outrageous-ways-big-pharma-has-bribed-doctors-to-shill-drugs/

https://chomsky.info/199804__-2/
They are out to ruin all of our lives and make a chit-load of money in the process. All the pharma reps I know, and a big-wig at a major pharma company have huge homes, and living big off of the fears of everyone. It's rather disgusting how they skip over products they cannot patent, yet most assuredly would save lives and money.

That and the faulty insurance industry. People having to work well past their 65th birthday to afford their meds.
I work with an 80 year old man. He's former military, is sharp as they come (mostly), (He sometimes tells me the same joke twice in a day) but he's like a second father. It pains me, he has to work full-time still.
 

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It is just legislation to stifle innovation. It's really horrible stuff. If this is enforced we wouldn't even be able to get 90% of what we can now.
 

kisaj

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This should be on all the forums. Otherwise, this will probably be very bad news for the supplement user. It takes like 2 or 3 minutes to sign...it is mind-boggling that there aren't more signatures
People don't know about it. If it wasn't posted here I'd have no idea.
 
ryane87

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People don't know about it. If it wasn't posted here I'd have no idea.
I was more commenting on the lack of signatures even with the amount of people here that could see it. There were only 300. I wouldn't have heard about it either. I am just surprised it is this quiet. If I had a supplement company or supplement distributor, I would be posting on every fitness forum I could
 

ma70

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Well, we'll see how everything plays out. I guess the Kratom community is much bigger/stronger than the general bodybuilding community cause their petitions got 135k+ easily.
 
rascal14

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How much do these petitions actually do in preventing these things from happening?
 

ma70

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How much do these petitions actually do in preventing these things from happening?
Well, if everything goes according to what is actually supposed to happen, the white house is forced to "respond" to the petition instead of just ignoring it completely.
 

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