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URGENT: FDA trying to push anti-supplement policy by next year

 
Anonymous Coward
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United States
07/27/2021 10:26 AM
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URGENT: FDA trying to push anti-supplement policy by next year
Please sign the following petition to fight against supplementation apocalypse.

[link to anh-usa.org (secure)]


Overview

The FDA could be preparing to unleash an anti-supplement policy as early as next year that could eliminate tens of thousands of products from the market—in the middle of a pandemic. Action Alert!

Recently, the FDA announced that, by the end of June 2022, it plans to release drafts or final versions of a number of policies, and among them is the “new dietary ingredient” (NDI) guidance (“new supplement” guidance, in plain English). It is no exaggeration to say that this is the most dangerous threat to supplements we’ve seen in decades. We must continue to vehemently oppose the guidance as currently written and demand that substantial changes are made before the final version is released. It is especially dangerous given that we are in a pandemic situation that is constantly evolving, with scientists warning of viral variants that evade vaccine-induced immunity.

Here is some brief background. Under the Dietary Health and Supplement Education Act (DSHEA), any dietary supplement introduced to the market in the US after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of marketing the product. In implementing this policy, however, the FDA has turned a simple notification procedure into a de facto pre-approval process akin to that which is required of pharmaceutical drugs.

The FDA’s policy is nothing less than a massive broadside aimed at crippling the supplement industry. How do we know this? An economic analysis estimated that the guidance would result in:

tens of thousands of products disappearing from store shelves;
an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA’s NDI notification protocols; and
the loss of between 55,270 and 104,475 jobs in the supplement industry.
How does the FDA’s guidance do this? First, the guidance imposes safety requirements on new supplements that are not even expected of drugs! The FDA’s guidance describes how to determine what kind of safety studies to submit with an NDI notification. The agency states that additional safety studies may be needed if the target population of supplements changes. For example, if a history of safe use has been established with adults, but a substance will be used in a dietary supplement marketed for young children, the FDA would require another NDI notification. Not even drugs are held to this standard: the FDA states that “most drugs prescribed for children have not been tested in children.”

Safety studies for supplements may sound reasonable, but just remember: requiring these studies is part of the FDA approval process for drugs. Drugs can afford them because they are patentable. Supplements are natural and are not strongly patentable, so if they are also required to conduct pre-market studies, they don’t have the same ability to recoup those costs. This will either force companies to go out of business or it will make supplements so expensive that they are priced out of the market. Supplements also have a consistently sterling record of safety.

The FDA is also broadening the group of substances that must submit new supplement notifications by adopting a loose definition of what it means for a supplement to be “chemically altered.” If a post-DSHEA ingredient has been present in the food supply and has not been chemically altered, it is exempted from submitting an NDI notification. The problem is that the FDA’s definition of “chemically altered” is so broad that only the most basic manufacturing methods would not “chemically alter” an ingredient. This language will stifle innovations in manufacturing and ignores the fact that new and more effective ways of producing supplements have arisen in the last twenty-two years since DSHEA passed.

There are even more problems with the guidance that interested readers can reference in our previous coverage of this topic.

If the FDA sticks to its timeline of June 2022, the release of the final guidance could seriously hinder our ability to stay healthy, naturally, during this pandemic. And using supplements to shore up our immune system against COVID is even more important as scientists learn more about the ability of multiple COVID variants to adapt and “escape” the immunity conferred by current vaccines and even natural infection. As noted in Science, “Such ‘immune escapes’ could mean more people who have had COVID-19 remain susceptible to reinfection, and that proven vaccines may, at some point, need an update.”

In light of these concerns, our friends at ANH International have wisely advised that we don’t rely exclusively on vaccines; we need a diverse array of tools to protect ourselves, including access to quality supplements. We can’t use these strategies if the FDA makes sure they’re out of reach. We must push back against this bureaucratic indifference to our health and well-being.

Action Alert! Write to Congress and the FDA to urge drastic changes to the NDI guidance to protect supplement access. Please send your message immediately.
Anonymous Coward
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07/27/2021 10:38 AM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
What's next, banning foods rich in nutrients?
Anonymous Coward
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Greece
07/27/2021 10:50 AM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
What's next, banning foods rich in nutrients?
 Quoting: Anonymous Coward 76400490


YES!!!

WAKE UP!!!
Anonymous Coward
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United States
07/27/2021 10:51 AM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
guess I will stock up..take a crap load of vitamins etc every day
Anonymous Coward
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07/27/2021 10:52 AM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
There's no end to this shit.. 5 stars
Anonymous Coward
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Greece
07/27/2021 10:53 AM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
Supplements that modulate, boost, fortify the immune system, or are anti-biotic, anti-viral, anti-parasitic, -anti cancer etc ARE DIRECTLY AGAINST THE AGENDA OF BIG PHARMA!!!

THEY DIRECTLY COMPETE AGAINST THE NWO AGENDA OF COVID-19, THEY DIRECTLY HINDER PROFITS OF BIG PHARMA THEY GIVE THE SOVEREIGN HUMANS TOO MUCH POWER OVER THEIR OWN BODIES AND HEALTH.
Anonymous Coward
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Greece
07/27/2021 10:57 AM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
Specifically targeted will be any supplement found to treat or cure COVID-19, supplements that give neuroprotective properties, supplements that help prevent strokes and blood clots, and supplements that work with the immune system to prevent things like over active or under active immune system...

BASICALLY ANYTHING THAT IS GOING TO HINDER THE AGENDA OF THE CORRUPT RULING ELITE AND THEIR PLAN FOR THE NWO AND TOTALITARIAN CONTROL OVER A WORLD WIDE DUMBED DOWN UNHEALTHY SLAVE CLASS.
Anonymous Coward
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07/27/2021 10:59 AM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
keep signing those petitions mate
Anonymous Coward (OP)
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United States
07/27/2021 11:00 AM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
bottom line, the system makes money when people are sick. A lifetime of servitude to meds and medical treatments is where the $$$$ is at. This is why we can fit a micro-processor on the head of a pin, but cannot cure cancer. There is no $$$$ in cures and self-health. this is why the system hates supplements....cuz they cannot control them.
Anonymous Coward
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07/27/2021 11:18 AM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
What more proof do you people need that this isn’t about curing you but that this is about controlling us and allowing the politically incorrect to die?
Anonymous Coward
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07/27/2021 11:31 AM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
They want you dead!
SentientTransient

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07/27/2021 11:44 AM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
What's next, banning foods rich in nutrients?
 Quoting: Anonymous Coward 76400490


YES.

-ONLY FDA APPROVED SHOTS AND ADVANCED MED
-ONLY SOYLENT GREEN/GATES GMO AGRICULTURE
-ONLY WALMART OR TARGET
-ONLY AMAZON
-ONLY FACEBOOK
-ONLY TWITTER
-ONLY LIMITED INTERNET
-ONLY GOVT NEWS AND PUBLIC INFO
-ONLX GOVT APPROVED READING MATERIAL
-ONLY ALLOTTED CAPPED ELECTRIC USAGE
-ONLY "APPROVED" WATER SUPPLY AND BEVERAGE
-ONLY GRAPHENE MASKS- BUT MANDATORY
-ONLY VACCINATED ALLOWED TO BUY OR SELL
-ONLY GOVT ISSUED CRYPTO DIGI CURRENCY
-ONLY GOVT APPROVED EDUCATION
-ONLY GOVT MANAGED HOUSING
-ONLY GOVT CONTROLLED RENT
-ONLY GOVT APPROVED RELIGION
-ONLY GOVT APPROVED BELIEFS & OPINIONS
-ONLY GOVT APPROVED ENTERTAINMEMT
-ONLY GOVT APPROVED ART AND DEVELOPMENT
-ONLY GOVT ISSUED EMPLOYMENT
-ONLY GOVT AUTHORIZED AUTOMATED TRANSPORT
-ONLY GOVT AUTHORIZED REPRODUCTION
-ONLY GOVT AUTHORIZED ORGANIC HUMANS
-ONLY GOVT ISSUED THC OPIATE
-ONLY GOVT AUTHORIZED VACATION EXPERIENCES
If it isn't in The Bible then it is just conspiracy theory.
Batman is cool

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07/27/2021 12:00 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
bump
Anonymous Coward
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United States
07/27/2021 03:46 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
Why bother with the slow kill?

Just come one out with the death chambers, put one on every corner. More convenient that way. Make it quick.

If they're trying to kill the herd slowly, so that the herd doesn't catch on, they're not being very subtle about it at this point.

Hello Georgia Guidestones. . .
Anonymous Coward
User ID: 38907753
United States
07/27/2021 03:49 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
Please sign the following petition to fight against supplementation apocalypse.

[link to anh-usa.org (secure)]


Overview

The FDA could be preparing to unleash an anti-supplement policy as early as next year that could eliminate tens of thousands of products from the market—in the middle of a pandemic. Action Alert!

Recently, the FDA announced that, by the end of June 2022, it plans to release drafts or final versions of a number of policies, and among them is the “new dietary ingredient” (NDI) guidance (“new supplement” guidance, in plain English). It is no exaggeration to say that this is the most dangerous threat to supplements we’ve seen in decades. We must continue to vehemently oppose the guidance as currently written and demand that substantial changes are made before the final version is released. It is especially dangerous given that we are in a pandemic situation that is constantly evolving, with scientists warning of viral variants that evade vaccine-induced immunity.

Here is some brief background. Under the Dietary Health and Supplement Education Act (DSHEA), any dietary supplement introduced to the market in the US after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of marketing the product. In implementing this policy, however, the FDA has turned a simple notification procedure into a de facto pre-approval process akin to that which is required of pharmaceutical drugs.

The FDA’s policy is nothing less than a massive broadside aimed at crippling the supplement industry. How do we know this? An economic analysis estimated that the guidance would result in:

tens of thousands of products disappearing from store shelves;
an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA’s NDI notification protocols; and
the loss of between 55,270 and 104,475 jobs in the supplement industry.
How does the FDA’s guidance do this? First, the guidance imposes safety requirements on new supplements that are not even expected of drugs! The FDA’s guidance describes how to determine what kind of safety studies to submit with an NDI notification. The agency states that additional safety studies may be needed if the target population of supplements changes. For example, if a history of safe use has been established with adults, but a substance will be used in a dietary supplement marketed for young children, the FDA would require another NDI notification. Not even drugs are held to this standard: the FDA states that “most drugs prescribed for children have not been tested in children.”

Safety studies for supplements may sound reasonable, but just remember: requiring these studies is part of the FDA approval process for drugs. Drugs can afford them because they are patentable. Supplements are natural and are not strongly patentable, so if they are also required to conduct pre-market studies, they don’t have the same ability to recoup those costs. This will either force companies to go out of business or it will make supplements so expensive that they are priced out of the market. Supplements also have a consistently sterling record of safety.

The FDA is also broadening the group of substances that must submit new supplement notifications by adopting a loose definition of what it means for a supplement to be “chemically altered.” If a post-DSHEA ingredient has been present in the food supply and has not been chemically altered, it is exempted from submitting an NDI notification. The problem is that the FDA’s definition of “chemically altered” is so broad that only the most basic manufacturing methods would not “chemically alter” an ingredient. This language will stifle innovations in manufacturing and ignores the fact that new and more effective ways of producing supplements have arisen in the last twenty-two years since DSHEA passed.

There are even more problems with the guidance that interested readers can reference in our previous coverage of this topic.

If the FDA sticks to its timeline of June 2022, the release of the final guidance could seriously hinder our ability to stay healthy, naturally, during this pandemic. And using supplements to shore up our immune system against COVID is even more important as scientists learn more about the ability of multiple COVID variants to adapt and “escape” the immunity conferred by current vaccines and even natural infection. As noted in Science, “Such ‘immune escapes’ could mean more people who have had COVID-19 remain susceptible to reinfection, and that proven vaccines may, at some point, need an update.”

In light of these concerns, our friends at ANH International have wisely advised that we don’t rely exclusively on vaccines; we need a diverse array of tools to protect ourselves, including access to quality supplements. We can’t use these strategies if the FDA makes sure they’re out of reach. We must push back against this bureaucratic indifference to our health and well-being.

Action Alert! Write to Congress and the FDA to urge drastic changes to the NDI guidance to protect supplement access. Please send your message immediately.
 Quoting: Anonymous Coward 80007429

dosent mean it will work "TRYING"
Anonymous Coward
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07/27/2021 03:49 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
Thread: EWWWWWWWWW! MUH COVID MASK! Joe Biden Left His Filthy Face Diaper In A Random Boy's Hand?




yaksiren2
Coy

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07/27/2021 03:50 PM

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Re: URGENT: FDA trying to push anti-supplement policy by next year
Freedom, liberty and good health! FDA is contrary to these ideals. Frankly, they hate God.
Butch DeFeo
Itz The MonkeyPauxCommyUsurpPocalypse

User ID: 69436271
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07/27/2021 03:52 PM

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Re: URGENT: FDA trying to push anti-supplement policy by next year
They've been trying to do this for decades
ENDTHESHUTDOWN77redblueLEDDONTBEAPANDEMICS
Only you can stop the fake pandemic for yourself, no one will ever tell you the pandemic is over. It's time to WIN.
Itz The MonkeyPauxCommyUsurpPocalypse - Pronounced "MONKEY POE COMMY YOU SIR POCKA LIPS"
Anonymous Coward
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07/27/2021 03:52 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
FYI guys: One of the vital they may go after is vit D. No worries there is a vitamin D lamp u can buy if u have to. It's more expensive than just popping vits, but better than nothing. I have the Sperti. U can probably still find online.
Reality Czar dodger007

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07/27/2021 03:54 PM

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Re: URGENT: FDA trying to push anti-supplement policy by next year
What's next, banning foods rich in nutrients?
 Quoting: Anonymous Coward 76400490


Why not?
Sunlight has been under chemtrail assault for years now

When vitamins are criminalized, only criminals will have vitamins

Last Edited by Dodger007 on 07/27/2021 03:55 PM
“That men do not learn very much from the lessons of history is the most important of all the lessons that history has to teach.”
Aldous Huxley
OneFeather

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07/27/2021 03:54 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
FYI guys: One of the vital they may go after is vit D. No worries there is a vitamin D lamp u can buy if u have to. It's more expensive than just popping vits, but better than nothing. I have the Sperti. U can probably still find online.
 Quoting: Anonymous Coward 79947489


Sun is free usually.
Anonymous Coward
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United States
07/27/2021 03:57 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
They've been trying to do this for decades
 Quoting: Butch DeFeo


hesright
Anonymous Coward
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United States
07/27/2021 03:58 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
They've been trying to do this for decades
 Quoting: Butch DeFeo


hesright
 Quoting: Anonymous Coward 80013689


I WOULDNT worry about this "trying" isnt doing.
Anonymous Coward
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07/27/2021 04:01 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
What's next, banning foods rich in nutrients?
 Quoting: Anonymous Coward 76400490


why the hell do you think Gates is pushing bug butter and cockroach meat substitutes?
Anonymous Coward
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Canada
07/27/2021 04:23 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
What's next, banning foods rich in nutrients?
 Quoting: Anonymous Coward 76400490


YES!!!

WAKE UP!!!
 Quoting: Anonymous Coward 80268073


That would actually be really funny and maybe finally get the upper crust interested in the tyranny
Anonymous Coward
User ID: 79780865
Canada
07/27/2021 04:24 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
FYI guys: One of the vital they may go after is vit D. No worries there is a vitamin D lamp u can buy if u have to. It's more expensive than just popping vits, but better than nothing. I have the Sperti. U can probably still find online.
 Quoting: Anonymous Coward 79947489


Um no, they will never be able to get Vit D supplements off the market. Stop your fear mongering.
They are going after shit like NAC, which is still bad enough, but they will fail. Buffy and Fluffy and the rest of the hollywood bitches want their products.
Anonymous Coward
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07/27/2021 04:24 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
What's next, banning foods rich in nutrients?
 Quoting: Anonymous Coward 76400490


They will just leave us with Cheetos little Debbie’s and grape drank. They want us dead so bad.
SentientTransient

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07/27/2021 04:25 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
Why bother with the slow kill?

Just come one out with the death chambers, put one on every corner. More convenient that way. Make it quick.

If they're trying to kill the herd slowly, so that the herd doesn't catch on, they're not being very subtle about it at this point.

Hello Georgia Guidestones. . .
 Quoting: Anonymous Coward 2563290


It's more fun for them to do it slowly. For after they complete their project- THEN what?
If it isn't in The Bible then it is just conspiracy theory.
Anonymous Coward
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United States
07/27/2021 04:25 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
Supplements that modulate, boost, fortify the immune system, or are anti-biotic, anti-viral, anti-parasitic, -anti cancer etc ARE DIRECTLY AGAINST THE AGENDA OF BIG PHARMA!!!

THEY DIRECTLY COMPETE AGAINST THE NWO AGENDA OF COVID-19, THEY DIRECTLY HINDER PROFITS OF BIG PHARMA THEY GIVE THE SOVEREIGN HUMANS TOO MUCH POWER OVER THEIR OWN BODIES AND HEALTH.
 Quoting: Anonymous Coward 80268073


The biggest thing is they keep us alive. Well they can’t ban pine needle tea and all the nutritious weeds in my yard.
Peepaws

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07/27/2021 04:26 PM

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Re: URGENT: FDA trying to push anti-supplement policy by next year
What's next, banning foods rich in nutrients?
 Quoting: Anonymous Coward 76400490


YES!!!

WAKE UP!!!
 Quoting: Anonymous Coward 80268073


That was my first thought in reading this.
Peepaws
Anonymous Coward
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07/27/2021 04:27 PM
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Re: URGENT: FDA trying to push anti-supplement policy by next year
They comin for dem assault vitamins. Too many chilluns gettin pisoned by those vitamin C, D,G, J and Ls.

Hint: they want us dead. Shoon.





GLP