- The Americans banned NAC
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Hey healthier people
I thought I'd tell you the story of NAC in America, as I'm sure quite alot of you in the UK haven't heard what happened around NAC during Co-Vid.
Grab a coffee as its one of my usual emails, although I think most of you will find it interesting if you are into your health :)
Quickly, what is N-Acetyl-L-Cysteine (NAC)
NAC (N-Acetyl-L-Cysteine) is a derivative of the amino acid L-cysteine and a precursor to the powerful antioxidant glutathione. It's widely recognised for its antioxidant and mucolytic properties and is used to treat acetaminophen (Tylenol) overdose and to help clear mucus in respiratory conditions.
It's also one of the most widely used supplements for liver support, detox, mental health, and longevity.
The Americans (FDA) banned it, for a while.
The Timeline. When Did This Happen?
The seeds were planted early: In 2010, the FDA issued a warning letter stating that it believed NAC was a drug and, as such, is not allowed to be used as an ingredient in dietary supplements. But this first shot went mostly unnoticed.
In July of 2020, the FDA sent warning letters to specific companies stating that N-acetyl-L-cysteine (NAC) cannot be lawfully marketed as a dietary supplement. This was when COVID-19 was raging, and NAC was generating serious scientific interest as a potential immune support tool.
The FDA took unprecedented action to prohibit sales of NAC as a dietary supplement, which had been safely on the market for over 25 years, was found in hundreds of products, and on which thousands of consumers relied.
The core of the matter centers on the "drug preclusion" clause within the Dietary Supplement Health and Education Act (DSHEA) of 1994, a rule that prohibits ingredients from being marketed as dietary supplements if they were first approved as a drug in America.
The FDA's argument: NAC was approved as a drug in 1963, therefore it can't be a supplement. Simple as that, decades of safe use be doesnt matter it seems.
So why ban it then ? during Co-vid
NAC was being studied as a treatment for COVID-19 in several actively recruiting clinical trials across the country. The FDA moved to restrict a supplement that was showing COVID promise right in the middle of a pandemic, while a new FDA commissioner hadn't even been appointed yet.
Big Pharma was circling NAC:
A drug company was investigating NAC as a treatment for a rare genetic disorder that damages the myelin sheath, which insulates nerve cells in the brain.
A search through the American government's clinical trials database shows considerable interest from the pharmaceutical industry in NAC. There were 19 trials looking at NAC, in both drug and supplement form, in the treatment of COVID.
Additionally, there were over 50 trials looking at NAC for a variety of other conditions, including autism spectrum disorder, obsessive compulsive disorder, alcohol abuse disorder, rhinosinusitis, bronchiolitis, and cardiac arrhythmia.
If pharma could monopolise NAC as a patented drug treatment, cheap supplement versions needed to go.
No safety concerns whatsoever:
On its webpage devoted to Dietary Supplements in the Time of COVID-19, the National Institutes of Health stated that, "No safety concerns have been reported for products labeled as dietary supplements that contain NAC." The FDA did not cite any safety problems in any of its NAC-related warning letters.
So the FDA's move had nothing to do with consumer safety. Zero.
Some within the natural products industry believe that in targeting NAC supplements, the agency was doing the bidding of pharmaceutical companies. There were 19 clinical studies of NAC for COVID-19 care in the government's Clinical Trials registry, including several looking at NAC-based drugs.
No shit Sherlock ? This is their playbook, and it's happening with Ashwagandha right now in the UK
The FDA said NAC was a drug first, approved back in 1963, so it can't be a supplement. But when the industry went and checked the FDA's own paperwork, one document said 1963 and another said 1985.
They couldn't even agree with themselves on the basic facts they were using to ban it. Hard to take the ban seriously when the people enforcing it don't know their own records.
The Fightback
The supplement industry didn't roll over in America. Senators, trade groups, and a lawsuit all pushed back hard.
Senator Mike Lee (R-UT) called on the FDA to hold a public hearing on the NAC issue, a request that the FDA denied. Rep. Jeff Duncan (R-SC) sent a letter to the FDA demanding that regulators clarify their position on NAC, and cite any adverse events or other safety concerns that would warrant action to restrict sales.
The Resolution
The industry pushed back hard enough that in August 2022 the FDA backed down, issuing guidance saying they'd leave NAC alone "for now."
They admitted they'd found zero safety issues and acknowledged it had been used safely for over 25+ years. The lawsuit was dropped.
But here's the thing, the legal status of NAC as a supplement hasn't actually changed in America. They could come back for it any time they like, this is what they all love.
Leave everything as open as possible, so they can attack whoever they like, whenever they like. Here in the UK its called "Novel foods" same shit, different country.
They can pick any supplement they want and say - Send us proof this was on sale before 1996 in the UK, and if you can not send them proof they can ban us from selling said supplement.
Ashwagandha
In July 2024, the UK's Food Standards Agency launched a formal consultation on ashwagandha, asking for safety data.
Experts are already warning of a possible UK ban.
Denmark has already banned it. Sweden and Finland are looking at following suit.
The report that triggered all this European scrutiny? Widely criticised.
Academics have pointed out it drew conclusions from studies on parts of the ashwagandha plant that aren't even used in supplements.
Ashwagandha helps people manage stress. Takes the edge off. Helps people sleep. A lot of our customers use it instead of or alongside coming off antidepressants or anxiety meds.
The usual then ?
Something that works (alot of the time), that's natural, that's affordable, that helps people without a prescription, that's a threat to their business model. They can not patent Ashwagandha.
The Western diet leads to pills, pills and more pills, and that's exactly why they don't want you having access to the natural medicine that actually works,
because you have direct swaps for lots of their stuff, and you actually feel great rather than like shit on their drugs.
Anyway, our Ashwagandha is still available for now, and so is our NAC.
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Already noticed improvement
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Love!!!!
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Tumeric
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saw palmetto
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Would recommend!
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They do what they say!
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Good luck to you all in your fight against online scammers!"
Win - win is the goal :) stack links below to help narrow down what can potentially help you and your family.
Best wishes
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