Posted on 04/22/2022 10:38:49 AM PDT by nickcarraway
FDA on Thursday announced the availability of a draft guidance that, if finalized, would state the agency’s “intent to exercise enforcement discretion” regarding the distribution and sale of products labeled as dietary supplements and containing NAC (N-acetyl-L-cysteine).
The draft guidance, which is scheduled to be published April 22 in the Federal Register, was released three weeks after FDA reaffirmed its position in responses to two citizen petitions that NAC is excluded from the definition of a dietary supplement because the ingredient was first approved as a drug in 1963.
FDA, however, is still considering commencing a rulemaking to permit the use of NAC in supplements. To date, the agency has not identified any safety concerns related to the ingredient.
“The enforcement discretion policy would apply to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of ‘dietary supplement’ and that are not otherwise in violation of the FD&C [Federal Food, Drug & Cosmetic] Act,” FDA stated in the draft guidance, which was announced via a constituent update.
Unless FDA identifies “safety-related concerns” during its continuing review, the agency said it intends to “exercise enforcement discretion” until it completes notice-and-comment rulemaking to permit the use of NAC in supplements or it denies the rulemaking request.
"While our full safety review of NAC remains ongoing, our initial review has not revealed safety concerns with respect to the use of this ingredient in or as a dietary supplement," FDA stated in the draft guidance. "In addition, NAC-containing products represented as dietary supplements have been sold in the United States for more than 30 years, and consumers continue to seek access to such products."
FDA said it would notify stakeholders by withdrawing or revising the guidance if it determined the enforcement discretion policy was no longer proper.
To ensure FDA considers comments about the draft guidance before it begins its work on a final document, the agency has requested electronic or written comments within 30 days of the draft guidance’s publication in the Federal Register.
Although draft guidance, when finalized, will represent FDA’s current thinking on NAC products labeled as dietary supplements, the guidance neither creates any rights for anyone nor is binding on FDA or the public, the agency said.
A New Treatment for Pot Addiction [U.S. Government Moves to Ban it]
When your goal is Population Control, you can’t have too many effective healing agents available....
This is a govt that is outright at war with the People.
It does NOTHING to help anyone, except it’s immediate UniParty members.
they wanted to execute the CEOs and burn the buildings
of these GRAS (generally recognized as SAFE vitamins),
but too many, so absent the usual payoffs and lambos,
this is what the Public face from these proven criminals.
Ping!
The FDA has ‘approved’ the Covid ‘vaccines.’ Do you trust them to look out for you? Remember Ronald Regan’s Nine Words.....
Will Amazon start to carry it again?
NAC has been an effective component of my family’s daily Covid prevention regimen, which is why they want to “regulate”. 2.5 years, not even a cold. A pox on these people.
Vitacost and other health and nutrition stores have always had it.
I don’t remember the details, but I think there are different forms of NAC. The kind that vitamin/supplement outlets have always sold may be different from the prescription type.
Ping
They want to outlaw anything that may interfere with big pharma profits.
I bought mine last year on Amazon.
I’m surprised to see it no longer available at any brand or price.
I found the exact same (Best Naturals, NAC, 600mg, 250 capsules) at ebay.com, along with a whole bunch of others brands, sizes and doses.
Why did Amazon take it off sale?
Amazon stopped carrying it last July, because the government was taking action.
I am having to deal with a metabolic issue. Most of the Drs have been clueless about the biochemistry...or what to do with abnormal results. It’s like they know the words and that’s it.
There are very few metabolic genetics Drs in any given State.
NAC is a key component.
If you feel like crap just give NAC a try to see if it helps stabilize things. I have seen many discussions by the Dr..don’t remember his name..about NAC and Covid. It makes biochemical sense.
So does taking liposomal liquid glutathione.
The funds haven’t cleared in the account yet. That’s why there’s a delay.
Nac is 40 percent off at life extension..they may be trying to clear inventory ahead of a forced stop of sale.
Last year Life Extension told me they aren’t going to stop selling it, but things could have changed.
I’ve been taking this stuff for 15 years. I’m gonna chance it and not even read this.
Soooo, what they are saying is that it works, right?
.
You can buy it on eBay.
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