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FDA Requests Information Relevant to the Use of NAC as a Dietary Supplement​

November 24, 2021
The Food and Drug Administration (FDA) is requesting information on the past use of N-acetyl-L-cysteine (NAC) in products marketed as dietary supplements.
Earlier this year, the FDA received two citizen petitions asking the agency to reconsider its position on the use of NAC as a dietary supplement. In June 2021, the Council for Responsible Nutrition (CRN) asked the FDA to reverse the agency’s position that NAC-containing products cannot be dietary supplements. In August 2021, the Natural Products Association (NPA) asked the FDA to either determine that NAC is not excluded from the definition of a dietary supplement or, in the alternative, initiate rulemaking to make NAC a lawful dietary supplement under the Federal Food, Drug, and Cosmetic Act.
Today, the FDA issued tentative responses to both citizen petitions, requesting additional information from the petitioners and interested parties and noting that the agency needs additional time to carefully and thoroughly review the complex questions posed in these petitions.
To help the agency respond to the petitions, the FDA is interested in receiving data and information on the earliest date that NAC was marketed as a dietary supplement or as a food, the safe use of NAC in products marketed as a dietary supplement, and any safety concerns. If applicable, the FDA will use the information submitted to the public docket and other applicable information to determine if rulemaking to make NAC lawful as a dietary supplement is appropriate.
The FDA is asking interested parties to submit such information by January 25, 2022, while the agency continues to evaluate both citizen petitions. The agency will use the information submitted for our analysis and provide a final response to both petitioners directly once we complete our review.

To Submit Comments:
You may submit electronic comments or written comments regarding these petitions at any time up until the docket is closed; however, we request that submissions be received by January 25, 2022, in order to ensure that the FDA is able to review all information in a timely manner. Submit electronic comments to Regulations.gov.
All written comments should be identified with the docket number [FDA-2021-P-0938]. For questions regarding this document, contact the FDA’s Office of Dietary Supplement Programs at 240-402-2375.

Additional Information:

 
I am in Canada and here you cannot buy/sell things like Pregnenolone, DHEA etc but it is allowed to import small amounts for personal use. I recently found out that I can order (and have successfully done so) these products from Amazon.COM (in Canada you typically use Amazon.CA) and when shopping it shows if a product ships to Canada or not. I have no way to test this in reverse but it may be worth trying to order NAC from the Canadian site? As of just now there are a lot of NAC supplements available on '.CA'.
Just aheads up.
 
sp0r412 said:
I'm pretty sure nac can cause kidney stones. I take the now 600mg with selenium and molybdenum 25mcg and 60mcg respectively. I think this is the best brand. I've tried many including piping rock.
NAC is sold everywhere who cares what Amazon does. They are destroying this country you shouldn't ship there anyhow! Get NAC for under ten dollars here Discount Vitamins, Supplements & Natural Health Products | PipingRock Health Products
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In rare cases, NAC may cause kidney stones to form.
 
NAC is still available in some cases on Amazon, to sell it, some manufacturers have changed the name on their labels to L-Cysteine, Acetyl L-Cysteine, etc. Nutricost went all in and rebranded theirs as N-Acetyl L-Cysteine, however, they only sell it through their website at a higher price.
 
Ardoc2 said:
I am in Canada and here you cannot buy/sell things like Pregnenolone, DHEA etc but it is allowed to import small amounts for personal use. I recently found out that I can order (and have successfully done so) these products from Amazon.COM (in Canada you typically use Amazon.CA) and when shopping it shows if a product ships to Canada or not. I have no way to test this in reverse but it may be worth trying to order NAC from the Canadian site? As of just now there are a lot of NAC supplements available on '.CA'.
Just aheads up.
Click to expand...
Which DHEA product are you ordering? My hormone specialist has recommended buying DHEA from the US to save on ridiculous pricing in Canada.
 
Anyone notice a difference in GAD or other anxiety like symptoms after supplementing with NAC? I’ve read a few studies regarding OCD like disorders and improvements are taking NAC. Would love to hear some stories if you have found any improvements in this aspect
 
I have a chronic reactivating varicella virus without the zoster rash, known as "internal shingles". This is typically a sign of immune deficiency - older people, people with HIV/AIDS, cancer patients, transplant patients etc.

I do not take any supplemental concentrated anti-oxidants that would additionally suppress my immunity - I just eat vegetables and get vitamins in their natural amounts to which our bodies have adapted for thousands of years.

Current anti-oxidant supplements contain huge amounts and the long term effect of those in the human bodies have not been tested by the evolution. There are articles that unnaturally high levels of antioxidants promote cancers.

NAC is a precursor of Glutathione, which has an unclear status for the immune system. On one hand, glutathione activates the cells of the immune system - increases the cytotoxic capacity of NK cells. On other hand, glutathione is an antioxidant, which neutralizes the reactive oxygen species that some immune cells use to kill pathogens and infected cells. I feel unpleasant effects every time I take glutathione.

NAC should be more benign because it is a precursor so your body decides to a degree if it will use it to make more glutathione.
 
You should take valacyclovir - it has a longer half life and more convenient dosing schedule. However that prophylaxis works only for HSV-1 or HSV-2.

Varicella (HSV-3) is a more potent virus and taking antivirals for it daily in such low doses is not recommended - it can develop resistance, especially in immunocompromised people.

I have been taking hyper doses of valacyclovir or famciclovir for months - they do reduce the severity of symptoms but don't stop the infection from constantly trying to flair up.

My VZV may be already resistant to the first line of drugs, so I am considering doing more aggressive intravenous antivirals, like foscarnet or cidofovir. Then I will probably get vaccinated with Shingrix to boost the cellular immunity, although that vaccine is dangerously overdone.
 
Beyond Testosterone Book by Nelson Vergel
Nelson Vergel said:
View attachment 211

NAC does not cause rash or flushing as Niacin. Men on high doses of testosterone have low HDL.

Pharmacol Res. 1993 Oct-Nov;28(3):213-8.
Dose-related increase of HDL-cholesterol levels after N-acetylcysteine in man.
Franceschini G, Werba JP, Safa O, Gikalov I, Sirtori CR.
Source
Centre E. Grossi Paoletti, University of Milano, Italy.
Abstract

Changes in plasma lipid-lipoprotein levels were evaluated in 10 hyperlipidemic patients during treatment with progressive doses (from 1200 mg day-1 to 3600 mg day-1) of N-acetylcysteine (NAC). Plasma total cholesterol and triglyceride levels, as well as those of lipoprotein (a) did not change to an appreciable extent, even with the highest dosage. However, the HDL-cholesterol levels showed a significant, dose-related rise, the mean absolute increase, with the highest NAC dose, being of approximately 10 mg dl-1 (16.2%). The rise of HDL-cholesterol was independent of changes in other lipid-lipoprotein parameters, suggesting a possible direct effect of NAC on the HDL system.


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N-Acetylcysteine: A Review of Clinical Usefulness

Objective. To review the clinical usefulness of N-acetylcysteine (NAC) as treatment or adjunctive therapy in a number of medical conditions. Use in Tylenol overdose, cystic fibrosis, and chronic obstructive lung disease has been well documented, but there is emerging evidence many other...
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The mechanism of action of N-acetylcysteine (NAC)

ABSTRACT Initially adopted as a mucolytic about 60 years ago, the cysteine prodrug N-acetylcysteine (NAC) is the standard of care to treat paracetamol intoxication and is included on the World Health Organization’s list of essential medicines. Additionally, NAC increasingly became the epitome...
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Ive heard Nac and glycine is also a good combination for glutathione production.
 
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