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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:

 

Ardoc2

Member
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.
 

Vince

Super Moderator
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
In rare cases, NAC may cause kidney stones to form.
 

MDavidW76

Member
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.
 
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.
Which DHEA product are you ordering? My hormone specialist has recommended buying DHEA from the US to save on ridiculous pricing in Canada.
 
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