It’s been just over a year since the US Food and Drug Agency (FDA) notified health supplement manufacturers that it was refusing their petition against the decision to block the marketing of NAC (N-acetyl-L-cysteine, aka n-acetylcysteine) as a food supplement. This decision has deep consequences for all of the parties involved in the supply chain of NAC, and also for consumers.
As research progresses into the multiple benefits of NAC, more and more uses are being found for it. But as long as the bureaucratic hurdles are being maintained by the authorities in the US, the best place to find a source of n-acetylcysteine is here on IsraelPharm, the home of medical-grade NAC in the form of Reolin.
Bottom line – it makes far better sense to follow the lead of science and apply these findings than to wait for the committees in Washington to find their way onto the current market.
Bureaucratic blocks have been thrown up by the FDA, citing the Dietary Supplement Health and Education Act of 1994 (DSHEA), which defines the term “dietary supplement” and changed the way dietary supplements are regulated.
As part of this new framework for dietary supplement regulation, DSHEA also amended the FD&C Act by defining the term “new dietary ingredient (NDI)”, and this requires the manufacturer or distributor of an NDI, or of the dietary supplement that contains the NDI, to submit a premarket notification to FDA (an NDI notification) unless the “new dietary ingredient” was not marketed in the United States before October 1994 and does not include any dietary ingredient which was marketed in the United States before that date.
The exclusion clause does not distinguish between dietary ingredients marketed before October 1994, and those first marketed after that date. Nor does the exclusion clause distinguish between drugs approved before and those approved after that date.
The FDA has reached this decision based on the position that NAC was, in fact, registered as a prescription-only drug before it was marketed as a dietary supplement, and must therefore be withdrawn from general sale unless it’s against a prescription.
How we got to this block in the road for .
Here’s a short summary of the history of NAC, bringing us up to the present:1963 | Patent registered for N-acetyl-L-cysteine | Mucolytic-nu-acylated sulfhydryl compositions and process for treating animal mucus. |
1968 – 1985 | Approved by the FDA for use intravenously, by mouth, or inhaled as a mist. |
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2000 – present | Off-label use by prescription |
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2017 – | Research into new usage of NAC to combat the negative effect of oxidative stress |
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Studies into other uses, with positive results in several fields: |
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2021 | Listed by the World Health Organization as one of the 100 essential medicines – under Antidotes and other substances used in poisoning | |
2021 | FDA notified manufacturers and retail platforms like Amazon that NAC can not be marketed as a dietary supplement, because it had previously been registered or approved as a drug. | |
April 2022 | Following petitions from suppliers, the FDA released draft guidance on its policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine. | |
August 2022 | The FDA announced final guidance on its policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). |