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Gotu Kola Benefits!
Professional Supplements & Nutritional Products Since 1998

FAQ: N-acetyl-L-Cysteine (NAC)

Why can't I order NAC or supplements containing NAC online?

Due to FDA guidelines and discretionary statements the essential amino acid cannot currently be purchased as an over the counter supplement. You may still purchase NAC and/or supplements containing NAC at a licensed physicians office.

While we are owned and operated by an Integrative Functional Medicine physician, we too are not allowed to offer NAC online as an over the counter dietary supplement.

 

If you are a patient with Stephen Smith, M.D. at his medical facility, NW Integrative Medicine:

You may call or come into our medical office to make your purchase. Only patients of the doctor can receive phone order or in house fulfillment.

 

If you are not a patient with Stephen Smith, M.D. at his medical facility, NW Integrative Medicine:

Call for an appointment to receive a recommendation of NAC or visit your local licensed medical physicians office to purchase.

Read more...

 

What is N-acetyl-L-Cysteine (NAC)?

N-Acetyl-L-Cysteine (NAC) is an essential amino acid that is a precursor to tripeptide glutathione, the body’s most powerful antioxidant, which helps promote optimal detoxification. NAC is heavily researched for its role in optimizing lung health, and it is also used to support recovery after workouts. NAC is also beneficial to help protect against normal exposure to heavy metals.

  

Why does the FDA have an issue with NAC supplements?

"As we discussed in a recent response to two citizen petitions, the FDA has determined that NAC is excluded from the dietary supplement definition under the FD&C Act because NAC was approved as a new drug before it was marketed as a dietary supplement or as a food."

- FDA Register/Vol. 87, No. 147/Tuesday, August 2, 2022/Notices

 

Will NAC become illegal or prescription only?

Dietary supplements containing N-acetyl-L-Cysteine (NAC) could be hard to obtain beginning in 2022. This is unless the supplement nutrition industry can prove to the Food and Drug Administration (FDA) that NAC was more widely used as a supplement, prior to it being recognized as an inhaled drug in 1963.

Although a decision has not yet been made by the FDA, they are still combing through the data and comments from the public. The FDA has responded to some citizen petitions, one petition response from the federal register is shown below. This response indicates that they are seriously considering all angles in which they will be reviewing this subject, to make a sound and informed decision.

 

"In addition, we described that one citizen petition asked FDA to issue a regulation that would determine NAC to be lawful under the FD&C Act.We described that we have not yet reached a final decision on this request, but are considering initiating rulemaking under section 201(ff)(3)(B) of the FD&C Act to permit the use of NAC in or as a dietary supplement (i.e., to provide by regulation that NAC is not excluded from the definition of dietary supplement). If, among other considerations, we do not identify safety-related concerns as we continue our review of the available data and information, we are likely to propose a rule providing that NAC is not excluded from the definition of dietary supplement."

- Federal Register/Vol. 87, No. 147/Tuesday, August 2, 2022/Notices

 

Resources

FDA Guidance for Industry: Policy Regarding N-acetyl-L-cysteine AUGUST 2022