FDA Warning Letters Targeting N-Acetyl Cysteine (NAC) Supplements

FDA Warning Letters Targeting N-Acetyl Cysteine (NAC) Supplements
Background on NAC

N-acetyl-L-cysteine (NAC) has been approved by the FDA to treat liver side effects from an overdose of Tylenol (acetaminophen), and to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease, according to a summary of the study sponsored by the Memorial Sloan Kettering Cancer Center in New York. NAC is an amino acid that was approved by the FDA as a drug in 1963. 

NAC has also been widely marketed in another category of products overseen by FDA—dietary supplements. However, there have been several instances where the FDA has challenged the legality of NAC use in dietary supplements.

FDA Warning Letters

In 2010, the FDA issued a warning letter indicating that it believed that NAC was a drug and as such is not allowed to be used as an ingredient in dietary supplements. However, the FDA has still received several dietary supplement claims notifications including NAC as an ingredient tied to a structure/function claim. Up until recently, NAC had been successfully marketed as a dietary supplement product with no enforcement action.

As of recently, the FDA has issued warning letters to companies marketing dietary supplements indicated for treatment of hangovers, as the ingredient NAC is excluded from the definition of a dietary supplement (since it was already categorized as a drug in 1963). Dietary Supplement products containing NAC are considered an unapproved drug product, and therefore illegal.

Response from Retailers

Amazon has recently been quietly removing dietary supplement products containing NAC from their site, shortly after the news of FDA’s warning letters. There has also been a push by Amazon and other retailers such as Walgreens to ensure products that are being sold through their channels are compliant.

How can we help

Our Experts at Quality Smart Solutions can offer support to your needs for dietary supplements, foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

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