By Mike Montemarano, Associate Editor12.06.21
This story was updated on December 7, 2021.
In the latest response to citizen petitions it received from dietary supplement trade associations, the U.S. Food and Drug Administration (FDA) has not provided a conclusive determination on the status of N-Acetyl-Cysteine, and whether it considers it lawful to market it as a dietary ingredient.
Since last year, FDA has made it apparent that it holds a newfound position that NAC, an amino acid metabolite and precursor to glutathione which has been widely incorporated into dietary supplements for several decades, is excluded from meeting the definition of a dietary ingredient.
This revelation came in December 2020 when FDA issued multiple warning letters to companies selling supplements containing NAC. The agency cited that NAC was approved as a new drug in 1963. Since the warning letters were first issued, several major retailers have discontinued the sales of supplements containing NAC on their platforms, including Amazon.
Since the agency issued these warn
In the latest response to citizen petitions it received from dietary supplement trade associations, the U.S. Food and Drug Administration (FDA) has not provided a conclusive determination on the status of N-Acetyl-Cysteine, and whether it considers it lawful to market it as a dietary ingredient.
Since last year, FDA has made it apparent that it holds a newfound position that NAC, an amino acid metabolite and precursor to glutathione which has been widely incorporated into dietary supplements for several decades, is excluded from meeting the definition of a dietary ingredient.
This revelation came in December 2020 when FDA issued multiple warning letters to companies selling supplements containing NAC. The agency cited that NAC was approved as a new drug in 1963. Since the warning letters were first issued, several major retailers have discontinued the sales of supplements containing NAC on their platforms, including Amazon.
Since the agency issued these warn
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