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US FDA Put On The Clock About NAC's Use As Dietary Ingredient After Amazon Ends Sales

CRN Files Citizen Petition After Letter To Agency Prompts No Action

Executive Summary

Trade group asked FDA six months ago to reverse position it revealed in July 2020 that products containing NAC cannot be marketed as dietary supplements. After Amazon in May reported pulling NAC supplements from its site, CRN decided to ask again.

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Window Of Opportunity Opened Narrowly For Continued Use Of NAC As Dietary Ingredient In US

FDA will “determine if rulemaking to make NAC lawful as a dietary supplement is appropriate.” Agency issued tentative responses to Council for Responsible Nutrition and Natural Products Association’s petitions asking for halt to warnings and other enforcement against firms marketing supplements containing NAC.

AHPA Offers Hard Copy Supporting NAC's Use In Dietary Supplements Pre-DSHEA

American Herbal Products Association submits comments to on CRN and NPA petitions encouraging FDA to grant an industry request to issue a regulation finding NAC is a lawful dietary ingredient.

Comments On Petition As Good As Public Hearing On NAC’s Use As Dietary Ingredient – US FDA

Agency "does not believe a hearing is necessary at this time given the other mechanisms at stakeholders’ disposal to interact with FDA on this issue, including submission of comments" for citizen petition CRN submitted on NAC, Andrew Tantillo, acting associate commissioner for legislative affairs, tells Sen. Mike Lee.

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