Petition To US FDA For Using NMN In Supplements Reminds Agency Of Its Reversal On NAC
Natural Products Association and Alliance for Natural Health USA petition FDA to reconsider its stance on beta-nicotinamide mononucleotide. Excluding NMN from use in supplements “adversely affects the entire dietary supplement stakeholder community,” petition says.
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US Supplement Industry Left Waiting For Changes In FDA ‘Unified’ Food Programs Reorganization
“Something needed to be done” to improve FDA’s regulation of human foods supply, says Commissioner Califf says. “Dietary supplements is a whole different kettle of fish that we can discuss at a later time.”
It’s Official: US Enforcement Discretion For NAC In Supplements, And Regulatory Options For FDA
Draft guidance states enforcement discretion allowing sales of N-acetyl-L-cysteine supplements which FDA in 2020 ordered firms to halt selling due to its use as a drug ingredient. However, NAC supplements, as they have remained since 2020, were available to US consumers when draft was published.
For First US OTC Birth Control Application, FDA Extends Time For Advisory Panel Discussion
After postponing planned November advisory committees’ meeting to have time to review more information it requested from sponsor HRA Pharma, FDA sets meeting for 9-10 May. Expanding meeting from one day to a day and a half should allow considering all views and questions about contraceptives.