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Draft guidance states enforcement discretion allowing sales of N-acetyl-L-cysteine supplements which FDA in 2020 ordered firms to halt selling due to its use as a drug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.
You may also be interested in...
Renue By Science agrees with National Advertising Division recommendations to “clearly and conspicuously disclose” material connections in online advertising by employees, nonprofits and others offering sales to its supplements containing nicotinamide mononucleotide, quercetin or resveratrol.
Trade group contends FDA’s misuse of regulation prohibiting any substance studied or approved as a drug in US from being used as dietary ingredients undermines innovation in supplement industry and is detrimental to consumer choice and health.
Because FDA “suddenly changed its position and advised companies of its determination that NMN is excluded from the definition of a dietary supplement,” Rep. Jeff Duncan states, a public hearing “would be incredibly beneficial as the dietary supplement industry seeks clarity on the FDA’s actions.”