In the US, a TXA toner is classified as a cosmetic under FDA 21 CFR as long as claims stay cosmetic (e.g., 'visibly evens skin tone') rather than drug claims ('treats melasma'). There is no approved OTC drug monograph for TXA in the US as of 2024, so drug-style claims risk FDA action. Always review label copy with a regulatory consultant before launch.
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