Yes. Products used alongside facial devices are regulated as cosmetics under 21 CFR and must comply with FDA labeling rules, ingredient safety, and claim boundaries. Claims implying drug action — such as 'rebuilds collagen' or 'stimulates muscle' — can trigger FDA scrutiny. EU brands must also comply with EC No 1223/2009. AJ Cosmo Labs connects founders with regulatory consultants experienced in device-adjacent cosmetics.
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