Therabody TheraFace PRO Facial Health Device

Are there FDA regulations I need to follow for skincare used with facial devices?

By Blake Mereby · Last reviewed September 4, 2026

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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