If “wellness” cosmetics are regulated, why isn't “wellness" tech?
While diving into a new cosmetics project, I saw this angle, then tilted my head and... "I couldn’t help but wonder": do people realise cosmetics carry real compliance duties despite no medical claims?
Cosmetics must show, at mininum:
▶️ Manufacturing quality: GMP (ISO 22716) + national rules (e.g., EU 1223/2009, FDA 21 CFR 700)
▶️ Safety & testing: microbial load, stability/shelf life, toxicological assessment
▶️ Accountability & traceability: labelling, INCIs disclosure, product registration (e.g., EU CPNP), adverse event reporting
▶️ Governance: a designated Responsible Person, inspection-ready procedures & technical documentation
In principle, not at all far from medical devices, just rightly lighter in scope and depth.
I’m seeing both directions lately: wellness products drifting into medical territory and claim downgrades to step out of it (especially post-MDR transition end). As medical regulations tighten, new categories - and opportunities - emerge at the edges. The fluid interface is such an exciting place to be ❤️🔥.
My view:
Health/body-affecting products should meet proportionate standardisation and accountability. I’d favour a distinct “health and wellness-tech” category with its own rules (as cosmetics have, as the FDA is exploring) over forcing medical device frameworks around them.
Do you agree? Do you also see a rise in review of claim strategy by health product manufacturers (whether upwards or downwards)?