How Should Skin Products Made from Human Cells Be Regulated?
Official title: Consultation: Classification of topical products containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media
Health Canada asked whether certain skin products containing human cell components should be classified as cosmetics or drugs. These products use exosomes, extracellular vesicles, and cell-conditioned media—essentially tiny particles and fluids derived from human cells. The classification matters because drugs face stricter safety testing than cosmetics.
Why This Matters
Ever seen a fancy serum claiming to use "stem cell technology" or "cellular regeneration"? This is about those products. If they're classified as drugs, they'll need to prove they're safe before hitting store shelves. If they stay as cosmetics, the rules are looser.
What Could Change
Products containing human-derived exosomes and similar cell components may be reclassified as drugs rather than cosmetics. That would require manufacturers to get Health Canada approval before selling them. Some products currently on the market might need to be pulled until they meet drug safety standards.
Key Issues
- Should topical products containing human-derived exosomes be classified as drugs or cosmetics?
- What regulatory approach should apply to products containing human extracellular vesicles?
- How should products with human cell-conditioned media be regulated?
How to Participate
- Review the Guidance Document: Classification of Products at the Cosmetic-Drug Interface to understand Health Canada's current approach.
- Comments could be submitted to the Therapeutic Products Classification Committee Secretariat at drug-device.classification.drogue-instrument@hc-sc.gc.ca.