Audit of cosmetic product positioning: understanding and avoiding risks

Borderline products: where is the regulatory limit?

In the world of cosmetics, certain products lie on the boundary between multiple regulatory categories, such as medicines, medical devices, or biocides. These so-called “borderline” products may contain claims that bring them closer to other regulatory classifications.

The cosmetic status is determined by three key criteria:

✔️ The primary function of the product
✔️ Its composition
✔️ The claims used in communication

A poor positioning strategy can result in product reclassification, leading to stricter regulatory requirements.

Practical case: massage oil and regulatory positioning

Issue identified: a claim beyond the scope of cosmetics

🔍 Example of a problematic claim:
“The Draining Oil is specially designed to promote lymphatic drainage through massage, addressing feelings of fatigue and heaviness in the lower limbs.”

🛑 Errors Identified:

The claim refers to lymphatic drainage, which involves a physiological effect.

It mentions an impact on blood circulation, which falls outside the scope of a cosmetic product and may lead to reclassification as a medical device.

Analysis and compliance with regulatory requirements

A cosmetic product must meet three fundamental regulatory criteria:

1️⃣ Form: The product must be intended for application to the skin.
2️⃣ Function: Its purpose must be to clean, perfume, protect, maintain, or beautify the skin. In this case, the product claims a physiological function.
3️⃣ Application Area: It must be intended for the skin, hair, nails, lips, etc.

Conclusion

By mentioning lymphatic drainage and the sensation of heavy legs, the product goes beyond the cosmetic scope and risks reclassification as a medical device or medicine.