Regulation of products based on valerian root

Dietary supplement or medicine? The case of valerian-based products

Indication and active substance

📌 Indication: sleep
📌 Active substance: valerian root extract

Regulatory regime

A product based on valerian can be marketed under two distinct statuses:
✔️ dietary supplement, under certain conditions
✔️ herbal-based medicine, if the composition and claims go beyond the scope of dietary supplements

Risk of reclassification as a medicine

A product containing between 400 and 600 mg of ethanol extract of valerian root with an extraction ratio of 4/1 is likely to be reclassified as a medicine by function.

Why?

✔️ Valerian has a monograph in well-established medical use, validated by the European Medicines Agency (EMA).
✔️ A high dosage and a particular extraction method can shift the product’s status to medicine.

Solution to avoid reclassification

✔️ Adapt the composition and dosage to remain within the scope of dietary supplements.
✔️ Avoid any therapeutic claims that could suggest an effect comparable to a medicine.

Conclusion

Valerian-based products are subject to strict regulations. It is essential to clearly define the formulation and claims to avoid reclassification as a medicine and ensure compliant market release.