NAFDAC HERBAL MEDICINE AND RELATED PRODUCTS LABELLING REGULATIONS 2019

What Is This Policy?

Regulations prescribing the specific labelling requirements for herbal medicines and related products registered in Nigeria, ensuring that labels carry accurate, complete, and consumer-protective information.

Who Does It Target?

Manufacturers and importers of herbal medicines and related products Distributors and retailers of herbal health products NAFDAC as the regulatory authority

What Does It Aim to Achieve?

To protect consumers from misleading label claims, ensure that product composition, usage instructions, contraindications, and expiry information are clearly displayed, and reduce risks from improper use of herbal products.

Key Features

Mandatory Label Elements: Labels must include product name, NAFDAC number, ingredients, directions, contraindications, and expiry. Claim Restrictions: Health claims must be evidence-based and approved by NAFDAC prior to use. Language Requirement: Primary language of labelling must be English; additional local languages are permitted. Font and Visibility: Prescribed minimum font sizes ensure key information is legible. Penalties: Products with non-compliant labels are subject to seizure and the manufacturer to prosecution.

Current Status

In force. Enforced by NAFDAC as part of its broader herbal medicine regulation regime, with non-compliant product labelling subject to regulatory action including product seizure and market withdrawal.

Manufacturers submit artwork for label review during product registration Existing registered products were given a transition period to update labels Label changes must be approved by NAFDAC before implementation Application method: NAFDAC headquarters, Abuja, and zonal offices

Important Terms

No product may be sold with a non-compliant label after the grace period Post-market surveillance identifies non-compliant products for enforcement action False label information carries criminal liability

Official Resources

Website: www.nafdac.gov.ng Policy Summary Document | Federal Republic of Nigeria

Legal Framework

The NAFDAC Herbal Medicine and Related Products Labelling Regulations are issued under the NAFDAC Act and operate alongside the Standards Organisation of Nigeria Act, the Consumer Protection Council Act, and the National Policy on Traditional Medicine (2nd Edition). International alignment is with WHO Guidelines for Good Agricultural and Collection Practices (GACP) for Medicinal Plants and the African Pharmacopoeia labelling standards.