The global demand for herbal medicines, nutraceuticals, and botanical products continues to grow increasing the need for quality, safety, and compliance. World Health Organization (WHO) provides labeling guidelines for herbal products through global frameworks for Good Manufacturing Practices (GMP) and pharmacovigilance safety monitoring. WHO herbal product labelling guidelines, with assistance from WHO traditional medicine framework and traditional medicine WHO guidelines, will enable manufacturers to improve regulatory compliance, traceability, and globally acceptable manufacturing processes for their herbal medicine products. [1]

WHO Herbal Product Labelling Guidelines: A Manufacturer's Guide

Regulation, Latest News . July 14, 2026

The global demand for herbal medicines, nutraceuticals, and botanical products continues to grow increasing the need for quality, safety, and compliance. World Health Organization (WHO) provides labeling guidelines for herbal products through global frameworks for Good Manufacturing Practices (GMP) and pharmacovigilance safety monitoring. WHO herbal product labelling guidelines, with assistance from WHO traditional medicine framework and traditional medicine WHO guidelines, will enable manufacturers to improve regulatory compliance, traceability, and globally acceptable manufacturing processes for their herbal medicine products. [1]

Why WHO Herbal Product Labelling Guidelines Matter for Manufacturers

Herbal medicines can vary in quality depending on how they were cultivated, harvested and processed. WHO ensures that internationally accepted quality principles that help manufacturers to create consistent, safe and high-quality herbal products while supporting regulatory compliance and consumer confidence.

Benefits for Manufacturers

Following WHO recommendations will help manufactures:

Increase consistency between production batches.
Ensure supply chain traceability.
Create confidence among regulators, healthcare providers, distributors, and consumers.
Simplify product registration for international market.
Enhance quality management and reduce manufacturing risks.

These principles also support custom herbal formulation development by helping manufacturers produce safe, standardized, and regulatory-compliant botanical products.

WHO Traditional Medicine Framework and Evolving Priorities

From its earlier efforts to ensure the proper use of traditional medicines, WHO has evolved to adopt a lifecycle approach encompassing quality, safety, efficacy, and traceability. In accordance with the WHO traditional medicine framework, the Global Traditional Medicine Strategy 2025–2034 focuses on improving governance, scientific development, sustainable use of medicinal plants, and increasing access to quality-assured herbal medicines.

Another significant project that comes under the WHO is the International Herbal Pharmacopoeia (IHP). The objective of IHP is to create a set of harmonized global quality standards through standardized botanical description, analytical methods, and quality specifications. Such advancements encourage the manufacturers of custom herbal medicine formulations to adopt scientific quality systems and validated manufacturing procedures intended for domestic and international markets. [2]

WHO Herbal Medicine Standardization: From Botanical Authentication to Quality Assurance

Effective WHO herbal medicine standardization involves raw material authentication and continues during the manufacturing process to achieve consistent Herbal formulation, product safety and quality.

Raw Material Authentication for Herbal Formulation

Manufacturers are supposed to:

Check the identity the plant materials through botanical, microscopic, chemical or molecular methods.
Audit the supplier to avoid adulteration, substitution and contamination.
Set specifications for identification, purity, moisture content, ash values and marker compounds.

Standardized Manufacturing

Standardization of Herbal formulation and development depend on validated processing methods, including:

Standardized extraction processes (solvents, temperature and time of process).
Controlled drying and storage conditions.
Standardized manufacturing procedures to reduce batch-to-batch variation.

Herbal Product Quality Control WHO: Analytical Testing and Documentation

Manufacturers should employ validated analytical methods such as HPLC, HPTLC, TLC and GC to authenticate botanical identity, phytochemistry profiles and batch consistency. This will help in improving the herbal GMP manufacturing standards, traceability of products and regulatory inspection. Documentation that includes raw material, manufacturing logs, analytical report, validation information and stability study supports herbal medicine regulatory compliance, product traceability, and regulatory inspections. [3]

Mandatory Packaging Components and Herbal Product Labelling Requirements

The packaging of the product is vital in the communication of the right information concerning the product to the relevant parties including the manufacturers, regulatory authority, healthcare practitioners, and consumers. According to the WHO herbal product labelling guidelines, the label information should be clear, accurate, and standardized as this ensures safety, traceability and transparency of the product based on country-specific regulatory requirements.

Recommended Packaging Information

Labelling Component	Requirement	Example
Product Name	Commercial or trade name	Herbal Immunity Capsules
Botanical Name	Latin binomial and part of the plant	Curcuma longa L. (Rhizome)
Dosage Form	Capsule, tablet, powder, extract, tea, etc.	500 mg Capsule
Net Quantity	Quantity of product in the package	60 Capsules
Directions for Use	Recommended dosage instructions	Take 1 capsule twice daily after meals
Storage Conditions	Stability based storage instructions	Store in a cool, dry place below 25°C
Manufacturer Information	Name, address, manufacturing licence, and country of origin	XYZ Herbal Pvt. Ltd., India
Manufacturing & Expiry Date	Manufacturing and expiry dates	MFG: 06/2026 • EXP: 06/2028
Batch/Lot Number	Unique production identifier	Batch No. HC240601
Warning Statements	Contraindications, allergens, and precautions	Not recommended during pregnancy
Country-Specific Compliance	Applicable regional regulations	AYUSH • THMPD • DSHEA

Apart from accurate herbal product labelling requirements for products include proper use of botanical nomenclature, standardized information on extracts where appropriate, and provision of traceability through digital means like QR codes which link to Certificates of Analysis (CoAs) and batch-specific product information. [4]

Health Claims and Marketing Under Traditional Medicine WHO Guidelines

All product claims should be evidence-based and comply with applicable regulations.

Acceptable Claims

Manufacturers can make general wellness claims like supporting digestive health or normal immune function if there is sufficient scientific evidence to support the same.

Restricted Claims

Claims that relate to the curing or treatment of any disease must be made if there is regulatory approval as well as strong scientific evidence.

Traditional Use Statements

Statements such as “Traditionally used in Ayurveda” should clearly indicate historical use without implying clinically proven therapeutic benefits.

Traceability, Batch Testing Herbal Products, and Quality Assurance

A robust traceability system helps ensure that every herbal medicine regulatory compliance requirement since all information relating to its origin, manufacturing and distribution is known to the company. Batch testing herbal products and Batch Manufacturing Record (BMR) help in assuring product quality before market release, while digital quality systems improve traceability and regulatory readiness.

Global Regulatory Alignment and Herbal Export Labelling Requirements

The recommendations of WHO must be combined with other national regulations to facilitate the process of product registration and global access to markets.

Region	Primary Regulation
WHO	GMP, GHPP, Quality and Labeling guidelines
India	AYUSH
European Union	THMPD
United States	FDA/DSHEA
ASEAN	Traditional Medicines Guidelines
Codex	Food Supplement Standards
ISO	Quality Management Standards

Manufacturers ensure that their products, labels and documentation meet the requirements of destination countries to facilitate herbal export labelling requirements and successful global commercialization. [5]

Conclusion

Application of WHO herbal product labelling guidelines enables manufacturers to achieve product safety, regulatory compliance and quality assurance, which are essential in the global marketing.

Food Research Lab helps manufacturers with herbal formulation services, analytical testing, pilot manufacturing, regulatory affairs and quality assessment, thereby enabling the development of safe and compliant herbal products.

Frequently Asked Question

What is the purpose of the WHO herbal product labelling guidelines?

The international guidelines are developed to ensure quality, safety, traceability, and compliance with national regulations of herbal products.

What are the mandatory herbal product labelling requirements?

Label should include name of the product, its botanical name, form of dosage, net weight, instruction for use, storage instructions, manufacturer information, date of manufacture and expiry date, batch or lot number, and warning statements.

What quality control tests are recommended for herbal products?

The tests include botanical identification, physicochemical analysis, microbial test, heavy metals and pesticide test, chromatographic fingerprinting (HPLC, HPTLC or TLC) and stability studies.

What health claims are permitted for herbal products?

Evidence-based health claims of general wellness nature can be made by manufacturers. Disease treatment or curing claims require approval and scientific basis.

How do WHO recommendations support herbal product traceability?

WHO recommends assigning lot or batch numbers which would refer to manufacturing records and testing data to improve traceability and supply chain transparency.

What challenges do small herbal manufacturers face in meeting WHO recommendations?

Small manufacturers often face high testing costs, limited access to advanced analytical equipment, and reliance on third-party laboratories, which can increase costs and delay compliance

References

World Health Organization. (2017). WHO guidelines on good herbal processing practices for herbal medicines (WHO Technical Report Series No. 1010, Annex 1). World Health Organization. Retrieved from https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/production/trs1010-annex1-herbal-processing.pdf
Wasiullah, M., Yadav, P., Yadav, S., Chauhan, A., & Prajapati, V. (2026). A review on WHO guidelines of quality control for herbal drugs. Journal of Emerging Technologies and Innovative Research (JETIR), 13(4), 265–272. Retrieved from https://www.jetir.org/papers/JETIRHT06030.pdf
Jain, S. D., Shrivastava, S. K., Agrawal, A., & Gupta, A. K. (2024). WHO guidelines for quality control of herbal medicines: From cultivation to consumption. International Journal of Pharmaceutical Chemistry and Analysis, 11(3), 212–225. https://doi.org/10.18231/j.ijpca.2024.031
World Health Organization. (2023). WHO global traditional medicine strategy 2025–2034. World Health Organization. Retrieved from https://iris.who.int/server/api/core/bitstreams/444528f5-6c78-434e-a39d-0bb6c36e4c30/content
Chen, Q., Cheng, H. J., Bian, Z. X., Lyu, A. P., Yang, Y., & Chan, K. W. (2025). Regulatory frameworks and evidence requirements for traditional, complementary and integrative medicines. Bulletin of the World Health Organization, 103(11), 696–707C. https://doi.org/10.2471/BLT.25.293437