Regulation of Chinese Herbal Supplements in HK: The Food vs. Medicine Divide

The Regulatory Divide: Chinese Herbal Supplements in Hong Kong

Proprietary Chinese Medicine (pCm) supplements, often marketed as health food or dietary aids, occupy a distinct regulatory space in Hong Kong. Unlike registered pCm, which are legally defined as medicines intended for treatment, diagnosis, or prevention, supplements fall primarily under the food safety framework—unless their labeling or advertising crosses the line into making therapeutic claims.

For manufacturers and importers, understanding this regulatory distinction is crucial for achieving Chinese herbal supplement compliance.

Regulatory Authority and Legal Classification

The classification of a Chinese herbal product depends entirely on its intended use and the claims made by the product owner.

1. Supplements (Food Status)

Products that utilize Chinese herbs but restrict their claims to general health maintenance, nutritional support, or improving body functions (e.g., 'supports vitality,' 'boosts well-being') are regulated as food under the Public Health and Municipal Services Ordinance (Cap. 132).

Regulating Body: The Centre for Food Safety (CFS), under the Food and Environmental Hygiene Department (FEHD), is the primary enforcement body.

Key Requirement: Products must be fit for human consumption and comply with food labeling standards.

2. Proprietary Chinese Medicine (pCm) (Medicine Status)

If a product makes any therapeutic claims (e.g., 'treats cough,' 'diagnoses insomnia,' 'prevents cold and flu'), it is immediately classified as a pCm and must undergo mandatory registration with the Chinese Medicine Council of Hong Kong (CMCHK).

Mandatory Compliance Pillars for Supplements

While supplements avoid the rigorous CMCHK dossier review, they face strict requirements focused on safety and honesty in advertising.

1. Safety and Purity Standards

Like all food products, Chinese herbal supplements must demonstrate a high standard of safety. Crucial requirements include:

Prohibited Substances: The product must be free from unauthorized Western pharmaceutical ingredients. The presence of such substances is a common cause for regulatory enforcement and immediate recall.

Contaminant Limits: Supplements must comply with food-level regulations for heavy metals, pesticides, and microbial load, which may differ from the stricter pCm limits but remain rigorous.

2. Labeling and Claim Integrity

Labeling is the primary tool the CFS uses to determine a product's regulatory category. Compliance in this area is non-negotiable.

No Therapeutic Claims: The packaging, leaflets, and all promotional materials must not suggest treatment, diagnosis, cure, or prevention of disease.

Mandatory Disclosure: The label must clearly list all ingredients, net content, and the manufacturer's details, adhering to food labeling requirements.

Ingredient Differentiation: If the product contains Chinese herbs that are typically only used as medicine, the CFS may flag it for re-evaluation, regardless of the claims.

3. Manufacturing Standards

Although the CMCHK GMP system is not mandatory for food-status supplements, manufacturers are strongly encouraged to adopt robust quality assurance systems like HACCP (Hazard Analysis and Critical Control Points) or international food safety ISO standards to ensure consistent production and consumer trust.

Risk of Misclassification and Enforcement

A significant risk for supplement companies is regulatory misclassification. If the CFS or CMCHK determines that a product marketed as a 'supplement' is actually making illegal therapeutic claims, it can be immediately reclassified as an unregistered pCm, leading to:

Immediate Withdrawal: Mandatory product recall and withdrawal from the market.

Penalties: Significant fines and, in severe cases, criminal prosecution for selling unregistered medicine.

Therefore, continuous monitoring of all marketing and labeling materials is essential to maintain compliance and avoid the regulatory cross-over.