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How can I effectively distinguish whether a product falls into the medicine or health food category?

A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.

Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.

Drug Office, Department of Health Chinese Medicines Board

Q497 · Category J: Cross-border pharmaceuticals and industry practice (Q451-Q500)
The key to distinguishing medicines from health foods lies in the product’s claims and ingredients. Medicines usually contain active medicinal ingredients and claim to treat, diagnose or prevent diseases, and are regulated under the Pharmacy and Poisons Ordinance (Cap. 138). Health foods are intended to maintain health or supplement nutrition and must not make claims to treat diseases. Rengangyongsheng (Hong Kong) Limited recommends assessing the product category through ingredient analysis and market positioning, together with guidance from the Drug Office, Department of Health, to ensure that the product is promoted lawfully.

📘 Regulatory basis

Section 2 of the Pharmacy and Poisons Ordinance (Cap.138), Trade Descriptions Ordinance (Cap.362)

📗 Drew Tang's recommendations

We recommend that businesses seek advice from legal professionals and industry consultants rather than making their own assessments, which could lead to misclassification and affect subsequent submissions and marketing activities.

📕 Risk notice

Incorrect classification may lead to regulatory penalties, product recall and damage to brand reputation, and may even constitute a criminal offence.

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