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How does Hong Kong law define and regulate “cosmeceuticals”?

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

Q30 · Category A: Licensing system and regulatory fundamentals (Q1–Q50)
As with “health supplements”, “cosmeceutical” is not a legally defined category under Hong Kong law. Whether a product is treated as a “cosmetic” or a “pharmaceutical product” depends entirely on its ingredients and claimed effects. Under the Consumer Goods Safety Ordinance (Cap. 456), cosmetics are subject to its general safety requirements. However, if a “cosmeceutical” contains any Western medicine ingredient controlled under the Pharmacy and Poisons Ordinance (for example, certain antibiotics used to treat acne, hydroquinone used for skin whitening, or steroids), or is promoted as being able to treat or prevent a skin disease (such as eczema or psoriasis), it will be classified immediately as a “pharmaceutical product”. Once classified as a pharmaceutical product, it must comply with the full range of pharmaceutical regulatory requirements: the product must be registered (obtaining an HK-XXXXX number), and the seller must hold a pharmaceutical licence. As a result, many products sold overseas as “cosmeceuticals” may be regarded as medicines in Hong Kong and cannot be sold in ordinary cosmetics shops or department stores.

📘 Regulatory basis

Product classification depends on the definition of “pharmaceutical product” in section 2 of the Pharmacy and Poisons Ordinance and the classification guidance issued by the Department of Health. Whether an ingredient is listed in the Poisons Schedules is one of the key criteria.

📗 Drew Tang's recommendations

For companies importing cosmetics, a thorough compliance review is essential when introducing new product lines, particularly products claiming “medical” or “drug-like” effects. We can help clients analyse product ingredient lists and all promotional materials, and assess the legal risks in Hong Kong.

📕 Risk notice

Selling “medicated cosmetics” containing undeclared medicinal ingredients as ordinary cosmetics is a common trap and is subject to strict enforcement by the Department of Health and Customs. If discovered, the products may all be withdrawn and destroyed, and the company and responsible persons may face criminal prosecution.

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