Medicaments vs oral hygiene preparations: products with therapeutic ingredients remain medicaments where their essential character is medicinal.

Products with therapeutic active ingredients used to treat or prevent gingivitis and oral ulcers were treated as medicaments because their composition, licensing and restricted availability showed a primary medicinal character. Chapter Note 2 of Chapter 33 applies only where a product is primarily a cosmetic or toilet preparation, even if it has subsidiary pharmaceutical or antiseptic constituents or some curative value. On that reasoning, oral-hygiene use or mouthwash labelling did not shift the products into Chapter 33. The products were therefore classifiable under heading 3003.10 and not under heading 3306.90.

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Issues: Whether the products Rexidin, Remedin and Dentogel were classifiable as medicaments under chapter sub-heading 3003.10 or as preparations for oral or dental hygiene under chapter sub-heading 3306.90.

Analysis: The products contained active ingredients recognised in pharmacopeias for treatment and prevention of gingivitis and ulcers, and their composition and use showed that they were primarily medicaments. Chapter Note 2 of Chapter 33 applies only where the product is primarily a cosmetic or toilet preparation, even if it contains subsidiary pharmaceutical or antiseptic constituents or has subsidiary curative or prophylactic value. The products were licensed by the Food and Drugs Administration and were purchasable only on professional recommendation. In these circumstances, they could not be brought under Chapter 33 merely because they were used for oral hygiene or labelled as mouth washes.

Conclusion: The products were correctly classifiable under chapter sub-heading 3003.10 and not under chapter sub-heading 3306.90.

Ratio Decidendi: A product falls under Chapter 33 only if it is primarily a cosmetic or toilet preparation; where its essential character is that of a medicament, it remains classifiable as a medicament notwithstanding subsidiary oral-hygiene use or antiseptic properties.

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