NCS/ARS/CL/10355

We acknowledge receipt of your request for tariff classification regarding the following products: Sudrex Cold and Cough Tablets, Sudrex Extra, and Sudrex Headache Fever. Accompanying your request are comprehensive documents, including product literature, production process details, and chemical analyses to support the tariff determination.

PRODUCT ANALYSIS

Your documentation indicates that these medicaments comprise:

Sudrex Cold and Cough: Contains an analgesic-antipyretic nasal decongestant and anti-tissue components, specifically 500mg Paracetamol, 10mg Phenylephrine, 12mg Dextromethorphan, and 30mg Caffeine.

Sudrex Extra: A non-narcotic analgesic formulated for headaches, fever, muscle, and joint pain associated with influenza and common cold. It includes Paracetamol 325mg, Ibuprofen 200mg, and 30mg Caffeine.

Sudrex Headache Fever: Formulated with Paracetamol 500mg and 30mg Caffeine, indicated for headaches, fever, muscle, and joint pain in cases of influenza and common cold.

Caffeine is a common active ingredient in all aforementioned medicaments and is chemically classified as an alkaloid belonging to the trimethylxanthine family. Your laboratory report asserts that the caffeine present is synthetic, produced in the laboratory, and therefore lacks properties attributed to plant-derived alkaloids.

LABORATORY ANALYSIS SUBMITTED BY APPLICANT

According to the submitted documents, caffeine was extracted from cocoa powder, and anhydrous caffeine used in Sudrex tablets was also obtained as a pure substance. The extracted caffeine underwent alkaloid identification tests (Wagner Test) and FTIR spectrometry analysis to compare functional groups and molecular structures. The results indicate that caffeine sourced from cocoa powder tested positive for alkaloids, while the anhydrous caffeine tested negative. However, no molecular structural differences between anhydrous and plant-derived caffeine were presented.

CUSTOMS CERTIFIED PHARMACIST’S POSITION ON THE LABORATORY REPORT AND DISTINCTION BETWEEN ANHYDROUS CAFFEINE AND PLANT-SOURCED CAFFEINE

A review of pharmacological, clinical, and analytical chemistry literature confirms that there is no distinction in the chemical structure of caffeine whether derived naturally or synthesized. Both forms possess the identical molecular formula (C8H10N4O2) and configuration. Consequently, both natural and synthetic caffeine are considered alkaloids due to their nitrogen-containing heterocyclic structure.

Scientifically and regulatorily, this implies:

(i) Natural and synthetic caffeine are chemically identical in structure and function.

(ii) Both types exhibit congruent pharmacokinetic and pharmacodynamic profiles, encompassing absorption, distribution, metabolism, and physiological effects.

(iii) Any apparent variations in effect stem from additional compounds present in natural sources (e.g., polyphenols in coffee or tea) or differences in product formulation, rather than from the caffeine molecule itself.

3.           Advanced analytical techniques such as isotope ratio mass spectrometry can distinguish caffeine by origin, yet these methods do not indicate any structural or functional divergence within the molecule.

References

(i) Reddy, V.S., et al. (2024). Pharmacology of caffeine and its effects on the human body. Journal of Applied Research in Nutrition and Metabolism.

(ii) Zhang, L. et al. (2012). Caffeine in your drink: Natural or synthetic? Journal of Agricultural and Food Chemistry, 60(39),10096-10104.

(iii) International Organization for Standardization (ISO). (2019). Determination of caffeine content - High-performance liquid chromatography method. ISO 20481.

(iv) European Food Safety Authority (EFSA). (2015). Scientific opinion on the safety of caffeine. EFSA Journal, 13(5),4102.

CLARIFICATION FROM THE WCO HARMONISED SYSTEM NOMENCLATURE

Classification according to the Harmonized System Nomenclature (HSN) is governed by the General Interpretative Rules, annexed to the Harmonized System Convention (HSC) of 1983, to which Nigeria is a signatory. Rule 1 stipulates that classification under the HS should be primarily determined by product heading terms, section/chapter notes, and subheading notes.

The HS provides two relevant headings for medicaments: chapter 29 (organic chemicals) covers raw materials used in pharmaceutical manufacturing, whereas chapter 30 (pharmaceutical products) encompasses processed medicaments intended for bulk or retail sale.

Heading 2939—"Alkaloids, natural or reproduced by synthesis, and their salts, ethers, esters and other derivatives"—acknowledges both natural and synthetic alkaloids without distinguishing between them, including caffeine (2939.30).

The HS Explanatory Notes (EN 2939) state: “These alkaloids are complex organic bases; they have strong physiological action. Some are obtained by synthesis.” … Furthermore, "This heading includes hydrogenated, dehydrogenated, oxygenated, and deoxygenated alkaloid derivatives; generally, any derivative whose structure closely mirrors that of the natural alkaloid."

In EN2939 part (C), Caffeine and its salts are specifically recognized as "extracted from coffee beans, tea, and cola nuts; or obtained by synthesis. Silky crystals; used in medicine."

TARIFF CLASSIFICATION ANALYSIS AND CONCLUSION

In conclusion, based on your submitted documents, laboratory analyses, expert opinions, and Harmonized System provisions related to alkaloids, the medicaments Sudrex Cold and Cough Tablets, Sudrex Extra, and Sudrex Headache Fever are classified under tariff heading 3004.49.00.00:

"Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. -- Other’. 

This classification carries a 0% duty rate, 0% VAT, and 20% IAT, in accordance with ECOWAS CET 2022 – 2027 provisions.

LEGAL FRAMEWORK AND JUSTIFICATION

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