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HQ 562316

April 1, 2002

MAR-2-05 RR:CR:SM 562316 MLR


Robert J. Leo, Esq.
Meeks & Sheppard
330 Madison Ave., 39th Floor
New York, NY 10017

RE: Country of Origin Marking for products containing nicotine

Dear Mr. Leo:

This is in reference to your various letters (the latest dated January 17, 2002), requesting a ruling on behalf of Pharmacia Corp. and its Pharmacia & Upjohn Consumer Healthcare, concerning the country of origin marking for products containing nicotine.


Bulk Nicotine will be imported into Sweden from either Ireland or Switzerland and manufactured with other components of Swedish or U.S. origin into three finished drug products packaged for retail sale: trans-dermal patches, inhalers, and nasal spray, classifiable under subheading 3004.90, Harmonized Tariff Schedule of the United States (HTSUS). It is stated that the bulk nicotine is poisonous and unsuitable for administration to humans. The trans-dermal patch, oral inhaler, and nasal spray are intended to be used by people who wish to stop smoking by delivering safe levels of nicotine solution into their bodies.

The trans-dermal patch system consists of either 7 or 14 patches, an audiotape, a booklet, and cards containing “Kick the habit” tips. The patch is a flexible, rectangular, multilaminate with a beige matte-finish backing, an adhesive layer, and a clear release liner that is removed prior to application. The patch itself is comprised of polyisobutylenes, polybutene non-woven polyester, pigmented aluminized and clear polyesters, all of Swedish origin. In Sweden, the patch is impregnated with the nicotine and designed to deliver nicotine to the user over a 16 hour period.

The inhaler is described as a unique nicotine dosage form that delivers nicotine saturated in air via oral inhalation. The bulk nicotine imported into Sweden is tested for potency and mixed with levomethanol, ethanol, nitrogen gas, and a polyethylene porous plug to form the inhaler. The plug is inserted into a barex tube and foil sealed at each end, producing a loaded cartridge. The loaded cartridge is designed for insertion into a shaped mouthpiece to allow the release of the gaseous nicotine solution from the porous plug. The inhaler also is provided with a removable cover and a plastic case to allow the storage of the inhaler and six cartridges.

To make the nasal spray, the bulk nicotine imported into Sweden is tested for potency and mixed with disodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate, citric acid, sodium chloride, polysorbate, aroma, methylparaben, propylparaben, edetate disodium, and water. The solution is then filtered and filled in brown glass containers. Each glass container is equipped with a spray pump aggregate and a nose piece, packaged for retail sale. It is claimed that the finished products should be marked “Made in Sweden.”


Whether the bulk nicotine imported into Sweden undergoes a substantial transformation when it is made into a trans-dermal patch, oral inhaler, or nasal spray, such that the finished products may be marked “Made in Sweden” for purposes of 19 U.S.C. 1304.


The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article. Part 134, Customs Regulations (19 CFR Part 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304.

Section 134.1(b), Customs Regulations {19 CFR 134.1(b)}, defines “country of origin” as the country of manufacture, production or growth of any article of foreign origin entering the U.S. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the “country of origin” within the meaning of the marking laws and regulations. For country of origin marking purposes, a substantial transformation of an imported article occurs when it is used in the U.S. in manufacture, which results in an article having a name, character, or use differing from that of the imported article. See 19 CFR 134.35.

It is claimed that the bulk nicotine is substantially transformed in Sweden, such that the trans-dermal patch, oral inhaler, and nasal spray may be appropriately marked as a product of Sweden. For purposes of the inhaler, it is stated that the bulk nicotine will be transformed from a form that is dangerous for human ingestion to an inhaler that delivers controlled doses, of uniform potency and at human tolerance levels.

It is our opinion that the bulk nicotine in this case undergoes a substantial transformation in Sweden when it is used to make patches, inhalers, and sprays. In each instance, there is a change in name from nicotine to a “patch,” “inhaler,” or “nasal spray.” There is also a change in character, from a bulk ingredient into a completely different article such as an adhesive dressing formulated for timed release, a cigarette-shaped cartridge and mouthpiece, or an aerosol spray. There is a change in use as an ingredient that is unsuitable to be administered to humans to a form that can be used as an aid in breaking a person’s addiction to smoking. Without the processing in Sweden the bulk ingredient is unfit for human use, and the processing in this instance allows the ingredient to become a purified solution of uniform potency. There is also sufficient change in form from an active ingredient to a different article, unlike a situation such as Headquarters Ruling Letter (HRL) 734558 dated July 22, 1992, where the original article, a water dispersible herbicide, could be used in the same application as the finished article, an encapusulated herbicide, albeit not in a form that was as user friendly. Therefore, it is our opinion that the finished patch, inhaler, and spray should be marked “Made in Sweden” for purposes of 19 U.S.C. 1304.


Based upon the information provided, it is our opinion that the bulk nicotine is substantially transformed in Sweden when made into a patch, inhaler, or nasal spray for use as an aid in helping people stop smoking. Therefore, the patch, inhaler, and nasal spray will be required to be marked as products of Sweden pursuant to 19 U.S.C. 1304. A copy of this ruling letter should be attached to the entry documents filed at the time the goods are entered. If the documents have been filed without a copy, this ruling should be brought to the attention of the Customs officer handling the transaction.


John Durant, Director
Commercial Rulings Division

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