The MCC response follows the claim by Twisp, a major manufacturer and distributor of the e-cigarette, that the Medicines and Related Substances Act does not apply to the product as it is not marketed as a medical device.

Health-e reported recently that an amendment to the Medicines and Related Substances Act last year classified nicotine as a schedule 2 and 3 substance that has to be registered by the MCC and can only be sold at pharmacies. This made the sale of e-cigarettes at shopping centre kiosks and other general retailers illegal.

But Philip Bartholomew from Twisp defended the sale of the product. He claimed that, as long as the product isn’€™t marketed as a medical device, the scheduling does not apply.

The amended Medicines and Related Substances Act, as published in the Government Gazette in March last year, states that nicotine is classified as a Schedule 3 substance when ‘€œintended for human medicinal use as an aid to smoking cessation or as a substitute for a tobacco product’€.

MCC Registrar Mandisa Hela holds firm that, regardless of how it is marketed, the nicotine fluid as well as the e-cigarette device is subject to medical scheduling and is therefore being sold illegally at outlets that are not registered pharmacies.

‘€œThe intention of inhaling nicotine vapour can be for no other reason than to satisfy a craving for it,’€ said a representative with the national Department of Health.

‘€œThe law was particularly structured to include the e-cigarette because we are unsure about the safety. Concentrated nicotine, like that used with the e-cigarette, can be a safety risk for patients.’€

Andy Gray, from the University of KwaZulu Natal’€™s Division of Pharmacology also believes that the Act still applies to nicotine, whether it is marketed as a medical substance or not.

‘€œThe simple logic behind the scheduling change in 2012 is that nicotine is a pharmacologically active substance that requires control,’€ says Gray.

‘€œThere is a complex relationship between medicines and substances, and the Act itself is therefore called the ‘€˜Medicines and Related Substances Act’€™,’€ says Gray. ‘€œIt is clear that not every substance that is captured in the Schedules is registrable as a medicine ‘€“ raw materials, which have yet to be formulated as medicines suitable for administration, are still controlled as ‘€˜substances’€™.

‘€œE-cigarettes are also delivery devices for nicotine and have not been assessed for efficacy, safety or quality,’€ says Gray.