South Africa: E-Cigarettes Have to Comply to Medicines Law

Source from:  Health-e (Cape Town) 04/27/2013

The Medicines Control Council (MCC) has refuted claims by electronic cigarette distributor Twisp that it does not have to comply with medicine-related laws, confirming that the product is subject to medical scheduling and can only be sold at pharmacies.

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 "intended 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.

"The 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.

"The 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.

"The simple logic behind the scheduling change in 2012 is that nicotine is a pharmacologically active substance that requires control," says Gray.

"There is a complex relationship between medicines and substances, and the Act itself is therefore called the 'Medicines and Related Substances Act'," says Gray. "It 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'.

"E-cigarettes are also delivery devices for nicotine and have not been assessed for efficacy, safety or quality," says Gray. Enditem