The change to the Medicines and Related Substances Act classified nicotine, an ingredient in the e-cigarette, as a schedule 3 substance that can only be sold by pharmacists.

The new regulations require e-cigarettes to be registered in terms of the Medicines Act or sold in terms of the Tobacco Control Act, which does not allow any marketing of the product. According to the Medicines Act the product may also not be displayed openly and must be stored out of sight.   Consumers also need a doctor’€™s prescription to buy an e-cigarette or the refill liquid – the e-cigarette apparatus is the delivery devices for a scheduled substance and therefore also has to be registered.

Mandisa Hela, registrar for the Medicines Control Council (MCC), confirmed that the form and quantity of nicotine sold for the e-cigarette is classified as a schedule 3 substance.

‘€œUnless the product is registered by the MCC and intended as aids to smoking cessation, it  may be classified as a Schedule 2 depending on the nicotine content per cartridge,’€ said Hela. Schedule 2 substances may also only be sold from pharmacies.

However, since the promulgation of the Act there has been no enforcement of this regulation and e-cigarette kiosks have sprung up at shopping centres across South Africa.

The sale of these products is supposed to be regulated by inspectors appointed by the Director General. ‘€œIllegal sale must be investigated and depending on the outcome, a case could be opened with SAPS,’€ said Hela. She said that the public should report transgressions to the department and inspectors will follow up.

E-cigarette manufacturers and distributors expressed their anger when the regulations were first published in the Government Gazette a year ago.

‘€œThe initial reaction from the e-cigarette manufacturers was to (unsuccessfully) brow-beat everyone into accepting that the schedules did not apply to their products at all. And nothing has happened since,’€ says Dr Andy Gray from the University of KwaZulu-Natal’€™s Division of Pharmacology.

Before the scheduling e-cigarettes were unregulated as the Tobacco Products Control Act only applied to products that contain tobacco.

Dr Yussuf Saloojee of the National Council Against Smoking confirms that ‘€œNicotine itself is harmful and increases the risk of heart disease.’€

The classification of the product as a medical substance comes after retailers started marketing it as an aid to help smokers quit, and sold it as a healthier alternative to smoking.

‘€œIn theory the e-cigarette should be less harmful than tobacco smoke, but it is definitely not safe,’€ says Saloojee.

Because it is a relatively new product there is no evidence on the effect of long-term use, but it is suspected that the chemical components could be harmful to a user’€™s health.

A 2009 analysis of the e-cigarette by the US Food and Drug Administration identified trace levels of tobacco-specific nitrosamines (TSNAs) – cancer-causing compounds commonly found in traditional cigarettes, albeit at a much lower concentration. But the FDA also found diethylene glycol, a component of antifreeze and brake fluids that is classed as a poison by the World Health Organisation as it can cause kidney damage, nerve dysfunction and respiratory failure.

A recent study also found particles of silver, iron, aluminium and silicate, and nanoparticles of tin, chromium and nickel in the vapour released by e-cigarettes. According to the researchers, many of these elements are known to cause respiratory distress and disease.