Regulatory confusion regarding e-cigarettes & vaping will be resolved
By Vapour Product Association
Topics Health & Pharmaceutical Law
09 Nov 2017
Confusion continues to surround legislation regarding e-cigarettes and vaping. But, as more organisations publish findings regarding the use of vaping to reduce tobacco smoking and its health risks, so the regulatory tide is beginning to turn, says South Africa’s Vapour Product Association (VPA).
The irony surrounding the categorisation of e-cigarettes and vaping is that both electronic devices and vapours-which contain varying levels of nicotine – are treated as tobacco products, although they contain no tobacco at all.
“In fact,” says Kabir Kaleechurn, Director of the VPA, “the two smoking processes are different. Tobacco smoking relies on burning of tobacco, the cause of all cigarette-smoking health risks while vaping relies on a gentle heating process to deliver its nicotine. It is probably the word ‘cigarette’ used for both products that is causing legislative confusion,” he says.
“In many countries, the legislation places e-cigarettes in the same category as tobacco. In South Africa, e-cigarettes are not covered by the Tobacco Products Control Act, or by the Medicines and Related Substances Control Act. It seems that the act of combustion and smoke preclude e-cigarettes being regarded as cigarettes. They also do not fall under the Medicines Act as they are marketed solely for recreational purposes.”
Whilst e-cigarettes and vaping presently fall into the gap between smoking and medicinal legislation in South Africa, there have been calls locally for it to be classified under both sets of legislation. Protagonists for this viewpoint feel that it should be regarded as a medical treatment, with ‘other’ consumption falling under the Tobacco Act because it ‘should be regarded as a health risk like all tobacco products’.
In the VPA’s view, this is contradictory. Authorities internationally are stating that vaping is reducing smoking by active tobacco smokers. Vaping is also weaning people off tobacco smoking by still offering the hit experienced by nicotine – medically regarded as the least dangerous of the all the substances found in tobacco cigarettes according to 2017 May report entitled ‘Where there’s no smoke, is there still fire? ethical aspects of tobacco harm reduction ‘published by the Africa Harm Reduction Alliance (AHRA).
“The Vaping Industry needs to be considered as a partner to the Health agenda in South Africa, should all smokers move to harm reduced vaping products the impact is bound to be extremely positive from a Non-communicable diseases point of view. It is our duty to ensure that we provide a safer alternative to the millions of smokers in the country” he says.
In South Africa, members of the VPA have responded to the legislative situation by adhering to their own code of conduct. We voluntarily have committed ourselves to not selling the product to and by people under the age of 18.
“In the meantime,” says Kaleechurn, “South Africa is not alone. In the UK, e-cigarettes may be brought to market as either medicines or consumer products. Those wanting medicines approval to undergo the standard licensing process; Norway makes provision for vaping devices to be classified as either medicinal products or tobacco surrogates. France has allowed e-cigarettes to be marketed as medicines and consumer products.”
In the United States, Food and Drug Administration (FDA) regards e-cigarettes and other electronic delivery systems as tobacco products, except in cases where they are ‘marketed as drugs, devices or combination products’.
However, now under the leadership of Dr Scott Gottlieb, the FDA appears to be moving towards regulatory changes that are designed to move smokers towards e-cigarettes. The Reuters news agency (July 17, 2017) said the government proposed cutting nicotine in cigarettes to ‘non-addictive’ levels.
The FDA cannot reduce nicotine levels to zero, nor can it ban cigarettes. But Gottlieb said the agency would study regulating nicotine levels with a view toward the “FDA’s potential to render cigarettes minimally addictive or non-addictive.”
“Nicotine itself is not responsible for cancer, lung disease and heart disease that kill hundreds of thousands of Americans each year,” he said. “It’s the other chemical compounds in tobacco and in the smoke created by setting tobacco on fire that directly causes illness and death.” Analysts said they expect regulators in Europe to study similar actions on nicotine products.
The action shakes up a debate among public health advocates as to whether e-cigarettes represent a health risk or potential benefit. “While there’s still much research to be done on these products and the risks that they may pose, they may also present benefits that we must consider,” Gottlieb said.
During an April hearing on whether to advance his nomination for the FDA position, he said some e-cigarettes may have the potential to wean smokers off combustible cigarettes and be less harmful.
“As the debate on legislation continues, so more medical research is being released on the benefits of e-cigarettes and vaping. Anti-smoking bodies and medical bodies such as the World Health Organisation (WHO) have entered the debate with positive findings on vaping and the role it plays in reducing risk within the smoking community.”
It may take time, but it is inevitable that as the body of available research increases, so legislators will begin to review their stance on vaping. Organisations like the VPA are committed to supplying information available, while ethically serving the market,” says Kaleechurn.