(Catania, 4th August 2021). Electronic cigarettes are products that create an aerosol, commonly called vapour, similar to the smoke produced by a conventional cigarette. The rise in popularity of such devices has seen a spike in the number of consumers, forcing national and transnational authorities to create a regulatory framework that includes the whole spectrum of vaping products.
E-liquids are the most regulated products and should meet safety requirements for the nicotine concentration, warning labels, colour additives and shape.
Worldwide approaches to range from absolute bans to the total lack of regulation. Furthermore, uncertainty and controversy have contributed to wide variation in e-cigarettes market access.
CoEHAR gathered up-to-date information on regulations in the most important international markets.
EUROPEAN UNION
At the international level, the European Union is the institution with the most restrictive legislation on e-liquids, with many requirements that electronic liquids must meet to enter the European market.
There are numerous characteristics that electronic liquids must meet to enter the European market. Among the specifications, the maximum concentration of nicotine allowed, which must not exceed 10 ml per bottle and which in any case must not exceed 20 mg/ml. Furthermore, it must not contain carcinogenic substances, colouring additives, or any other additive in unburned form. The e-liquid bottle must include a spout at least 9 mm long with child-resistant caps. In addition to the structural characteristics, importers and producers must provide test requirements. Independent laboratories must run tests on toxicological data of the e-liquids, the purity of the ingredients, and the cannabidiol content. The requirements included labels with warnings, an information message.
UNITED STATES
Another important market is in the United States of America, which requires manufacturers and importers minimum standards for their products. To enter the US market, companies must register the products on a special list of the Food and Drug Administration (FDA), a US government body that deals with the regulation of food and pharmaceutical goods. The FDA starts then a review process in which scientific data on the non-toxicity of liquids will need to be attached by further product-specific tests. The entire process should not exceed six months for large firms and nine months for smaller companies. An additional requirement requested by the US authorities involves the risk warnings in the packaging, which must comply with the formats and standards approved by the FDA. Finally, as for the European health authorities, the Child Nicotine Poisoning Prevention Act (CPSC) demands additional rules to prevent harm to children from the accidental ingestion of nicotine and regulates the packaging of these liquids to be safe for children.
SOUTH-EAST ASIA
Southeast Asian countries vary considerably in their policies on e-liquids. Singapore, Brunei and Thailand imposed strict measures that preventively ban any heat-not-burn device. Laos and Cambodia imposed laws to ban the import, distribution and sale of the e-cigarette and the components even before the market could be established. Indonesia and Myanmar lack any legislation on e-cigarettes. Philippines, Taiwan, Malaysia, Hong Kong and Vietnam have restrictions on advertising, accessibility and use of these devices among consumers.
LATIN AMERICA
In Latin America, vaping is illegal or no specific laws regulate electronic liquids. Vaping is prohibited in countries such as Argentina and Mexico. Peru and Colombia don’t have laws to ban their import and sale. In the entire region, there are only five countries – Brazil, Ecuador, Honduras, Paraguay and Costa Rica – where the sale of electronic cigarettes and related products are legal and permitted under certain conditions.
CoEHAR studies on e-liquids
Numerous studies carried out by the Center of Excellence for the acceleration of Harm Reduction (CoEHAR) have shown that the use of e-liquids is significantly less harmful to human cells.
Several studies at CoEHAR focused on the exposure of human bronchial epithelial cells (NCI-H292) to cigarette smoke and ENDS aerosol to measure and evaluate the cytotoxic effects of smoke and aerosol.
“Our studies determined that exposure of bronchial cells to vapours from electronic cigarettes substantially reduces cellular toxicity compared to conventional cigarettes. Our research group conducted a multicenter study in which we replicated some work conducted by tobacco companies. In this study, we did not observe any reduction in the viability of cells exposed to e-cigarettes compared to cells exposed to air. A clear difference with cells exposed to cigarette smoke with mortality as higher as 70-80% compared to air” explains Rosalia Emma, a research fellow at the Science Department of Biomedical and the Biotechnological University of Catania specialized in exposure to smoke and vapour of electronic cigarettes using automated tools (smoking / vaping machine).
An attitude that goes against the growing popularity of electronic cigarettes and e-liquids among consumers.
“From a scientific point of view – emphasizes Dr Emma – it is relatively safe to say that electronic cigarettes on the market are less toxic than conventional cigarettes. Unlike combustible cigarettes – where the temperature of tobacco reaches 800-950 ° C- electronic cigarettes (not containing tobacco but liquids based on PG / VG and aromas) reach temperatures between 200-320 ° C. As a result, e-cigs do not release combustion products (such as tar) and contain less toxic substances than classic cigarettes.”
Different approaches mean more confusion
The distinctive approach between the United States and the European Union on restrictions on e-liquids has also increased the unsettling. The limits in the percentages of nicotine and flavourings are different between the two markets, with a regulatory framework that is much restrictive in Europe and aimed at the safety of liquid components.
“The common vaping products used by European smokers to quit have nothing to do with products in the US black market that caused a serious public health issue in the past,” said Professor Riccardo Polosa, founder of the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) and European Coordinator of the Working Group on “Requirements and Test Methods for E-Cigarette Emissions“.
In the United States, there are no limits on nicotine concentration, maximum content per bottle, or restrictions on components in liquids unless they are toxic. But the main difficulty lies in information: in 2019, the deaths and hospitalizations initially attributed to the use of ecigs caused a process of collective hysteria towards electronic cigarettes and a consequent further restriction in the regulatory process around the world. US health authorities eventually discovered that hospitalized people inhaled illegally purchased liquids containing THC oil. An ad-hoc investigation then revealed that the deaths and intoxications were caused by the vitamin E acetate used as a solvent for THC and by myclobutanil, a fungicide that transforms into hydrogen cyanide at high temperatures.
“A careful check on cannabis-based vaporizing products is due now more than ever – continues Polosa – certainly not on electronic cigarettes which by law is already monitored in Europe. The Cen / Tc 437 Commission (Electronic cigarettes and e-liquids), set up within the European Committee for Standardization aim to develop safety standards for the production and sale of electronic cigarettes in Europe. The focus of the debate among the European experts, including the delegates of the Uni Italian Standardization Body, is the US regulation market and the steps to be taken to avoid a new similar case.“
