E-Cigarette: It Tastes So Good But What About The Law On It?

In recent years, the electronic cigarette (“E-Cigarette”) has enjoyed a boom in popularity and has become a trend among urbanites.

But What Are E-Cigarette?

An e-cigarette is a battery-operated smoking device designed to deliver nicotine or related substances to users in the form of an aerosol.

It typically consists of a heating element, a cartridge that contains liquid nicotine or other substances and an atomizer that, when heated, convert the contents of the cartridge into an aerosol that the user inhales. As the liquid solution is converted into vapour, E-Cigarette is sometimes referred to as “vaping”, rather than smoking.

There are two main categories of E-Cigarette!

One is a closed system, in which pre-filled cartridges are used; the other one is an open system, where users are allowed to manually add solutions to a refillable cartridge.

When E-Cigarettes were first introduced, they were shaped like cigarettes, cigars or pipes. Over the years, the designs and ingredients have evolved. Today, E-Cigarettes come in hundreds of brands with a variety of shapes and flavours, with some even mimicking common household products such as pens, lipsticks and power banks.

Sales of E-Cigarettes have risen exponentially over the years. It is speculated that sales of E-Cigarettes might even overtake conventional cigarettes within the next 5-10 years.

Safety and Public Health Impact

Many public health organizations and policymakers are concerned about the safety and public health impact of E-Cigarettes. This is due to the lack of manufacturing standards and ingredient disclosure requirements. They agree that further scientific study needs to be undertaken to assess the safety claims about E-Cigarettes and to determine the public health impact of E-Cigarettes.

The nicotine in E-Cigarettes, like any other tobacco products, is highly addictive and can be toxic if taken in high doses.

For example, E-Cigarette cartridge typically contains between 6 and 24 mg of nicotine per millilitre, but in some brands, the nicotine level has been found to be much higher.

It is also still unknown about the health impacts of E-Cigarette aerosol on both the users and those in close proximity who are exposed to the second-hand aerosol.

One study conducted by the U.S. Food and Drug Administration (“FDA”) has found that E-Cigarettes contain a number of dangerous substances.

The World Health Organization has strongly advised consumers against the use of E-Cigarettes until they are “deemed safe and effective and of acceptable quality by a competent national regulatory body.”

As a result of this, governments around the world have stepped in to regulate the sale, price, and use of E-Cigarettes. The regulation varies across countries. Some countries have come up with regulations while some have completely banned E-Cigarettes altogether.

Legal Status of E-Cigarette around the World

In the US, at the Federal level, the FDA has regulated cigarettes, smokeless, and roll-your-own tobacco since 2009. On 8^th August 2016, the FDA finalised a rule that extends its regulatory authority to all tobacco products, including E-Cigarettes, cigars and hookah and pipe tobacco, as part of its goal to improve public health.

“Before this final rule, these products could be sold without any review of their ingredients, how they were made, and their potential dangers,” explains Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.

“Under this new rule, we’re taking steps to protect Americans from the dangers of tobacco products, ensure these tobacco products have health warnings and restrict sales to minors.”

The New Rule

The new rule does numerous things.

As mentioned, the new rule extends the FDA’s regulatory authority to all tobacco products, including E-Cigarettes (also called electronic cigarettes or electronic nicotine delivery systems (ENDS)), all cigars, hookah (also called waterpipe tobacco), pipe tobacco, nicotine gels and dissolvables that did not previously fall under the FDA’s authority.

It requires health warnings on roll-your-own tobacco, cigarette tobacco, and certain newly regulated tobacco products and also bans free samples. In addition, manufacturers of newly regulated tobacco products that were not on the market as of 15^th February 2007 will have to show that their products meet the applicable public health standard set by the law. Most importantly, these manufacturers will have to receive marketing authorisation from the FDA.

Furthermore, the new rule also restricts youth access to newly regulated tobacco products by not allowing such products to be sold to those younger than 18 and not allowing tobacco products to be sold in vending machines (unless in an adult-only facility).

Finally, it gives a foundation for future FDA actions related to tobacco.

At the state level, local governments can pass their own state laws to regulate the use of E-Cigarettes. In California, it is illegal to sell or otherwise furnish an E-Cigarette to a person under 18 years of age.

Some states have imposed a tax on E-Cigarettes as they are treated as tobacco products while some states have extended their indoor smoking bans to include E-Cigarettes. The U.S. Department of Transportation has stated that it interprets the federal regulations that prohibit smoking on aeroplanes to apply to E-Cigarettes.

In some parts of Europe, E-Cigarettes are currently banned while some other EU member states allow the sale and use of E-Cigarettes, albeit with some restrictions.

The EU has passed a revised Tobacco Products Directive (“Directive”) which aims to improve the functioning of the internal market for tobacco and related products while ensuring a high level of health protection for European citizens. The Directive, which is based on the proposal of the European Commission, entered into force on 19^th May 2014 and became applicable in the EU Member States on 20^th May 2016.

The Directive includes E-Cigarettes as tobacco-related products and introduces certain new rules on how E-Cigarettes can be sold and manufactured, as well as how they can be displayed in shops.

The Directive also requires health warnings, instructions for use, information on addictiveness and toxicity to be displayed on packages on E-Cigarettes and it controls the maximum sizes of the liquid bottles (2ml for cartridges and 10ml for refill containers) and the maximum nicotine level they can contain (not more than 20mg).

It also requires the manufacturers to submit detailed and transparent reports on the ingredients used in E-Cigarettes. All substances contained in the E-Cigarettes and the nicotine content must be listed on the packages.

In Singapore, E-Cigarettes are currently prohibited under the Tobacco (Control of Advertisements and Sale) Act, which prohibits the importation, distribution, sale or offer for sale of any confectionery or other food product or any toy or other articles:

1. that resembles, or is designed to resemble a tobacco product;
2. that is capable of being smoked;
3. that may be used in such a way as to mimic the act of smoking; or

the packaging of which resembles, or is designed to resemble, the packaging commonly associated with tobacco products.

Current Status in Malaysia

In Malaysia, at least 5 states have banned the sale and use of E-Cigarettes.

The government has already begun raiding vaping suppliers and seizing items containing nicotine. It is estimated that there are between 400,000 and 1.25 million vapers in Malaysia out of a smoking population of about five million (Aljazeera News, 31 December 2015).

The Food Act 1983 empowers the Minister of Health to;

regulate the advertising of tobacco products, labeling of cigarette containers, smoking in certain buildings or places, selling of tobacco products to persons below the age of 18 years and minimum cigarette price, etc.

The regulations define “tobacco” as;

any product obtained from the leaf of the Nicotiana Tobacum plant or other related plants and includes any tobacco product; “tobacco product” as tobacco, cigarette or cigar or any other product the main ingredient of which is tobacco and which is designed for human consumption;

“cigarette” as;

any product which consists wholly or partly of cut, shredded or manufactured tobacco, or of any tobacco derivative or substitute, rolled up in a single or more wrapper of paper, and which is capable of being immediately used for smoking;

while “smoking” as;

inhaling and expelling the smoke or vapor of any tobacco product and includes the holding of or control over any ignited, heated or vaporized tobacco product.

Looking at the definitions, particularly the word “cigarette”, it appears that E-Cigarettes fall outside of the regulations.

The government is mulling the ban of E-Cigarettes and vaping products as well as increasing the minimum age for the sale and purchase of tobacco and tobacco products from 18 to 21. Health Minister Dr Dzulkefly Ahmad said this was among several items included in the draft for a proposed Control of Tobacco and Smoking Product Act being deliberated by the ministry’s legal advisers.

It is no doubt that the Government has expressed its intention to regulate E-Cigarettes. Thus, we can expect new legislation or amendments to existing legislation be tabled to the Parliament in a matter of time.

What about Poison Act 1952?

In November 2015, the Ministry of Health officials began a series of raids across Malaysia to confiscate nicotine-laced bottles of “juice” – e-liquids which are widely stocked at vape stores alongside E-Cigarettes and peripheral equipment.

The Ministry of Health justified the seizures by stating that nicotine is subject by law under the Poison Act 1952. Thus, its distribution, sale and use are heavily regulated in Malaysia.

It remains a hotly debated topic whether E-Cigarettes should be regulated or banned altogether.

Supporters of regulations have expressed concerns that E-Cigarettes could serve as a “gateway” to smoking actual cigarettes and pose a new health risk. Meanwhile, opponents claim that they are a helpful tool for people quitting smoking

Whether it is helpful or not, some form of regulations is indeed necessary to ensure the safety of E-Cigarettes.

After all, if conventional cigarettes are tightly regulated, why should there be a different/lenient treatment accorded to E-Cigarettes, if E-Cigarettes also contain some form of nicotine?

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About the author:
This article was written by Edwin Lee Yong Cieh, Partner of LPP Law – law firm in Kuala Lumpur, Malaysia (+6016 928 6130, [email protected]).

This article was first published in CHIP Magazine Malaysia.

The view expressed in this article is intended to provide a general guide to the subject matter and does not constitute professional legal advice. You are advised to seek proper legal advice for your specific situation.