Regulatory Response to E-cigarettes

• Jurisdiction: United States,Federal
• Citation: Vol. 45 No. 3
• Publication year: 2017

REGULATORY RESPONSE TO E-CIGARETTES

Morgan Johnson^*

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TABLE OF CONTENTS

I. INTRODUCTION ...............................................................................646

II. BACKGROUND .................................................................................647

A. Product Design: How e-Cigarettes Work.................................647
B. Evolution of the e-Cigarette Market.........................................648
C. Health Effects...........................................................................651
D. Marketing.................................................................................653
E. Existing Regulation .................................................................. 654

1. World Health Organization Regulatory Framework.........654
2. Existing Regulation............................................................656
3. Regulation and Trade Agreements....................................662

III. ANALYSIS ........................................................................................664

IV. CONCLUSION ...................................................................................666

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I. INTRODUCTION

Public health organizations have been fighting the "war on cigarettes" for years, trying to put an end to the tobacco industry that is credited with causing an estimated 100 million deaths over the last century.¹ In the United States alone tobacco use continues to be the leading cause of preventable disease and death, with cigarette smoking causing about one in every five deaths each year, totaling over 480,000 deaths annually.² Recently, a new product has entered the market that some fear will undo the progress made against nicotine addiction and smoking. Electronic cigarettes, also called e-cigarettes, vapes, vape pens, or ENDS (electronic nicotine delivery systems), first entered commercial markets in the mid-2000s.³ Since that time, countries and regulatory agencies have grappled with how best to define and regulate the product. E-cigarette regulation is a difficult area because of the competing public health concerns and implications surrounding the product's use. Proponents of e-cigarettes argue that the devices serve an important harm-reduction function. For chronic smokers, switching from traditional cigarettes to e-cigarettes can arguably reduce the amount of toxins consumed and serve as a gateway to cessation.⁴ Additionally, e-cigarettes can greatly reduce the societal harm associated with second-hand smoke inhalation because the devices discharge a less-harmful vapor. However, others argue that e-cigarettes pose a significant public health risk because they facilitate nicotine addiction, "re-normalize and re-glamorize smoking to vulnerable youth and developing world populations,"⁵ and are both accessible and appealing to a young population.⁶ countries attempting to regulate these new products must sort e-cigarettes into one of the following categories: medical device, drug, tobacco product, or regular consumer product.

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Furthermore they must choose a regulatory scheme that best mitigates the risk to their population while maximizing potential harm-reduction benefits.

Part II of this Note will discuss the background of e-cigarettes, including the product design, market history, growing social use among teenagers, and health effects. Then this Note will compare the current regulatory schemes, including the framework for regulation promulgated by the World Health Organization. Part III will discuss benefits and shortcomings of regulation against a scheme of little or no regulation. Part IV will offer concluding remarks.

II. BACKGROUND

A. Product Design: How e-Cigarettes Work

E-cigarettes are "battery-powered devices that vaporize a flavored propylene glycol or glycerin solution, with or without nicotine, to simulate cigarette smoking."⁷ The vapor is inhaled as one would inhale cigarette smoke. Users will experience a nicotine high similar to that of cigarette or hookah tobacco.⁸ Nicotine has been described by users as a cure all. "When you are sleepy it wakes you; when you are anxious, it relaxes you; when you are hungry, it takes your hunger away."⁹

Originally, the products were designed to resemble traditional cigarettes. Now, users can choose from a broad range of designs. Some are slim, resembling a pen or cigar; others are bulkier and closer to the size of a pocket flask.

Once users have obtained the e-cigarette, they can then buy the liquid that will be vaporized. Although the designs vary, the user will generally put a few drops of liquid into the device which will then turn to vapor via heat by a coil. The liquid generally contains approximately 12% of nicotine, but higher concentrations are available. Liquid with no nicotine is usually geared toward users who are under eighteen and unable to buy the nicotine product. The pleasant flavors of the liquid, akin to the flavored tobacco in a hookah pipe, are what make the product appealing. Users can choose from a wide array of flavors, such as cinnamon roll, lemonade, fruit roll-up, gusher, coffee, coconut,

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ice cream, and apple juice. An e-liquid cartridge, ranging in price from $5 at the gas station to $30 for an upscale brand at a specialty store, can last anywhere from a month to a day depending on how often users vape. Because the nicotine is contained in the liquid, regulation may be more heavily focused on the liquid than on the e-cigarette device itself. However, product design regulations governing how hot the coil can heat to will also be necessary.

B. Evolution of the e-Cigarette Market

Chinese pharmacist Hon Lik patented the first e-cigarette in 2003. A smoker himself, Lik lost his father to lung cancer and was searching for a safer way to get a nicotine fix.¹⁰ E-cigarettes became available in both U.S. and European markets approximately four years later.¹¹ Since e-cigarettes' introduction to the market demand has exploded. While China is still the biggest producer of e-cigarettes and e-liquids, in 2013, the industry was worth $1.8 billion in the U.S. alone.¹² In 2014, that number increased to $2.5 billion, and in 2015, to $3.5 billion.¹³ The "e-cigarette global industry is projected to reach $10 billion by 2017."¹⁴

Large transnational tobacco companies not wanting to lose their grip on the $800 billion tobacco industry began investing in e-cigarette technology almost immediately. The current e-cigarette market is mostly split between e-cigarettes made by Big Tobacco,¹⁵ valued at $1.5 billion, and vaporizers that use refillable liquid nicotine from small manufacturers, valued at $2 billion.¹⁶ While the e-cigarette market was initially "dominated by companies with no links to the tobacco industry, it is increasingly owned by the tobacco industry." "All main transnational tobacco companies sell ENDS," and one company is even "launching legal proceedings over patents against its rivals as they become increasingly aggressive in the battle for the fast-growing e-cigarette market."¹⁷ The tobacco industry is "trying to regain the respectability it lost long ago by appearing to offer a solution with one

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hand, while continuing to create mass destruction with the other."¹⁸ Now, "e-cigarettes are sold at Walmart, vaped by Katherine Heigl and Leonardo DiCaprio and advertised during the Super Bowl and the Oscars and on the hoods of NASCAR race cars."¹⁹

Prior to August of 2016, e-cigarettes fell blissfully outside of the FDA's tobacco regulatory powers. In a climate of little to no regulation in the United States, "more than 8,500 vape shops have sprung up in strip malls and stand alone stores across the country."²⁰ Much of the industry's "early success comes thanks to [its] near complete freedom from regulation, which has allowed dozens of small players to flourish."²¹ Vape shops are not set up like typical retail stores; instead, they resemble bars or cafes. Users can enter with their vape pens and chat with the staff, sample new flavors, and socialize at the bar.

As the market has evolved, e-cigarettes have become part of a youthful cultural movement often referred to as "vape culture."²² Vaping is seen as a social activity rather than a therapeutic one; in fact, "several studies demonstrated the recreational element of e-cigarette use. In one study that included two surveys of more than 3,500 e-cigarette users, only one showed a marginally significant correlation between use and a quit attempt in the last three months."²³ Another study found that among university students, there was "no established association between e-cigarette use and intention to quit smoking."²⁴ According to the Centers for Disease Control and Prevention (CDC), e-cigarette use in the United States by "tweens and teens tripled in 2014 to 13.4% from 4.5% in 2013."²⁵ Besides the flavors, another large appeal for young consumers is the amount of vapor e-cigarettes produce. E-cigarettes "produce much more vapor, especially when adjusted to operate at high temperatures, than conventional cigarettes, which helps

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facilitate . . . vapor tricks."²⁶ Vapers hold what are called cloud competitions where they compete to perform the best tricks and create the biggest and densest vapor clouds.²⁷ Thousands of YouTube and Instagram videos are posted daily "demonstrating expert vaping and how to perform tricks."²⁸

E-cigarette liquid, sometimes called "e-liquid," "juice," "vape juice," or "e-juice" by users, comes in many different flavors labeled and marketed for aesthetic appeal. A recent study indicated that e-liquids are "marketed in 7764 unique flavours."²⁹ Ripe Vapes, a handcrafted line of e-cigarette liquids, features flavors such as Pear Almond ("envoking the polished pastries of Europe") and Coconut Thai ("smooth coconut, rich and slightly sweet followed by after notes of fresh thai basil and bright lemongrass").³⁰ Most lines are marketed toward a younger, hipper demographic...