In the rapidly evolving landscape of tobacco alternatives, Electronic Nicotine Delivery Systems (ENDS), commonly known as e-cigarettes, have emerged as a prominent player. These devices, which use electronic mechanisms to deliver nicotine by heating a liquid, have gained significant popularity worldwide. ENDS caters to various preferences with various flavors and adjustable settings, offering an alternative to traditional tobacco products. This article dives into the intricacies of ENDS, their usage, associated risks, and how Evalueserve's expert insights can support businesses in navigating these products' regulatory and safety challenges.

Types of ENDS

To better understand ENDS, it's essential to recognize the different types available. There are two primary types of ENDS: open systems and closed "pod" systems. Open systems feature an atomizer unit with controls, a battery, heating coils, and a user-fillable tank. In contrast, pod systems use prefilled, sealed e-liquid tanks known as pods. Both types allow users to adjust settings like power and voltage to control vapor production.
The latest 4th generation devices target consumers and have the potential to serve as prescription smoking cessation tools.

Regulatory Landscape

Given the variety of ENDS devices, it is crucial to consider how they are regulated. Most countries heavily regulate the sale and use of ENDS devices and e-liquids. Some nations outright ban these products, while others view them as a harm-reduction tool and have established regulatory frameworks for their approval and sale.

Who Uses ENDS?

Understanding the regulatory landscape is essential, but knowing who uses these products is equally critical. According to the latest Annual National Youth Tobacco Survey, 10.0% of students, which equates to approximately 2.80 million youths, are currently using some form of tobacco product. Breaking this down, 12.6% of high school students (1.97 million) and 6.6% of middle school students (800,000) reported current use.

Additionally, 3.4% of students (920,000) use combustible tobacco products, and another 3.4% (940,000) use multiple (two or more) tobacco products. Among the most commonly used tobacco products, e-cigarettes lead with a usage rate of 7.7%, followed by cigars and cigarettes at 1.6% each, and nicotine pouches at 1.5%.

Other products include smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%). Specifically, e-cigarettes are used by more than 2.1 million youth, with popular brands including Elf Bars, Esco Bars, Vuse, Juul, and Mr. Fog. Notably, nearly 90% of these users prefer flavored e-cigarettes.

Current usage rates for e-cigarettes stand at 7.7% of students (2.13 million), with 10.0% of high school students (1.56 million) and 4.6% of middle school students (550,000) using them. Usage frequency is high, with over 25% using e-cigarettes daily and nearly 35% using them on at least 20 of the last 30 days.

The majority of these e-cigarette users (89.4%) favor flavored varieties, particularly fruit flavors, followed by candy, desserts, or other sweets, mint, and menthol. More than half of the users reported using flavors with "ice" or "iced" in their names. Disposables are the most commonly used e-cigarette devices (60.7%), followed by prefilled/refillable pods or cartridges (16.1%). The most popular brands among current users are Elf Bar (56.7%), Esco Bars (21.6%), Vuse (20.7%), JUUL (16.5%), and Mr. Fog (13.6%).

ENDS - Assessing Their Toxicity

To comprehend the full scope of ENDS, assessing their potential harm is imperative. While ENDS are not without harm, they are generally considered less harmful than traditional cigarettes. Governments worldwide are promoting smoke-free health policies, and the tobacco industry is exploring harm reduction strategies by developing less toxic products. Toxicologists conduct risk assessments of ENDS devices with regulatory assessors, analytical chemists, and ENDS producers.

ENDS products usually contain nicotine, which is highly addictive and toxic to developing fetuses. Nicotine exposure can also negatively impact adolescent and young adult brain development. The vapor from ENDS devices may contain harmful chemicals, including metals like lead, nickel, and chromium, as well as toxic volatile organic compounds, some of which are carcinogenic. However, exposure to these toxic chemicals is significantly lower in ENDS than in the over 7,000 harmful chemicals in cigarette smoke. Leading health organizations in the UK, including the Royal College of Physicians, the British Medical Association, and Cancer Research UK, concur that while e-cigarettes are not without risks, they are significantly less harmful than traditional smoking.

Evalueserve's IP and R&D Role in Risk Assessment

Given the potential risks associated with ENDS, businesses must conduct thorough risk assessments. This approach is where Evalueserve's expertise comes into play.

How Can Evalueserve IP and R&D Assist in Risk Assessment for Your ENDS and e-Liquid Products?

Elements in ENDS vapor can originate from the device materials, e-liquid ingredients, or the heating process. Our toxicologists thoroughly search public databases to identify known hazards associated with these chemicals. Evalueserve's digital solutions enhance the risk assessment process by efficiently retrieving relevant information from up to 70 databases, allowing toxicologists to focus on evaluation.

We compile data on chemical properties, use cases, and toxicological findings, including acute and general toxicity, irritation, sensitization potential, reproductive and developmental toxicities, carcinogenicity, and mutagenicity. Our expert analyses and regulatory health values support comprehensive risk assessments for human exposure in various settings.

We can provide a toxicological repository that connects product use, material choices, and supplier information to regulatory frameworks, offering a clear understanding of chemical safety across your product portfolio.

Evalueserve Capabilities

Our Chemical Safety & Regulatory Affairs team offers various toxicology and risk assessment services across multiple industries.

We specialize in chemical safety and risk assessment for cosmetics, personal care products, home care products, agrochemicals, ENDS and oral nicotine products, food and nutritional products, and medical devices. Additionally, we provide bespoke digital solutions for toxicology information retrieval, management, and updates.

Moving forward

While ENDS offer a less harmful alternative to traditional smoking, they are not devoid of risks. Understanding these risks and ensuring regulatory compliance is crucial for businesses in the ENDS market. Evalueserve provides comprehensive support, leveraging advanced digital solutions and expert analyses to help companies navigate the complexities of toxicological risk assessments. As the demand for ENDS grows, staying informed and compliant will be vital to ensuring consumer safety and maintaining industry standards.

Talk to One of Our Experts

Get in touch today to find out about how Evalueserve can help you improve your processes, making you better, faster and more efficient.  

Written by

Alexander Bell
Solution Architect, Toxicology Consulting and Life Sciences & MedTech

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